Condition category
Skin and Connective Tissue Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
04/11/2010
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

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes