Comparison of fasciotomy with fasciectomy in the treatment of Dupuytren's contracture

ISRCTN	ISRCTN61718349
DOI	https://doi.org/10.1186/ISRCTN61718349
Protocol serial number	N0237086821
Sponsor	Department of Health (UK)
Funder	St Helens and Knowsley Hospitals NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Miss L Feldberg
Scientific

Consultant
Burns & Plastics
Whiston Hospital
Prescot
Prescot, Merseyside
L35 5DR
United Kingdom

Phone	+44 (0)151 426 1600

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To compare the long term outcomes of treatment of palmar bands with metacarpophalangeal joint (MCPJ) contracture by fasciotomy with fasciectomy.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2008

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Key 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.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2001
Date of final enrolment	31/12/2008

Consultant

Prescot, Merseyside
L35 5DR
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan