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Conservative treatment for CMC Osteoarthritis of the thumb


- candidate number24717
- NTR NumberNTR6040
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-aug-2016
- Secondary IDsMEC-2015-691 Fonds NutsOhra project 1402-056
- Public TitleConservative treatment for CMC Osteoarthritis of the thumb
- Scientific TitleOutcome of conservative treatment for CMC Osteoarthritis of the thumb
- ACRONYMPrimary CMC I osteoarthritis
- hypothesis- Conservative treatment for CMC-1 OA has good outcome on pain and function
- conservative treatment can delay surgical treatment
- 1 out of 5 patients will undergo surgical treatment
- conservative treatment should be admitted for at least 12 months
- There are patient specific factors at baseline to predict if patients 1) will benefit from conservative treatment and 2) will receive additional surgical treatment
- Healt Condition(s) or Problem(s) studiedCarpometacarpal osteoarthritis thumb
- Inclusion criteria1. >18 years
2. Patient is diagnosed with primary CMC I atrhritis and planed for conservative treatment;
3. Right and left handed;
4. One or both hands are involved;
5. CMC I Arthritis Eaton and Glickels classification I-IV
- Exclusion criteria1. previous CMC surgery
2. posttraumatic CMC osteoarthritis
3. previous intra-articular corticosteroid injections
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-nov-2011
- planned closingdate1-nov-2016
- Target number of participants2000
- Interventions3 months of conservative therapy for CMC osteoarthritis, consisting of hand therapy, splinting or a combination (based on judgements of both the patient and the therapist)
- Primary outcome1. Pain (VAS)
2. Function (MHQ)
3. Surgical treatment (yes/no)
- Secondary outcome3. Satisfaction (VAS)
4. Return to work
- TimepointsPreoperatively and at 3 and 12 months postoperative.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES G.M. Vermeulen
- CONTACT for SCIENTIFIC QUERIES Kim Spekreijse
- Sponsor/Initiator Erasmus Medical Center, Xpert Clinic Nederland
- Funding
(Source(s) of Monetary or Material Support)
Fonds Nuts-Ohra
- Publications
- Brief summaryThis study is a prospective cohort of all patients, treated conservatively for CMC osteoarthritis of the thumb, to research the outcome of treatment, to compare different treatments for efficacy, and to compare different combinations of conservative treatment for efficacy.
- Main changes (audit trail)
- RECORD1-aug-2016 - 28-okt-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl