A prospective, randomised, clinical trial comparing trapezial denervation with trapeziectomy for the surgical treatment of arthritis at the base of the thumb
| ISRCTN | ISRCTN66686094 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66686094 |
| Protocol serial number | N0077111388 |
| Sponsor | Department of Health (UK) |
| Funder | Southern Derbyshire Acute Hospitals NHS Trust (UK) - NHS R&D Support Funding and Charitable Funds |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 23/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof FD Burke
Scientific
Scientific
Southern Derbyshire Acute Hospitals NHS Trust
Pulvertaft Hand Centre
Derbyshire Royal Infirmary
London Road
Derby
DE1 2QY
United Kingdom
| Phone | +44 (0)1332 347141 ext 2258 |
|---|---|
| frank.burke@virgin.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A prospective, randomised, clinical trial comparing trapezial denervation with trapeziectomy for the surgical treatment of arthritis at the base of the thumb |
| Study objectives | Trapezial denervation offers the most effective option available with a shorter operating time and rapid rehabilitation at less cost to both patient and hospital. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Treatment of arthritis at the base of the thumb |
| Intervention | A range of objective and subjective assessments carried out by the Occupational Therapists at three intervals: 1. Prior to surgery 2. 6 months after surgery 3. 12 months after surgery 4. 5 years after surgery Measure of Health Status, using EQ5D. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
1. Strength |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Total final enrolment | 55 |
| Key inclusion criteria | Patients with osteo-arthritis at the base of the thumb who attend the Pulvertaft Hand Centre. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/07/2002 |
| Date of final enrolment | 31/12/2013 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Southern Derbyshire Acute Hospitals NHS Trust
Derby
DE1 2QY
United Kingdom
DE1 2QY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 13/02/2019 | 23/04/2025 | Yes | No |
Editorial Notes
23/04/2025: Publication reference and total final enrolment added.
30/04/2018: No publications found, study status unverified.
04/03/2016: No publications found, verifying study status with principal investigator.
