Trial Comparing Treatment Strategies in Dupuytren's Contracture

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.

Conditions

• Dupuytren Contracture

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.

Sponsors & Collaborators

• Central Finland Hospital District

  collaborator OTHER

• Helsinki University Central Hospital

  collaborator OTHER

• Turku University Hospital

  collaborator OTHER_GOV

• Tampere University Hospital

  collaborator OTHER

• Kuopio University Hospital

  collaborator OTHER

• Oulu University Hospital

  collaborator OTHER

• Medcare Oy

  collaborator OTHER

• Finnish Institute for Health and Welfare

  collaborator OTHER_GOV

• Orton Orthopaedic Hospital

  collaborator OTHER

• Tampere University

  lead OTHER

Principal Investigators

• Mikko P Räisänen, M.D. · Tampere University Hospital

• Harry J Göransson, M.D., Ph.D., adjunct professor · Tampere University Hospital

• Aleksi RP Reito, M.D., Ph.D., adjunct professor · Central Finland Central Hospital

• Hannu Kautiainen, MSc · Medcare Ltd

• Antti OV Malmivaara, M.D., Ph.D., adjunct professor · Finnish Institute for Health and Welfare

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-09-15

Primary Completion

2026-05-31

Completion

2031-05-31

FDA Drug

Yes

Countries

• Finland

Study Locations