Comparison of fasciotomy with fasciectomy in the treatment of Dupuytren's contracture
| ISRCTN | ISRCTN61718349 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61718349 |
| Secondary identifying numbers | N0237086821 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 04/10/2013
- 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
Miss L Feldberg
Scientific
Scientific
Consultant
Burns & Plastics
Whiston Hospital
Prescot
Prescot, Merseyside
L35 5DR
United Kingdom
| Phone | +44 (0)151 426 1600 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | To compare the long term outcomes of treatment of palmar bands with metacarpophalangeal joint (MCPJ) contracture by fasciotomy with fasciectomy. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Musculoskeletal Diseases: Dupuytren's disease |
| Intervention | Patients will be randomised to undergo either fasciotomy or fasciectomy. Both procedures will be performed under general anaesthetic with an upper arm tourniquet as a day case, unless contraindicated, in which case admission will be arranged. Both procedures will be performed through 'zig-zag' palmar incisions ensuring identification and protection of the digital nerves. |
| Intervention type | Other |
| Primary outcome measure | There are currently no prospective studies comparing fasciotomy with fasciectomy for patients requiring surgery for palmar Dupuytren's with MCPJ contracture. Currently both procedures are performed in our unit according to the surgeons preference. Previous retrospective studies have shown benefits of fasciotomy for MCPJ contracture. Study endpoints: 5 year follow-up observing any disease recurrence and the degree of improvement of MCPJ contracture. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2001 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Recruitment will be from new referrals from out patient clinics. Patients will be included if they are >35 years with palmar Dupuytren's causing contracture at the metacarpophalangeal joint (MCPJ) which interferes with hand function. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2001 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Consultant
Prescot, Merseyside
L35 5DR
United Kingdom
L35 5DR
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
St Helens and Knowsley Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
