Status:
ACTIVE_NOT_RECRUITING
All-poly Versus Metal-backed
Lead Sponsor:
Region Skane
Conditions:
Osteoarthritis
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
The primary objective is the assessment of prosthetic migration results after two years of the Triathlon PS Knee System with all-polyethylene tibial components compared to the Triathlon PS Knee System...
Detailed Description
The secondary objective will be the prediction of the long-term survival based on the two-year migration patterns combined with clinical factors and radiographic aspects. In order to identify other cl...
Eligibility Criteria
Inclusion
- 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 11. Sepsis 12. Patient who is expected to need lower limb joint replacement for another joint within one year. 13. The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. 14. The subject has a systemic or metabolic disorder leading to progressive bone deterioration. 15. The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements. 16. The subject's bone stock in compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis. 17. The subject has had a knee fusion to the affected joint. 18. Female patients planning a pregnancy during the course of the study. 19. The patient is unable or unwilling to sign the Informed Consent specific to this study
Exclusion
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04358601
Start Date
November 1 2014
End Date
December 31 2025
Last Update
September 4 2025
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