ISRCTN04081530
Active, Not Recruiting
Phase 3
Migration and survival of all-polyethylene tibial components compared to the metal-backed modular components of the Triathlon CS Total Knee System. A RSA study
Stryker European Operations BV (Netherlands)0 sites60 target enrollmentSeptember 22, 2014
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Osteoarthritis
- Sponsor
- Stryker European Operations BV (Netherlands)
- Enrollment
- 60
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35099566/ (added 05/12/2023) 2018 Results article in https://pubmed.ncbi.nlm.nih.gov/29714073/ 2-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 eligible and scheduled to undergo primary total knee replacement with any of the following indication
- •2\.1\. Painful and disabled knee joint resulting from osteoarthritis (Ahlbäck stage II to V)
- •2\.2\. One or more compartments are involved
- •3\. Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow\-up evaluations
- •4\. A good nutritional state of the patient
- •5\. 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 \> 37
- •2\. Previous major knee surgery
- •3\. 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 \> 3 months ago with good outcome can be included in the study)
- •4\. Patients with other severe concurrent joint involvements that can affect their outcome
- •5\. Patient has a flexion contracture of 15° and more
- •6\. Patient has a varus/valgus contracture of 15° and more
- •7\. The subject will be operated bilaterally
- •8\. The subject has an active or suspected latent infection in or about the knee joint
- •9\. Osteomyelitis
- •10\. The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device
Outcomes
Primary Outcomes
Not specified
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