Contact information
Type
Scientific
Primary contact
Mr Neil Citron
ORCID ID
Contact details
Epsom and St Helier NHS Trust
Department of Trauma and Orthopaedics
St Helier Hospital
Wrythe Lane
Carshalton
Surrey
SM5 1AA
United Kingdom
+44 (0)181 296 2427
neil.citron@esth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0112112975
Study information
Scientific title
Acronym
Study hypothesis
A prospective randomised trial of two incisions to see whether or not there is a significant difference in the recurrence rate at 2 years after operation.
Ethics approval
Not provided at time of registration
Study design
A prospective randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Dupuytren's disease
Intervention
Two incisions - Bruner versus Z-Plasty are compared to see whether or not there is a significant difference in the recurrence rate of Dupuytren's disease at two years after operation.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Whether or not there is a significant difference in the recurrence rate at two years after operation of the two incisions.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/1999
Overall trial end date
01/01/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Consecutive patients with affected X-rays diagnosed as having Dupuytren's Disease.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
1. Patients with recurrent disease in the affected x-ray were excluded
2. Patients who could be treated by the lesser procedure of fasciotomy were also excluded
Recruitment start date
01/04/1999
Recruitment end date
01/01/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Epsom and St Helier NHS Trust
Surrey
SM5 1AA
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
Epsom and St Helier University 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
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16140442
Publication citations
-
Results
Citron ND, Nunez V, Recurrence after surgery for Dupuytren's disease: a randomized trial of two skin incisions., J Hand Surg Br, 2005, 30, 6, 563-566, doi: 10.1016/j.jhsb.2005.07.001.