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The treatment of joint degeneration of the thumb with two different operation techniques


- candidate number3488
- NTR NumberNTR1353
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-jun-2008
- Secondary IDsNL20348.100.07 R-07.21D/CMC-I
- Public TitleThe treatment of joint degeneration of the thumb with two different operation techniques
- Scientific TitleCMC I arthrodesis or trapeziectomy with ligament reconstruction for patients with primary CMC I arthritis: a Randomised Clinical trial
- ACRONYMPrimary CMC I arthritis
- hypothesisPatients 12 months after CMC I arthrodesis have less difficulties during daily life compared to patients after trapeziectomy with ligament reconstruction.
- Healt Condition(s) or Problem(s) studiedArthritis, Carpometacarpal joint (CMC), Thumb , Arthrodesis, Trapeziectomy
- Inclusion criteria1. Woman > 40 years patient is diagnosed with primary CMC I atrhritis and planed for operation
2. Right and left handed one or both hands are involved
3. CMC I Arthritis Eaton and Glickels classification II and III
- Exclusion criteria1. Man
2. STT arthritis (CMC I Eaton and Glickels classification type IV)
3. Operations for CMC I arthritis in history
4. Secondary CMC I arthritis
5. Muscle, neurological or other problems that could influence the postoperative management.
6. Patients who cannot complete the randomisation procedure
7. Less knowledge of the Dutch language
8. Psychiatry in history
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2008
- planned closingdate1-feb-2010
- Target number of participants100
- InterventionsIn this randomised clinical trial we compare two whidely used operation techniques: the CMC I arthrodesis versus the trapeziectomy with ligament reconstruction.
- Primary outcomeAre there subjective differences in functional activities of daily living 12 months after surgery? (CMC I arthrodesis versus trapeziectomy with ligament reconstruction)

The 'Patient Rated Wrist/Hand Evaluation – Dutch Language Version’ (PRWHE-dlv) and the ‘Disabilities of the arm, Shoulder, and Hand – Dutch Language Version (DASH-dlv) outcome data collection instruments are used
- Secondary outcome• Differences in pain 12 months after surgery: using the PRWHE-dlv pain subscale.

• Differences in strength 12 months after surgery using:
- E-link strength-measurement-system measuring the tip pinch strength
- Key pinch strength
- Three-point pinch strength - Grip strength.

• Differences in mobility of the thumb 12 months after surgery based on:
- IP joint flexion/extension
- MCP-joint flexion/extension
- CMC-joint:
* Palmar abduction measured using the intermetacarpal distance (IMD: the thumb is placed in full palmar abduction, the easily identifiable middorsal points on the subcutaneous surface of the first and second metacarpal heads are marked and the separation between these is measured in millimetres),
* Opposition measured using the Kapandji score
* Extension measured how much the tip of the thumb can be elevated in millimetres with the hand flat on the table and the thumb in maximal radial abduction.

• Differences in complications 12 months after after surgery: during 12 months all complications after surgery are scored.
- TimepointsPreoperatively and at 3 and 12 months postoperative.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES G.M. Vermeulen
- CONTACT for SCIENTIFIC QUERIES G.M. Vermeulen
- Sponsor/Initiator Hand- en Polscentrum Nederland, Diakonessenhuis Zeist
- Funding
(Source(s) of Monetary or Material Support)
Hand- en Polscentrum Nederland, Diakonessenhuis Zeist
- PublicationsN/A
- Brief summaryIn this randomised clinical trial we compare two whidely used operation techniques: the CMC I arthrodesis versus the trapeziectomy with ligament reconstruction to treat primairy osteoarthritis of the CMC I Joint.
- Main changes (audit trail)
- RECORD18-jun-2008 - 25-jul-2008


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