Joint distraction in the treatment of severe knee osteoarthritis; optimizing the method.
Withdrawn
- Conditions
- arthrosisjoint degenerationosteoarthritis10023213
- Registration Number
- NL-OMON33996
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 4
Inclusion Criteria
Age < 60 yrs
Primarily tibia-femoral osteoarthritis
Clinical indication for arthroplasty or osteotomy
Radiographic knee OA; K&L > 2
Exclusion Criteria
Bilateral knee osteoarthritis
Joint malalignment > 10°
History of infectious arthritis
Primarily patello-femoral osteoarthitis
Knee instability with physical examination
Psychological difficulties which interfer with joint distraction
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome parameter will be clinical effectivity determined by the<br /><br>WOMAC questionair on pain, function and stiffness. Structural effectivity will<br /><br>be analysed on x-ray and MR. The treatment with one month distraction is<br /><br>considered effective if three out of four patients have comparable results with<br /><br>the previous study of two months distraction.</p><br>
- Secondary Outcome Measures
Name Time Method <p>A secundary outcome parameter is clinical effectivity based on physical<br /><br>examination. There will also be a more specific analysis on biological change<br /><br>of the joint by biomarker and MR analysis.<br /><br>Pin tract infections will be registered and retrospectively compared to the two<br /><br>month distraction study.</p><br>