Arthroplasty, Replacement, Knee
Conditions
Brief summary
The purpose of this study is to evaluate the clinical outcomes (range of motion, pain, function, radiographic stability, and health related quality of life) of patients receiving the Triathlon® Cruciate Retaining (CR) Total Knee System. These outcomes will be evaluated by comparing pre-operative to post-operative scores, as well as to a control group. The control group is the Scorpio® CR Total Knee System.
Detailed description
The Triathlon® Cruciate Retaining (CR) Total Knee System components are for use in cemented total knee arthroplasty for painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis (excluded from this study according to protocol). The components are designed to improve range of motion (ROM) and stability. This study serves to demonstrate that subjects have reduced pain, increased ROM and improved stability following implantation with the Triathlon Cruciate Retaining (CR) Total Knee System as compared to the historical control.
Interventions
DEVICETriathlon® CR Total Knee System
The purpose is to evaluate the Triathlon® CR Total Knee System.
Sponsors
Stryker Orthopaedics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. The subject is a male or non-pregnant female between the ages of 21 and 80. 2. The subject requires a primary cemented total knee replacement. 3. The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN). 4. The subject has intact collateral ligaments. 5. The subject has signed the IRB-approved, study specific Informed Patient Consent Form. 6. The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Exclusion criteria
1. Patient has inflammatory arthritis. 2. The subject is morbidly obese, BMI \> 40. 3. The subject has a history of total or unicompartmental reconstruction of the affected joint. 4. Patient has had a high tibial osteotomy or femoral osteotomy. 5. The subject has no obvious charcot (i.e. a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device). 6. The patient has a systemic or metabolic disorder leading to progressive bone deterioration. 7. The subject is immunologically suppressed, or receiving chronic steroids (\> 30 days duration). 8. The subject's bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prothesis. 9. The subject has had a knee fusion to the affected joint. 10. The subject has an active or suspected latent infection in or about the knee joint. 11. The subject is a prisoner.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Active Range of Motion | 2 Years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM) | 1, 2, and 5 years | Knee range of motion is measured by the number of degrees flexion and extension observed. Active motion is the number of degrees that a participant can extend and flex their knee independently. Passive motion is the number of degrees that an examiner is able to extend and flex the knee without the assistance of the participant. The Knee Society Score range of motion utilized for this study defines the range from 0 degrees of extension to 125 degrees of flexion. |
| Number of Knees With Radiographic Failure Assessed Via the Knee Society Total Knee Arthroplasty Roentgenographic Score | 1, 2, and 5 years | Parameters for radiographic failures will follow the guidelines that have been set by the Knee Society. The scoring system for each of the three components is determined by measuring the width of the radiolucent lines for each of the zones in millimeters for each of the three components. The total widths in millimeters are added for each zone for each of the three prostheses. The total produces a numerical score for each component. Failure is defined as a score of 10 or greater, regardless of symptoms. |
| Change in SF-36 Health Survey Over Time | preoperative, 1, 2, 3, 4, and 5 years | The SF-36 Health Survey is a 36 item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state. |
| Change in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Over Time | preoperative,1, 2, 3, 4 and 5 years | The WOMAC collects information specific to osteoarthritis outcomes. The questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and physical findings. Pain is scored from 0 to 100 for each set of factors, with 0 indicating no pain and 100 indicating extreme pain. Total WOMAC scores range from 0 to 300. Lower values represent better outcomes. |
| Change in Knee Society Score (KSS) Over Time | preoperative, 1, 2, and 5 years | The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, ROM and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome. |
| Patellar Subluxation, Dislocation and Fracture Rate | 5 years | The incidence of patellar subluxation, dislocation or fracture is reported. |
| Patient Outcome Long Term Follow-up Questionnaire Over Time | 6, 7, 8, 9, and 10 years | Patient-reported outcome is collected using a long-term follow-up questionnaire at 6, 7, 8, 9, and 10 years postoperative for the subjects who consent to participation in the long-term follow-up study. The questionnaire consists of three yes or no questions: 1. Do you have any pain in your knee that has the study knee replacement? 2. Are you satisfied with the results of your study total knee replacement? 3. Have you had any surgery on your study knee since the time of your last study required visit/contact? |
| Implant Survivorship | 10 years | Implant survivorship at 10 years postoperative is determined using the Kaplan-Meier method. |
| Change in Lower-Extremity Activity Scale (LEAS) Over Time | preoperative, 1, 2, 3, 4, and 5 years | The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. |
Countries
United States
Participant flow
Pre-assignment details
467/500 participants/knees enrolled;56 participants/60 knees censored = 411/440 participants/knees followed
Participants by arm
| Arm | Count |
|---|---|
| Triathlon® CR Total Knee System Participants who received the Triathlon® CR Total Knee System and were not censored from analysis. | 411 |
| Total | 411 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | 2yr ROM Data Not Evaluable | 12 |
| Overall Study | Death | 3 |
| Overall Study | Intercurrent Illness | 2 |
| Overall Study | Investigative Site Terminated | 61 |
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | Revision/ Removal of Study Implant | 3 |
| Overall Study | Withdrawal by Subject | 24 |
Baseline characteristics
| Characteristic | Triathlon® CR Total Knee System |
|---|---|
| Age, Continuous | 65.5 years STANDARD_DEVIATION 8.63 |
| Region of Enrollment United States | 411 participants |
| Sex: Female, Male Female | 239 Participants |
| Sex: Female, Male Male | 172 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 79 / 440 | 0 / 411 |
| serious Total, serious adverse events | 21 / 440 | 90 / 411 |
Outcome results
Primary
Active Range of Motion
Time frame: 2 Years
Population: Participants/knees with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Triathlon® CR Total Knee System | Active Range of Motion | 119.2 Degrees | Standard Deviation 10.66 |
Secondary
Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM)
Knee range of motion is measured by the number of degrees flexion and extension observed. Active motion is the number of degrees that a participant can extend and flex their knee independently. Passive motion is the number of degrees that an examiner is able to extend and flex the knee without the assistance of the participant. The Knee Society Score range of motion utilized for this study defines the range from 0 degrees of extension to 125 degrees of flexion.
Time frame: 1, 2, and 5 years
Population: Participants/knees with available data. Overall number of participants and units analyzed is based upon preoperative population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triathlon® CR Total Knee System | Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM) | Active Flexion 1 Year | 118.47 degrees | Standard Deviation 10.59 |
| Triathlon® CR Total Knee System | Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM) | Active Flexion 2 Years | 119.53 degrees | Standard Deviation 10.26 |
| Triathlon® CR Total Knee System | Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM) | Active Flexion 5 Years | 120.74 degrees | Standard Deviation 9 |
| Triathlon® CR Total Knee System | Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM) | Active Extension 1 Year | 0.37 degrees | Standard Deviation 1.66 |
| Triathlon® CR Total Knee System | Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM) | Active Extension 2 Years | 0.28 degrees | Standard Deviation 1.71 |
| Triathlon® CR Total Knee System | Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM) | Active Extension 5 Years | 0.26 degrees | Standard Deviation 1.49 |
| Triathlon® CR Total Knee System | Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM) | Passive Flexion 1 Year | 121.55 degrees | Standard Deviation 10.43 |
| Triathlon® CR Total Knee System | Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM) | Passive Flexion 2 Years | 122.89 degrees | Standard Deviation 10.39 |
| Triathlon® CR Total Knee System | Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM) | Passive Flexion 5 Years | 123.41 degrees | Standard Deviation 8.53 |
| Triathlon® CR Total Knee System | Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM) | Passive Extension 1 Year | 0.19 degrees | Standard Deviation 1.23 |
| Triathlon® CR Total Knee System | Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM) | Passive Extension 2 Years | 0.08 degrees | Standard Deviation 0.91 |
| Triathlon® CR Total Knee System | Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM) | Passive Extension 5 Years | 0.16 degrees | Standard Deviation 1.01 |
Comparison: Change from pre-op to 1, 2, and 5 yearp-value: <0.0001Sign test
Secondary
Change in Knee Society Score (KSS) Over Time
The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, ROM and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score 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: preoperative, 1, 2, and 5 years
Population: Participants/knees with available data. Overall number of participants and units analyzed is based upon the preoperative population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triathlon® CR Total Knee System | Change in Knee Society Score (KSS) Over Time | Pain/Motion Mean Preoperative Score | 37.39 units on a scale | Standard Deviation 13.8 |
| Triathlon® CR Total Knee System | Change in Knee Society Score (KSS) Over Time | Pain/Motion Mean 1 Year Score | 92.12 units on a scale | Standard Deviation 10.13 |
| Triathlon® CR Total Knee System | Change in Knee Society Score (KSS) Over Time | Pain/Motion Mean 2 Year Score | 93.83 units on a scale | Standard Deviation 7.93 |
| Triathlon® CR Total Knee System | Change in Knee Society Score (KSS) Over Time | Pain/Motion Mean 5 Year Score | 94.86 units on a scale | Standard Deviation 8.48 |
| Triathlon® CR Total Knee System | Change in Knee Society Score (KSS) Over Time | Function Mean Preoperative Score | 53.34 units on a scale | Standard Deviation 17.46 |
| Triathlon® CR Total Knee System | Change in Knee Society Score (KSS) Over Time | Function Mean 1 Year Score | 86.04 units on a scale | Standard Deviation 17.4 |
| Triathlon® CR Total Knee System | Change in Knee Society Score (KSS) Over Time | Function Mean 2 Year Score | 86.08 units on a scale | Standard Deviation 17.98 |
| Triathlon® CR Total Knee System | Change in Knee Society Score (KSS) Over Time | Function Mean 5 Year Score | 85.49 units on a scale | Standard Deviation 19.62 |
Comparison: Change from pre-op to 1 year, 2 year and 5 yearp-value: <0.0001Sign test
Secondary
Change in Lower-Extremity Activity Scale (LEAS) Over Time
The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.
Time frame: preoperative, 1, 2, 3, 4, and 5 years
Population: Participants/knees with available data. Overall number of participants and units analyzed is based upon the preoperative population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triathlon® CR Total Knee System | Change in Lower-Extremity Activity Scale (LEAS) Over Time | LEAS Preoperative | 9.30 units on a scale | Standard Deviation 2.87 |
| Triathlon® CR Total Knee System | Change in Lower-Extremity Activity Scale (LEAS) Over Time | LEAS 1 Year | 11.22 units on a scale | Standard Deviation 2.71 |
| Triathlon® CR Total Knee System | Change in Lower-Extremity Activity Scale (LEAS) Over Time | LEAS 2 Years | 11.45 units on a scale | Standard Deviation 2.91 |
| Triathlon® CR Total Knee System | Change in Lower-Extremity Activity Scale (LEAS) Over Time | LEAS 3 Years | 11.10 units on a scale | Standard Deviation 2.76 |
| Triathlon® CR Total Knee System | Change in Lower-Extremity Activity Scale (LEAS) Over Time | LEAS 4 Years | 11.10 units on a scale | Standard Deviation 2.89 |
| Triathlon® CR Total Knee System | Change in Lower-Extremity Activity Scale (LEAS) Over Time | LEAS 5 Years | 11.44 units on a scale | Standard Deviation 2.94 |
Comparison: LEAS score change from preop to 1, 2, 3, 4, and 5 yearsp-value: <0.0001Sign test
Secondary
Change in SF-36 Health Survey Over Time
The SF-36 Health Survey is a 36 item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
Time frame: preoperative, 1, 2, 3, 4, and 5 years
Population: Participants/knees with available data. Overall number of participants and units analyzed is based upon the preoperative population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triathlon® CR Total Knee System | Change in SF-36 Health Survey Over Time | Physical Score Preoperative | 32.54 units on a scale | Standard Deviation 7.5 |
| Triathlon® CR Total Knee System | Change in SF-36 Health Survey Over Time | Physical Score 1 Year | 47.77 units on a scale | Standard Deviation 7.96 |
| Triathlon® CR Total Knee System | Change in SF-36 Health Survey Over Time | Physical Score 2 Years | 47.48 units on a scale | Standard Deviation 8.71 |
| Triathlon® CR Total Knee System | Change in SF-36 Health Survey Over Time | Physical Score 3 Years | 46.94 units on a scale | Standard Deviation 9.06 |
| Triathlon® CR Total Knee System | Change in SF-36 Health Survey Over Time | Physical Score 4 Years | 46.22 units on a scale | Standard Deviation 9.46 |
| Triathlon® CR Total Knee System | Change in SF-36 Health Survey Over Time | Physical score 5 Years | 46.04 units on a scale | Standard Deviation 9.57 |
| Triathlon® CR Total Knee System | Change in SF-36 Health Survey Over Time | Mental Score Preoperative | 52.55 units on a scale | Standard Deviation 12.13 |
| Triathlon® CR Total Knee System | Change in SF-36 Health Survey Over Time | Mental Score 1 Year | 55.60 units on a scale | Standard Deviation 7.79 |
| Triathlon® CR Total Knee System | Change in SF-36 Health Survey Over Time | Mental Score 2 Years | 55.79 units on a scale | Standard Deviation 7.86 |
| Triathlon® CR Total Knee System | Change in SF-36 Health Survey Over Time | Mental Score 3 Years | 55.53 units on a scale | Standard Deviation 7.72 |
| Triathlon® CR Total Knee System | Change in SF-36 Health Survey Over Time | Mental Score 4 Years | 54.72 units on a scale | Standard Deviation 7.87 |
| Triathlon® CR Total Knee System | Change in SF-36 Health Survey Over Time | Mental Score 5 Years | 55.65 units on a scale | Standard Deviation 8.37 |
Comparison: SF36 Physical Component Score change from preop to 1 yearp-value: <0.0001Sign test
Comparison: SF36 Mental Component Score change from preop to 1 yearp-value: 0.0002Sign test
Comparison: SF36 Physical Component Score change from preop to 2 yearsp-value: <0.0001t-test, 2 sided
Comparison: SF36 Mental Component Score change from preop to 2 yearsp-value: 0.0177Sign test
Comparison: SF36 Physical Component Score change from preop to 3 yearp-value: <0.0001t-test, 2 sided
Comparison: SF36 Mental Component Score change from preop to 3 yearp-value: 0.0393Sign test
Comparison: SF36 Physical Component Score change from preop to 4 yearp-value: <0.0001t-test, 2 sided
Comparison: SF36 Mental Component Score change from preop to 4 yearp-value: 0.4905t-test, 2 sided
Comparison: SF36 Physical Component Score change from preop to 5 yearp-value: <0.0001t-test, 2 sided
Comparison: SF36 Mental Component Score change from preop to 5 yearp-value: 0.0037Sign test
Secondary
Change in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Over Time
The WOMAC collects information specific to osteoarthritis outcomes. The questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and physical findings. Pain is scored from 0 to 100 for each set of factors, with 0 indicating no pain and 100 indicating extreme pain. Total WOMAC scores range from 0 to 300. Lower values represent better outcomes.
Time frame: preoperative,1, 2, 3, 4 and 5 years
Population: Participants/knees with available data. Data for the WOMAC is only available at the 2, 3, 4 and 5 year intervals in limited numbers due to typographical errors noted on earlier interval forms rendering them invalid for comparison.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triathlon® CR Total Knee System | Change in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Over Time | Total WOMAC 2 Years | 94.54 units on a scale | — |
| Triathlon® CR Total Knee System | Change in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Over Time | Total WOMAC 3 Years | 11.68 units on a scale | — |
| Triathlon® CR Total Knee System | Change in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Over Time | Total WOMAC 4 Years | 36.33 units on a scale | Standard Deviation 48.92 |
| Triathlon® CR Total Knee System | Change in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Over Time | Total WOMAC 5 Years | 26.71 units on a scale | Standard Deviation 36.18 |
Secondary
Implant Survivorship
Implant survivorship at 10 years postoperative is determined using the Kaplan-Meier method.
Time frame: 10 years
Population: Participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Triathlon® CR Total Knee System | Implant Survivorship | Kaplan-Meier estimate (based on 5-year cases) | 98.62 percentage of knees |
| Triathlon® CR Total Knee System | Implant Survivorship | Kaplan-Meier estimate (based on 10-year cases) | 100 percentage of knees |
Secondary
Number of Knees With Radiographic Failure Assessed Via the Knee Society Total Knee Arthroplasty Roentgenographic Score
Parameters for radiographic failures will follow the guidelines that have been set by the Knee Society. The scoring system for each of the three components is determined by measuring the width of the radiolucent lines for each of the zones in millimeters for each of the three components. The total widths in millimeters are added for each zone for each of the three prostheses. The total produces a numerical score for each component. Failure is defined as a score of 10 or greater, regardless of symptoms.
Time frame: 1, 2, and 5 years
Population: Participants/knees with available data. Overall number of participants and units analyzed is based upon the one year population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Triathlon® CR Total Knee System | Number of Knees With Radiographic Failure Assessed Via the Knee Society Total Knee Arthroplasty Roentgenographic Score | Radiographic Failure at 1 Year | 1 Total number of knees |
| Triathlon® CR Total Knee System | Number of Knees With Radiographic Failure Assessed Via the Knee Society Total Knee Arthroplasty Roentgenographic Score | Radiographic Failure at 2 Years | 1 Total number of knees |
| Triathlon® CR Total Knee System | Number of Knees With Radiographic Failure Assessed Via the Knee Society Total Knee Arthroplasty Roentgenographic Score | Radiographic Failure at 5 Years | 0 Total number of knees |
Secondary
Patellar Subluxation, Dislocation and Fracture Rate
The incidence of patellar subluxation, dislocation or fracture is reported.
Time frame: 5 years
Population: Participants/knees with available data at 5 years.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Triathlon® CR Total Knee System | Patellar Subluxation, Dislocation and Fracture Rate | Patellar fracture | 4 knees |
| Triathlon® CR Total Knee System | Patellar Subluxation, Dislocation and Fracture Rate | Patellar subluxation | 0 knees |
| Triathlon® CR Total Knee System | Patellar Subluxation, Dislocation and Fracture Rate | Patellar dislocation | 0 knees |
Secondary
Patient Outcome Long Term Follow-up Questionnaire Over Time
Patient-reported outcome is collected using a long-term follow-up questionnaire at 6, 7, 8, 9, and 10 years postoperative for the subjects who consent to participation in the long-term follow-up study. The questionnaire consists of three yes or no questions: 1. Do you have any pain in your knee that has the study knee replacement? 2. Are you satisfied with the results of your study total knee replacement? 3. Have you had any surgery on your study knee since the time of your last study required visit/contact?
Time frame: 6, 7, 8, 9, and 10 years
Population: Participants/knees with available data. Overall number of participants and units analyzed is based upon the eight year postoperative population, as this was the largest available population between the 6-10 year postoperative intervals.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Triathlon® CR Total Knee System | Patient Outcome Long Term Follow-up Questionnaire Over Time | Absence of Surgery on Study Knee at 7 Yr | 79 knees |
| Triathlon® CR Total Knee System | Patient Outcome Long Term Follow-up Questionnaire Over Time | Pain in Study Knee at 6 Yr | 8 knees |
| Triathlon® CR Total Knee System | Patient Outcome Long Term Follow-up Questionnaire Over Time | Pain in Study Knee at 7 Yr | 9 knees |
| Triathlon® CR Total Knee System | Patient Outcome Long Term Follow-up Questionnaire Over Time | Pain in Study Knee at 8 Yr | 8 knees |
| Triathlon® CR Total Knee System | Patient Outcome Long Term Follow-up Questionnaire Over Time | Pain in Study Knee at 9 Yr | 9 knees |
| Triathlon® CR Total Knee System | Patient Outcome Long Term Follow-up Questionnaire Over Time | Pain in Study Knee at 10 Yr | 9 knees |
| Triathlon® CR Total Knee System | Patient Outcome Long Term Follow-up Questionnaire Over Time | Satisfied with Results of Knee Replacement at 6 Yr | 47 knees |
| Triathlon® CR Total Knee System | Patient Outcome Long Term Follow-up Questionnaire Over Time | Satisfied with Results of Knee Replacement at 7 Yr | 79 knees |
| Triathlon® CR Total Knee System | Patient Outcome Long Term Follow-up Questionnaire Over Time | Satisfied with Results of Knee Replacement at 8 Yr | 88 knees |
| Triathlon® CR Total Knee System | Patient Outcome Long Term Follow-up Questionnaire Over Time | Satisfied with Results of Knee Replacement at 9 Yr | 83 knees |
| Triathlon® CR Total Knee System | Patient Outcome Long Term Follow-up Questionnaire Over Time | Satisfied with Results of Knee Replacement at 10Yr | 89 knees |
| Triathlon® CR Total Knee System | Patient Outcome Long Term Follow-up Questionnaire Over Time | Absence of Surgery on Study Knee at 6 Yr | 47 knees |
| Triathlon® CR Total Knee System | Patient Outcome Long Term Follow-up Questionnaire Over Time | Absence of Surgery on Study Knee at 8 Yr | 93 knees |
| Triathlon® CR Total Knee System | Patient Outcome Long Term Follow-up Questionnaire Over Time | Absence of Surgery on Study Knee at 9 Yr | 87 knees |
| Triathlon® CR Total Knee System | Patient Outcome Long Term Follow-up Questionnaire Over Time | Absence of Surgery on Study Knee at 10 Yr | 91 knees |