No registrations found.
ID
Source
Brief title
Health condition
CMC I arthritis
thumb arthritis
CMC I artrodesis
trapeziectomy with ligament reconstruction
Sponsors and support
Intervention
Outcome measures
Primary outcome
Are 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.
Background summary
In 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.
Study objective
Patients 12 months after CMC I arthrodesis have less difficulties during daily life compared to patients after trapeziectomy with ligament reconstruction.
Study design
Preoperatively and at 3 and 12 months postoperative.
Intervention
In this randomised clinical trial we compare two whidely used operation techniques: the CMC I arthrodesis versus the trapeziectomy with ligament reconstruction.
Inclusion criteria
1. 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 criteria
1. 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
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1305 |
| NTR-old | NTR1353 |
| CCMO | NL20348.100.07 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |
| OMON | NL-OMON31693 |