Trapezium implant versus sling procedure in the treatment of thumb carpometacarpal arthritis: a randomised, assessor-blinded controlled trial
| ISRCTN | ISRCTN35722082 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35722082 |
| Protocol serial number | N0284126130 |
| Sponsor | Department of Health |
| Funder | Wrightington, Wigan and Leigh NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 14/06/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Mike Hayton
Scientific
Scientific
Wrightington, Wigan & Leigh NHS Trust
Wrightington Hospital
Hall Lane
Appley Bridge
Wigan
WN6 9EP
United Kingdom
| Phone | +44 (0)1257 252110 |
|---|---|
| mjhayton@aol.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Trapezium implant versus sling procedure in the treatment of thumb carpometacarpal arthritis: a randomised, assessor-blinded controlled trial |
| Study objectives | Does a trapezium sling offer no extra benefit in the treatment of thumb metacarpal arthritis over the sling procedure alone? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Musculoskeletal Diseases: Osteoarthritis of the thumb |
| Intervention | Trapezium sling offer vs sling procedure alone. Patients who have had the procedure and patients who have not had the procedure will be assessed. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/05/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Female |
| Target sample size at registration | 40 |
| Key inclusion criteria | 1. Female 2. Aged 50-80 years |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 29/04/2002 |
| Date of final enrolment | 01/05/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Wrightington, Wigan & Leigh NHS Trust
Wigan
WN6 9EP
United Kingdom
WN6 9EP
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 |
Editorial Notes
14/06/2017: No publications found in PubMed, verifying study status with principal investigator
