Osteoarthritis or rheumatoid arthritis affecting the knee Musculoskeletal Diseases Osteoarthritis or rheumatoid arthritis
Conditions
Interventions
The study is a partially blinded, randomised controlled trial of the three knee implants. Adult patients requiring a primary knee replacement for osteoarthritis or rheumatoid arthritis will be randomi
Sponsors
Joint UCL/UCLH/Royal Free Biomedical Research Unit (UK)
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Knee range of motion measured in degrees, at six months post-operative 2. The study has been powered to detect a difference of 10 degrees between any two implants 3. The primary outcome will be analysed by linear regression with study group as the explanatory variable | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Validated Health Related Quality of Life measures 1.1. American Knee Society Score 1.2. Oxford Knee Score 1.3. Western Ontario and McMasters University Osteoarthitis (WOMAC) 1.4. SF-36 Health Survey 1.5. UCLH functional score 2. Radiological analysis 3. Survivorship information 4. Complication rates 5. Knee ROM Measured at six months post-operative | — |
Countries
United Kingdom
Outcome results
None listed