A pilot randomized controlled trial comparing the effect of a percutaneous and lipofilling technique in patients with a secondary Dupuytren*s contracture with standard fasciectomy surgery on convalenscence, contracture correction and recurrence rate.
Completed
- Conditions
- hand diseasesSecondary Dupuytren's contracture1001076110040795
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
-males and females
- patients of 18 years and older
- secondary Dupuytren's contracture
- PIP > 30 degrees / MCP > 20 degrees
- one or more affected rays
- severe or less severe diatheses
- ASA criteria I, II, and III
Exclusion Criteria
- Primary Dupuytren*s contracture
- Amputation of 1 or more fingers of the affected hand.
- More than 2 times hand surgery in the affected ray.
- disorder (trauma/congenital) in the past that affects the affected finger (0-situation is unknown).
- Dystrophic characteristics in the past.
- use of anticoagulants that can not be stopped for surgery
- ASA IV and V
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Convalescence: return to function and return to work<br /><br>- VAS score: standardized list of questions about pain and well-being of the<br /><br>patient; to register the pain of the hand and donor site.<br /><br>- Contracture reductions:<br /><br>1) Total passive extension deficity (TPED): the sum of the passive extension<br /><br>deficits of the metacarpophalangeal, proximal interphalangeal, and distal<br /><br>interphalangeal joints.<br /><br>2) Boyes measure: measuring the distance from pulp to distal palmar crease with<br /><br>the hand in a maximum fist position. Flexion is defined as reduced if the<br /><br>distance is more than 1.5 cm.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Intervention:<br /><br>o Register the anaesthetics drugs administered and vital signs during surgery.<br /><br>o Register of arthrolysis (if it is used)<br /><br><br /><br>Hand sensibility and complications due to intervention:<br /><br>o Semmes Weinstein testo Swelling measured following hand volume<br /><br>o DASH score: standardized list of questions about hand and arm function of the<br /><br>patient<br /><br>o CISS-score: cold-intollerance<br /><br>o Esthetic and contracture correction: Kodak photos<br /><br><br /><br><br /><br>o EQ-5D: cost-effectiveness<br /><br><br /><br>o MRI: fat monitoring<br /><br>o cord: investigate the new intervention technique<br /><br><br /><br>Patients satisfaction:<br /><br>o To determine the patient satisfaction, a questionaire with VAS-scale was<br /><br>made.</p><br>