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

School of Allied Health Professions
University of East Anglia
Norwich
NR4 7TJ
United Kingdom

Phone +44 (0)1603 593316
Email c.jerosch-herold@uea.ac.uk

Study information

Study designPragmatic, multi-centre, randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleSplinting after Contracture Release for Dupuytren's: a pragmatic, multi-centre, randomised controlled trial
Study acronymSCoRD
Study objectivesTo 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 Dupuytren’s 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) studiedDupuytren's contracture
InterventionAll 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 typeOther
Primary outcome measureSelf-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 measures1. 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 date01/10/2007
Completion date30/04/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants128
Key inclusion criteria1. Aged over 18 years, either sex
2. Awaiting surgical release of Dupuytren’s contractures by fasciectomy or dermofasciectomy
3. Have given written informed consent
Key exclusion criteria1. Aged under 18 years
2. Unable to give fully informed consent
Date of first enrolment01/10/2007
Date of final enrolment30/04/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

School of Allied Health Professions
Norwich
NR4 7TJ
United Kingdom

Sponsor information

University of East Anglia (UK)
University/education

University Plain
Norwich
NR4 7TJ
England
United Kingdom

Website http://www.uea.ac.uk/
ROR logo "ROR" https://ror.org/026k5mg93

Funders

Funder type

Charity

Action Medical Research (UK)
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.