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Trial Comparing Treatment Strategies in Dupuytren's Contracture
Sponsor: Tampere University
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.
Official title: DupuytrEn Treatment EffeCtiveness Trial (DETECT): Needle Fasciotomy, Surgery or Collagenase Injection for Dupuytren's Contracture
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
302
Start Date
2017-09-15
Completion Date
2031-05-31
Last Updated
2025-03-26
Healthy Volunteers
No
Conditions
Interventions
Percutaneous needle fasciotomy (PNF)
The division of the cord can be made under local anesthesia in the clinic and takes only a few minutes to perform. It can be performed whenever the cord is palpable. There are only puncture wounds left, and hence, the patient can start normal use of the hand the day after the procedure. If patient seeks for a treatment and the recurrence of the disease can not be treated by the PNF or patient is not willing to new PNF patient will be treated with LF.
Collagenase Clostridium Histolyticum (CCH) 2.9 MG/ML [Xiaflex]
CCH chemically dissolves type I collagen of which the cord is composed of. It is injected inside the cord at least three different places in the outpatient clinic and the cord can be ruptured by gently force after one to three days. If patient seeks for a treatment and the recurrence of the disease can not be treated by the CCH or patient is not willing to new CCH patient will be treated with LF.
Limited fasciectomy (LF)
LF is performed in general or regional anesthesia in operating room. Constricting cords will be excised under direct vision. LF has been the dominant technique of surgical treatment. If patient seeks for a treatment the recurrence of the disease will be treated with LF as long as needed.
Locations (6)
Central Hospital of Central Finland
Jyväskylä, Central Finland, Finland
Oulu University hospital
Oulu, North Ostrobothnia, Finland
Kuopio University hospital
Kuopio, Northern Savonia, Finland
Tampere University Hospital
Tampere, Pirkanmaa, Finland
Turku University Hospital
Turku, Southwest Finland, Finland
Helsinki University hospital
Helsinki, Uusimaa, Finland