Percutaneous needle fasciotomy versus limited fasciectomy in Dupuytren's disease

ISRCTN	ISRCTN58554745
DOI	https://doi.org/10.1186/ISRCTN58554745
Protocol serial number	02.0107
Sponsor	University Medical Centre Groningen (UMCG) (Netherlands)
Funder	University Medical Centre of Groningen (UMCG) (Netherlands)

Submission date: 29/11/2010
Registration date: 06/06/2011
Last edited: 06/06/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Paul Werker
Scientific

Hanzeplein 1
Groningen
9713 GZ
Netherlands

Study information

Primary study design	Interventional
Study design	Single centre single blind randomised active controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Percutaneous needle fasciotomy versus limited fasciectomy in Dupuytren's disease: A randomised controlled clinical trial
Study objectives	Now that the armentarium to treat Dupuytrens Disease is increasing, there is a need for comparative studies. We study the 5-year follow-up results of our randomised controlled study that compared percutaneous needle fasciotomy (PNF) and limited fasciectomy (LF). Primary outcome parameters are results, complications and recurrences. Secondary outcome parameters are patient satisfaction and hand function.
Ethics approval(s)	The Dutch Medical Ethics Committee approved in July 2002 (ref: 02.0107)
Health condition(s) or problem(s) studied	Dupuytren's disease
Intervention	Patients were randomised to one of the following treatments 1. Percutaneous needle fasciotomy 2. Limited fasciectomy All patients were treated only once, within 1 month of inclusion. All were seen in the outpatient clinic 1 week, 6 weeks, 6 months and thereafter yearly until 5 years in the outpatient clinic and examined by a plastic surgeon.
Intervention type	Other
Primary outcome measure(s)	1. Treatment results: Total Passive Extension Deficit (degrees) assessed postoperatively at 1 week, 6 weeks, 6 months, and then yearly for 5 years 2. Recurrence: Recurrence was defined as an increase of total passive extension deficit of at least 30 degrees compared to the 6 weeks follow-up values in the area previously treated. At the time of registration patients suffering from recurrent disease and treated for recurrence, are still in follow-up.
Key secondary outcome measure(s)	1. Flexion (Boyes, cm) assessed postoperatively at 1 week, 6 weeks, 6 months, and then yearly for 5 years 2. Sensibility (Semmes-Weinstein) assessed postoperatively at 1 week, 6 weeks, 6 months, and then yearly for 5 years 3. Complications assessed postoperatively at 1 week, 6 weeks, 6 months, and then yearly for 5 years 4. Satisfaction (scale) assessed by questionnaire at 1, 2, 3, 4, 5, 6 weeks, and 6 months, and thereafter yearly until 5 years
Completion date	01/01/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	120
Key inclusion criteria	1. Patients with Dupuytrens disease presenting at the Department for Plastic, Reconstructive and Hand Surgery of the Isala Klinieken, Zwolle from August 2002 2. Total passive extension deficit of at least 30° in the metacarpophalangeal (MCP) joint, proximal interphalangeal (PIP) joint and/or distal interphalangeal (PIP) joint 3. Existence of a clearly defined palmar cord 4. Willingness to participate in this trial. Following counselling written consent was obtained from all patients that entered the study
Key exclusion criteria	1. Postsurgical recurrence or extension of the disease 2. Patients who were not allowed to stop their anticoagulants 3. Generally unfit for surgery 4. Patients with a specific treatment modality wish
Date of first enrolment	01/08/2002
Date of final enrolment	01/01/2011

Locations

Countries of recruitment

Netherlands

Study participating centre

Hanzeplein 1

Groningen
9713 GZ
Netherlands

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2006		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes