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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list