Splinting after Contracture Release for Dupuytren's

ISRCTN	ISRCTN57079614
DOI	https://doi.org/10.1186/ISRCTN57079614
Protocol serial number	AP1076
Sponsor	University of East Anglia (UK)
Funder	Action Medical Research (UK)

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

Primary study design	Interventional
Study design	Pragmatic, multi-centre, randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/04/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

School of Allied Health Professions

Norwich
NR4 7TJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	21/06/2011		Yes	No
Protocol article	protocol found at	30/04/2008		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

16/01/2018: internal review.