We will compare two non-operative treatment options for Dupuytrens contracture

Phase 1

• Conditions: Dupuytrens contracture of the hand; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2014-000673-40-NO
• Lead Sponsor: ous

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-09
• Last Update Posted: 6 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Symptomatic Dupuytrens contracture with palpable cord, involving MCP joint, and total contracture > 30 degrees.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

Eksklusjonskriterier:
Tidligere operert Dupuytrens kontraktur på samme hånd.
Mer enn tre behandlingstrengende affiserte stråler.
Man vil ikke inkludere tomler.
Andre tilstander i hånden som affiserer leddenes bevegelighet.
ASA>3.
Infeksjon/antibiotikabehandling.
Kvinner i fertil alder må bruke prevensjonsmidler
Age under 18 years
Previous treated for Dupuytrens contracture in same hand
max 3 rays
not thumbs
patients with other conditions affecting finger movement
ASA>3
infection
Pregnancy potential

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: We will compare Percutaneous Needle Fasciotomy and Xiapex injection for Dupuytrens contracture to se if the treatments art equal in regard of treating the contracture and in regard of recurrence. <br>Main end point is at 5 years.;Secondary Objective: Postoperative contracture<br>1 year contracture<br>3 year contracture<br>reoperation;Primary end point(s): Total finger contracture afteer 5 years;Timepoint(s) of evaluation of this end point: 5 year evaluation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): postoperative contracture<br>1 year contracture<br>3 year contracture<br>reoperation;Timepoint(s) of evaluation of this end point: treatment day<br>1 and 3 year examination