Degenerative Arthritis of Knee
Conditions
Brief summary
The objective of this study is to assess outcomes following TKA, utilizing two surgical techniques. Patients will be randomized to one of two arms: TKA with standard instrumentation and TKA with VISIONAIRE™ patient-matched cutting blocks. Data will be collected at preoperative, operative/discharge, 3 months, 1 year and 2 years after TKA. The secondary objective of this study is to compare the safety, quality of life, and economic outcomes of TKA when these two techniques are utilized. This study does not involve treatment or investigational products, as all components are FDA cleared and are commercially available.
Detailed description
This is a prospective study comparing VISIONAIRE™ to standard TKA instrumentation. The objective of this study is to evaluate the safety and efficacy of TKA using VISIONAIRE™ when compared with standard instrumentation, including device survival, improvement in function and implant alignment after TKA. This study will also document any device-related, surgical complications and/or adverse radiographic observations. In contrast with the control group clinical outcomes following TKA completed with VISIONAIRE™ have yet to be assessed. The current investigation will determine if there is any difference in TKA outcomes when VISIONAIRE™ patient matched technology is utilized versus standard instrumentation. All patients meeting the inclusion/exclusion criteria specified in this protocol will be asked to participate in the study. If the patient consents to participate, they will be enrolled in the study and randomized to one of the two study arms. Patients requiring TKA will be implanted with Legion, Genesis II or Journey BCS (Smith & Nephew) total knee implant systems. Standard instrumentation will be used to assist the surgeon in placing the implant in the control group. In the VISIONAIRE™ group, standard instrumentation will not be used in the surgery. Patients randomized to the VISIONAIRE™ arm will have an MRI preoperatively that will be used to create the customized cutting blocks. All patients will have an x-ray at each postoperative interval.
Interventions
OTHERVISIONAIRE Total Knee Arthroplasty
TKA will be performed with VISIONAIRE instrumentation, depending on randomization assignment.
TKA will be performed with standard instrumentation, depending on randomization assignment.
Sponsors
Smith & Nephew, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Patients must meet all of the inclusion criteria. 1. Patient diagnosed with degenerative arthritis of the knee requiring a unilateral primary TKA. 2. Patient is of legal age to consent and is skeletally mature. 3. Patient is willing to sign and date an ethics-approved consent form. 4. Patient is willing to be available for two-year follow-up postoperatively
Exclusion criteria
Patients must not meet any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Total Score | 2 years postoperatively | The KSS was used to rate both the prosthesis function and the patient's functional abilities after TKA. The KSS Total Score (0-100 points) included a combined evaluation of joint motion (0-25 points), instability (0-25 points), alignment (0-25 points), and symptoms (0-25 points). A higher score indicated a better outcome for subjects. |
| Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | 2 years postoperatively | The KSS was used to rate both the prosthesis function and the patient's functional abilities after TKA. The KSS clinical evaluation included a questionnaire completed by the investigators to assess for pain, stability, flexion contracture, extension lag, and alignment and evaluated based on number of subjects experiencing any of these issues at the 2-year postoperative visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | 1 year postoperatively | X-ray evaluations performed to assess for evidence of implant loosening by radiolucencies (\> 2 mm). Anterior-posterior (AP) and lateral serial x-ray evaluations were performed. The span of the bone-prosthesis interface, for each component, was broken down into zone systems. The scoring system for each of the 3 components was determined by measuring the radiolucent lines (mm) for each of these zones. |
| Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | 1 year postoperatively | X-ray evaluations performed to assess for evidence of implant loosening by lack of evidence of surface wear or particulate debris generation, indications of early osteolysis, implant migration, and/or other clinical or radiographic abnormalities. Anterior-posterior (AP) and lateral serial x-ray evaluations were performed. |
| Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | 2 years postoperatively | X-ray evaluations performed to assess for evidence of implant loosening by radiolucencies (\> 2 mm), lack of evidence of surface wear or particulate debris generation, indications of early osteolysis, implant migration, and/or other clinical or radiographic abnormalities. Anterior-posterior (AP) and lateral serial x-ray evaluations were performed. The span of the bone-prosthesis interface, for each component, was broken down into zone systems. The scoring system for each of the 3 components was determined by measuring the radiolucent lines (mm) for each of these zones. |
| Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | 2 years postoperatively | X-ray evaluations performed to assess for evidence of implant loosening by lack of evidence of surface wear or particulate debris generation, indications of early osteolysis, implant migration, and/or other clinical or radiographic abnormalities. Anterior-posterior (AP) and lateral serial x-ray evaluations were performed. |
| Evaluation of Mechanical Alignment Assessed as Either Neutral or Varus/Valgus 3 Months Postoperatively Using a Full Leg X-ray | 3 months postoperative | Long radiographic anterior-posterior (AP) (full-leg standing x-rays) of the entire limb are superior for measuring alignment of the knee as the limb mechanical axes may be more precisely computed. For full-leg x-rays, 2 lines were drawn on the radiograph. First, a line was drawn from the center of the femoral head to the center of the femoral intercondylar notch and the line was extended through to the ankle. Second, a line was drawn from the center of the tibial spine to the center of the ankle talus. The angle between the first and second line was measured to determine mechanical alignment and assessed as either neutral (0 degrees) or a number of degrees of varus or valgus. |
| Evaluation of Health Economic Criteria - Blood Loss | During and immediately following surgery | Analysis of health data captured during and immediately following surgery: anesthesia time, operative time (skin-to-skin), tray setup, duration of operation, blood loss, incision length, number of instrument trays setup, and number of instrument trays used. |
| Evaluation of Health Economic Criteria - Incision Length | During and immediately following surgery | Analysis of health data captured during and immediately following surgery: anesthesia time, operative time (skin-to-skin), tray setup, duration of operation, blood loss, incision length, number of instrument trays setup, and number of instrument trays used. |
| Evaluation of Health Economic Criteria - Instrument Tray Use | During and immediately following surgery | Analysis of health data captured during and immediately following surgery: anesthesia time, operative time (skin-to-skin), tray setup, duration of operation, blood loss, incision length, number of instrument trays setup, and number of instrument trays used. |
| Evaluation of Health Economic Surgical Criteria | During and immediately following surgery | Analysis of health data captured during and immediately following surgery: surgical approach, cut order, final status of posterior cruciate ligament (PCL), and need for perioperative prophylaxis antibiotics. |
| Evaluation of Health Economic Criteria - Surgical Time Details | During and immediately following surgery | Analysis of health data captured during and immediately following surgery: anesthesia time, operative time (skin-to-skin), tray setup, duration of operation, blood loss, incision length, number of instrument trays setup, and number of instrument trays used. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | Baseline (preoperative), 3 months, 1 year, and 2 years postoperatively | Evaluation of KOOS questionnaire total scores including categories for symptoms, pain, function of daily living, function of sports and recreational activities, and quality of life. KOOS total scores ranged from 0 to 100, with 0 indicating worst (no function) and 100 indicating no symptoms at all. |
Countries
Australia, United States
Participant flow
Recruitment details
The study was planned to enroll 196 subjects; 134 subjects were recruited to the study prior to its termination due to insufficient total enrollment. Subjects were enrolled from 21 June 2012 to 15 April 2014. Early termination was approved May 2014 and sites were officially notified of study termination in September 2015.
Participants by arm
| Arm | Count |
|---|---|
| VISIONAIRE Instrumentation TKA with VISIONAIRE instrumentation
Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy. | 68 |
| Standard Instrumentation TKA with standard instrumentation
Total Knee Arthroplasty was performed using conventional instrumentation. | 65 |
| Total | 133 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 1 Year | Lost to Follow-up | 3 | 0 |
| 1 Year | Study Termination | 0 | 7 |
| 1 Year | Withdrawal by Subject | 0 | 1 |
| 2 Years | Lost to Follow-up | 5 | 2 |
| 2 Years | Study Termination | 3 | 2 |
| 2 Years | Withdrawal by Subject | 1 | 0 |
| 3 Months | Death | 1 | 0 |
| 3 Months | Study Termination | 2 | 2 |
| Baseline | Withdrawal by Subject | 7 | 6 |
Baseline characteristics
| Characteristic | Total | VISIONAIRE Instrumentation | Standard Instrumentation |
|---|---|---|---|
| Age, Continuous | 68.9 years STANDARD_DEVIATION 8.2 | 69.7 years STANDARD_DEVIATION 8.71 | 67.5 years STANDARD_DEVIATION 7.7 |
| Height | 168.0 cm STANDARD_DEVIATION 9.94 | 168.0 cm STANDARD_DEVIATION 9.84 | 168.0 cm STANDARD_DEVIATION 10.12 |
| Race/Ethnicity, Customized Aus-Asian | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Aus-Caucasian | 26 Participants | 12 Participants | 14 Participants |
| Race/Ethnicity, Customized Black, Not Hispanic | 5 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White, Not Hispanic | 98 Participants | 52 Participants | 46 Participants |
| Sex: Female, Male Female | 77 Participants | 40 Participants | 37 Participants |
| Sex: Female, Male Male | 56 Participants | 28 Participants | 28 Participants |
| Weight | 86.1 kg STANDARD_DEVIATION 17.86 | 88.3 kg STANDARD_DEVIATION 17.8 | 83.7 kg STANDARD_DEVIATION 17.77 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 68 | 0 / 66 |
| other Total, other adverse events | 43 / 68 | 38 / 66 |
| serious Total, serious adverse events | 0 / 68 | 0 / 66 |
Outcome results
Primary
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
The KSS was used to rate both the prosthesis function and the patient's functional abilities after TKA. The KSS clinical evaluation included a questionnaire completed by the investigators to assess for pain, stability, flexion contracture, extension lag, and alignment and evaluated based on number of subjects experiencing any of these issues at the 2-year postoperative visit.
Time frame: 2 years postoperatively
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Pain - none | 26 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Pain - severe | 1 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Medio-lateral Stability - <6 degrees | 44 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Extension Lag - 11-20 degrees | 0 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Extension Lag - > 20 degrees | 0 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Alignment - 4 or 11 degrees valgus | 1 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Alignment - 2 or 13 degrees valgus | 0 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Alignment - 1 or 14 degrees valgus | 0 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Alignment - varus or > 15 degrees valgus | 0 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Pain - mild or occasional | 12 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Pain - stairs only | 1 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Pain - walking & stairs | 1 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Pain - moderate occasional | 2 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Pain - moderate continuous | 3 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Pain - missing response | 0 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | AP Stability - <5 mm | 43 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | AP Stability - 5-10 mm | 1 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | AP Stability - >10 mm | 0 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | AP Stability - missing response | 2 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Medio-lateral Stability - 6-9 degrees | 0 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Medio-lateral Stability - 10-14 degrees | 0 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Medio-lateral Stability - >14 degrees | 0 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Medio-lateral Stability - missing response | 2 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Flexion Contracture - 0-4 degrees | 42 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Flexion Contracture - 5-10 degrees | 2 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Flexion Contracture - 11-15 degrees | 0 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Flexion Contracture - 16-20 degrees | 0 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Flexion Contracture - > 20 degrees | 0 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Flexion Contracture - missing response | 2 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Extension Lag - 0 degrees | 43 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Extension Lag - < 10 degrees | 1 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Extension Lag - missing response | 2 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Alignment - 5 or 10 degrees valgus (normal) | 40 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Alignment - 3 or 12 degrees valgus | 1 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Alignment - 0 or 15 degrees valgus | 1 Participants |
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Alignment - missing response | 3 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Medio-lateral Stability - 6-9 degrees | 0 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Pain - none | 27 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Extension Lag - 0 degrees | 44 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Medio-lateral Stability - 10-14 degrees | 0 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Alignment - 1 or 14 degrees valgus | 1 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Extension Lag - 11-20 degrees | 0 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Medio-lateral Stability - >14 degrees | 1 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Extension Lag - < 10 degrees | 0 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Alignment - 4 or 11 degrees valgus | 1 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Medio-lateral Stability - missing response | 1 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Alignment - 2 or 13 degrees valgus | 0 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Extension Lag - > 20 degrees | 1 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Flexion Contracture - 0-4 degrees | 42 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Alignment - missing response | 2 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Pain - mild or occasional | 14 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Flexion Contracture - 5-10 degrees | 2 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Pain - stairs only | 1 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Extension Lag - missing response | 1 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Pain - walking & stairs | 1 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Flexion Contracture - 11-15 degrees | 0 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Pain - moderate occasional | 1 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Alignment - 0 or 15 degrees valgus | 0 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Pain - moderate continuous | 1 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Pain - severe | 0 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Flexion Contracture - 16-20 degrees | 0 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Pain - missing response | 1 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Alignment - 5 or 10 degrees valgus (normal) | 41 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | AP Stability - <5 mm | 43 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Flexion Contracture - > 20 degrees | 0 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | AP Stability - 5-10 mm | 1 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Alignment - varus or > 15 degrees valgus | 0 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | AP Stability - >10 mm | 1 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Flexion Contracture - missing response | 2 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | AP Stability - missing response | 1 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Medio-lateral Stability - <6 degrees | 44 Participants |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire | Alignment - 3 or 12 degrees valgus | 1 Participants |
Primary
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Total Score
The KSS was used to rate both the prosthesis function and the patient's functional abilities after TKA. The KSS Total Score (0-100 points) included a combined evaluation of joint motion (0-25 points), instability (0-25 points), alignment (0-25 points), and symptoms (0-25 points). A higher score indicated a better outcome for subjects.
Time frame: 2 years postoperatively
Population: The Knee Society Clinical Score was not completed for all enrolled subjects. Data was only available for 83 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VISIONAIRE Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Total Score | 91.4 score on a scale | Standard Deviation 13.7 |
| Standard Instrumentation | Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Total Score | 94.3 score on a scale | Standard Deviation 8.9 |
Secondary
Evaluation of Health Economic Criteria - Blood Loss
Analysis of health data captured during and immediately following surgery: anesthesia time, operative time (skin-to-skin), tray setup, duration of operation, blood loss, incision length, number of instrument trays setup, and number of instrument trays used.
Time frame: During and immediately following surgery
Population: Not all analysis values were available for all enrolled subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VISIONAIRE Instrumentation | Evaluation of Health Economic Criteria - Blood Loss | 105.2 mL | Standard Deviation 85.1 |
| Standard Instrumentation | Evaluation of Health Economic Criteria - Blood Loss | 93.8 mL | Standard Deviation 39 |
Secondary
Evaluation of Health Economic Criteria - Incision Length
Analysis of health data captured during and immediately following surgery: anesthesia time, operative time (skin-to-skin), tray setup, duration of operation, blood loss, incision length, number of instrument trays setup, and number of instrument trays used.
Time frame: During and immediately following surgery
Population: Not all analysis values were available for all enrolled subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VISIONAIRE Instrumentation | Evaluation of Health Economic Criteria - Incision Length | 153.6 mm | Standard Deviation 21.2 |
| Standard Instrumentation | Evaluation of Health Economic Criteria - Incision Length | 156.8 mm | Standard Deviation 18.4 |
Secondary
Evaluation of Health Economic Criteria - Instrument Tray Use
Analysis of health data captured during and immediately following surgery: anesthesia time, operative time (skin-to-skin), tray setup, duration of operation, blood loss, incision length, number of instrument trays setup, and number of instrument trays used.
Time frame: During and immediately following surgery
Population: Not all analysis values were available for all enrolled subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VISIONAIRE Instrumentation | Evaluation of Health Economic Criteria - Instrument Tray Use | Instrument trays used in setup | 5.3 number of trays | Standard Deviation 4.2 |
| VISIONAIRE Instrumentation | Evaluation of Health Economic Criteria - Instrument Tray Use | Instrument trays used | 5.1 number of trays | Standard Deviation 3.8 |
| Standard Instrumentation | Evaluation of Health Economic Criteria - Instrument Tray Use | Instrument trays used in setup | 8.2 number of trays | Standard Deviation 2.6 |
| Standard Instrumentation | Evaluation of Health Economic Criteria - Instrument Tray Use | Instrument trays used | 8.0 number of trays | Standard Deviation 2.6 |
Secondary
Evaluation of Health Economic Criteria - Surgical Time Details
Analysis of health data captured during and immediately following surgery: anesthesia time, operative time (skin-to-skin), tray setup, duration of operation, blood loss, incision length, number of instrument trays setup, and number of instrument trays used.
Time frame: During and immediately following surgery
Population: Not all analysis values were available for all enrolled subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VISIONAIRE Instrumentation | Evaluation of Health Economic Criteria - Surgical Time Details | Anesthesia time | 128.8 minutes | Standard Deviation 37.2 |
| VISIONAIRE Instrumentation | Evaluation of Health Economic Criteria - Surgical Time Details | Skin to skin time | 74.9 minutes | Standard Deviation 23.5 |
| VISIONAIRE Instrumentation | Evaluation of Health Economic Criteria - Surgical Time Details | Tray setup time | 16.5 minutes | Standard Deviation 13.9 |
| VISIONAIRE Instrumentation | Evaluation of Health Economic Criteria - Surgical Time Details | Duration of operation | 110.6 minutes | Standard Deviation 29.5 |
| Standard Instrumentation | Evaluation of Health Economic Criteria - Surgical Time Details | Duration of operation | 110.9 minutes | Standard Deviation 26.8 |
| Standard Instrumentation | Evaluation of Health Economic Criteria - Surgical Time Details | Anesthesia time | 126.5 minutes | Standard Deviation 32.8 |
| Standard Instrumentation | Evaluation of Health Economic Criteria - Surgical Time Details | Tray setup time | 19.7 minutes | Standard Deviation 11.7 |
| Standard Instrumentation | Evaluation of Health Economic Criteria - Surgical Time Details | Skin to skin time | 75.4 minutes | Standard Deviation 23.6 |
Secondary
Evaluation of Health Economic Surgical Criteria
Analysis of health data captured during and immediately following surgery: surgical approach, cut order, final status of posterior cruciate ligament (PCL), and need for perioperative prophylaxis antibiotics.
Time frame: During and immediately following surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VISIONAIRE Instrumentation | Evaluation of Health Economic Surgical Criteria | Surgical approach - missing | 0 participants |
| VISIONAIRE Instrumentation | Evaluation of Health Economic Surgical Criteria | Surgical approach - medial parapatellar | 58 participants |
| VISIONAIRE Instrumentation | Evaluation of Health Economic Surgical Criteria | Cut order - anterior cut first | 5 participants |
| VISIONAIRE Instrumentation | Evaluation of Health Economic Surgical Criteria | Cut order - missing | 0 participants |
| VISIONAIRE Instrumentation | Evaluation of Health Economic Surgical Criteria | Cut order - tibial cut first | 0 participants |
| VISIONAIRE Instrumentation | Evaluation of Health Economic Surgical Criteria | Final status of PCL - excised | 29 participants |
| VISIONAIRE Instrumentation | Evaluation of Health Economic Surgical Criteria | Surgical approach - subvastus | 0 participants |
| VISIONAIRE Instrumentation | Evaluation of Health Economic Surgical Criteria | Final status of PCL - released | 2 participants |
| VISIONAIRE Instrumentation | Evaluation of Health Economic Surgical Criteria | Cut order - distal cut first | 57 participants |
| VISIONAIRE Instrumentation | Evaluation of Health Economic Surgical Criteria | Final status of PCL - intact | 13 participants |
| VISIONAIRE Instrumentation | Evaluation of Health Economic Surgical Criteria | Surgical approach - midvastus | 4 participants |
| VISIONAIRE Instrumentation | Evaluation of Health Economic Surgical Criteria | Final status of PCL - N/A (PS component used) | 18 participants |
| VISIONAIRE Instrumentation | Evaluation of Health Economic Surgical Criteria | Perioperative prophylaxis antibiotics - yes | 62 participants |
| VISIONAIRE Instrumentation | Evaluation of Health Economic Surgical Criteria | Final status of PCL - missing | 0 participants |
| VISIONAIRE Instrumentation | Evaluation of Health Economic Surgical Criteria | Surgical approach - lateral parapatellar | 0 participants |
| VISIONAIRE Instrumentation | Evaluation of Health Economic Surgical Criteria | Perioperative prophylaxis antibiotics - no | 0 participants |
| VISIONAIRE Instrumentation | Evaluation of Health Economic Surgical Criteria | Surgical approach - other | 0 participants |
| Standard Instrumentation | Evaluation of Health Economic Surgical Criteria | Perioperative prophylaxis antibiotics - no | 0 participants |
| Standard Instrumentation | Evaluation of Health Economic Surgical Criteria | Surgical approach - other | 1 participants |
| Standard Instrumentation | Evaluation of Health Economic Surgical Criteria | Surgical approach - missing | 0 participants |
| Standard Instrumentation | Evaluation of Health Economic Surgical Criteria | Cut order - anterior cut first | 13 participants |
| Standard Instrumentation | Evaluation of Health Economic Surgical Criteria | Cut order - tibial cut first | 1 participants |
| Standard Instrumentation | Evaluation of Health Economic Surgical Criteria | Perioperative prophylaxis antibiotics - yes | 60 participants |
| Standard Instrumentation | Evaluation of Health Economic Surgical Criteria | Surgical approach - medial parapatellar | 56 participants |
| Standard Instrumentation | Evaluation of Health Economic Surgical Criteria | Surgical approach - subvastus | 0 participants |
| Standard Instrumentation | Evaluation of Health Economic Surgical Criteria | Surgical approach - midvastus | 2 participants |
| Standard Instrumentation | Evaluation of Health Economic Surgical Criteria | Surgical approach - lateral parapatellar | 1 participants |
| Standard Instrumentation | Evaluation of Health Economic Surgical Criteria | Cut order - distal cut first | 46 participants |
| Standard Instrumentation | Evaluation of Health Economic Surgical Criteria | Cut order - missing | 0 participants |
| Standard Instrumentation | Evaluation of Health Economic Surgical Criteria | Final status of PCL - excised | 27 participants |
| Standard Instrumentation | Evaluation of Health Economic Surgical Criteria | Final status of PCL - released | 3 participants |
| Standard Instrumentation | Evaluation of Health Economic Surgical Criteria | Final status of PCL - intact | 15 participants |
| Standard Instrumentation | Evaluation of Health Economic Surgical Criteria | Final status of PCL - N/A (PS component used) | 15 participants |
| Standard Instrumentation | Evaluation of Health Economic Surgical Criteria | Final status of PCL - missing | 0 participants |
Secondary
Evaluation of Mechanical Alignment Assessed as Either Neutral or Varus/Valgus 3 Months Postoperatively Using a Full Leg X-ray
Long radiographic anterior-posterior (AP) (full-leg standing x-rays) of the entire limb are superior for measuring alignment of the knee as the limb mechanical axes may be more precisely computed. For full-leg x-rays, 2 lines were drawn on the radiograph. First, a line was drawn from the center of the femoral head to the center of the femoral intercondylar notch and the line was extended through to the ankle. Second, a line was drawn from the center of the tibial spine to the center of the ankle talus. The angle between the first and second line was measured to determine mechanical alignment and assessed as either neutral (0 degrees) or a number of degrees of varus or valgus.
Time frame: 3 months postoperative
Population: Evaluation of Mechanical Alignment 3 Months Postoperatively was not completed for all enrolled subjects. Only data for 88 participants was available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VISIONAIRE Instrumentation | Evaluation of Mechanical Alignment Assessed as Either Neutral or Varus/Valgus 3 Months Postoperatively Using a Full Leg X-ray | Alignment - Neutral | 19 Participants |
| VISIONAIRE Instrumentation | Evaluation of Mechanical Alignment Assessed as Either Neutral or Varus/Valgus 3 Months Postoperatively Using a Full Leg X-ray | Varus | 11 Participants |
| VISIONAIRE Instrumentation | Evaluation of Mechanical Alignment Assessed as Either Neutral or Varus/Valgus 3 Months Postoperatively Using a Full Leg X-ray | Valgus | 14 Participants |
| VISIONAIRE Instrumentation | Evaluation of Mechanical Alignment Assessed as Either Neutral or Varus/Valgus 3 Months Postoperatively Using a Full Leg X-ray | Missing | 0 Participants |
| Standard Instrumentation | Evaluation of Mechanical Alignment Assessed as Either Neutral or Varus/Valgus 3 Months Postoperatively Using a Full Leg X-ray | Missing | 0 Participants |
| Standard Instrumentation | Evaluation of Mechanical Alignment Assessed as Either Neutral or Varus/Valgus 3 Months Postoperatively Using a Full Leg X-ray | Alignment - Neutral | 10 Participants |
| Standard Instrumentation | Evaluation of Mechanical Alignment Assessed as Either Neutral or Varus/Valgus 3 Months Postoperatively Using a Full Leg X-ray | Valgus | 6 Participants |
| Standard Instrumentation | Evaluation of Mechanical Alignment Assessed as Either Neutral or Varus/Valgus 3 Months Postoperatively Using a Full Leg X-ray | Varus | 28 Participants |
Secondary
Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively
Evaluation of KOOS questionnaire total scores including categories for symptoms, pain, function of daily living, function of sports and recreational activities, and quality of life. KOOS total scores ranged from 0 to 100, with 0 indicating worst (no function) and 100 indicating no symptoms at all.
Time frame: Baseline (preoperative), 3 months, 1 year, and 2 years postoperatively
Population: Not all enrolled subjects completed the KOOS questionnaire at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VISIONAIRE Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | Symptoms - 1 year postoperative | 81.6 score on a scale | Standard Deviation 17.2 |
| VISIONAIRE Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | Symptoms - 2 years postoperative | 85.7 score on a scale | Standard Deviation 10.9 |
| VISIONAIRE Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | Activities of Daily Living (ADLs) - preoperative | 46.5 score on a scale | Standard Deviation 18.9 |
| VISIONAIRE Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | ADLs - 3 months postoperative | 78.8 score on a scale | Standard Deviation 14.6 |
| VISIONAIRE Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | ADLs - 1 year postoperative | 86.8 score on a scale | Standard Deviation 14.9 |
| VISIONAIRE Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | ADLs - 2 years postoperative | 89.3 score on a scale | Standard Deviation 14.6 |
| VISIONAIRE Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | Sports/Rec - 3 months postoperative | 42.4 score on a scale | Standard Deviation 29.6 |
| VISIONAIRE Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | Sports/Rec - 1 year postoperative | 62.0 score on a scale | Standard Deviation 32 |
| VISIONAIRE Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | Quality of Life (QoL) - preoperative | 21.0 score on a scale | Standard Deviation 17.2 |
| VISIONAIRE Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | Pain - preoperative | 40.9 score on a scale | Standard Deviation 17 |
| VISIONAIRE Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | Pain - 3 months postoperative | 73.7 score on a scale | Standard Deviation 15.5 |
| VISIONAIRE Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | Pain - 1 year postoperative | 85.4 score on a scale | Standard Deviation 16.7 |
| VISIONAIRE Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | Pain - 2 years postoperative | 89.4 score on a scale | Standard Deviation 13.2 |
| VISIONAIRE Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | Symptoms - preoperative | 46.6 score on a scale | Standard Deviation 21.2 |
| VISIONAIRE Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | Symptoms - 3 months postoperative | 66.4 score on a scale | Standard Deviation 17.5 |
| VISIONAIRE Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | Sports/Rec - preoperative | 19.0 score on a scale | Standard Deviation 19 |
| VISIONAIRE Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | Sports/Rec - 2 years postoperative | 74.9 score on a scale | Standard Deviation 26.6 |
| VISIONAIRE Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | QoL - 3 months postoperative | 58.6 score on a scale | Standard Deviation 21.7 |
| VISIONAIRE Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | QoL - 1 year postoperative | 68.1 score on a scale | Standard Deviation 26.2 |
| VISIONAIRE Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | QoL - 2 years postoperative | 75.1 score on a scale | Standard Deviation 23.2 |
| Standard Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | Symptoms - preoperative | 49.9 score on a scale | Standard Deviation 17.7 |
| Standard Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | Symptoms - 1 year postoperative | 82.5 score on a scale | Standard Deviation 16.4 |
| Standard Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | Pain - preoperative | 43.9 score on a scale | Standard Deviation 16.6 |
| Standard Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | Symptoms - 2 years postoperative | 88.2 score on a scale | Standard Deviation 9.4 |
| Standard Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | QoL - 3 months postoperative | 64.1 score on a scale | Standard Deviation 19.9 |
| Standard Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | Activities of Daily Living (ADLs) - preoperative | 51.4 score on a scale | Standard Deviation 18.8 |
| Standard Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | Pain - 3 months postoperative | 76.3 score on a scale | Standard Deviation 16.1 |
| Standard Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | ADLs - 3 months postoperative | 84.1 score on a scale | Standard Deviation 13.8 |
| Standard Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | Symptoms - 3 months postoperative | 73.1 score on a scale | Standard Deviation 13.6 |
| Standard Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | ADLs - 1 year postoperative | 89.5 score on a scale | Standard Deviation 12.4 |
| Standard Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | Pain - 1 year postoperative | 88.5 score on a scale | Standard Deviation 16.7 |
| Standard Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | ADLs - 2 years postoperative | 92.3 score on a scale | Standard Deviation 10.4 |
| Standard Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | Sports/Rec - preoperative | 23.1 score on a scale | Standard Deviation 22.8 |
| Standard Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | QoL - 2 years postoperative | 78.0 score on a scale | Standard Deviation 18.3 |
| Standard Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | Sports/Rec - 3 months postoperative | 48.2 score on a scale | Standard Deviation 31.3 |
| Standard Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | Pain - 2 years postoperative | 92.3 score on a scale | Standard Deviation 10.2 |
| Standard Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | Sports/Rec - 2 years postoperative | 74.4 score on a scale | Standard Deviation 25.6 |
| Standard Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | Sports/Rec - 1 year postoperative | 62.5 score on a scale | Standard Deviation 32.6 |
| Standard Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | Quality of Life (QoL) - preoperative | 22.5 score on a scale | Standard Deviation 17.2 |
| Standard Instrumentation | Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively | QoL - 1 year postoperative | 72.9 score on a scale | Standard Deviation 23.7 |
Secondary
Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively
X-ray evaluations performed to assess for evidence of implant loosening by lack of evidence of surface wear or particulate debris generation, indications of early osteolysis, implant migration, and/or other clinical or radiographic abnormalities. Anterior-posterior (AP) and lateral serial x-ray evaluations were performed.
Time frame: 1 year postoperatively
Population: Not all subjects completed the serial radiographic evaluations at the specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Fixation - x-ray unclear | 0 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Patella tracking - normal | 53 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Patella tracking - lateralized | 1 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Patella tracking - subluxation | 0 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Patella tracking - dislocation | 0 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Fixation - Ingrowth | 35 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Fixation - indifferent, bone unchanged | 34 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Fixation - increased osseointegration | 1 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Fixation - bone loss | 0 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Fixation - implant at risk | 0 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Fixation - implant loosening | 0 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Fixation - revision indication | 0 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Observations - periosteal hypertrophy | 0 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Observations - osteolysis | 0 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Observations - subsidence | 0 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Observations - other | 0 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Evidence of deformity - no | 54 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Evidence of deformity - yes | 0 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Observations - osteolysis | 0 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Fixation - implant at risk | 0 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Patella tracking - normal | 49 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Evidence of deformity - yes | 0 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Patella tracking - lateralized | 0 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Fixation - implant loosening | 0 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Patella tracking - subluxation | 1 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Observations - subsidence | 0 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Patella tracking - dislocation | 0 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Fixation - revision indication | 0 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Fixation - Ingrowth | 32 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Fixation - x-ray unclear | 1 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Evidence of deformity - no | 50 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Fixation - indifferent, bone unchanged | 29 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Observations - periosteal hypertrophy | 0 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Fixation - increased osseointegration | 2 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Observations - other | 0 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively | Fixation - bone loss | 0 participants |
Secondary
Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively
X-ray evaluations performed to assess for evidence of implant loosening by lack of evidence of surface wear or particulate debris generation, indications of early osteolysis, implant migration, and/or other clinical or radiographic abnormalities. Anterior-posterior (AP) and lateral serial x-ray evaluations were performed.
Time frame: 2 years postoperatively
Population: Not all subjects completed the serial radiographic evaluations at the specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Patella tracking - dislocation | 0 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Fixation - bone loss | 0 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Fixation - increased osseointegration | 0 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Fixation - implant at risk | 1 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Patella tracking - subluxation | 0 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Fixation - implant loosening | 0 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Fixation - x-ray unclear | 0 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Fixation - revision indication | 0 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Observations - periosteal hypertrophy | 0 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Observations - osteolysis | 0 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Patella tracking - normal | 42 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Observations - subsidence | 0 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Patella tracking - lateralized | 2 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Observations - other | 1 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Patella tracking - missing | 1 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Evidence of deformity - no | 45 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Fixation - indifferent, bone unchanged | 27 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Evidence of deformity - yes | 0 participants |
| VISIONAIRE Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Fixation - fixation/ingrowth | 28 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Evidence of deformity - yes | 0 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Patella tracking - subluxation | 0 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Patella tracking - dislocation | 0 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Fixation - x-ray unclear | 0 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Fixation - indifferent, bone unchanged | 24 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Fixation - increased osseointegration | 0 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Fixation - revision indication | 0 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Patella tracking - lateralized | 0 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Patella tracking - missing | 0 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Fixation - fixation/ingrowth | 24 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Fixation - bone loss | 0 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Fixation - implant at risk | 0 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Fixation - implant loosening | 0 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Observations - periosteal hypertrophy | 0 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Observations - osteolysis | 0 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Observations - subsidence | 0 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Observations - other | 0 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Evidence of deformity - no | 43 participants |
| Standard Instrumentation | Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively | Patella tracking - normal | 43 participants |
Secondary
Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
X-ray evaluations performed to assess for evidence of implant loosening by radiolucencies (\> 2 mm), lack of evidence of surface wear or particulate debris generation, indications of early osteolysis, implant migration, and/or other clinical or radiographic abnormalities. Anterior-posterior (AP) and lateral serial x-ray evaluations were performed. The span of the bone-prosthesis interface, for each component, was broken down into zone systems. The scoring system for each of the 3 components was determined by measuring the radiolucent lines (mm) for each of these zones.
Time frame: 2 years postoperatively
Population: Not all subjects completed the serial radiographic evaluations at the specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 2 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone A (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 2 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 5 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 3 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 3 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 4 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 1 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 4 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 6 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 6 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 5 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 5 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 6 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 5 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 4 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 4 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 7 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 5 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 7 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 6 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 7 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 7 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 1 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 2 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 1 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 7 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone B (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 2 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone B (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 3 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 1 (> 2 mm) | 1 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 3 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone B (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 1 (≤ 2 mm) | 1 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 3 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 2 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 4 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 1 (≤ 2 mm) | 2 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 4 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 1 (> 2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 4 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 2 (≤2 mm and progressive) | 1 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 4 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 2 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 5 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 2 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 5 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 3 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 5 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 1 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 5 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 3 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 6 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 3 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 6 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 3 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 6 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 2 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 3 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 7 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 2 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 7 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 5 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 8 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 8 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 4 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 8 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femor0al zone 4 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 8 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 2 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 9 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 5 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 9 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 9 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 5 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 4 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone A (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 5 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone A (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 3 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone B (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 6 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone B (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 6 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone B (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 3 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone B (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 6 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 1 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 7 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 1 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 6 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 1 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 2 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 7 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 2 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 7 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 2 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 7 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 2 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 7 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 3 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 3 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 4 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 3 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 1 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 3 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 1 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 4 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 6 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 4 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 1 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 5 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 9 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 5 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 1 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 5 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 4 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone A (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone A (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone A (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone A (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone A (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 2 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 4 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone B (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 1 (≤ 2 mm and progressive) | 1 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone B (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 1 (≤ 2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 2 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 2 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 2 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 2 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 4 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 4 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 5 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 5 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 7 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 7 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 1 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 2 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 3 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 3 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 3 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 4 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 5 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 6 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 7 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 7 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 7 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 1 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 1 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 2 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 2 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 6 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 7 (≤ 2 mm) | 1 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 8 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 9 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 9 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone A (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 1 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 1 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 3 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 3 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 4 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 5 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone A (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone A (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone A (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone B (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 1 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 1 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 1 (> 2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 3 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 3 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 3 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 3 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 4 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femor0al zone 4 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 5 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 5 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 6 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 6 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 6 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 6 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 7 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - femoral zone 7 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 1 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 1 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 1 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 2 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 2 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 2 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 3 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 4 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 4 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 4 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 5 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 5 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 5 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 6 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 6 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 6 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - patella zone 7 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 1 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 1 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 2 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 2 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 3 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 3 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 3 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 3 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 4 (≤ 2 mm) | 1 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 4 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 4 (> 2 mm) | 1 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 4 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 5 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 5 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 5 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 5 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 6 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 6 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 6 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 7 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 7 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 7 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 8 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 8 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 8 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 9 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone 9 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone A (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone A (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone A (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone B (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone B (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone B (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial AP zone B (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 1 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 1 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 2 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 2 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 2 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 2 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 3 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 3 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 4 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 4 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 4 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 5 (≤ 2 mm) | 1 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 5 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone 5 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone A (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone B (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively | Lucency - tibial ML zone B (> 2 mm) | 0 participants |
Secondary
Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
X-ray evaluations performed to assess for evidence of implant loosening by radiolucencies (\> 2 mm). Anterior-posterior (AP) and lateral serial x-ray evaluations were performed. The span of the bone-prosthesis interface, for each component, was broken down into zone systems. The scoring system for each of the 3 components was determined by measuring the radiolucent lines (mm) for each of these zones.
Time frame: 1 year postoperatively
Population: Not all subjects completed the serial radiographic evaluations at the specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 6 (≤ 2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone B (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 4 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone B (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 5 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 1 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone A (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 1 (≤ 2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 3 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 1 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone A (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 1 (> 2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 3 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 2 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone A (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 2 (≤ 2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone B (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 2 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone B (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 2 (> 2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 6 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 3 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone A (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 3 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 3 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 4 (≤ 2 mm) | 1 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone A (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 4 (≤ 2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 4 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 4 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 4 (> 2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone A (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 5 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 4 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 5 (> 2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone B (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 6 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 7 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone B (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 6 (> 2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 6 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 7 (≤ 2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone B (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 7 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 4 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 7 (> 2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone B (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 1 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 6 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 1 (≤ 2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 1 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 1 (> 2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 1 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 2 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 6 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 2 (≤ 2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 2 (> 2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 3 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 1 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 3 (≤ 2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 5 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 3 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 6 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 3 (> 2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 4 (≤ 2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 2 (≤ 2 mm) | 1 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 7 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 5 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 2 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 5 (≤ 2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 4 (> 2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 5 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 2 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 5 (> 2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 8 (≤ 2 mm) | 1 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 6 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 2 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 6 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 6 (≤ 2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 6 (> 2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 3 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 7 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 8 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 7 (≤ 2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 3 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 7 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 3 (> 2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 1 (≤ 2 mm) | 3 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 3 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 1 (≤ 2 mm and progressive | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 7 (> 2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 1 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 1 (> 2 mm and progressive | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 3 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 2 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 9 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 2 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 2 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 4 (≤ 2 mm) | 1 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 3 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 1 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 4 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 5 (≤ 2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 4 (≤ 2 mm) | 2 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 4 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 9 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 4 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 5 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 5 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 2 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 5 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 9 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 5 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 5 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 5 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone A (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 5 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 7 (≤ 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 2 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 7 (≤2 mm and progressive) | 1 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 1 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 7 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone A (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 8 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 8 (>2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 4 (> 2 mm) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 9 (≤2 mm and progressive) | 0 participants |
| VISIONAIRE Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 3 (≤ 2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 9 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 3 (≤ 2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 4 (≤ 2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 4 (> 2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 5 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 6 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 7 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 1 (≤ 2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 2 (≤ 2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 2 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 2 (> 2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 3 (> 2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 4 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 4 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 6 (≤ 2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 7 (> 2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 1 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 2 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 2 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 3 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 4 (≤ 2 mm) | 1 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 4 (> 2 mm) | 1 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 5 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 6 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 6 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 7 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 8 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 8 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 8 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 9 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 9 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 9 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 1 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 4 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone A (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone A (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone B (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone A (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone A (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone A (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone A (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone B (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone B (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone B (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone B (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 1 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 1 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 1 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 2 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 2 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 2 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 2 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 3 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 3 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 3 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 3 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 4 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 4 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 4 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 5 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 5 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 5 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone 5 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone A (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone A (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone B (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone B (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial ML zone B (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 1 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 1 (≤ 2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 1 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 1 (> 2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 2 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 2 (≤ 2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 2 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 2 (> 2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 3 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 3 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 3 (> 2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 4 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 4 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 5 (≤ 2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 5 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 5 (> 2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 6 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 6 (≤ 2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 6 (> 2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 7 (≤ 2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 7 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - femoral zone 7 (> 2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 1 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 1 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 1 (> 2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 2 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 3 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 3 (≤ 2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 3 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 4 (≤ 2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 4 (> 2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 5 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 5 (≤ 2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 5 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 5 (> 2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 6 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 6 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 6 (> 2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 7 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 7 (≤ 2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - patellar zone 7 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 1 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 1 (≤ 2 mm and progressive | 1 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 1 (> 2 mm and progressive | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 2 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 2 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 3 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 3 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 3 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 4 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 4 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 5 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 5 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 5 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 6 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 6 (>2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 7 (≤ 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 7 (≤2 mm and progressive) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 7 (> 2 mm) | 0 participants |
| Standard Instrumentation | Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively | Lucency - tibial AP zone 8 (>2 mm and progressive) | 0 participants |