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Surgical treatment of joint degeneration of the thumb, a cohort of all treated patients.


- candidate number24716
- NTR NumberNTR6039
- ISRCTNISRCTN no longer applicable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 TitleSurgical treatment of joint degeneration of the thumb, a cohort of all treated patients.
- Scientific TitlePredicting outcome after surgery for carpometacarpal osteoarthritis; a prospective study
- ACRONYMPrimary CMC1 osteoarthritis
- hypothesis- surgical treatment for CMC OA is effective in terms of pain, function and satisfaction
- There is a relatively large group of patients with significant residual pain and functional impairment or deterioration of their complaints
- Baseline factors like MCP-hyperextension, sex, age and pre-operative pain levels can predict succes or failure after surgery
- een significant deel van de patienten die conservatief zijn behandeld worden alsnog chirurgisch behandeld (%?)
- Healt Condition(s) or Problem(s) studiedCarpometacarpal osteoarthritis thumb
- Inclusion criteria1. Patients > 18 years
2. Patient is diagnosed with primary CMC I osteoatrhritis and planned for operation;
3. Right and left handed;
4. One or both hands are involved;
5. Surgical treatment with trapeziectomy and LRTI
6. Eaton and Glickel stage II-IV
- Exclusion criteria1. previous surgical treatment
2. posttraumatic osteoarthritis
3. surgery, primarily for STT osteoarthritis
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytype[default]
- planned startdate 1-nov-2011
- planned closingdate1-nov-2016
- Target number of participants1000
- InterventionsTrapeziectomy + LRTI
- Primary outcome1. Pain (VAS), pain during activities, rest and overal pain in the last week
2. Function (MHQ)
- Secondary outcome3. Satisfaction with the hand (VAS)
4. Return to work
5. Strength (kg), grip/pinch
6. Complications
- Timepoints Preoperatively and at 3 and 12 months postoperative.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Kim Spekreijse
- 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 summaryIn this prospective cohort, we include all surgically treated patients for CMC OA for data-analysis, efficacy analysis or comparison with other therapies such as conservative therapy or different surgical procedures
- Main changes (audit trail)
- RECORD1-aug-2016 - 28-okt-2016


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