Joint distraction for thumb base osteoarthritis
Recruiting
- Conditions
- degenerative joint diseaseosteoarthritis10023213
- Registration Number
- NL-OMON44915
- Lead Sponsor
- Sint Antonius Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
Patients considered for operative intervention for CMC1 OA according to standard clinical practice
Age below 65 years
Radiological joint damage: Eaton Littler classification II or III
Failed conservative treatment
Established indication for invasive surgical treatment
Willingness to participate in the study and ability to understand distractor maintenance and hygiene instructions
Exclusion Criteria
Psychological inabilities or difficult to instruct
Not able to undergo MRI examination (standard protocol)
Inflammatory or rheumatoid arthritis present or in history
> 30% joint subluxation
Involvement of scaphoid-trapezium-trapezoid (STT) joint
Surgical treatment of the CMC joint in the past
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the clinical outcome, determined by VAS for pain,<br /><br>Range of Motion, strength, MHQ and DASH score at 2, 3, 6 and 12 months. Also,<br /><br>we would like to answer the question if invasive surgery can be postponed or<br /><br>prevented by CMC1-JD in patients requiring surgical treatment of an<br /><br>osteoarthritic CMC1 joint after 12 months of follow-up.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary parameters are the joint space on X-ray examination and the aspects<br /><br>(including thickness) of the cartilage on MRI.</p><br>