A pilot randomized controlled trial comparing the effect of minimal invasive technique vs. standard (dermo)fasciectomy surgery in patients with secondary Dupuytren's contractur on convalescence, contraction correction and recurrence rate.
Recruiting
- Conditions
- Secondary/ recurrent Dupuytren's disease
- Registration Number
- NL-OMON20615
- Lead Sponsor
- Erasmus Medical Center - Department of Plastic and Reconstructive Surgery
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
1. Males and females;
2. Age;
Exclusion Criteria
1. > 2 times surgery on affected ray;
2. congenital/trauma in past that affects the affected ray in a way that there is no 0 value;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Convalescence (in days): VAS, 6 questions (diary);<br /><br>2. Contracture reduction (in degrees): range motion (in degrees), boyes measure (in cm.), pictures.
- Secondary Outcome Measures
Name Time Method 1. Intervention (Register the anaesthetics drugs administered and vital signs during surgery, no protocol is used; Register the therapy used for PIP joint);<br /><br>2. Hand sensibility and complications due to intervention: semmes weinstein ( 5 filaments (2.83; 3.61; 4.31; 4.56; 6.65)), volume (in cm.), DASH;<br /><br>3. Patient satisfaction (VAS scale);<br /><br>4. MRI and Echo (selection of the intervention group).