N/A
Completed N=411
Triathlon® Cruciate Retaining (CR) Total Knee System Outcomes Study
Arthroplasty, Replacement, Knee
Source: ClinicalTrials.gov NCT00957723 ↗
Enrolled (actual)
411
Serious AEs
13.0%
Results posted
Apr 2014
Primary outcomePrimary: Active Range of Motion — 119.2 Degrees
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Active Range of Motion |
119.2 | — |
| SECONDARY Change in Knee Society Score (KSS) Over Time |
37.39; 92.12; 93.83; 94.86; 53.34; 86.04 | <0.0001 sig |
| SECONDARY Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM) |
118.47; 119.53; 120.74; 0.37; 0.28; 0.26 | <0.0001 sig |
| SECONDARY Number of Knees With Radiographic Failure Assessed Via the Knee Society Total Knee Arthroplasty Roentgenographic Score |
1; 1; 0 | — |
| SECONDARY Change in SF-36 Health Survey Over Time |
32.54; 47.77; 47.48; 46.94; 46.22; 46.04 | <0.0001 sig |
| SECONDARY Change in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Over Time |
94.54; 11.68; 36.33; 26.71 | — |
| SECONDARY Change in Lower-Extremity Activity Scale (LEAS) Over Time |
9.30; 11.22; 11.45; 11.10; 11.10; 11.44 | <0.0001 sig |
| SECONDARY Patellar Subluxation, Dislocation and Fracture Rate |
4; 0; 0 | — |
| SECONDARY Patient Outcome Long Term Follow-up Questionnaire Over Time |
8; 9; 8; 9; 9; 47 | — |
| SECONDARY Implant Survivorship |
98.62; 100 | — |
Eligibility Criteria
Inclusion Criteria
- The subject is a male or non-pregnant female between the ages of 21 and 80.
- The subject requires a primary cemented total knee replacement.
- The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
- The subject has intact collateral ligaments.
- The subject has signed the IRB-approved, study specific Informed Patient Consent Form.
- The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Exclusion Criteria
- Patient has inflammatory arthritis.
- The subject is morbidly obese, BMI > 40.
- The subject has a history of total or unicompartmental reconstruction of the affected joint.
- Patient has had a high tibial osteotomy or femoral osteotomy.
- 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).
- The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
- The subject is immunologically suppressed, or receiving chronic steroids (> 30 days duration).
- The subject's bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prothesis.
- The subject has had a knee fusion to the affected joint.
- The subject has an active or suspected latent infection in or about the knee joint.
- The subject is a prisoner.
Data sourced from ClinicalTrials.gov (NCT00957723). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.