Arthroplasties, Knee Replacement
Conditions
Brief summary
This is a prospective, randomized, longitudinal study of the clinical outcomes of osteoarthritis patients treated by two different alignment philosophies for total knee replacement. In this study ShapeMatch® cutting guides will be compared to the conventional approach.
Interventions
DEVICEOtisMed® ShapeMatch® Technology
The appropriate Stryker ShapeMatch® Cutting Guides will be used to guide the surgeons bone resections. The surgeon will implant the knee prostheses following the surgical protocol for Triathlon® Knee System with OtisMed® ShapeMatch® Technology
DEVICEStryker Precision Knee Navigation
Stryker PrecisioN Knee (4.0) Navigation System, comprising of computer hardware and software and associated instrumentation, will be used for intra-operative alignment and orientation of implant. Navigation trackers will be secured to the femur and tibia and registration of the limb will be undertaken according to the PrecisioN Knee System surgical technique.Femoral and tibial resections, followed by device implantation, will be performed according to the Triathlon Knee System Surgical Protocol.
PROCEDURETotal Knee Replacement
DEVICEStryker Triathlon® Total Knee System
Prosthetic components to be implanted including * Triathlon® Cruciate Retaining (CR) Total Knee System (cemented), including Femoral Component and Primary Tibial Baseplate; * Triathlon® Cruciate Substituting (CS) X3® polyethylene insert; * Triathlon® X3 Patella (asymmetric) - treated selectively by surgeon.
Sponsors
Stryker South Pacific
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* The patient is a male or non-pregnant female between the ages of 40-80 years. * The patient requires a primary total knee replacement and is indicated for computer-assisted surgery. * Patient is deemed appropriate for a cruciate retaining knee replacement. * 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, ethics-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. * Patient has had a previous osteotomy around the knee. * 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. * 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 |
|---|---|---|
| Oxford Knee Score | Preoperatively, 6-week, 6-months, 12 months, 2 years and 5 years postoperatively | To demonstrate, through calculation of Oxford Knee Score (OKS) post operatively, that total knee replacement (TKR) performed using the ShapeMatch® Cutting Guide provides improvement from preoperative levels of patient pain and function comparable to the improvement obtained with TKR performed using computer-assisted Navigation. Oxford Knee Scores will be calculated pre-operatively and at 6 weeks, 6 months, 12 months, 2 years and 5 years. The OKS is a participant completed 12 question form on activities of daily living that assess function and pain. Scores can range from 0 to 48 with lower scores indicating a poor outcome and higher scores indicating a more satisfactory joint outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost Effectiveness: Wound Length | Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes. | To compare the cost-effectiveness and cost-utility of the procedure between the ShapeMatch® Cutting Guide group and the computer-assisted Navigation control group the surgical incision length is reported in mm. |
| Cost Effectiveness: Cost of Consumable Items Used During Operating Procedure | Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes. | To compare the cost-effectiveness and cost-utility of the procedure between the ShapeMatch® Cutting Guide group and the computer-assisted Navigation control group. The data for the cost of consumable items used during the operating procedure is not available. Due to limited site resources, a decision was made not to collect this secondary outcome measure data. |
| Cost Effectiveness: Length of Stay in Hospital | 14 days | To compare the cost-effectiveness and cost-utility of the procedure between the ShapeMatch® Cutting Guide group and the computer-assisted Navigation control group the length of stay in number of days spent in the hospital is reported.. |
| Cost Effectiveness: Quality-adjusted Life-years (QALYs) From EQ-5D-3L | 12 months | A quality-adjusted life-year (QALY) takes into account both the quantity and quality of life generated by healthcare interventions. It is the arithmetic product of life expectancy and a measure of the quality of the remaining life-years. A QALY places a weight on time in different health states. A year of perfect health is worth 1 and a year of less than perfect health is worth less than 1. Death is considered to be equivalent to 0; however,some health states may be considered worse than death and have negative scores. |
| Knee Pain | Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively | 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. |
| Cost Effectiveness: Total Duration of Operating Procedure (Anaesthetic Time and Skin-to-skin Incision Time) | Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes. | Skin to skin time is the time in minutes from initial skin incision to skin closure. Anaesthesia time is the time in minutes that anaesthesia administration is started to the time it is stopped. Data for anaesthesia time is not available due to an error on the original case report form that did not correctly capture anaesthesia time. |
| Health-related Quality of Life (EQ-5D-3L) | Preoperatively, 6-week, 6-month and 12 month visits, 2 years and 5 years | The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The participant is asked to indicate his/her health state by indicating the most appropriate level for each of the 5 dimensions. Responses may be converted into a single summary index by applying a formula that essentially attaches values (also called weights) to each of the levels in each dimension. The index can be calculated by deducting the appropriate weights from 1= the value for full health. The EQ VAS records the participant's self-rated health on a vertical, visual analogue scale where the endpoints are labelled from 100 ='Best imaginable health state' to 0= 'Worst imaginable health state'. |
| The Forgotten Joint Score (FJS-12) | 6 week, 6 month, 12 month , 2 years and 5 years visits | The Forgotten Joint Score (FJS) is a 12 question form that asks the patient their level of awareness of their artificial joint in 12 scenarios commonly encountered in daily life. Scores can range from 0 to 100 with a higher score indicating a better outcome (high degree of forgetting the joint in everyday life). |
| The International Knee Society Score (IKSS) | Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively | 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. |
| Perth CT Protocol | 3 months | The Perth CT protocol is a comprehensive assessment of total knee replacement (TKR) component position and orientation. The alignment of the TKR components is measured against the mechanical axis and the transepicondylar axis of the lower extremity. The posted data represents the mean angle between the femoral component and mechanical axis of the femur, the angle between tibial component and mechanical axis of the tibia, the tibial component slope relative to the sagittal mechanical axis, and the femoral component rotation relative to surgical epicondylar axis (positive value=external rotation). For all degree values posted a positive (+) value= valgus and a negative (-) value = varus. |
| The Western Ontario and McMaster Universities Arthritis Index (WOMAC) | Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively | The WOMAC is completed by the participant and measures five items for pain (score range 0-100), two for stiffness (score range 0-100), and 17 for functional limitation (score range 0-100). The total score is the sum of these three categories. |
Participant flow
Pre-assignment details
For all results participants=knees.
Participants by arm
| Arm | Count |
|---|---|
| OtisMed® ShapeMatch® With Triathlon Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology. | 49 |
| Stryker Precision Knee Navigation Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation. | 50 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not receive study intervention | 1 | 0 |
Baseline characteristics
| Characteristic | OtisMed® ShapeMatch® With Triathlon | Total | Stryker Precision Knee Navigation |
|---|---|---|---|
| Age, Continuous | 71.9 years STANDARD_DEVIATION 6.5 | 70.8 years STANDARD_DEVIATION 7 | 69.6 years STANDARD_DEVIATION 7.5 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment New Zealand | 49 participants | 99 participants | 50 participants |
| Sex: Female, Male Female | 25 Participants | 51 Participants | 26 Participants |
| Sex: Female, Male Male | 24 Participants | 48 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 50 |
| other Total, other adverse events | 24 / 49 | 25 / 50 |
| serious Total, serious adverse events | 39 / 49 | 38 / 50 |
Outcome results
Primary
Oxford Knee Score
To demonstrate, through calculation of Oxford Knee Score (OKS) post operatively, that total knee replacement (TKR) performed using the ShapeMatch® Cutting Guide provides improvement from preoperative levels of patient pain and function comparable to the improvement obtained with TKR performed using computer-assisted Navigation. Oxford Knee Scores will be calculated pre-operatively and at 6 weeks, 6 months, 12 months, 2 years and 5 years. The OKS is a participant completed 12 question form on activities of daily living that assess function and pain. Scores can range from 0 to 48 with lower scores indicating a poor outcome and higher scores indicating a more satisfactory joint outcome.
Time frame: Preoperatively, 6-week, 6-months, 12 months, 2 years and 5 years postoperatively
Population: Shapematch: 49 had preoperative,48 had 6 week, 46 had 6 months, 48 had 12 month, 49 had 2 year and 47 had 5 year scores.~Navigation: 50 had preoperative, 47 had 6 week, 46 had 6 months, 49 had 12 month, 50 had 2 years and 48 had 5 years scores.~Participants=knees
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OtisMed® ShapeMatch® With Triathlon | Oxford Knee Score | Oxford preoperative | 20.3 units on a scale | Standard Deviation 5.7 |
| OtisMed® ShapeMatch® With Triathlon | Oxford Knee Score | Oxford 6 weeks | 32.5 units on a scale | Standard Deviation 6.8 |
| OtisMed® ShapeMatch® With Triathlon | Oxford Knee Score | Oxford 6 months | 41.0 units on a scale | Standard Deviation 4.8 |
| OtisMed® ShapeMatch® With Triathlon | Oxford Knee Score | Oxford 12 months | 41.8 units on a scale | Standard Deviation 6.1 |
| OtisMed® ShapeMatch® With Triathlon | Oxford Knee Score | Oxford 2 years | 42.1 units on a scale | Standard Deviation 6.1 |
| OtisMed® ShapeMatch® With Triathlon | Oxford Knee Score | Oxford 5 years | 41.4 units on a scale | Standard Deviation 7.2 |
| Stryker Precision Knee Navigation | Oxford Knee Score | Oxford 2 years | 41.1 units on a scale | Standard Deviation 6 |
| Stryker Precision Knee Navigation | Oxford Knee Score | Oxford preoperative | 21.1 units on a scale | Standard Deviation 6.2 |
| Stryker Precision Knee Navigation | Oxford Knee Score | Oxford 12 months | 43.0 units on a scale | Standard Deviation 7.7 |
| Stryker Precision Knee Navigation | Oxford Knee Score | Oxford 6 weeks | 32.8 units on a scale | Standard Deviation 7.7 |
| Stryker Precision Knee Navigation | Oxford Knee Score | Oxford 5 years | 41.7 units on a scale | Standard Deviation 6.3 |
| Stryker Precision Knee Navigation | Oxford Knee Score | Oxford 6 months | 38.2 units on a scale | Standard Deviation 7.3 |
Comparison: Improvement from preoperative to 6 weeks for the control casesp-value: <0.0001t-test, 2 sided
Comparison: Improvement from preoperative to 6 weeks for the Shapematch casesp-value: <0.0001t-test, 2 sided
Comparison: To compare improvement of OKS from preoperative to 6 weeks between both groups.p-value: 0.0004t-test, 2 sided
Comparison: Improvement from preoperative to 6 months for Control cases.p-value: <0.0001t-test, 2 sided
Comparison: Improvement form preoperative to 6 months for Shapematch cases.p-value: <0.0001t-test, 2 sided
Comparison: To compare improvement of OKS from preoperative to 6 months between both groups.p-value: 0.3894t-test, 2 sided
Comparison: Improvement from preoperative to 12 months for the Control casesp-value: <0.0001t-test, 2 sided
Comparison: Improvement from preoperative to 12 months for the Shapematch casesp-value: <0.0001t-test, 2 sided
Comparison: To compare improvement of OKS from preoperative to 12 months between both groups.p-value: 0.4387t-test, 2 sided
Comparison: To compare improvement of OKS from preoperative to 2 years between both groups.p-value: 0.261t-test, 2 sided
Comparison: To compare improvement of OKS from preoperative to 5 years between both groups.p-value: 0.8458t-test, 2 sided
Secondary
Cost Effectiveness: Cost of Consumable Items Used During Operating Procedure
To compare the cost-effectiveness and cost-utility of the procedure between the ShapeMatch® Cutting Guide group and the computer-assisted Navigation control group. The data for the cost of consumable items used during the operating procedure is not available. Due to limited site resources, a decision was made not to collect this secondary outcome measure data.
Time frame: Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.
Population: Cost effectiveness data is not available.
Secondary
Cost Effectiveness: Length of Stay in Hospital
To compare the cost-effectiveness and cost-utility of the procedure between the ShapeMatch® Cutting Guide group and the computer-assisted Navigation control group the length of stay in number of days spent in the hospital is reported..
Time frame: 14 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OtisMed® ShapeMatch® With Triathlon | Cost Effectiveness: Length of Stay in Hospital | 5.1 days | Standard Deviation 3 |
| Stryker Precision Knee Navigation | Cost Effectiveness: Length of Stay in Hospital | 4.2 days | Standard Deviation 4.2 |
Comparison: To compare average length of hospital stay between both groups.p-value: 0.07t-test, 2 sided
Secondary
Cost Effectiveness: Quality-adjusted Life-years (QALYs) From EQ-5D-3L
A quality-adjusted life-year (QALY) takes into account both the quantity and quality of life generated by healthcare interventions. It is the arithmetic product of life expectancy and a measure of the quality of the remaining life-years. A QALY places a weight on time in different health states. A year of perfect health is worth 1 and a year of less than perfect health is worth less than 1. Death is considered to be equivalent to 0; however,some health states may be considered worse than death and have negative scores.
Time frame: 12 months
Population: Shapematch preoperative N=48, 12 month N=48.~Navigation preoperative N=50, 12 month N-49.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OtisMed® ShapeMatch® With Triathlon | Cost Effectiveness: Quality-adjusted Life-years (QALYs) From EQ-5D-3L | Preoperative QALY | 0.507 QALY life year | Standard Deviation 0.17 |
| OtisMed® ShapeMatch® With Triathlon | Cost Effectiveness: Quality-adjusted Life-years (QALYs) From EQ-5D-3L | 12 Month QALY | 0.895 QALY life year | Standard Deviation 0.16 |
| Stryker Precision Knee Navigation | Cost Effectiveness: Quality-adjusted Life-years (QALYs) From EQ-5D-3L | Preoperative QALY | 0.484 QALY life year | Standard Deviation 0.21 |
| Stryker Precision Knee Navigation | Cost Effectiveness: Quality-adjusted Life-years (QALYs) From EQ-5D-3L | 12 Month QALY | 0.852 QALY life year | Standard Deviation 0.19 |
Comparison: Comparison of baseline differencesp-value: 0.55t-test, 2 sided
Comparison: Analysis of QALY between each instrument platform at 12-monthsp-value: 0.23t-test, 2 sided
Secondary
Cost Effectiveness: Total Duration of Operating Procedure (Anaesthetic Time and Skin-to-skin Incision Time)
Skin to skin time is the time in minutes from initial skin incision to skin closure. Anaesthesia time is the time in minutes that anaesthesia administration is started to the time it is stopped. Data for anaesthesia time is not available due to an error on the original case report form that did not correctly capture anaesthesia time.
Time frame: Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OtisMed® ShapeMatch® With Triathlon | Cost Effectiveness: Total Duration of Operating Procedure (Anaesthetic Time and Skin-to-skin Incision Time) | 82.6 minutes | Standard Deviation 26 |
| Stryker Precision Knee Navigation | Cost Effectiveness: Total Duration of Operating Procedure (Anaesthetic Time and Skin-to-skin Incision Time) | 92.2 minutes | Standard Deviation 32 |
Comparison: To compare mean duration of surgery between both groups.p-value: 0.1t-test, 2 sided
Secondary
Cost Effectiveness: Wound Length
To compare the cost-effectiveness and cost-utility of the procedure between the ShapeMatch® Cutting Guide group and the computer-assisted Navigation control group the surgical incision length is reported in mm.
Time frame: Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OtisMed® ShapeMatch® With Triathlon | Cost Effectiveness: Wound Length | 223 millimeters | Standard Deviation 29 |
| Stryker Precision Knee Navigation | Cost Effectiveness: Wound Length | 233 millimeters | Standard Deviation 34 |
Comparison: To compare wound length between both groups.p-value: 0.05t-test, 2 sided
Secondary
Health-related Quality of Life (EQ-5D-3L)
The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The participant is asked to indicate his/her health state by indicating the most appropriate level for each of the 5 dimensions. Responses may be converted into a single summary index by applying a formula that essentially attaches values (also called weights) to each of the levels in each dimension. The index can be calculated by deducting the appropriate weights from 1= the value for full health. The EQ VAS records the participant's self-rated health on a vertical, visual analogue scale where the endpoints are labelled from 100 ='Best imaginable health state' to 0= 'Worst imaginable health state'.
Time frame: Preoperatively, 6-week, 6-month and 12 month visits, 2 years and 5 years
Population: Patients did not complete CRF to protocol in some instances, resulting in exclusion/missing data points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OtisMed® ShapeMatch® With Triathlon | Health-related Quality of Life (EQ-5D-3L) | 6-month EQ-5D VAS | 86.00 score on a scale | Standard Deviation 13.86 |
| OtisMed® ShapeMatch® With Triathlon | Health-related Quality of Life (EQ-5D-3L) | 6-week EQ-5D Index | 0.67 score on a scale | Standard Deviation 0.14 |
| OtisMed® ShapeMatch® With Triathlon | Health-related Quality of Life (EQ-5D-3L) | 1-year EQ-5D Index | 0.89 score on a scale | Standard Deviation 0.16 |
| OtisMed® ShapeMatch® With Triathlon | Health-related Quality of Life (EQ-5D-3L) | 5-year EQ-5D VAS | 78.21 score on a scale | Standard Deviation 16.51 |
| OtisMed® ShapeMatch® With Triathlon | Health-related Quality of Life (EQ-5D-3L) | 1-year EQ-5D VAS | 85.48 score on a scale | Standard Deviation 12.46 |
| OtisMed® ShapeMatch® With Triathlon | Health-related Quality of Life (EQ-5D-3L) | 6-week EQ-5D VAS | 79.38 score on a scale | Standard Deviation 13.58 |
| OtisMed® ShapeMatch® With Triathlon | Health-related Quality of Life (EQ-5D-3L) | 2-year EQ-5D Index | 0.77 score on a scale | Standard Deviation 0.3 |
| OtisMed® ShapeMatch® With Triathlon | Health-related Quality of Life (EQ-5D-3L) | Pre-op EQ-5D VAS | 71.43 score on a scale | Standard Deviation 18.11 |
| OtisMed® ShapeMatch® With Triathlon | Health-related Quality of Life (EQ-5D-3L) | 2-year EQ-5D VAS | 81.80 score on a scale | Standard Deviation 18.57 |
| OtisMed® ShapeMatch® With Triathlon | Health-related Quality of Life (EQ-5D-3L) | 5-year EQ-5D Index | 0.82 score on a scale | Standard Deviation 0.2 |
| OtisMed® ShapeMatch® With Triathlon | Health-related Quality of Life (EQ-5D-3L) | 6-month EQ-5D Index | 0.82 score on a scale | Standard Deviation 0.18 |
| OtisMed® ShapeMatch® With Triathlon | Health-related Quality of Life (EQ-5D-3L) | Pre-op EQ-5D Index | 0.51 score on a scale | Standard Deviation 0.17 |
| Stryker Precision Knee Navigation | Health-related Quality of Life (EQ-5D-3L) | 5-year EQ-5D VAS | 78.58 score on a scale | Standard Deviation 17.02 |
| Stryker Precision Knee Navigation | Health-related Quality of Life (EQ-5D-3L) | Pre-op EQ-5D Index | 0.48 score on a scale | Standard Deviation 0.21 |
| Stryker Precision Knee Navigation | Health-related Quality of Life (EQ-5D-3L) | Pre-op EQ-5D VAS | 75.66 score on a scale | Standard Deviation 14.28 |
| Stryker Precision Knee Navigation | Health-related Quality of Life (EQ-5D-3L) | 6-week EQ-5D Index | 0.68 score on a scale | Standard Deviation 0.18 |
| Stryker Precision Knee Navigation | Health-related Quality of Life (EQ-5D-3L) | 6-week EQ-5D VAS | 80.28 score on a scale | Standard Deviation 19.41 |
| Stryker Precision Knee Navigation | Health-related Quality of Life (EQ-5D-3L) | 6-month EQ-5D Index | 0.78 score on a scale | Standard Deviation 0.2 |
| Stryker Precision Knee Navigation | Health-related Quality of Life (EQ-5D-3L) | 6-month EQ-5D VAS | 84.04 score on a scale | Standard Deviation 14.52 |
| Stryker Precision Knee Navigation | Health-related Quality of Life (EQ-5D-3L) | 1-year EQ-5D Index | 0.84 score on a scale | Standard Deviation 0.2 |
| Stryker Precision Knee Navigation | Health-related Quality of Life (EQ-5D-3L) | 1-year EQ-5D VAS | 85.91 score on a scale | Standard Deviation 12.22 |
| Stryker Precision Knee Navigation | Health-related Quality of Life (EQ-5D-3L) | 2-year EQ-5D Index | 0.70 score on a scale | Standard Deviation 0.3 |
| Stryker Precision Knee Navigation | Health-related Quality of Life (EQ-5D-3L) | 5-year EQ-5D Index | 0.86 score on a scale | Standard Deviation 0.18 |
| Stryker Precision Knee Navigation | Health-related Quality of Life (EQ-5D-3L) | 2-year EQ-5D VAS | 84.70 score on a scale | Standard Deviation 11.63 |
Comparison: To compare EQ-5D index preoperatively between both groups.p-value: 0.452t-test, 2 sided
Comparison: To compare EQ-5D VAS preoperatively between both groups.p-value: 0.201t-test, 2 sided
Comparison: To compare EQ-5D index at 6-weeks between both groups.p-value: 0.741t-test, 2 sided
Comparison: To compare EQ-5D VAS at 6-weeks between both groups.p-value: 0.794t-test, 2 sided
Comparison: To compare EQ-5D index at 6-months between both groups.p-value: 0.232t-test, 2 sided
Comparison: To compare EQ-5D VAS at 6-months between both groups.p-value: 0.513t-test, 2 sided
Comparison: To compare EQ-5D index at 1-year between both groups.p-value: 0.18t-test, 2 sided
Comparison: To compare EQ-5D VAS at 1-year between both groups.p-value: 0.864t-test, 2 sided
Comparison: To compare EQ-5D index at 2-year between both groups.p-value: 0.223t-test, 2 sided
Comparison: To compare EQ-5D VAS at 2-year between both groups.p-value: 0.355t-test, 2 sided
Comparison: To compare EQ-5D index at 5-year between both groups.p-value: 0.314t-test, 2 sided
Comparison: To compare EQ-5D VAS at 5-year between both groups.p-value: 0.914t-test, 2 sided
Secondary
Knee Pain
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: Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively
Population: Patients did not complete CRF to protocol in some instances, resulting in exclusion/missing data points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OtisMed® ShapeMatch® With Triathlon | Knee Pain | Pre-op Pain at Rest | 4.36 score on a scale | Standard Deviation 2.03 |
| OtisMed® ShapeMatch® With Triathlon | Knee Pain | 6-month Pain at Mobilisation | 1.15 score on a scale | Standard Deviation 1.97 |
| OtisMed® ShapeMatch® With Triathlon | Knee Pain | 1-year Pain at Mobilisation | 0.79 score on a scale | Standard Deviation 1.83 |
| OtisMed® ShapeMatch® With Triathlon | Knee Pain | 6-week Pain at Rest | 1.95 score on a scale | Standard Deviation 1.93 |
| OtisMed® ShapeMatch® With Triathlon | Knee Pain | 2-year Pain at Rest | 0.67 score on a scale | Standard Deviation 0.94 |
| OtisMed® ShapeMatch® With Triathlon | Knee Pain | 1-year Pain at Rest | 0.53 score on a scale | Standard Deviation 1.35 |
| OtisMed® ShapeMatch® With Triathlon | Knee Pain | 2-year Pain at Mobilisation | 1.14 score on a scale | Standard Deviation 1.35 |
| OtisMed® ShapeMatch® With Triathlon | Knee Pain | 6-week Pain at Mobilisation | 2.51 score on a scale | Standard Deviation 2.11 |
| OtisMed® ShapeMatch® With Triathlon | Knee Pain | 5-year Pain at Rest | 0.84 score on a scale | Standard Deviation 1.56 |
| OtisMed® ShapeMatch® With Triathlon | Knee Pain | Pre-op Pain at Mobilisation | 5.78 score on a scale | Standard Deviation 2.32 |
| OtisMed® ShapeMatch® With Triathlon | Knee Pain | 5-year Pain at Mobilisation | 1.21 score on a scale | Standard Deviation 1.64 |
| OtisMed® ShapeMatch® With Triathlon | Knee Pain | 6-month Pain at Rest | 0.97 score on a scale | Standard Deviation 1.78 |
| Stryker Precision Knee Navigation | Knee Pain | 5-year Pain at Mobilisation | 1.17 score on a scale | Standard Deviation 2.06 |
| Stryker Precision Knee Navigation | Knee Pain | 6-month Pain at Mobilisation | 1.50 score on a scale | Standard Deviation 2.38 |
| Stryker Precision Knee Navigation | Knee Pain | Pre-op Pain at Rest | 4.20 score on a scale | Standard Deviation 2.48 |
| Stryker Precision Knee Navigation | Knee Pain | Pre-op Pain at Mobilisation | 6.01 score on a scale | Standard Deviation 2.49 |
| Stryker Precision Knee Navigation | Knee Pain | 6-week Pain at Rest | 1.79 score on a scale | Standard Deviation 2.01 |
| Stryker Precision Knee Navigation | Knee Pain | 6-week Pain at Mobilisation | 2.49 score on a scale | Standard Deviation 2 |
| Stryker Precision Knee Navigation | Knee Pain | 6-month Pain at Rest | 1.20 score on a scale | Standard Deviation 2.04 |
| Stryker Precision Knee Navigation | Knee Pain | 1-year Pain at Mobilisation | 1.35 score on a scale | Standard Deviation 2.3 |
| Stryker Precision Knee Navigation | Knee Pain | 2-year Pain at Rest | 1.00 score on a scale | Standard Deviation 1.72 |
| Stryker Precision Knee Navigation | Knee Pain | 2-year Pain at Mobilisation | 1.31 score on a scale | Standard Deviation 1.84 |
| Stryker Precision Knee Navigation | Knee Pain | 5-year Pain at Rest | 0.63 score on a scale | Standard Deviation 1.07 |
| Stryker Precision Knee Navigation | Knee Pain | 1-year Pain at Rest | 0.84 score on a scale | Standard Deviation 1.63 |
Comparison: To compare VAS mobilisation preoperatively between both groups.p-value: 0.7545t-test, 2 sided
Comparison: To compare VAS rest at 6 weeks between both groups.p-value: 0.6921t-test, 2 sided
Comparison: To compare VAS rest preoperatively between both groups.p-value: 0.724t-test, 2 sided
Comparison: To compare VAS mobilisation at 6 weeks between both groups.p-value: 0.9601t-test, 2 sided
Comparison: To compare VAS rest at 6 months between both groups.p-value: 0.0697t-test, 2 sided
Comparison: To compare VAS mobilisation at 6 months between both groups.p-value: 0.0342t-test, 2 sided
Comparison: To compare VAS rest at 12 months between both groups.p-value: 0.3487t-test, 2 sided
Comparison: To compare VAS mobilisation at 1 year between both groups.p-value: 0.2201t-test, 2 sided
Comparison: To compare VAS rest at 2 years between both groups.p-value: 0.2291t-test, 2 sided
Comparison: To compare VAS mobilisation at 2 years between both groups.p-value: 0.6436t-test, 2 sided
Comparison: To compare VAS rest at 5 years between both groups.p-value: 0.4344t-test, 2 sided
Comparison: To compare VAS mobilisation at 5 years between both groups.p-value: 0.8732t-test, 2 sided
Secondary
Perth CT Protocol
The Perth CT protocol is a comprehensive assessment of total knee replacement (TKR) component position and orientation. The alignment of the TKR components is measured against the mechanical axis and the transepicondylar axis of the lower extremity. The posted data represents the mean angle between the femoral component and mechanical axis of the femur, the angle between tibial component and mechanical axis of the tibia, the tibial component slope relative to the sagittal mechanical axis, and the femoral component rotation relative to surgical epicondylar axis (positive value=external rotation). For all degree values posted a positive (+) value= valgus and a negative (-) value = varus.
Time frame: 3 months
Population: Participants=knees
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OtisMed® ShapeMatch® With Triathlon | Perth CT Protocol | Coronal angle tibial comp and mech axis tibia | -2.8 degrees | Standard Deviation 3.1 |
| OtisMed® ShapeMatch® With Triathlon | Perth CT Protocol | Coronal angle fem comp and mech axis femur | 2.0 degrees | Standard Deviation 2.6 |
| OtisMed® ShapeMatch® With Triathlon | Perth CT Protocol | Sagital tibial component slope | 3.6 degrees | Standard Deviation 2.5 |
| OtisMed® ShapeMatch® With Triathlon | Perth CT Protocol | Femcomp rotationrelative to surg epicond axis+=ER | -0.5 degrees | Standard Deviation 2.5 |
| OtisMed® ShapeMatch® With Triathlon | Perth CT Protocol | Coronal mechanical axis:hip knee ankle angle | -0.4 degrees | Standard Deviation 3.5 |
| Stryker Precision Knee Navigation | Perth CT Protocol | Femcomp rotationrelative to surg epicond axis+=ER | 1.5 degrees | Standard Deviation 2.5 |
| Stryker Precision Knee Navigation | Perth CT Protocol | Sagital tibial component slope | 1.3 degrees | Standard Deviation 2.4 |
| Stryker Precision Knee Navigation | Perth CT Protocol | Coronal angle fem comp and mech axis femur | 0.6 degrees | Standard Deviation 1.6 |
| Stryker Precision Knee Navigation | Perth CT Protocol | Coronal angle tibial comp and mech axis tibia | -0.7 degrees | Standard Deviation 1.9 |
| Stryker Precision Knee Navigation | Perth CT Protocol | Coronal mechanical axis:hip knee ankle angle | -0.7 degrees | Standard Deviation 2 |
Comparison: Comparison of coronal mechanical axis:hip knee ankle angle between both groups.p-value: 0.6t-test, 2 sided
Comparison: Comparison of coronal angle fem comp and mech axis femur between both groups.p-value: 0.002t-test, 2 sided
Comparison: Comparison of coronal angle tibial comp and mech axis tibia between both groups.p-value: <0.001t-test, 2 sided
Comparison: Comparison of sagital tibial component slope between both groups.p-value: <0.001t-test, 2 sided
Comparison: Comparison of Fem comp rotation relative to surg epicond axis+=ER between both groups.p-value: <0.001t-test, 2 sided
Secondary
The Forgotten Joint Score (FJS-12)
The Forgotten Joint Score (FJS) is a 12 question form that asks the patient their level of awareness of their artificial joint in 12 scenarios commonly encountered in daily life. Scores can range from 0 to 100 with a higher score indicating a better outcome (high degree of forgetting the joint in everyday life).
Time frame: 6 week, 6 month, 12 month , 2 years and 5 years visits
Population: Patients did not complete CRF to protocol in some instances, resulting in exclusion/missing data points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OtisMed® ShapeMatch® With Triathlon | The Forgotten Joint Score (FJS-12) | 6 month | 60.47 score on a scale | Standard Deviation 29.57 |
| OtisMed® ShapeMatch® With Triathlon | The Forgotten Joint Score (FJS-12) | 2 year | 69.21 score on a scale | Standard Deviation 25.93 |
| OtisMed® ShapeMatch® With Triathlon | The Forgotten Joint Score (FJS-12) | 12 month | 62.47 score on a scale | Standard Deviation 28.99 |
| OtisMed® ShapeMatch® With Triathlon | The Forgotten Joint Score (FJS-12) | 5 year | 68.04 score on a scale | Standard Deviation 28.824 |
| OtisMed® ShapeMatch® With Triathlon | The Forgotten Joint Score (FJS-12) | 6 week | 58.12 score on a scale | Standard Deviation 25.53 |
| Stryker Precision Knee Navigation | The Forgotten Joint Score (FJS-12) | 5 year | 74.12 score on a scale | Standard Deviation 23.38 |
| Stryker Precision Knee Navigation | The Forgotten Joint Score (FJS-12) | 6 week | 57.21 score on a scale | Standard Deviation 29.32 |
| Stryker Precision Knee Navigation | The Forgotten Joint Score (FJS-12) | 6 month | 59.96 score on a scale | Standard Deviation 28.27 |
| Stryker Precision Knee Navigation | The Forgotten Joint Score (FJS-12) | 12 month | 62.01 score on a scale | Standard Deviation 24.84 |
| Stryker Precision Knee Navigation | The Forgotten Joint Score (FJS-12) | 2 year | 66.22 score on a scale | Standard Deviation 25.54 |
Comparison: To compare FJS at 6-weeks between both groups.p-value: 0.523t-test, 2 sided
Comparison: To compare FJS at 6-months between both groups.p-value: 0.932t-test, 2 sided
Comparison: To compare FJS at 1-year between both groups.p-value: 0.934t-test, 2 sided
Comparison: To compare FJS at 2-year between both groups.p-value: 0.566t-test, 2 sided
Comparison: To compare FJS at 5-year between both groups.p-value: 0.263t-test, 2 sided
Secondary
The International Knee Society Score (IKSS)
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: Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively
Population: Patients did not complete CRF to protocol in some instances, resulting in exclusion/missing data points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OtisMed® ShapeMatch® With Triathlon | The International Knee Society Score (IKSS) | 5 year Range of Motion | 122.24 score on a scale | Standard Deviation 6.69 |
| OtisMed® ShapeMatch® With Triathlon | The International Knee Society Score (IKSS) | 6 month IKSS Function | 82.17 score on a scale | Standard Deviation 17.72 |
| OtisMed® ShapeMatch® With Triathlon | The International Knee Society Score (IKSS) | 6 month Range of Motion | 117.24 score on a scale | Standard Deviation 13.31 |
| OtisMed® ShapeMatch® With Triathlon | The International Knee Society Score (IKSS) | 12 month Range of Motion | 118.19 score on a scale | Standard Deviation 12.69 |
| OtisMed® ShapeMatch® With Triathlon | The International Knee Society Score (IKSS) | 2 year Range of Motion | 119.19 score on a scale | Standard Deviation 11.91 |
| OtisMed® ShapeMatch® With Triathlon | The International Knee Society Score (IKSS) | Pre-op IKSS Pain | 40.20 score on a scale | Standard Deviation 15.87 |
| OtisMed® ShapeMatch® With Triathlon | The International Knee Society Score (IKSS) | Pre-op IKSS Function | 54.06 score on a scale | Standard Deviation 15.7 |
| OtisMed® ShapeMatch® With Triathlon | The International Knee Society Score (IKSS) | Pre-op Range of Motion | 118.07 score on a scale | Standard Deviation 11.27 |
| OtisMed® ShapeMatch® With Triathlon | The International Knee Society Score (IKSS) | 6 week IKSS Pain | 63.02 score on a scale | Standard Deviation 15.37 |
| OtisMed® ShapeMatch® With Triathlon | The International Knee Society Score (IKSS) | 6 week IKSS Function | 63.33 score on a scale | Standard Deviation 16.9 |
| OtisMed® ShapeMatch® With Triathlon | The International Knee Society Score (IKSS) | 6 week Range of Motion | 108.64 score on a scale | Standard Deviation 17.58 |
| OtisMed® ShapeMatch® With Triathlon | The International Knee Society Score (IKSS) | 12 month IKSS Pain | 76.96 score on a scale | Standard Deviation 14.65 |
| OtisMed® ShapeMatch® With Triathlon | The International Knee Society Score (IKSS) | 12 month IKSS Function | 83.96 score on a scale | Standard Deviation 17.38 |
| OtisMed® ShapeMatch® With Triathlon | The International Knee Society Score (IKSS) | 2 year IKSS Pain | 73.67 score on a scale | Standard Deviation 9.92 |
| OtisMed® ShapeMatch® With Triathlon | The International Knee Society Score (IKSS) | 2 year IKSS Function | 83.06 score on a scale | Standard Deviation 17.94 |
| OtisMed® ShapeMatch® With Triathlon | The International Knee Society Score (IKSS) | 5 year IKSS Pain | 73.26 score on a scale | Standard Deviation 12.19 |
| OtisMed® ShapeMatch® With Triathlon | The International Knee Society Score (IKSS) | 5 year IKSS Function | 80.96 score on a scale | Standard Deviation 18.41 |
| OtisMed® ShapeMatch® With Triathlon | The International Knee Society Score (IKSS) | 6 month IKSS Pain | 76.32 score on a scale | Standard Deviation 12.72 |
| Stryker Precision Knee Navigation | The International Knee Society Score (IKSS) | 12 month IKSS Function | 80.82 score on a scale | Standard Deviation 20.22 |
| Stryker Precision Knee Navigation | The International Knee Society Score (IKSS) | 6 month IKSS Pain | 68.77 score on a scale | Standard Deviation 18.81 |
| Stryker Precision Knee Navigation | The International Knee Society Score (IKSS) | 6 week IKSS Function | 64.26 score on a scale | Standard Deviation 22.26 |
| Stryker Precision Knee Navigation | The International Knee Society Score (IKSS) | 2 year IKSS Function | 80.52 score on a scale | Standard Deviation 23 |
| Stryker Precision Knee Navigation | The International Knee Society Score (IKSS) | 6 week Range of Motion | 107.28 score on a scale | Standard Deviation 14.99 |
| Stryker Precision Knee Navigation | The International Knee Society Score (IKSS) | 12 month Range of Motion | 116.57 score on a scale | Standard Deviation 12.11 |
| Stryker Precision Knee Navigation | The International Knee Society Score (IKSS) | 6 month IKSS Function | 76.85 score on a scale | Standard Deviation 21.3 |
| Stryker Precision Knee Navigation | The International Knee Society Score (IKSS) | 2 year Range of Motion | 117.63 score on a scale | Standard Deviation 15.2 |
| Stryker Precision Knee Navigation | The International Knee Society Score (IKSS) | 5 year IKSS Pain | 74.71 score on a scale | Standard Deviation 8.95 |
| Stryker Precision Knee Navigation | The International Knee Society Score (IKSS) | 5 year Range of Motion | 120.43 score on a scale | Standard Deviation 9.16 |
| Stryker Precision Knee Navigation | The International Knee Society Score (IKSS) | 6 month Range of Motion | 113.09 score on a scale | Standard Deviation 21.31 |
| Stryker Precision Knee Navigation | The International Knee Society Score (IKSS) | Pre-op IKSS Pain | 37.33 score on a scale | Standard Deviation 14.82 |
| Stryker Precision Knee Navigation | The International Knee Society Score (IKSS) | 2 year IKSS Pain | 70.10 score on a scale | Standard Deviation 16.32 |
| Stryker Precision Knee Navigation | The International Knee Society Score (IKSS) | Pre-op IKSS Function | 55.50 score on a scale | Standard Deviation 14.82 |
| Stryker Precision Knee Navigation | The International Knee Society Score (IKSS) | 12 month IKSS Pain | 73.29 score on a scale | Standard Deviation 15.08 |
| Stryker Precision Knee Navigation | The International Knee Society Score (IKSS) | Pre-op Range of Motion | 116.17 score on a scale | Standard Deviation 15.51 |
| Stryker Precision Knee Navigation | The International Knee Society Score (IKSS) | 5 year IKSS Function | 85.96 score on a scale | Standard Deviation 16.64 |
| Stryker Precision Knee Navigation | The International Knee Society Score (IKSS) | 6 week IKSS Pain | 58.30 score on a scale | Standard Deviation 18.28 |
Comparison: To compare IKSS Pain preoperatively between both groups.p-value: 0.3768t-test, 2 sided
Comparison: To compare IKSS Function preoperatively between both groups.p-value: 0.6425t-test, 2 sided
Comparison: To compare IKSS ROM preoperatively between both groups.p-value: 0.5041t-test, 2 sided
Comparison: To compare IKSS Pain at 6-weeks between both groups.p-value: 0.223t-test, 2 sided
Comparison: To compare IKSS Function at 6-weeks between both groups.p-value: 0.8209t-test, 2 sided
Comparison: To compare IKSS ROM at 6-weeks between both groups.p-value: 0.6958t-test, 2 sided
Comparison: To compare IKSS Pain at 6-months between both groups.p-value: 0.0548t-test, 2 sided
Comparison: To compare IKSS Function at 6-months between both groups.p-value: 0.1958t-test, 2 sided
Comparison: To compare IKSS ROM at 6-months between both groups.p-value: 0.2786t-test, 2 sided
Comparison: To compare IKSS Pain at 1-year between both groups.p-value: 0.2399t-test, 2 sided
Comparison: To compare IKSS Function at 1-year between both groups.p-value: 0.4135t-test, 2 sided
Comparison: To compare IKSS ROM at 1-year between both groups.p-value: 0.5278t-test, 2 sided
Comparison: To compare IKSS Pain at 2-year between both groups.p-value: 0.2992t-test, 2 sided
Comparison: To compare IKSS Function at 2-year between both groups.p-value: 0.5462t-test, 2 sided
Comparison: To compare IKSS ROM at 2-year between both groups.p-value: 0.5765t-test, 2 sided
Comparison: To compare IKSS Pain at 5-year between both groups.p-value: 0.5493t-test, 2 sided
Comparison: To compare IKSS Function at 5-year between both groups.p-value: 0.1705t-test, 2 sided
Comparison: To compare IKSS ROM at 5-year between both groups.p-value: 0.2918t-test, 2 sided
Secondary
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
The WOMAC is completed by the participant and measures five items for pain (score range 0-100), two for stiffness (score range 0-100), and 17 for functional limitation (score range 0-100). The total score is the sum of these three categories.
Time frame: Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively
Population: Patients did not complete CRF to protocol in some instances, resulting in exclusion/missing data points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OtisMed® ShapeMatch® With Triathlon | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 6-week | 74.74 score on a scale | Standard Deviation 11.75 |
| OtisMed® ShapeMatch® With Triathlon | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 1-year | 90.86 score on a scale | Standard Deviation 11.14 |
| OtisMed® ShapeMatch® With Triathlon | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) | Pre-op | 50.05 score on a scale | Standard Deviation 13.07 |
| OtisMed® ShapeMatch® With Triathlon | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 2-year | 88.36 score on a scale | Standard Deviation 13.6 |
| OtisMed® ShapeMatch® With Triathlon | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 6-month | 87.89 score on a scale | Standard Deviation 9.73 |
| OtisMed® ShapeMatch® With Triathlon | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 5-year | 86.13 score on a scale | Standard Deviation 15.49 |
| Stryker Precision Knee Navigation | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 6-month | 81.79 score on a scale | Standard Deviation 15.94 |
| Stryker Precision Knee Navigation | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) | Pre-op | 50.36 score on a scale | Standard Deviation 14.91 |
| Stryker Precision Knee Navigation | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 6-week | 73.06 score on a scale | Standard Deviation 17.61 |
| Stryker Precision Knee Navigation | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 5-year | 89.14 score on a scale | Standard Deviation 15.11 |
| Stryker Precision Knee Navigation | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 1-year | 86.79 score on a scale | Standard Deviation 14.93 |
| Stryker Precision Knee Navigation | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 2-year | 85.46 score on a scale | Standard Deviation 16.79 |
Comparison: To compare WOMAC preoperatively between both groups.p-value: 0.911t-test, 2 sided
Comparison: To compare WOMAC at 6-weeks between both groups.p-value: 0.588t-test, 2 sided
Comparison: To compare WOMAC at 6-months between both groups.p-value: 0.03t-test, 2 sided
Comparison: To compare WOMAC at 1-year between both groups.p-value: 0.131t-test, 2 sided
Comparison: To compare WOMAC at 2-years between both groups.p-value: 0.347t-test, 2 sided
Comparison: To compare WOMAC at 5-years between both groups.p-value: 0.341t-test, 2 sided