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 | Not Recruiting
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

Trial Source

Health Conditions
  • Osteoarthritis or rheumatoid arthritis affecting the knee
Not Recruiting
Recruitment Status
ISRCTN60834248
Primary Trial ID Number
Summary
The null hypothesis is that there is no difference in range of motion (ROM) at six months post operative, between the three different designs of prosthesis. On the basis of the 3D knee prosthesis design, primary study hypotheses are: 1. Greater range of motion through posterior femoral roll back and maximum posterior condyler offset 2. Intrinsic stability will achieve functional strength comparable to other intrinsically stable designs The secondary study hypothesis is: Greater patient satisfaction as a result of the above
Primary Outcome Measures
  • 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 Outcome Measures
  • 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
Research Question
  • The null hypothesis is that there is no difference in range of motion (ROM) at six months post operative, between the three different designs of prosthesis. On the basis of the 3D knee prosthesis design, primary study hypotheses are: 1. Greater range of motion through posterior femoral roll back and maximum posterior condyler offset 2. Intrinsic stability will achieve functional strength comparable to other intrinsically stable designs The secondary study hypothesis is: Greater patient satisfaction as a result of the above
Design Type
Sorry, this information is not available
Ethics Approval
Approval pending as of 30/06/2011
Publications
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Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
Adult
Participant Type
Patient
Trial Sample Size
90
Participant 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 on the day of signing the Study Consent Form
  • 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
Participant 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
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 randomised to one of the implants.
Design Details
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Study Design
Single centre prospective partially blinded randomised controlled parallel three group trial
Results Reporting
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Acronym
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Scientific Title
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
Secondary Trial Identifying Number
1.5
Website
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Study Funded By
Investigator initiatied and funded
Funder Type
Sorry, this information is not available
Study Sponsored By
Joint UCL/UCLH/Royal Free Biomedical Research Unit (UK)
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment

01 Aug 2011

Recruitment End Date

31 Jul 2014

Trial End Date

31 Jul 2014

Date added to Registry

01 Aug 2011

Last Updated

28 Aug 2012