All-polyethylene tibia PS components compared to metal-backed tibia PS components in total knee replacement

Phase 3

• Conditions: Osteoarthritis; Musculoskeletal Diseases

• Registration Number: ISRCTN10744502
• Lead Sponsor: Stryker European Operations BV (Netherlands)

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-26
• Last Update Posted: 19 December 2023
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 60

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
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified