Condition category
Musculoskeletal Diseases
Date applied
14/02/2007
Date assigned
22/03/2007
Last edited
24/04/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 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

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 measures

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

Eligibility

Participant inclusion criteria

1. Aged over 18 years, either sex
2. Awaiting surgical release of Dupuytren’s 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

http://www.uea.ac.uk/

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

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes