ISRCTN10744502
Active, Not Recruiting
Phase 3
Migration and survival of all-polyethylene tibial components compared to the metal-backed modular components of the Triathlon PS Total Knee System. A RSA study
Stryker European Operations BV (Netherlands)0 sites60 target enrollmentNovember 26, 2014
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Stryker European Operations BV (Netherlands)
- Enrollment
- 60
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31550947/ 2-year results (added 05/12/2023) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35099566/ 5-year results (added 05/12/2023)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patient is able to understand the meaning of the study and is willing to sign the EC approved, study specific Informed Patient Consent Form
- •2\. Patients with a pre\-operative knee score of \< 70
- •3\. Patients scheduled to undergo primary total knee replacement with any of the following indication
- •3\.1\. Painful and disabled knee joint resulting from osteoarthritis
- •3\.2\. One or more compartments are involved
- •4\. No indication for Triathlon PS
- •5\. Need to obtain pain relief and improve function
- •6\. Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow\-up evaluations
- •7\. A good nutritional state of the patient
- •8\. The subject is a male or non\-pregnant female between 40 and 75 years of age
Exclusion Criteria
- •1\. The subject is morbidly obese, defined as Body Mass Index (BMI) of \> 40
- •2\. Patient has a flexion contracture of 15° and more
- •3\. Patient has a varus/valgus contracture of 15° and more
- •4\. Patients with a pre\-operative knee score of \>70
- •5\. The subject has a history of total or unicompartmental reconstruction of the affected joint
- •6\. The subject will be operated bilaterally
- •7\. Patients who had a Total Hip Arthroplasty (THA) on contralateral and/or ipsilateral side within the last year that is considered to have an unsatisfactory outcome (Patients with contralateral and/or ipsilateral THA \> 1 year ago with good outcome can be included in the study)
- •8\. Patients who had a Total Knee Arthroplasty (TKA) on contralateral side within the last 6 months that is considered to have an unsatisfactory outcome. (Patients with contralateral TKA \> 6 months ago with good outcome can be included in the study)
- •9\. The subject has an active or suspected latent infection in or about the knee joint
- •10\. Osteomyelitis
Outcomes
Primary Outcomes
Not specified
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