Osteoarthritis
Conditions
Keywords
Total Knee Arthroplasty, Rotational Alignment, Intraoperative Sensors, Patient Outcomes, Soft Tissue Balance
Brief summary
The objectives of the study are twofold: 1) Evaluate how intra-operative sensing may assist the surgeon with tibiofemoral rotational alignment by testing the precision and variability of setting tray rotation to the mid-third of the tibial tubercle. 2) Understand if patients with a combined axial rotation couple at the tibiofemoral joint and quantitative intercompartmental balance, achieved with the use of VERASENSE, exhibit less post-operative knee pain and improved clinical outcomes. Radiographic outcomes will also be assessed to measure post-operative alignment and to evaluate the prevalence and location of radiolucency and/or osteolysis.
Detailed description
Hypothesis: TKA with VERASENSE results in a more reliable and precise option for establishing implant-to-implant congruency and joint balance leading to less knee pain, faster return to normal activities and higher patient satisfaction compared to TKA without VERASENSE.
Interventions
DEVICETKA with Verasense
VERASENSE replaces the standard tibial trial inserts and is embedded with microelectronics and sensors to provide surgeons with real-time knee kinetic data. The data is wirelessly transmitted to a graphic display (VERASENSE Knee Application), allowing surgeons to quantify and assess soft tissue intercompartmental loads throughout the range of motion. The VERASENSE sensor is not an investigational device. OrthoSensor, Inc., received FDA pre-market submission (510K) clearance in 2009. The indication for use is a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE sensor is sterile and single patient use.
PROCEDURETKA without Verasense
TKA will be performed manually without the use of Verasense
Sponsors
Orthosensor, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients who meet the indications for use for Triathlon® Total Knee System using VERASENSE™ * Subject must be diagnosed with one or more of the following conditions * osteoarthritis * rheumatoid or other inflammatory arthritis * post-traumatic arthritis * Subject is likely to be available for all study visits * Subject is able and willing to sign the informed consent and follow study procedures
Exclusion criteria
* Prior Total Knee Arthroplasty * Avascular Necrosis * Any knee surgery other than meniscectomy (can be arthroscopic or open) * Ligament insufficiencies, prior surgeries such as anterior cruciate ligament (ACL) or PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures * Ipsilateral foot/ankle and hip arthritis * Range of motion less than 90°, flexion contracture greater than 20° * Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease) * Any subjects meeting any contraindication criteria as identified in the locally approved labeling for the device should be excluded from this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Quantitatively Balanced and Unbalanced Knees in Primary Unilateral Total Knee Arthroplasty | Intra-operative with trial implants in place and after completing all surgical corrections. | Evaluate how intra-operative sensing with VERASENSE may assist the surgeon with balancing. A load differential of up to 15 pound (lbs) or less between the medial and lateral condyles is indicative of soft-tissue balance. A load differential more than 15 lbs is indicative for soft-tissue unbalance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Knee Scoring System | pre-operative, 6 weeks, 6 months, 1 year, 2 years | Patient Satisfaction is a three-question 40-point scale and has a score of 0 (not satisfied) to 40 (very satisfied) that is collected preoperatively and at each follow-up visit. Patient Expectations is a five-question fifteen-point scale and has a score of 0 (low expectation) to 15 (high expectation) that is collected pre-operatively and post-operatively. The pre-operative questions reflect the patient's opinion on the extent to which the patient expects that the operation will improve their knee pain, and their ability to perform their activities of daily living and recreational activities. The post-operative questions reflect the extent to which the outcome after the operation has met the patient's pre-operative expectations with respect to pain and function. The functional score is composed of four subgroups (Walking and standing, standard activities, advanced activities, discretionary activities) and has a score of 0 (poor) to 100 (excellent). |
| Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). | Pre-operative, 6 weeks, 6 months, 1 year and 2 years | The EQ-5D Time Trade-off (TTO) descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/comfort and anxiety/depression. Each dimension has three levels: no problems, some problems and extreme problems. The scores range from -0.59 (worst possible health state) to 1 (best possible health state). |
| Forgotten Joint Score (FJS) | 6 weeks, 6 months, 1 year, 2 years | The FJS is based on the patients' ability to forget about a joint as a result of the treatment. The FJS assessment is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A TKA Without VERASENSE patients who undergo primary PCL-retaining or - sacrificing TKA without the use of VERASENSE to guide rotational alignment and balance.
TKA without Verasense: TKA will be performed manually without the use of Verasense | 170 |
| Group B TKA With VERASENSE patients who undergo primary PCL-retaining or - sacrificing TKA with the use of VERASENSE to guide rotational alignment and balance.
TKA with Verasense: VERASENSE replaces the standard tibial trial inserts and is embedded with microelectronics and sensors to provide surgeons with real-time knee kinetic data. The data is wirelessly transmitted to a graphic display (VERASENSE Knee Application), allowing surgeons to quantify and assess soft tissue intercompartmental loads throughout the range of motion. The VERASENSE sensor is not an investigational device. OrthoSensor, Inc., received FDA 510K clearance in 2009. The indication for use is a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE sensor is sterile and single patient use. | 162 |
| Total | 332 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Lost to follow-up (LTFU), Patient withdrawal or Physician decision but not specified | 86 | 112 |
| Overall Study | No Verasense type documented | 0 | 23 |
| Overall Study | Verasense type posterior stabilizing (PS) | 37 | 16 |
Baseline characteristics
| Characteristic | Group A TKA Without VERASENSE | Group B TKA With VERASENSE | Total |
|---|---|---|---|
| Age, Continuous | 67.29 years STANDARD_DEVIATION 8.42 | 68.06 years STANDARD_DEVIATION 8.12 | 67.73 years STANDARD_DEVIATION 8.25 |
| Body Mass Index (BMI) | 31.29 kg / m^2 STANDARD_DEVIATION 6.65 | 31.11 kg / m^2 STANDARD_DEVIATION 6.27 | 31.20 kg / m^2 STANDARD_DEVIATION 6.46 |
| Race/Ethnicity, Customized African American or Black | 19 Participants | 22 Participants | 41 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 6 Participants | 6 Participants | 12 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized White | 105 Participants | 109 Participants | 214 Participants |
| Sex: Female, Male Female | 112 Participants | 101 Participants | 213 Participants |
| Sex: Female, Male Male | 58 Participants | 59 Participants | 117 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 170 | 0 / 162 |
| other Total, other adverse events | 0 / 170 | 0 / 162 |
| serious Total, serious adverse events | 8 / 170 | 6 / 162 |
Outcome results
Primary
Number of Participants With Quantitatively Balanced and Unbalanced Knees in Primary Unilateral Total Knee Arthroplasty
Evaluate how intra-operative sensing with VERASENSE may assist the surgeon with balancing. A load differential of up to 15 pound (lbs) or less between the medial and lateral condyles is indicative of soft-tissue balance. A load differential more than 15 lbs is indicative for soft-tissue unbalance.
Time frame: Intra-operative with trial implants in place and after completing all surgical corrections.
Population: Data was not collected for all participants. Numbers analyzed represent evaluable cases.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A TKA Without VERASENSE | Number of Participants With Quantitatively Balanced and Unbalanced Knees in Primary Unilateral Total Knee Arthroplasty | Participants with balanced knee | 65 Participants |
| Group A TKA Without VERASENSE | Number of Participants With Quantitatively Balanced and Unbalanced Knees in Primary Unilateral Total Knee Arthroplasty | Participants with unbalanced knee | 68 Participants |
| Group B TKA With VERASENSE | Number of Participants With Quantitatively Balanced and Unbalanced Knees in Primary Unilateral Total Knee Arthroplasty | Participants with balanced knee | 103 Participants |
| Group B TKA With VERASENSE | Number of Participants With Quantitatively Balanced and Unbalanced Knees in Primary Unilateral Total Knee Arthroplasty | Participants with unbalanced knee | 20 Participants |
Secondary
Forgotten Joint Score (FJS)
The FJS is based on the patients' ability to forget about a joint as a result of the treatment. The FJS assessment is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities.
Time frame: 6 weeks, 6 months, 1 year, 2 years
Population: Data was not collected for all participants. Numbers analyzed represent evaluable cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A TKA Without VERASENSE | Forgotten Joint Score (FJS) | FJS 6 months | 55.11 units on a scale | Standard Deviation 26.89 |
| Group A TKA Without VERASENSE | Forgotten Joint Score (FJS) | FJS 6 weeks | 30.55 units on a scale | Standard Deviation 25.52 |
| Group A TKA Without VERASENSE | Forgotten Joint Score (FJS) | FJS 1 year | 57.88 units on a scale | Standard Deviation 28.23 |
| Group A TKA Without VERASENSE | Forgotten Joint Score (FJS) | FJS 2 years | 59.78 units on a scale | Standard Deviation 32.22 |
| Group B TKA With VERASENSE | Forgotten Joint Score (FJS) | FJS 2 years | 65.73 units on a scale | Standard Deviation 31.11 |
| Group B TKA With VERASENSE | Forgotten Joint Score (FJS) | FJS 6 months | 55.46 units on a scale | Standard Deviation 26.77 |
| Group B TKA With VERASENSE | Forgotten Joint Score (FJS) | FJS 1 year | 60.34 units on a scale | Standard Deviation 27.35 |
| Group B TKA With VERASENSE | Forgotten Joint Score (FJS) | FJS 6 weeks | 33.31 units on a scale | Standard Deviation 27.88 |
Secondary
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).
The EQ-5D Time Trade-off (TTO) descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/comfort and anxiety/depression. Each dimension has three levels: no problems, some problems and extreme problems. The scores range from -0.59 (worst possible health state) to 1 (best possible health state).
Time frame: Pre-operative, 6 weeks, 6 months, 1 year and 2 years
Population: Data was not collected for all participants. Numbers analyzed represent evaluable cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A TKA Without VERASENSE | Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). | EQ-5D TTO pre-operative | 0.66 units on a scale | Standard Deviation 0.18 |
| Group A TKA Without VERASENSE | Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). | EQ-5D TTO 6 weeks | 0.75 units on a scale | Standard Deviation 0.18 |
| Group A TKA Without VERASENSE | Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). | EQ-5D TTO 6 months | 0.87 units on a scale | Standard Deviation 0.14 |
| Group A TKA Without VERASENSE | Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). | EQ-5D TTO 1 year | 0.86 units on a scale | Standard Deviation 0.18 |
| Group A TKA Without VERASENSE | Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). | EQ-5D TTO 2 years | 0.86 units on a scale | Standard Deviation 0.14 |
| Group B TKA With VERASENSE | Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). | EQ-5D TTO 2 years | 0.73 units on a scale | Standard Deviation 0.18 |
| Group B TKA With VERASENSE | Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). | EQ-5D TTO 1 year | 0.87 units on a scale | Standard Deviation 0.13 |
| Group B TKA With VERASENSE | Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). | EQ-5D TTO pre-operative | 0.63 units on a scale | Standard Deviation 0.19 |
| Group B TKA With VERASENSE | Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). | EQ-5D TTO 6 months | 0.85 units on a scale | Standard Deviation 0.16 |
| Group B TKA With VERASENSE | Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). | EQ-5D TTO 6 weeks | 0.78 units on a scale | Standard Deviation 0.15 |
Secondary
Knee Society Knee Scoring System
Patient Satisfaction is a three-question 40-point scale and has a score of 0 (not satisfied) to 40 (very satisfied) that is collected preoperatively and at each follow-up visit. Patient Expectations is a five-question fifteen-point scale and has a score of 0 (low expectation) to 15 (high expectation) that is collected pre-operatively and post-operatively. The pre-operative questions reflect the patient's opinion on the extent to which the patient expects that the operation will improve their knee pain, and their ability to perform their activities of daily living and recreational activities. The post-operative questions reflect the extent to which the outcome after the operation has met the patient's pre-operative expectations with respect to pain and function. The functional score is composed of four subgroups (Walking and standing, standard activities, advanced activities, discretionary activities) and has a score of 0 (poor) to 100 (excellent).
Time frame: pre-operative, 6 weeks, 6 months, 1 year, 2 years
Population: Data was not collected for all participants. Numbers analyzed represent evaluable cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A TKA Without VERASENSE | Knee Society Knee Scoring System | Satisfaction Score 6 months | 31.11 units on a scale | Standard Deviation 8.71 |
| Group A TKA Without VERASENSE | Knee Society Knee Scoring System | Expectations 6 months | 10.01 units on a scale | Standard Deviation 2.82 |
| Group A TKA Without VERASENSE | Knee Society Knee Scoring System | Satisfaction Score pre-operative | 13.61 units on a scale | Standard Deviation 6.94 |
| Group A TKA Without VERASENSE | Knee Society Knee Scoring System | Expectations 1 year | 10.28 units on a scale | Standard Deviation 3.08 |
| Group A TKA Without VERASENSE | Knee Society Knee Scoring System | Satisfaction Score 1 year | 32.44 units on a scale | Standard Deviation 8.48 |
| Group A TKA Without VERASENSE | Knee Society Knee Scoring System | Expectations 2 years | 10.69 units on a scale | Standard Deviation 3.35 |
| Group A TKA Without VERASENSE | Knee Society Knee Scoring System | Functional Score pre-operative | 36.75 units on a scale | Standard Deviation 15.88 |
| Group A TKA Without VERASENSE | Knee Society Knee Scoring System | Satisfaction Score 2 years | 32.15 units on a scale | Standard Deviation 7.9 |
| Group A TKA Without VERASENSE | Knee Society Knee Scoring System | Functional Score 6 weeks 6 weeks | 44.84 units on a scale | Standard Deviation 19.02 |
| Group A TKA Without VERASENSE | Knee Society Knee Scoring System | Satisfaction Score 6 weeks | 26.20 units on a scale | Standard Deviation 7.93 |
| Group A TKA Without VERASENSE | Knee Society Knee Scoring System | Functional Score 6 months | 69.25 units on a scale | Standard Deviation 19.24 |
| Group A TKA Without VERASENSE | Knee Society Knee Scoring System | Functional Score 1 year | 71.82 units on a scale | Standard Deviation 17.34 |
| Group A TKA Without VERASENSE | Knee Society Knee Scoring System | Expectations 6 weeks | 9.62 units on a scale | Standard Deviation 2.72 |
| Group A TKA Without VERASENSE | Knee Society Knee Scoring System | Functional Score 2 years | 68.69 units on a scale | Standard Deviation 18.65 |
| Group A TKA Without VERASENSE | Knee Society Knee Scoring System | Expectations Score pre-operative | 14.30 units on a scale | Standard Deviation 1.4 |
| Group B TKA With VERASENSE | Knee Society Knee Scoring System | Functional Score 2 years | 69.77 units on a scale | Standard Deviation 18.29 |
| Group B TKA With VERASENSE | Knee Society Knee Scoring System | Satisfaction Score pre-operative | 13.35 units on a scale | Standard Deviation 6.85 |
| Group B TKA With VERASENSE | Knee Society Knee Scoring System | Satisfaction Score 6 weeks | 26.45 units on a scale | Standard Deviation 8.28 |
| Group B TKA With VERASENSE | Knee Society Knee Scoring System | Satisfaction Score 6 months | 31.30 units on a scale | Standard Deviation 8.93 |
| Group B TKA With VERASENSE | Knee Society Knee Scoring System | Satisfaction Score 1 year | 32.98 units on a scale | Standard Deviation 8.22 |
| Group B TKA With VERASENSE | Knee Society Knee Scoring System | Satisfaction Score 2 years | 33.21 units on a scale | Standard Deviation 7.32 |
| Group B TKA With VERASENSE | Knee Society Knee Scoring System | Expectations Score pre-operative | 14.19 units on a scale | Standard Deviation 1.48 |
| Group B TKA With VERASENSE | Knee Society Knee Scoring System | Expectations 6 weeks | 9.50 units on a scale | Standard Deviation 2.74 |
| Group B TKA With VERASENSE | Knee Society Knee Scoring System | Expectations 6 months | 9.92 units on a scale | Standard Deviation 2.89 |
| Group B TKA With VERASENSE | Knee Society Knee Scoring System | Expectations 1 year | 10.44 units on a scale | Standard Deviation 3.04 |
| Group B TKA With VERASENSE | Knee Society Knee Scoring System | Expectations 2 years | 10.81 units on a scale | Standard Deviation 3.25 |
| Group B TKA With VERASENSE | Knee Society Knee Scoring System | Functional Score pre-operative | 37.13 units on a scale | Standard Deviation 16.11 |
| Group B TKA With VERASENSE | Knee Society Knee Scoring System | Functional Score 6 weeks 6 weeks | 46.73 units on a scale | Standard Deviation 18.91 |
| Group B TKA With VERASENSE | Knee Society Knee Scoring System | Functional Score 6 months | 68.95 units on a scale | Standard Deviation 19.03 |
| Group B TKA With VERASENSE | Knee Society Knee Scoring System | Functional Score 1 year | 72.44 units on a scale | Standard Deviation 17.09 |