N/A
Completed N=354
Triathlon® Posteriorly Stabilized (PS) Total Knee System - Outcomes Study
Arthroplasty, Replacement, Knee
Source: ClinicalTrials.gov NCT00957021 ↗
Enrolled (actual)
354
Serious AEs
24.3%
Results posted
Dec 2013
Primary outcomePrimary: Range of Motion — 124 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® Posterior Stabilized (PS) Total Knee System. These outcomes will be evaluated using pre-operative scores and comparing them to post-operative scores in addition to being compared with cases who received the Scorpio® PS implant.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Range of Motion |
124 | — |
| SECONDARY Patient Outcome Knee Society Score |
93.77; 57.36; 86.26; 30.99; 93.96; 57.76 | <.0001 sig |
| SECONDARY Patient Outcome SF-36 |
48.16; 15.32; 55.21; 2.58; 47.34; 14.54 | <.0001 sig |
| SECONDARY Patient Outcome WOMAC |
45.11 | — |
| SECONDARY Patient Outcome Lower-Extremity Activity Scale |
11.22; 1.97; 11.04; 1.86; 11.15; 1.95 | <.0001 sig |
| SECONDARY Radiographic Outcome |
1; 2; 3 | — |
Eligibility Criteria
Inclusion Criteria
- The subject is a male or non-pregnant female 21-80 years of age at the time of enrollment.
- 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
- The subject has inflammatory arthritis.
- The subject is morbidly obese, BMI > 40.
- The subject has a history of total or unicompartmental reconstruction of the affected joint.
- The subject has had a high tibial osteotomy or femoral osteotomy.
- The subject has a neuromuscular or neurosensory deficiency that would limit the ability to assess the performance of the device.
- The subject 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 and cannot provide adequate support and/or fixation to the prosthesis.
- The subject has had a knee fusion at 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 (NCT00957021). 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.