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.|
|- candidate number||7760|
|- NTR Number||NTR2215|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-feb-2010|
|- Secondary IDs||MEC 2009-437 Erasmus MC, Rotterdam|
|- Public Title||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.|
|- Scientific Title||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.|
|- ACRONYM||Du Ro Trial - 2 |
|- hypothesis||The percutaneous and lipofilling technique has a shorter convalescence.|
|- Healt Condition(s) or Problem(s) studied||Secondary Dupuytren's disease|
|- Inclusion criteria||1. Males and females;|
3. Secondary Dupuytren's contracture;
4. PIP> 30º / MCP > 20º;
5. One or more affected diatheses;
6. ASA criteria I, II, and III.
|- 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;
3. Use of blood thinners that can not be stopped for surgery;
4. ASA IV and V;
5. severe CRPS in the past.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2010|
|- planned closingdate||1-jan-2012|
|- Target number of participants||80|
|- Interventions||1. Intervention: Percutaneous lipofilling technique;|
2. Control: (Dermo) fasciectomy surgery.
|- Primary outcome||1. Convalescence (in days): VAS, 6 questions (diary);|
2. Contracture reduction (in degrees): range motion (in degrees), boyes measure (in cm.), pictures.
|- Secondary outcome||1. Intervention (Register the anaesthetics drugs administered and vital signs during surgery, no protocol is used; Register the therapy used for PIP joint);|
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;
3. Patient satisfaction (VAS scale);
4. MRI and Echo (selection of the intervention group).
|- Timepoints||1. Pre operative: range of motion, VAS, DASH, Semmes & Weinstein, diary, pictures, volume measure, grip force;|
2. 2 weeks post operative: range of motion, VAS, Semmes & Weinstein, diary, pictures;
3. 3 weeks post operative: range of motion, VAS, Semmes & Weinstein, diary, volume measure, grip force;
4. 6 months post operative: range of motion, VAS, DASH, Semmes & Weinstein, patient satisfaction, diary, pictures;
5. 1 year post operative: range of motion, VAS, patient satisfaction.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. dr. S.E.R. Hovius|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. S.E.R. Hovius|
|- Sponsor/Initiator ||Erasmus Medical Center - Department of Plastic and Reconstructive Surgery|
(Source(s) of Monetary or Material Support)
|- Brief summary||Dupuytren’s disease (DD) is a benign, progressive, fibroproliferative disorder that results in the development of abnormal scar-like tissue in the palmar fascia of the hand. Extension to the digits causes progressive digital flexion contracture[1, 2]. In 2006, Dupuytren’s disease was diagnosed 7048 times in the Netherlands. In total, 5843 DD operations were performed that year (Prismant Informatie Expertise). The treatment of DD mainly consists of surgery. Accepted options for managing diseased skin and fascia are (1) limited fasciectomy, (2) segmental fasciectomy (3) fasciotomy (4) dermofasciectomy. Limited fasciectomy and, if necessary, limited dermofasciectomy are the most often-used techniques. With this technique, full recovery of hand function generally takes 2-3 months. In collaboration with the Miami Hand Center (Roger K. Khouri, MD), we developed a technique in which percutaneous release of fibrotic cords is refined in combination with subdermal fat grafting. Subdermal dissection of the cord is performed by making multiple superficial nicks along the entire cord. The cord then chops, disintegrates and separates from the dermis. This space is filled with fat grafts. This technique should have a shorter convalescence because it is less invasive compared with the conventional techniques. Aim of our study is to compare in patients with a secondary Dupuytren’s contracture the effect of a new percutaneous and lipofilling technique with standard fasciectomy surgery on convalescence, contracture correction and recurrence rate. We will use the VAS and DASH score and hand function test to measure the recovery of the hand function. This study may provide an insight into a better treatment option for patients with Dupuytren’s contractures and it may lower the costs of treatment by shortening the convalescence.|
1. Townley, W.A., et al., Dupuytren's contracture unfolded. Bmj, 2006. 332(7538): p. 397-400.
2. Thurston, A.J., Dupuytren's disease. J Bone Joint Surg Br, 2003. 85(4): p. 469-77.
3. McFarlane, R., D.A. McGrouther, and M.H. Flint, eds. Dupuytren's Disease. 1990, Churchill Livingstone: Edinburgh.
|- Main changes (audit trail)|
|- RECORD||12-feb-2010 - 26-feb-2010|
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