Condition category
Musculoskeletal Diseases
Date applied
29/11/2010
Date assigned
06/06/2011
Last edited
06/06/2011
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

Prof Paul Werker

ORCID ID

Contact details

Hanzeplein 1
Groningen
9713 GZ
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

02.0107

Study information

Scientific title

Percutaneous needle fasciotomy versus limited fasciectomy in Dupuytren's disease: A randomised controlled clinical trial

Acronym

Study hypothesis

Now that the armentarium to treat Dupuytren’s 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

The Dutch Medical Ethics Committee approved in July 2002 (ref: 02.0107)

Study design

Single centre single blind randomised active controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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.

Secondary outcome measures

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

Overall trial start date

01/08/2002

Overall trial end date

01/01/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with Dupuytren’s 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120 patients

Participant 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

Recruitment start date

01/08/2002

Recruitment end date

01/01/2011

Locations

Countries of recruitment

Netherlands

Trial participating centre

Hanzeplein 1
Groningen
9713 GZ
Netherlands

Sponsor information

Organisation

University Medical Centre Groningen (UMCG) (Netherlands)

Sponsor details

Department of Plastic Surgery
Hanzeplein 1
Groningen
9713 GZ
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

University Medical Centre of Groningen (UMCG) (Netherlands)

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

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16713831

Publication citations

  1. Results

    van Rijssen AL, Gerbrandy FS, Ter Linden H, Klip H, Werker PM, A comparison of the direct outcomes of percutaneous needle fasciotomy and limited fasciectomy for Dupuytren's disease: a 6-week follow-up study., J Hand Surg Am, 31, 5, 717-725, doi: 10.1016/j.jhsa.2006.02.021.

Additional files

Editorial Notes