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ACTIVE NOT RECRUITING
NCT03192020
PHASE4

Trial Comparing Treatment Strategies in Dupuytren's Contracture

Sponsor: Tampere University

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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.

DRUG

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.

PROCEDURE

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