Total Knee Arthroplasty
Conditions
Keywords
Knee Replacement, Arthroplasty
Brief summary
An open label, post-market, non-randomised, historical controlled, multi-centre study of the outcomes of the Triathlon Cruciate Retaining (CR) Total Knee System.
Detailed description
An open label, post-market, non-randomised, historical controlled, multi-centre study of the outcomes of the Triathlon Cruciate Retaining (CR) Total Knee System. The primary objective of this study will be to compare the active range of motion values for the Triathlon CR Total Knee System with those of the Scorpio CR Total Knee System, a historical control group. ROM values will be measured by use of a Goniometer according to the protocol. It is expected that the Triathlon CR Total Knee System group's range of motion is not 5 degrees worse or superior to the control group's range of motion at two-years.
Interventions
DEVICETriathlon CR Total Knee System
Primary total knee replacement
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. Patients willing to sign the Ethic Commission approved, study specific Informed Patient Consent Form. 2. Patients willing and able to comply with scheduled postoperative clinical and radiographic evaluations and rehabilitation. 3. Male or non-pregnant female between the ages of 21-80 years of age at the time of surgery. 4. Patients requiring a primary total knee replacement. 5. Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN). 6. Patients with intact collateral ligaments.
Exclusion criteria
1. Patients with inflammatory arthritis. 2. Patients that are morbidly obese, body mass index (BMI) \> 40. 3. Patients with a history of total / unicompartmental reconstruction of the affected joint. 4. Patients that have had a high tibial osteotomy or femoral osteotomy. 5. Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. 6. Patients with a systemic or metabolic disorder leading to progressive bone deterioration. 7. Patients that are immunologically compromised, or receiving chronic steroids (\>30 days duration). 8. Patients bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis. 9. Patients with a knee fusion to the affected joint. 10. Patients with an active or suspected latent infection in or about the knee joint. 11. Patients with a history of total joint replacement on the opposite knee within less than 1 year. 12. Patients requiring bilateral total knee replacement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Triathlon CR Active Range of Motion (ROM) | 2 years follow-up | Comparison of the active ROM values for patients receiving the Triathlon CR Total Knee System with historical active ROM values of the Scorpio CR Total Knee System, a control group by literature review at 2 years post Total Knee Arthroplasty. See Chaudhary R, et al 2008 JBJS included for historical control data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigation of Patient Outcome With Radiographic Analysis | Pre-operative, 3 months, 1, 2 and 5 years follow-up | Plain radiographs will be obtained for assessment of fixation of the device. |
| Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up | 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 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. |
| Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire | Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up | The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical (PSC) and mental status component (MCS) score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state. |
| Investigation of Clinical Performance and Patient Outcome With the Western Ontario McMaster Osteoarthritis Index (WOMAC) Patient Questionnaire | Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up | 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. |
Countries
Denmark, Finland, Germany, Spain
Participant flow
Recruitment details
The first patient included in the study was enrolled in October 2006. 168 cases received the Triathlon CR knee system over a 56 month period in a consecutive manner in 6 centers.
Participants by arm
| Arm | Count |
|---|---|
| Triathlon CR Total Knee System Progressive data: Primary total knee replacement | 168 |
| Total | 168 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Exclusion criteria: Bilateral implant | 4 |
| Overall Study | Lost to Follow-up | 10 |
| Overall Study | Missing data | 6 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | Triathlon CR Total Knee System |
|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 8.3 |
| Range of Motion (ROM) | 107.21 degree STANDARD_DEVIATION 12.5 |
| Sex: Female, Male Female | 114 Participants |
| Sex: Female, Male Male | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 168 |
| serious Total, serious adverse events | 23 / 168 |
Outcome results
Primary
Mean Triathlon CR Active Range of Motion (ROM)
Comparison of the active ROM values for patients receiving the Triathlon CR Total Knee System with historical active ROM values of the Scorpio CR Total Knee System, a control group by literature review at 2 years post Total Knee Arthroplasty. See Chaudhary R, et al 2008 JBJS included for historical control data.
Time frame: 2 years follow-up
Population: Comparison to data from the literature was not done.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Triathlon CR Total Knee System | Mean Triathlon CR Active Range of Motion (ROM) | 112.96 degree | Standard Deviation 13.708 |
Secondary
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)
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 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: Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up
Population: The number included in the analysis in one or more rows differs from the overall number analysed because that data were not collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triathlon CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | KSS Pain/Motion pre-operative | 38.2 units on a scale | Standard Deviation 21.7 |
| Triathlon CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | KSS Pain/Motion 3 months | 75.2 units on a scale | Standard Deviation 15.4 |
| Triathlon CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | KSS Pain/Motion 1 year | 81.7 units on a scale | Standard Deviation 13.8 |
| Triathlon CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | KSS Pain/Motion 2 years | 86 units on a scale | Standard Deviation 11.5 |
| Triathlon CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | KSS Pain/Motion 5 years | 88 units on a scale | Standard Deviation 9.7 |
| Triathlon CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | KSS Function Score pre-operative | 58.9 units on a scale | Standard Deviation 14.2 |
| Triathlon CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | KSS Function Score 3 months | 78.9 units on a scale | Standard Deviation 17.5 |
| Triathlon CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | KSS Function Score 1 year | 82.2 units on a scale | Standard Deviation 18.5 |
| Triathlon CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | KSS Function Score 2 years | 86.2 units on a scale | Standard Deviation 18 |
| Triathlon CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | KSS Function Score 5 years | 81.5 units on a scale | Standard Deviation 20.5 |
Secondary
Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire
The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical (PSC) and mental status component (MCS) score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
Time frame: Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up
Population: The number included in the analysis in one or more rows differs from the overall number analysed because that data were not collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triathlon CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire | 3 years MCS | 51.4 units on a scale | Standard Deviation 11.3 |
| Triathlon CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire | pre-operative PCS | 30.0 units on a scale | Standard Deviation 8.2 |
| Triathlon CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire | 3 months PCS | 37.5 units on a scale | Standard Deviation 8.8 |
| Triathlon CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire | 1 year PCS | 42.0 units on a scale | Standard Deviation 9.4 |
| Triathlon CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire | 2 years PCS | 44.6 units on a scale | Standard Deviation 9.7 |
| Triathlon CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire | 3 years PCS | 41.9 units on a scale | Standard Deviation 10.8 |
| Triathlon CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire | 4 years PCS | 42.1 units on a scale | Standard Deviation 10.7 |
| Triathlon CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire | 5 years PCS | 43.0 units on a scale | Standard Deviation 11.1 |
| Triathlon CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire | pre-operative MCS | 47.5 units on a scale | Standard Deviation 13.5 |
| Triathlon CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire | 3 months MCS | 50.7 units on a scale | Standard Deviation 10.8 |
| Triathlon CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire | 1 year MCS | 52.2 units on a scale | Standard Deviation 9.5 |
| Triathlon CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire | 2 years MCS | 50.8 units on a scale | Standard Deviation 10.5 |
| Triathlon CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire | 4 years MCS | 50.7 units on a scale | Standard Deviation 10.5 |
| Triathlon CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire | 5 years MCS | 53.9 units on a scale | Standard Deviation 10.3 |
Secondary
Investigation of Clinical Performance and Patient Outcome With the Western Ontario McMaster Osteoarthritis Index (WOMAC) Patient Questionnaire
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: Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up
Population: The number included in the analysis in one or more rows differs from the overall number analysed because that data were not collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triathlon CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Western Ontario McMaster Osteoarthritis Index (WOMAC) Patient Questionnaire | pre-operative total score | 166.42 units on a scale | Standard Deviation 60.88 |
| Triathlon CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Western Ontario McMaster Osteoarthritis Index (WOMAC) Patient Questionnaire | 3 months total score | 78.99 units on a scale | Standard Deviation 58.98 |
| Triathlon CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Western Ontario McMaster Osteoarthritis Index (WOMAC) Patient Questionnaire | 1 year total score | 45.04 units on a scale | Standard Deviation 47.14 |
| Triathlon CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Western Ontario McMaster Osteoarthritis Index (WOMAC) Patient Questionnaire | 2 years total score | 40.6 units on a scale | Standard Deviation 41.3 |
| Triathlon CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Western Ontario McMaster Osteoarthritis Index (WOMAC) Patient Questionnaire | 3 years total score | 46.28 units on a scale | Standard Deviation 51.02 |
| Triathlon CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Western Ontario McMaster Osteoarthritis Index (WOMAC) Patient Questionnaire | 4 years total score | 47.94 units on a scale | Standard Deviation 52.21 |
| Triathlon CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Western Ontario McMaster Osteoarthritis Index (WOMAC) Patient Questionnaire | 5 years total score | 43.64 units on a scale | Standard Deviation 53.1 |
Secondary
Investigation of Patient Outcome With Radiographic Analysis
Plain radiographs will be obtained for assessment of fixation of the device.
Time frame: Pre-operative, 3 months, 1, 2 and 5 years follow-up
Population: Radiographic data were not collected