A randomised controlled single blind trial comparing STTJ (scapho-trapezio-trapezoid joint)fusion and pyrocarbon interposition arthroplasty for osteoarthritis of the scapho-trapezio-trapezoid joint
| ISRCTN | ISRCTN12076542 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12076542 |
| Protocol serial number | N0106175335 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funder | Gloucestershire R&D Consortium (UK) |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 30/08/2012
- 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 Peter Tomlinson
Scientific
Scientific
Gloucestershire Hospitals NHS Foundation Trust
Cheltenham General Hospital
Sandford Road
Blackpool
GL53 7AN
United Kingdom
| Phone | +44 (0) 8454 223585 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled single blind trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Is the pyrocarbon interposition arthroplasty (pyrocarbon button) better than STTJ fusion for arthritis of the scapho-trapezio-trapezoid? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Musculoskeletal Diseases: Osteoarthritis (OA) |
| Intervention | Group 1 (n=40) = STTJ fusion - standard procedure Group 2 (n=40) = pyrocarbon interposition arthroplasty |
| Intervention type | Other |
| Primary outcome measure(s) |
Assessment of pain |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/11/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 80 |
| Key inclusion criteria | Patients who have STTJ osteoarthritis who have exhausted conservative methods of treatment. |
| Key exclusion criteria | Patents with extensive osteaoarthritis that includes the carpometacarpal joint who are not suitable for the procedure. |
| Date of first enrolment | 01/11/2005 |
| Date of final enrolment | 01/11/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Gloucestershire Hospitals NHS Foundation Trust
Blackpool
GL53 7AN
United Kingdom
GL53 7AN
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 |
