Condition category
Musculoskeletal Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
04/10/2013
Prospective/Retrospective
Retrospectively 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

Miss L Feldberg

ORCID ID

Contact details

Consultant
Burns & Plastics
Whiston Hospital
Prescot
Prescot
Merseyside
L35 5DR
United Kingdom
+44 (0)151 426 1600

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0237086821

Study information

Scientific title

Acronym

Study hypothesis

To compare the long term outcomes of treatment of palmar bands with metacarpophalangeal joint (MCPJ) contracture by fasciotomy with fasciectomy.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Musculoskeletal Diseases: Dupuytren's disease

Intervention

Patients will be randomised to undergo either fasciotomy or fasciectomy. Both procedures will be performed under general anaesthetic with an upper arm tourniquet as a day case, unless contraindicated, in which case admission will be arranged. Both procedures will be performed through 'zig-zag' palmar incisions ensuring identification and protection of the digital nerves.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

There are currently no prospective studies comparing fasciotomy with fasciectomy for patients requiring surgery for palmar Dupuytren's with MCPJ contracture. Currently both procedures are performed in our unit according to the surgeons preference. Previous retrospective studies have shown benefits of fasciotomy for MCPJ contracture.

Study endpoints: 5 year follow-up observing any disease recurrence and the degree of improvement of MCPJ contracture.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2001

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Recruitment will be from new referrals from out patient clinics. Patients will be included if they are >35 years with palmar Dupuytren's causing contracture at the metacarpophalangeal joint (MCPJ) which interferes with hand function.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2001

Recruitment end date

31/12/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Consultant
Prescot, Merseyside
L35 5DR
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

St Helens and Knowsley Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes