ISRCTN60834248
Completed
未知
A prospective randomised controlled study of the Fixed Bearing Lateral Stabilised DJO 3D Knee™ versus the Finsbury Medial Rotation Knee™ System versus the Stryker Triathlon® knee in primary total knee replacement for osteoarthritis and rheumatoid arthritis
Joint UCL/UCLH/Royal Free Biomedical Research Unit (UK)0 sites90 target enrollmentAugust 1, 2011
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Osteoarthritis or rheumatoid arthritis affecting the knee
- Sponsor
- Joint UCL/UCLH/Royal Free Biomedical Research Unit (UK)
- Enrollment
- 90
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. The patient and surgeon must agree that total knee replacement (TKR) is necessary
- •2\. The patient must be fit for TKR in the opinion of the Investigator
- •3\. The patient must be 18 years of age or older at the time of recruitment
- •4\. The inclusion of minors would introduce an extremely rare subset of TKR patients in which the surgeon?s choice of implant is desirable
- •5\. The patient must be able to fully understand the study and must therefore be fluent in English. If they are not fluent in English, a translator will be used
- •6\. The patient must be a permanent resident in an area accessible to the study site
- •7\. The indication for TKR must be osteoarthritis or rheumatoid arthritis
- •8\. This must be the patient?s first TKR
Exclusion Criteria
- •1\. Patient has clinical contra\-indications for use of the 3D, MRK or Triathlon Knee systems in the opinion of the Investigator
- •2\. Underlying neuromuscular/neurovascular problems
- •3\. The patient already has a TKR on the contralateral side
- •4\. Patient lacks the capacity to consent, is unwilling or unable to sign the consent form
- •5\. Patient aged \<18 years at time of consenting to study
Outcomes
Primary Outcomes
Not specified
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