Percutaneous needle fasciotomy versus limited fasciectomy in Dupuytren's disease
| ISRCTN | ISRCTN58554745 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58554745 |
| Secondary identifying numbers | 02.0107 |
- 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
Not provided at time of registration
Contact information
Prof Paul Werker
Scientific
Scientific
Hanzeplein 1
Groningen
9713 GZ
Netherlands
Study information
| Study design | Single centre single blind randomised active controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Percutaneous needle fasciotomy versus limited fasciectomy in Dupuytren's disease: A randomised controlled clinical trial |
| Study hypothesis | 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) |
| 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 |
| Primary outcome measure | 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 study start date | 01/08/2002 |
| Overall study end date | 01/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 120 patients |
| Participant 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 |
| 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
Study participating centre
Hanzeplein 1
Groningen
9713 GZ
Netherlands
9713 GZ
Netherlands
Sponsor information
University Medical Centre Groningen (UMCG) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Plastic Surgery
Hanzeplein 1
Groningen
9713 GZ
Netherlands
"ROR" |
https://ror.org/03cv38k47 |
|---|
Funders
Funder type
Hospital/treatment centre
University Medical Centre of Groningen (UMCG) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
