Thumb Carpometacarpal Osteoarthritis, Trapeziometacarpal Osteoarthritis
Conditions
Keywords
Osteoarthritis, Thumb, Total joint arthroplasty, Trapeziectomy
Brief summary
Trapeziometacarpal osteoarthritis is a common cause of pain and loss of hand function in postmenopausal women. Many surgical treatments have been described and recent literature has show that the relatively simple trapeziectomy gives equal results and less complications, when compared to other techniques such as ligament reconstructions and interpositions. A relatively new treatment modality, which has been further developed in recent years is the total joint arthroplasty. Randomized prospective trials and long-term results are lacking, but prospective cohorts show a faster recovery and good results after one year, without an increase in complication rate. We hypothesize that a total joint arthroplasty gives a better objective and subjective result after one year than a trapeziectomy.
Interventions
PROCEDURETotal Joint Arthroplasty
Total Joint Arthroplasty with device: Maïa® trapezio-metacarpal joint prosthesis, Groupe Lépine, Genay, France
PROCEDURETrapeziectomy
Trapeziectomy
Sponsors
Isala
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women. * 40 years of age or more. * Symptomatic trapeziometacarpal osteoarthritis. * Eaton & Glickel stage 2 and 3.
Exclusion criteria
* An operation for trapeziometacarpal osteoarthritis on the same hand in the past. * Participation in randomized clinical trial for trapeziometacarpal osteoarthritis with contralateral hand. * Secondary trapeziometacarpal osteoarthritis as result of trauma, rheumatoid arthritis, systemic lupus or gout. * Symptomatic carpal tunnel syndrome in same hand. * Symptomatic Quervain's tenosynovitis in same hand. * Neurological or other disorders of the affected side that can influence postoperative rehabilitation. * Insufficient knowledge of Dutch language.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Michigan Hand Outcomes Questionnaire (MHOQ) | 1 year after surgery | Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 year postoperatively, measured with the total score of the Michigan Hand Outcomes Questionnaire (MHOQ)? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disabilities of Arm Shoulder and Hand (DASH) | 1 and 5 years after surgery | Is there a difference is daily hand function after 1 and 5 years postoperatively between patients with a total joint arthroplasty and patients with a trapeziectomy measured with the Disabilities of Arm Shoulder and Hand (DASH)? |
| Grip strength | 1 and 5 years after surgery | Is there a difference in grip strength between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years? |
| Michigan Hand Outcomes Questionnaire (MHOQ) | 5 years after surgery | Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 5 years postoperatively, measured with the total score of the Michigan Hand Outcomes Questionnaire (MHOQ)? |
| Complications | 1 and 5 years after surgery | Is there a difference in postoperative complications between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years? |
| Return to work | 1 and 5 years after surgery | Is there a difference in return to work between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years? |
| Thumb mobility | 1 and 5 years after surgery | Is there a difference in mobility of the thumb between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years? |
Countries
Netherlands
Contacts
Primary ContactRamon P. de Wildt, MD
Outcome results
None listed