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


- candidate number5326
- NTR NumberNTR1674
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-feb-2009
- Secondary IDs25869.100.08 NL
- Public TitleThe treatment of joint degeneration of the thumb with two different operation techniques.
- Scientific TitleTrapeziectomy with ligament reconstruction (Weilby vs Burton Pellegrini technique) for patients with primary CMC I arthritis: a Randomised Clinical trial.
- ACRONYMPrimary CMC I arthritis II
- hypothesisPatients 12 months after Weilby procedure have less difficulties during daily life compared to patients after Burton Pellegrini procedure.
- Healt Condition(s) or Problem(s) studiedArthritis, Arthrosis
- Inclusion criteria1. Woman 40 > years;
2. Patient is diagnosed with primary CMC I atrhritis and planed for operation;
3. Right and left handed;
4. One or both hands are involved;
5. CMC I Arthritis Eaton and Glickels classification IV.
- Exclusion criteria1. Man;
2. CMC I Eaton and Glickels classification type I, II and III;
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-mrt-2009
- planned closingdate1-mrt-2012
- Target number of participants100
- InterventionsIn this randomised clinical trial we compare the Weilby procedure and Burton Pellegrini procedure as a treatment for primary CMC OA of the thumb.
- Primary outcome1. Are there subjective differences between the two groups in functional activities of daily living 12 months after surgery?;
2. The 'Patient Rated Wrist/Hand Evaluation ¨C Dutch Language Version¡¯ (PRWHE-dlv) and the ¡®Disabilities of the arm, Shoulder, and Hand ¨C Dutch Language Version (DASH-dlv) outcome data collection instruments are used;
3. Is there significantly less opartion time in the Weilby group?;
4. The operation time is measured as the mean arm tourniquet time used during the procedure.
- Secondary outcome1. Differences in pain 12 months after surgery: using the PRWHE-dlv pain subscale;
2. Differences in strength 12 months after surgery: using E-link strength-measurement-system maesuring the tip pinch strength, Key pinch strength, Three-point pinch strength and grip strength;
3. 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 and 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;
4. 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 operation techniques: the Weilby procedure versus the Burton Pellegrini technique to treat primairy osteoarthritis of the first CMC Joint.
- Main changes (audit trail)
- RECORD17-feb-2009 - 14-sep-2009


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