Splinting after Contracture Release for Dupuytren's
| ISRCTN | ISRCTN57079614 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57079614 |
| Secondary identifying numbers | AP1076 |
- Submission date
- 14/02/2007
- Registration date
- 22/03/2007
- Last edited
- 16/01/2018
- 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
Dr Christina Jerosch-Herold
Scientific
Scientific
School of Allied Health Professions
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
| Phone | +44 (0)1603 593316 |
|---|---|
| c.jerosch-herold@uea.ac.uk |
Study information
| Study design | Pragmatic, multi-centre, randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Splinting after Contracture Release for Dupuytren's: a pragmatic, multi-centre, randomised controlled trial |
| Study acronym | SCoRD |
| Study objectives | To assess whether the use of post-operative static night splinting provides a better outcome, specifically patient-reported hand function and finger mobility, in patients undergoing fasciectomy or dermofasciectomy for Dupuytrens contracture. Please note that as of 30/04/2008 the anticipated start and end dates of this trial were updated. The previous dates were: Previous anticipated start date: 01/07/2007 Previous anticipated end date: 30/01/2009 |
| Ethics approval(s) | The Cambridgeshire 2 Research Ethics Committee gave approval on the 26th July 2007 (ref: 07/Q0108/120) |
| Health condition(s) or problem(s) studied | Dupuytren's contracture |
| Intervention | All patients will undergo surgery for contracture release and receive usual post-operative hand therapy. Patients will be randomised at their first post-operative hand therapy appointment to one of two groups: one group will receive a static night splint to be worn for 6 months and the other will not receive a splint. |
| Intervention type | Other |
| Primary outcome measure | Self-reported function and disability using the Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire. Endpoint assessment is at 12 months after surgery with interim measures taken at 3 and 6 months. |
| Secondary outcome measures | 1. Range of movement using a hand-held goniometer 2. Patient satisfaction using an 10 point verbal rating scale 3. Recurrence of a contracture in the previously operated field Endpoint assessment is at 12 months after surgery with interim measures taken at 3 and 6 months. |
| Overall study start date | 01/10/2007 |
| Completion date | 30/04/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 128 |
| Key inclusion criteria | 1. Aged over 18 years, either sex 2. Awaiting surgical release of Dupuytrens contractures by fasciectomy or dermofasciectomy 3. Have given written informed consent |
| Key exclusion criteria | 1. Aged under 18 years 2. Unable to give fully informed consent |
| Date of first enrolment | 01/10/2007 |
| Date of final enrolment | 30/04/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
School of Allied Health Professions
Norwich
NR4 7TJ
United Kingdom
NR4 7TJ
United Kingdom
Sponsor information
University of East Anglia (UK)
University/education
University/education
University Plain
Norwich
NR4 7TJ
England
United Kingdom
| Website | http://www.uea.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/026k5mg93 |
Funders
Funder type
Charity
Action Medical Research (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- actionmedres, action medical research for children, AMR
- Location
- United Kingdom
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol found at | 30/04/2008 | Yes | No | |
| Results article | results | 21/06/2011 | Yes | No |
Editorial Notes
16/01/2018: internal review.
