Arthroplasties, Replacement, Knee
Conditions
Brief summary
This is a prospective, non-randomized, longitudinal study of the clinical outcomes of participants that receive the Stryker Triathlon® Total Knee System for Total Knee Arthroplasty implanted using ShapeMatch® Cutting Guides. Health status and functional outcome measures will be recorded to quantify functional status of subjects before surgery and at each follow-up interval. This sub-study involved the assessment of the placement of the ShapeMatch® Cutting Guides intraoperatively and post-operatively. An assessment of post-operative patient outcomes compared to pre-operative status was also analysed.
Detailed description
Protocol Attached in documentation.
Interventions
DEVICEShapeMatch Cutting Guides with Triathlon
All participants will undergo medical imaging assessment using Magnetic Resonance Imaging (MRI) of the affected lower limb.These images will be used to manufacture the patient-specific cutting guides for preparation of the bones prior to implantation of the total knee replacement (Pre-operatively). Patients will undergo primary total knee arthroplasty with the Triathlon® Total Knee System (Stryker Orthopaedics, Mahwah, NJ USA) using the Shapematch cutting guides to guide the bone resection. Patients will follow the standard postoperative rehabilitation program established by the investigator at each site.
Sponsors
Stryker South Pacific
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* The patient is a male or non-pregnant female between the ages of 50-90. * The patient requires a primary total knee replacement and is indicated for computer-assisted surgery. * The patient has a primary diagnosis of osteoarthritis (OA). * The patient has intact collateral ligaments. * The patient is able to undergo MRI scanning of the affected limb. * The patient has signed the study specific, HREC-approved, Informed Consent document. * The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations.
Exclusion criteria
* The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint. * The patient has had a high tibial osteotomy or femoral osteotomy. * The patient is morbidly obese (BMI ≥ 40). * The patient has a deformity which will require the use of stems, wedges or augments in conjunction with the Triathlon Total Knee System. * The patient has a varus/valgus malalignment ≥ 15° (relative to mechanical axis). * The patient has a fixed flexion deformity ≥ 15°. * The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. * The patient has a systemic or metabolic disorder leading to progressive bone deterioration. * The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements. * The patient has a cognitive impairment, an intellectual disability or a mental illness. * The patient is pregnant. * The patient has metal hardware present in the region of the hip, knee or ankle (as this is known to create geometrical distortion in the region of the implant). * The patient has any known contraindications for undergoing assessment by MRI (e.g. ferrous implants, metallic clips, magnetically activated implanted devices such as cardiac pacemakers, etc).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant Location/Assessment of Alignment | 3 months Post-Operatively | Implant location and limb alignment is assessed using CT scan 3 months after surgery. The mean deviation of the postoperative femoral and tibial alignment from the preoperative plan is measured in degrees. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS)_Symptoms | Pre-operative to 5 years post-operative | KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.) |
| Knee Injury and Osteoarthritis Outcome Score (KOOS)_ADL | Pre-operative to 5 years post-operative | KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.) |
| Knee Injury and Osteoarthritis Outcome Score (KOOS)_S&R | Pre-operative to 5 years Post-Operative | KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.) |
| Knee Injury and Osteoarthritis Outcome Score (KOOS)_QOL | Pre-operative to 5 years post-operative | KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.) |
| Short Form Health Survey 12 v2 (SF-12)_Physical Component Summary (PCS) | Pre-operative to 5 years Post-Operative | SF-12 provides a summary measure of health status after combining the physical health score (PCS) and mental health score (MCS). The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health and well-being. It includes a physical and mental status component score: each ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good health state. |
| VAS Pain at Rest | Pre-Operative to 5 years Post-Operative | Pain at rest and pain during mobilization was measured using a 10 centimeter Visual analogue scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS)_Pain | Pre-operative to 5 years post-operative | KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.) |
| Short Form Health Survey 12 (SF-12)_Mental Component Summary (MCS) | Pre-operative to 5 years Post-Operative | SF-12 provides a summary measure of health status after combining the physical health score (PCS) and mental health score (MCS). The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health and well-being. It includes a physical and mental status component score: each ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good health state. |
| Knee Society Clinical Rating System (KSS) Pain Scores | Pre-operative to 5 years Post-Operative | The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome. |
| Knee Society Clinical Rating System (KSS) Functional Scores | Pre-operative to 5 years Post-Operative | The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome. |
| Knee Society Clinical Rating System (KSS) Range of Motion Scores | Pre-operative to 5 years Post-Operative | The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome. |
| Forgotten Joint Score (FJS) | 1 to 5 years Post-Operative | The Forgotten Joint Score is a newly-developed twelve-item, self-reported assessment of how aware recipients of hip and knee joint replacement are of their joint in everyday life. The total score for the FJS is summed, averaged then multiplied by 25 (never = 0 points; almost never = 1 point; seldom = 2 points; sometimes = 3 points; mostly = 4 points). Total score range of 0 to 100. |
| VAS Pain Mobilised | Pre-Operative to 5 years post-operative | Pain at rest and pain during mobilization was measured using a 10 centimeter Visual analogue scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain. |
Participant flow
Recruitment details
Patients were assessed and then placed in either Part A or Part B. Patients in Part B were invited to participate in the extension follow-up to 5-years.
Participants by arm
| Arm | Count |
|---|---|
| ShapeMatch Cutting Guides With Triathlon Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides. | 96 |
| Total | 96 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Consent violation | 4 |
| Overall Study | Delay in or unfit for surgery | 16 |
| Overall Study | Failed MRI | 52 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | MRI contraindication | 6 |
| Overall Study | Only Recruited to Part A | 27 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 19 |
Baseline characteristics
| Characteristic | ShapeMatch Cutting Guides With Triathlon |
|---|---|
| Age, Continuous | 68.04 years STANDARD_DEVIATION 8.3 |
| Region of Enrollment Australia | 96 participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 96 |
| other Total, other adverse events | 47 / 96 |
| serious Total, serious adverse events | 48 / 96 |
Outcome results
Primary
Implant Location/Assessment of Alignment
Implant location and limb alignment is assessed using CT scan 3 months after surgery. The mean deviation of the postoperative femoral and tibial alignment from the preoperative plan is measured in degrees.
Time frame: 3 months Post-Operatively
Population: Participants with available data. Participants=knees.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ShapeMatch Cutting Guides With Triathlon | Implant Location/Assessment of Alignment | Femoral deviation pre-op to post-op | 1.70 degrees | Standard Deviation 1.46 |
| ShapeMatch Cutting Guides With Triathlon | Implant Location/Assessment of Alignment | Tibial deviation pre-op to post-op | 1.91 degrees | Standard Deviation 1.58 |
p-value: <0.001t-test, 2 sided
Secondary
Forgotten Joint Score (FJS)
The Forgotten Joint Score is a newly-developed twelve-item, self-reported assessment of how aware recipients of hip and knee joint replacement are of their joint in everyday life. The total score for the FJS is summed, averaged then multiplied by 25 (never = 0 points; almost never = 1 point; seldom = 2 points; sometimes = 3 points; mostly = 4 points). Total score range of 0 to 100.
Time frame: 1 to 5 years Post-Operative
Population: Participants with available data. Participants=knees.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ShapeMatch Cutting Guides With Triathlon | Forgotten Joint Score (FJS) | FJS 1 year | 54.48 units on a scale | Standard Deviation 30.58 |
| ShapeMatch Cutting Guides With Triathlon | Forgotten Joint Score (FJS) | FJS 2 years | 40.28 units on a scale | Standard Deviation 30.08 |
| ShapeMatch Cutting Guides With Triathlon | Forgotten Joint Score (FJS) | FJS 5 years | 68.82 units on a scale | Standard Deviation 31.17 |
Comparison: Change from 1 year to 2 year Forgotten Joint Scorep-value: 0.0161ANOVA
Comparison: Change from 2 year to 5 year Forgotten Joint Scorep-value: <0.0001ANOVA
Secondary
Knee Injury and Osteoarthritis Outcome Score (KOOS)_ADL
KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.)
Time frame: Pre-operative to 5 years post-operative
Population: Participants with available data. Participants=knees.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_ADL | Pre-op KOOS ADL | 38.08 units on a scale | Standard Deviation 20.12 |
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_ADL | 6 weeks KOOS ADL | 71.98 units on a scale | Standard Deviation 17.58 |
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_ADL | 3 months KOOS ADL | 78.75 units on a scale | Standard Deviation 18.2 |
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_ADL | 6 months KOOS ADL | 82.37 units on a scale | Standard Deviation 17.9 |
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_ADL | 1 year KOOS ADL | 88.14 units on a scale | Standard Deviation 14.39 |
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_ADL | 2 years KOOS ADL score | 89.60 units on a scale | Standard Deviation 15.46 |
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_ADL | 5 years KOOS ADL score | 88.80 units on a scale | Standard Deviation 15.09 |
Comparison: Change from preoperative to 6 weeks KOOS ADLp-value: <0.0001ANOVA
Comparison: Change from 6 weeks to 3 months KOOS ADLp-value: 0.0212ANOVA
Comparison: Change from 3 months to 6 months KOOS ADLp-value: 0.7173ANOVA
Comparison: Change from 6 months to 1 year KOOS ADLp-value: 0.1834ANOVA
Comparison: Change from 1 year to 2 year KOOS ADLp-value: 0.9957ANOVA
Comparison: Change from 6 months to 1 year KOOS ADLp-value: 0.9999ANOVA
Secondary
Knee Injury and Osteoarthritis Outcome Score (KOOS)_Pain
KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.)
Time frame: Pre-operative to 5 years post-operative
Population: Participants with available data. Participants=knees.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_Pain | Pre-op KOOS Pain score | 36.18 units on a scale | Standard Deviation 17.64 |
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_Pain | 6 weeks KOOS Pain score | 66.23 units on a scale | Standard Deviation 16.88 |
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_Pain | 3 months KOOS Pain score | 74.96 units on a scale | Standard Deviation 18.55 |
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_Pain | 6 months KOOS Pain score | 80.03 units on a scale | Standard Deviation 18.12 |
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_Pain | 1 year KOOS Pain score | 85.11 units on a scale | Standard Deviation 16.69 |
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_Pain | 2 years KOOS Pain score | 87.00 units on a scale | Standard Deviation 18.18 |
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_Pain | 5 years KOOS Pain score | 89.58 units on a scale | Standard Deviation 14.24 |
Comparison: Change from 6 months to 1 year KOOS Painp-value: 0.3366ANOVA
Comparison: Change from 1 year to 2 year KOOS Painp-value: 0.9826ANOVA
Comparison: Change from 6 weeks to 3 months KOOS Painp-value: 0.0013ANOVA
Comparison: Change from 3 months to 6 months KOOS Painp-value: 0.3316ANOVA
Comparison: Change from preoperative to 6 weeks KOOS Painp-value: <0.0001ANOVA
Comparison: Change from 2 year to 5 year KOOS Painp-value: 0.9276ANOVA
Secondary
Knee Injury and Osteoarthritis Outcome Score (KOOS)_QOL
KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.)
Time frame: Pre-operative to 5 years post-operative
Population: Participants with available data. Participants=knees.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_QOL | Pre-op KOOS QOL | 19.92 unit of a scale | Standard Deviation 17.63 |
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_QOL | 6 weeks KOOS QOL score | 51.87 unit of a scale | Standard Deviation 22.12 |
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_QOL | 3 months KOOS QOL score | 61.51 unit of a scale | Standard Deviation 21.14 |
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_QOL | 6 months KOOS QOL | 69.44 unit of a scale | Standard Deviation 25.39 |
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_QOL | 1 year KOOS QOL | 77.09 unit of a scale | Standard Deviation 20.78 |
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_QOL | 2 years KOOS QOL score | 79.82 unit of a scale | Standard Deviation 22.53 |
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_QOL | 5 years KOOS QOL | 80.19 unit of a scale | Standard Deviation 21.73 |
Comparison: Change from preoperative to 6 weeks KOOS QoLp-value: <0.0001ANOVA
Comparison: Change from 6 weeks to 3 months KOOS QoLp-value: 0.0135ANOVA
Comparison: Change from 3 months to 6 months KOOS QoLp-value: 0.0829ANOVA
Comparison: Change from 6 months to 1 year KOOS QoLp-value: 0.1729ANOVA
Comparison: Change from 1 year to 2 year KOOS QoLp-value: 0.9687ANOVA
Comparison: Change from 2 year to 5 year KOOS QoLp-value: >0.9999ANOVA
Secondary
Knee Injury and Osteoarthritis Outcome Score (KOOS)_S&R
KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.)
Time frame: Pre-operative to 5 years Post-Operative
Population: Participants with available data. Participants=knees
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_S&R | Pre-op KOOS S&R | 14.45 units on a scale | Standard Deviation 20.98 |
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_S&R | 1 year KOOS S&R | 65.05 units on a scale | Standard Deviation 25.48 |
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_S&R | 2 years KOOS S&R | 65.92 units on a scale | Standard Deviation 27.28 |
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_S&R | 5 years KOOS S&R | 64.78 units on a scale | Standard Deviation 27 |
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_S&R | 6 weeks KOOS S&R | 39.06 units on a scale | Standard Deviation 32.49 |
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_S&R | 3 months KOOS S&R | 48.58 units on a scale | Standard Deviation 28.74 |
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_S&R | 6 months KOOS S&R | 58.70 units on a scale | Standard Deviation 29.09 |
Comparison: Change from preoperative to 6 weeks KOOS S\&Rp-value: <0.0001ANOVA
Comparison: Change from 6 weeks to 3 months KOOS S\&Rp-value: 0.0522ANOVA
Comparison: Change from 3 months to 6 months KOOS S\&Rp-value: 0.1696ANOVA
Comparison: Change from 6 months to 1 year KOOS S\&Rp-value: 0.6942ANOVA
Comparison: Change from 1 year to 2 year KOOS S\&Rp-value: >0.9999ANOVA
Comparison: Change from 2 year to 5 year KOOS S\&Rp-value: >0.9999ANOVA
Secondary
Knee Injury and Osteoarthritis Outcome Score (KOOS)_Symptoms
KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.)
Time frame: Pre-operative to 5 years post-operative
Population: Participants with available data. Participants=knees
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_Symptoms | Pre-op KOOS Symptoms | 40.94 units on a scale | Standard Deviation 20.85 |
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_Symptoms | 6 weeks KOOS Symptoms | 64.78 units on a scale | Standard Deviation 16.01 |
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_Symptoms | 3 months KOOS Symptoms | 71.12 units on a scale | Standard Deviation 18.6 |
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_Symptoms | 6 months KOOS Symptoms | 75.16 units on a scale | Standard Deviation 18.54 |
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_Symptoms | 1 year KOOS Symptoms | 83.12 units on a scale | Standard Deviation 15.33 |
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_Symptoms | 2 years KOOS Symptoms score | 84.49 units on a scale | Standard Deviation 17.07 |
| ShapeMatch Cutting Guides With Triathlon | Knee Injury and Osteoarthritis Outcome Score (KOOS)_Symptoms | 5 years KOOS Symptoms | 87.90 units on a scale | Standard Deviation 13.13 |
Comparison: Change from preoperative to 6 weeks KOOS Symptomsp-value: <0.0001ANOVA
Comparison: Change from 6 weeks to 3 months KOOS Symptomsp-value: 0.0736ANOVA
Comparison: Change from 3 months to 6 months KOOS Symptomsp-value: 0.4675ANOVA
Comparison: Change from 6 months to 1 year KOOS Symptomsp-value: 0.0229ANOVA
Comparison: Change from 1 year to 2 year KOOS Symptomsp-value: 0.9968ANOVA
Comparison: Change from 2 year to 5 year KOOS Symptomsp-value: 0.7761ANOVA
Secondary
Knee Society Clinical Rating System (KSS) Functional Scores
The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome.
Time frame: Pre-operative to 5 years Post-Operative
Population: Participants with available data. Participants=knees.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ShapeMatch Cutting Guides With Triathlon | Knee Society Clinical Rating System (KSS) Functional Scores | KSS functional Preop | 43.45 units on a scale | Standard Deviation 19.25 |
| ShapeMatch Cutting Guides With Triathlon | Knee Society Clinical Rating System (KSS) Functional Scores | KSS functional 3 months | 66.82 units on a scale | Standard Deviation 20.07 |
| ShapeMatch Cutting Guides With Triathlon | Knee Society Clinical Rating System (KSS) Functional Scores | KSS functional 6 months | 75.45 units on a scale | Standard Deviation 20.28 |
| ShapeMatch Cutting Guides With Triathlon | Knee Society Clinical Rating System (KSS) Functional Scores | KSS functional 1 year | 76.99 units on a scale | Standard Deviation 19.79 |
| ShapeMatch Cutting Guides With Triathlon | Knee Society Clinical Rating System (KSS) Functional Scores | KSS functional 2 years | 74.82 units on a scale | Standard Deviation 23.62 |
| ShapeMatch Cutting Guides With Triathlon | Knee Society Clinical Rating System (KSS) Functional Scores | KSS functional 5 years | 71.44 units on a scale | Standard Deviation 25.47 |
Comparison: Change from preoperative to 3 months KSS Functionp-value: <0.0001ANOVA
Comparison: Change from 3 months to 6 months KSS Functionp-value: 0.0266ANOVA
Comparison: Change from 6 months to 1 year KSS Functionp-value: 0.988ANOVA
Comparison: Change from 1 year to 2 years KSS Functionp-value: 0.9699ANOVA
Comparison: Change from 2 year to 5 years KSS Functionp-value: 0.8575ANOVA
Secondary
Knee Society Clinical Rating System (KSS) Pain Scores
The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome.
Time frame: Pre-operative to 5 years Post-Operative
Population: Participants with available data. Participants=knees.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ShapeMatch Cutting Guides With Triathlon | Knee Society Clinical Rating System (KSS) Pain Scores | KSS Pain Preop | 32.95 units on a scale | Standard Deviation 14.06 |
| ShapeMatch Cutting Guides With Triathlon | Knee Society Clinical Rating System (KSS) Pain Scores | KSS Pain 3 months | 69.05 units on a scale | Standard Deviation 18.46 |
| ShapeMatch Cutting Guides With Triathlon | Knee Society Clinical Rating System (KSS) Pain Scores | KSS Pain 6 months | 71.36 units on a scale | Standard Deviation 15.21 |
| ShapeMatch Cutting Guides With Triathlon | Knee Society Clinical Rating System (KSS) Pain Scores | KSS Pain 1 year | 76.75 units on a scale | Standard Deviation 16.53 |
| ShapeMatch Cutting Guides With Triathlon | Knee Society Clinical Rating System (KSS) Pain Scores | KSS Pain 2 years | 78.04 units on a scale | Standard Deviation 16.32 |
| ShapeMatch Cutting Guides With Triathlon | Knee Society Clinical Rating System (KSS) Pain Scores | KSS Pain 5 years | 75.60 units on a scale | Standard Deviation 13.96 |
Comparison: Change from preoperative to 6 weeks KSS Painp-value: <0.0001ANOVA
Comparison: Change from 3 months to 6 months KSS Painp-value: 0.9465ANOVA
Comparison: Change from 6 months to 1 year KSS Painp-value: 0.1215ANOVA
Comparison: Change from 1 year to 2 years KSS Painp-value: 0.9912ANOVA
Comparison: Change from 2 year to 5 year KSS Painp-value: 0.8952ANOVA
Secondary
Knee Society Clinical Rating System (KSS) Range of Motion Scores
The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome.
Time frame: Pre-operative to 5 years Post-Operative
Population: Participants with available data. Participants=knees.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ShapeMatch Cutting Guides With Triathlon | Knee Society Clinical Rating System (KSS) Range of Motion Scores | KSS ROM Preop | 108.59 units on a scale | Standard Deviation 16.74 |
| ShapeMatch Cutting Guides With Triathlon | Knee Society Clinical Rating System (KSS) Range of Motion Scores | KSS ROM 3 months | 110.40 units on a scale | Standard Deviation 14.38 |
| ShapeMatch Cutting Guides With Triathlon | Knee Society Clinical Rating System (KSS) Range of Motion Scores | KSS ROM 6 months | 112.71 units on a scale | Standard Deviation 12.71 |
| ShapeMatch Cutting Guides With Triathlon | Knee Society Clinical Rating System (KSS) Range of Motion Scores | KSS ROM 1 year | 115.30 units on a scale | Standard Deviation 12.36 |
| ShapeMatch Cutting Guides With Triathlon | Knee Society Clinical Rating System (KSS) Range of Motion Scores | KSS ROM 2 years | 115.09 units on a scale | Standard Deviation 12.4 |
| ShapeMatch Cutting Guides With Triathlon | Knee Society Clinical Rating System (KSS) Range of Motion Scores | KSS ROM 5 years | 119.11 units on a scale | Standard Deviation 13.06 |
Comparison: Change from preoperative to 3 months KSS Range of Motionp-value: 0.8581ANOVA
Comparison: Change from 3 months to 6 months KSS Range of Motionp-value: 0.7664ANOVA
Comparison: Change from 6 months to 1 year KSS Range of Motionp-value: 0.7022ANOVA
Comparison: Change from 1 year to 2 year KSS Range of Motionp-value: >0.9999ANOVA
Comparison: Change from 2 year to 5 year KSS Range of Motionp-value: 0.2943ANOVA
Secondary
Short Form Health Survey 12 (SF-12)_Mental Component Summary (MCS)
SF-12 provides a summary measure of health status after combining the physical health score (PCS) and mental health score (MCS). The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health and well-being. It includes a physical and mental status component score: each ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good health state.
Time frame: Pre-operative to 5 years Post-Operative
Population: Participants with available data. Participants=knees.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ShapeMatch Cutting Guides With Triathlon | Short Form Health Survey 12 (SF-12)_Mental Component Summary (MCS) | SF12 MCS Preop | 47.02 units on a scale | Standard Deviation 12.49 |
| ShapeMatch Cutting Guides With Triathlon | Short Form Health Survey 12 (SF-12)_Mental Component Summary (MCS) | SF12 MCS 6 weeks | 49.91 units on a scale | Standard Deviation 10.56 |
| ShapeMatch Cutting Guides With Triathlon | Short Form Health Survey 12 (SF-12)_Mental Component Summary (MCS) | SF12 MCS 3 months | 52.18 units on a scale | Standard Deviation 9.96 |
| ShapeMatch Cutting Guides With Triathlon | Short Form Health Survey 12 (SF-12)_Mental Component Summary (MCS) | SF12 MCS 6 months | 52.58 units on a scale | Standard Deviation 9.15 |
| ShapeMatch Cutting Guides With Triathlon | Short Form Health Survey 12 (SF-12)_Mental Component Summary (MCS) | SF12 MCS 1 year | 52.93 units on a scale | Standard Deviation 9.28 |
| ShapeMatch Cutting Guides With Triathlon | Short Form Health Survey 12 (SF-12)_Mental Component Summary (MCS) | SF12 MCS 2 years | 52.78 units on a scale | Standard Deviation 9.27 |
| ShapeMatch Cutting Guides With Triathlon | Short Form Health Survey 12 (SF-12)_Mental Component Summary (MCS) | SF12 MCS 5 years | 52.95 units on a scale | Standard Deviation 10.39 |
Comparison: Change from preoperative to 6 weeks SF-12 MCSp-value: 0.3493ANOVA
Comparison: Change from 6 weeks to 3 months SF-12 MCSp-value: 0.48ANOVA
Comparison: Change from 3 months to 6 months SF-12 MCSp-value: >0.9999ANOVA
Comparison: Change from 6 months to 1 year SF-12 MCSp-value: >0.9999ANOVA
Comparison: Change from 1 year to 2 year SF-12 MCSp-value: >0.9999ANOVA
Comparison: Change from 2 year to 5 year SF-12 MCSp-value: >0.9999ANOVA
Secondary
Short Form Health Survey 12 v2 (SF-12)_Physical Component Summary (PCS)
SF-12 provides a summary measure of health status after combining the physical health score (PCS) and mental health score (MCS). The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health and well-being. It includes a physical and mental status component score: each ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good health state.
Time frame: Pre-operative to 5 years Post-Operative
Population: Participants with available data. Participants=knees.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ShapeMatch Cutting Guides With Triathlon | Short Form Health Survey 12 v2 (SF-12)_Physical Component Summary (PCS) | SF12 PCS Preop | 34.36 units on a scale | Standard Deviation 7.69 |
| ShapeMatch Cutting Guides With Triathlon | Short Form Health Survey 12 v2 (SF-12)_Physical Component Summary (PCS) | SF12 PCS 6 weeks | 40.27 units on a scale | Standard Deviation 6.98 |
| ShapeMatch Cutting Guides With Triathlon | Short Form Health Survey 12 v2 (SF-12)_Physical Component Summary (PCS) | SF12 PCS 3 months | 45.99 units on a scale | Standard Deviation 8.09 |
| ShapeMatch Cutting Guides With Triathlon | Short Form Health Survey 12 v2 (SF-12)_Physical Component Summary (PCS) | SF12 PCS 6 months | 47.35 units on a scale | Standard Deviation 8.89 |
| ShapeMatch Cutting Guides With Triathlon | Short Form Health Survey 12 v2 (SF-12)_Physical Component Summary (PCS) | SF12 PCS 1 year | 48.27 units on a scale | Standard Deviation 8.88 |
| ShapeMatch Cutting Guides With Triathlon | Short Form Health Survey 12 v2 (SF-12)_Physical Component Summary (PCS) | SF12 PCS 2 years | 49.90 units on a scale | Standard Deviation 8.64 |
| ShapeMatch Cutting Guides With Triathlon | Short Form Health Survey 12 v2 (SF-12)_Physical Component Summary (PCS) | SF12 PCS 5 years | 46.96 units on a scale | Standard Deviation 8.66 |
Comparison: Change from preoperative to 6 weeks SF-12 PCSp-value: <0.0001ANOVA
Comparison: Change from 6 weeks to 3 months SF-12 PCSp-value: <0.0001ANOVA
Comparison: Change from 3 months to 6 months SF-12 PCSp-value: 0.8189ANOVA
Comparison: Change from 6 months to 1 year SF-12 PCSp-value: 0.9845ANOVA
Comparison: Change from 1 year to 2 year SF-12 PCSp-value: 0.75ANOVA
Comparison: Change from 2 year to 5 year SF-12 PCSp-value: 0.1376ANOVA
Secondary
VAS Pain at Rest
Pain at rest and pain during mobilization was measured using a 10 centimeter Visual analogue scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain.
Time frame: Pre-Operative to 5 years Post-Operative
Population: Participants with available data. Participants=knees.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ShapeMatch Cutting Guides With Triathlon | VAS Pain at Rest | VAS pain at rest_Preop | 5.78 centimeters | Standard Deviation 2.49 |
| ShapeMatch Cutting Guides With Triathlon | VAS Pain at Rest | VAS pain at rest_6 weeks | 3.09 centimeters | Standard Deviation 2.56 |
| ShapeMatch Cutting Guides With Triathlon | VAS Pain at Rest | VAS pain at rest_3 months | 2.02 centimeters | Standard Deviation 2.14 |
| ShapeMatch Cutting Guides With Triathlon | VAS Pain at Rest | VAS pain at rest_6 months | 1.45 centimeters | Standard Deviation 1.98 |
| ShapeMatch Cutting Guides With Triathlon | VAS Pain at Rest | VAS pain at rest_ 1 year | 1.22 centimeters | Standard Deviation 1.84 |
| ShapeMatch Cutting Guides With Triathlon | VAS Pain at Rest | VAS pain at rest_ 2 years | 1.09 centimeters | Standard Deviation 1.82 |
| ShapeMatch Cutting Guides With Triathlon | VAS Pain at Rest | VAS pain at rest_ 5 years | 1.04 centimeters | Standard Deviation 1.65 |
Comparison: Change from preoperative to 6 week VAS Restp-value: <0.0001ANOVA
Comparison: Change from 6 weeks to 3 months VAS Restp-value: 0.0031ANOVA
Comparison: Change from 3 months to 6 months VAS Restp-value: 0.299ANOVA
Comparison: Change from 6 months to 1 year VAS Restp-value: 0.9832ANOVA
Comparison: Change from 1 year to 2 year VAS Restp-value: 0.9991ANOVA
Comparison: Change from 2 year to 5 year VAS Restp-value: >0.9999ANOVA
Secondary
VAS Pain Mobilised
Pain at rest and pain during mobilization was measured using a 10 centimeter Visual analogue scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain.
Time frame: Pre-Operative to 5 years post-operative
Population: Participants with available data. Participants=knees.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ShapeMatch Cutting Guides With Triathlon | VAS Pain Mobilised | VAS pain during mobilization_Preop | 7.28 units of a scale | Standard Deviation 2.07 |
| ShapeMatch Cutting Guides With Triathlon | VAS Pain Mobilised | VAS pain during mobilization_6 weeks | 3.47 units of a scale | Standard Deviation 2.74 |
| ShapeMatch Cutting Guides With Triathlon | VAS Pain Mobilised | VAS pain during mobilization_3 months | 2.39 units of a scale | Standard Deviation 2.48 |
| ShapeMatch Cutting Guides With Triathlon | VAS Pain Mobilised | VAS pain during mobilization_6 months | 1.83 units of a scale | Standard Deviation 2.23 |
| ShapeMatch Cutting Guides With Triathlon | VAS Pain Mobilised | VAS pain during mobilization_1 year | 1.43 units of a scale | Standard Deviation 1.99 |
| ShapeMatch Cutting Guides With Triathlon | VAS Pain Mobilised | VAS pain during mobilization_2 years | 1.41 units of a scale | Standard Deviation 2.19 |
| ShapeMatch Cutting Guides With Triathlon | VAS Pain Mobilised | VAS pain during mobilization_5 years | 1.22 units of a scale | Standard Deviation 1.92 |
Comparison: Change from preoperative to 6 weeks VAS Mobp-value: <0.0001ANOVA
Comparison: Change from 6 weeks to 3 months VAS Mobp-value: 0.0062ANOVA
Comparison: Change from 3 months to 6 months VAS Mobp-value: 0.373ANOVA
Comparison: Change from 6 months to 1 year VAS Mobp-value: 0.8499ANOVA
Comparison: Change from 1 year to 2 year VAS Mobp-value: >0.9999ANOVA
Comparison: Change from 2 year to 5 year VAS Mobp-value: 0.9958ANOVA