degenerative joint disease osteoarthritis
Conditions
Interventions
A standard hand distraction device will be placed over the affected CMC1 joint
under regional or general anesthesia. The external fixator will be anchored
transcutaneously with 2 proximal pins in th
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the clinical outcome, determined by VAS for pain, Range of Motion, strength, MHQ and DASH score at 2, 3, 6 and 12 months. Also, we would like to answer the question if invasive surgery can be postponed or prevented by CMC1-JD in patients requiring surgical treatment of an osteoarthritic CMC1 joint after 12 months of follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters are the joint space on X-ray examination and the aspects (including thickness) of the cartilage on MRI. | — |
Countries
Netherlands
Outcome results
None listed