Excision of the trapezium for osteoarthritis of the trapeziometacarpal joint. Is there any benefit to ligament reconstruction?
| ISRCTN | ISRCTN22417311 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22417311 |
| Protocol serial number | N0123138157 |
| Sponsor | Department of Health |
| Funder | University Hospitals of Leicester NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 17/04/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Joseph Dias
Scientific
Scientific
University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To see if the longer recovery time for the more complex operation is justified and produces a better thumb than the simpler operation. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Trapeziometacarpal osteoarthritis |
| Intervention | Patients randomised to: 1. Simple trapeziectomy 2. Trapeziectomy with palmaris longus interposition 3. Trapeziectomy with ligament reconstruction and tendon interposition using 50% of the flexor carpi radialis tendon All patients wore a thumb splint for 6 weeks. Patients were followed up for 1 year. |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 183 |
| Key inclusion criteria | Patients with osteoarthritis of the trapeziometacarpal join. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/2001 |
| Date of final enrolment | 01/09/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom
LE1 4PW
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 | One-year results | 01/11/2004 | Yes | No |
