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

Phase 3

• Conditions: Osteoarthritis; Musculoskeletal Diseases

• Registration Number: ISRCTN04081530
• Lead Sponsor: Stryker European Operations BV (Netherlands)

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-22
• Last Update Posted: 19 December 2023
• Study Completion: 2024-12-31

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 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
11. The subject has a systemic or metabolic disorder leading to progressive bone deterioration
12. The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements
13. Female patients planning a pregnancy during the course of the study
14. The patient is unable or unwilling to sign the Informed Consent specific to this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure will be prosthetic migration after two years of the Triathlon CS Knee System with all-polyethylene tibial components and the Triathlon CS Knee System with metal backed modular components by means of Roentgen Stereophotogrammetry. It is hypothesized that there will be no difference between groups. The difference in migration between components must not exceed 0.3 mm for translations and 0.25° for the rotations to determine equivalence.

Secondary Outcome Measures

Name	Time	Method
The secondary outcome measure will be long-term survival based on the two-year migration patterns combined with clinical factors and radiographic aspects. In order to identify other clinical parameters besides the fixation of the prosthesis components, clinical scores and radiographic aspects will be correlated with the RSA outcome. The 10 years results will be used to verify the predicted long-term survival results.