Trial Comparing Treatment Strategies in Dupuytren's Contracture

  • STATUS
    Recruiting
  • End date
    May 31, 2031
  • participants needed
    303
  • sponsor
    Tampere University
Updated on 17 February 2021
collagenase
dupuytren's contracture
xiaflex
fasciotomy

Summary

Trial is a prospective, randomized, controlled, outcome assessor-blinded, three armed parallel 1:1:1, multicenter trial. The research objective is to determine, which treatment strategy 1) primary percutaneous needle fasciotomy (PNF) followed by surgical limited fasciectomy (LF) in patients who do not respond to PNF, 2) primary collagenase clostridium histolyticym (CCH) followed by LF in patients who do not respond to CCH or 3) LF as the primary (and secondary) treatment modality is the most cost-effective in treating Dupuytrens contracture.

Description

Dupuytren's contracture (DC) is a fibroproliferative disorder of the palmar fascia, which in time leads to flexion contracture in one or more fingers. Etiology of the disease is still unknown, but it strongly seems that genetic factors play a major role. DC is associated most commonly with Caucasian population groups from Northern Europe. The estimated global prevalence among whites is 3% to 6%, and increases with age. Men women ratio is 7:1. There is no definitive cure for DC. The treatment aims at relieving the symptoms by releasing the contracture by percutaneous or operative techniques.

The investigators planned a prospective, randomized, controlled, outcome assessor-blinded, three armed parallel 1:1:1, multicenter trial comparing the cost-effectiveness of 1) collagenase clostridium histolyticum followed by limited fasciectomy in non-responsive cases, 2) percutaneous needle fasciotomy followed by limited fasciectomy in non-responsive cases and 3) primary limited fasciectomy in short- and long-term follow-up in DC.

Protocol is approved by Tampere university hospital institutional review board and Finnish Medicine Agency (Fimea). All patients will give written informed consent. The results of the trial will be disseminated as published articles in peer-reviewed journals.

Treatment of Duputren's contracture aims at reducing the functional deficit caused by the contracture. Recurrence is almost inevitable, if the follow-up is long enough. Therefore, the investigators aim to analyze the effectiveness of three different treatment strategies, which include multiple interventions rather than just single intervention. The investigators chose a pragmatic primary outcome, which comprises both objective and subjective standpoint and reflects the needs of the patients as well as goals of the healthcare system. Furthermore, our long-term follow-up gives a good perspective to the cost-effectiveness of the strategies.

Details
Condition CONNECTIVE TISSUE DISEASE, Connective Tissue Diseases, Dermatomyositis (Connective Tissue Disease), Dupuytren's Contracture, Dupuytren's Disease, Dermatomyositis (Connective Tissue Disease), Connective Tissue Diseases, Dupuytren's Disease
Treatment Percutaneous needle fasciotomy, Collagenase Clostridium Histolyticum 2.9 MG/ML [Xiaflex], Limited fasciectomy
Clinical Study IdentifierNCT03192020
SponsorTampere University
Last Modified on17 February 2021

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