Clinical Trials Logo

Clinical Trial 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 Dupuytren´s contracture. Short- and long-term results will be published.


Clinical Trial 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 in long-term follow-up, in addition to short-term follow-up, 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 short-term results give good high quality level evidence of effectiveness of all the three treatments and long-term follow-up a good perspective to the cost-effectiveness of the strategies. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03192020
Study type Interventional
Source Tampere University
Contact
Status Active, not recruiting
Phase Phase 4
Start date September 15, 2017
Completion date May 31, 2031

See also
  Status Clinical Trial Phase
Recruiting NCT03155854 - The Effects of Prophylactic Limited Palmar Fasciectomy on Surgical Outcomes and Scarring N/A
Recruiting NCT05300893 - Effectiveness of Night Splinting After Percutaneous Needle Fasciotomy in Dupuytren's Contracture N/A
Completed NCT02647619 - Dupuytren´s Disease Study. Primary Disease, MCP Joint, Xiapex, PNF Phase 4
Recruiting NCT01184586 - Dupuytren's Disease and Extracorporeal Shockwave Therapy (DupuyShock-2010) Phase 2
Recruiting NCT04122313 - Post-contracture Release Radiation for Dupuytren's Disease
Withdrawn NCT01776892 - Collagenase and Needle Aponeurotomy: Single Modality Versus Combination Treatment for Dupuytren's Disease Phase 3
Completed NCT02983162 - Is wGRS Associated With DD Recurrence?
Completed NCT01923103 - Natural Disease Progress of Dupuytren Disease
Enrolling by invitation NCT03982719 - Comparing the Effectiveness of Two Post-fasciectomy Rehabilitation Protocols in Patients With Dupuytren's Disease N/A
Not yet recruiting NCT04907812 - The Role of Tranexamic Acid in Reducing Post Operative Hand Edema After Hand and Wrist Surgery Phase 4
Withdrawn NCT03031080 - BOND Study: the Benefit Of Night Splinting in Dupuytrens' N/A
Active, not recruiting NCT04874870 - Effectiveness of Splinting After Collagenase Injection Phase 3
Active, not recruiting NCT03407820 - Different Sutures in Hand Surgery N/A
Recruiting NCT03000114 - Collagenase Injection vs Percutaneous Needle Aponeurotomy for Dupuytren's Disease Phase 4
Recruiting NCT05440240 - Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture Phase 4
Completed NCT03331926 - Collagenase is a Common Treatment of MCP and PIP Joint Contractures in Dupuytrens Disease
Active, not recruiting NCT03741764 - Treatment of Dupuytren's Disease With Minimal Invasive Surgery and VIVOSORB® Resorbable Implant Device N/A
Completed NCT01876498 - Registry of Patient With M. Dupuytren and Validation of the Brief MHQ N/A
Completed NCT03868449 - Question Prompt List for Common Hand Conditions N/A
Completed NCT03573765 - Epidemiology and Outcomes of Upper Limb Surgery: Analysis of Routine Data