N/A
Completed N=168
Clinical Outcome Study for the Triathlon Cruciate Retaining (CR) Total Knee
Source: ClinicalTrials.gov NCT02535741 ↗Enrolled (actual)
168
Serious AEs
13.7%
Results posted
Dec 2015
Primary outcomePrimary: Mean Triathlon CR Active Range of Motion (ROM) — 112.96 degree
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Triathlon CR Active Range of Motion (ROM) |
112.96 | — |
| SECONDARY Investigation of Patient Outcome With Radiographic Analysis |
— | — |
| SECONDARY Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) |
38.2; 75.2; 81.7; 86; 88; 58.9 | — |
| SECONDARY Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire |
30.0; 37.5; 42.0; 44.6; 41.9; 42.1 | — |
| SECONDARY Investigation of Clinical Performance and Patient Outcome With the Western Ontario McMaster Osteoarthritis Index (WOMAC) Patient Questionnaire |
166.42; 78.99; 45.04; 40.6; 46.28; 47.94 | — |
Eligibility Criteria
Inclusion Criteria
- Patients willing to sign the Ethic Commission approved, study specific Informed Patient Consent Form.
- Patients willing and able to comply with scheduled postoperative clinical and radiographic evaluations and rehabilitation.
- Male or non-pregnant female between the ages of 21-80 years of age at the time of surgery.
- Patients requiring a primary total knee replacement.
- Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
- Patients with intact collateral ligaments.
Exclusion Criteria
- Patients with inflammatory arthritis.
- Patients that are morbidly obese, body mass index (BMI) > 40.
- Patients with a history of total / unicompartmental reconstruction of the affected joint.
- Patients that have had a high tibial osteotomy or femoral osteotomy.
- Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
- Patients with a systemic or metabolic disorder leading to progressive bone deterioration.
- Patients that are immunologically compromised, or receiving chronic steroids (>30 days duration).
- Patients bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
- Patients with a knee fusion to the affected joint.
- Patients with an active or suspected latent infection in or about the knee joint.
- Patients with a history of total joint replacement on the opposite knee within less than 1 year.
- Patients requiring bilateral total knee replacement.
Data sourced from ClinicalTrials.gov (NCT02535741). 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.