Contact information
Type
Scientific
Primary contact
Dr Christina Jerosch-Herold
ORCID ID
Contact details
School of Allied Health Professions
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
+44 (0)1603 593316
c.jerosch-herold@uea.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
AP1076
Study information
Scientific title
Splinting after Contracture Release for Dupuytren's: a pragmatic, multi-centre, randomised controlled trial
Acronym
SCoRD
Study hypothesis
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
The Cambridgeshire 2 Research Ethics Committee gave approval on the 26th July 2007 (ref: 07/Q0108/120)
Study design
Pragmatic, multi-centre, randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/10/2007
Overall trial end date
30/04/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
128
Participant exclusion criteria
1. Aged under 18 years
2. Unable to give fully informed consent
Recruitment start date
01/10/2007
Recruitment end date
30/04/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Allied Health Professions
Norwich
NR4 7TJ
United Kingdom
Sponsor information
Organisation
University of East Anglia (UK)
Sponsor details
University Plain
Norwich
NR4 7TJ
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Action Medical Research (UK)
Alternative name(s)
AMR
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2008 protocol found at http://www.ncbi.nlm.nih.gov/pubmed/18447898
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21693044
Publication citations
-
Protocol found at
Jerosch-Herold C, Shepstone L, Chojnowski AJ, Larson D, Splinting after contracture release for Dupuytren's contracture (SCoRD): protocol of a pragmatic, multi-centre, randomized controlled trial., BMC Musculoskelet Disord, 2008, 9, 62, doi: 10.1186/1471-2474-9-62.
-
Results
Jerosch-Herold C, Shepstone L, Chojnowski AJ, Larson D, Barrett E, Vaughan SP, Night-time splinting after fasciectomy or dermo-fasciectomy for Dupuytren's contracture: a pragmatic, multi-centre, randomised controlled trial., BMC Musculoskelet Disord, 2011, 12, 136, doi: 10.1186/1471-2474-12-136.