Injectable Collagenase and Percutaneous Needle Fasciotomy for Dupuytren's Contracture

Not Applicable

Completed

• Conditions: Dupuytrens Contracture
• Interventions: Drug: Xiapex; Procedure: Percutaneous needle fasciotomy

• Registration Number: NCT01538017
• Lead Sponsor: Jeppe Lange, MD

Brief Summary

Comparing injectable collagenase and percutaneous needle fasciotomy for Dupuytren's contracture affecting proximal interphalangeal joints. An open label, medico-independent randomized controlled trial.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-18
• Study First Submitted QC: 2012-02-18
• Study First Posted: 2012-02-23
• Status Verified: 2016-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-03
• Last Update Posted: 2016-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• DC affecting PIP joint with Passive Extension Deficit (PED) more than 20 degrees
• Clearly defined strings

Exclusion Criteria

• Allergies to used medication
• International Normalised Ratio more than 2.0
• Pregnancy and breastfeeding
• Previous treatment for DC in affected finger
• Former inclusion in the study with another string
• Activity in disease at time of study
• PED more than 20 degrees for Metacarpophalangeal or Distal Interphalangeal joint in affected digit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Collagenase injection	Xiapex	Injection of collagenase obtained from Clostridium Histolyticum in contracture string
Percutaneous needle fasciotomy	Percutaneous needle fasciotomy	PNF ad modum Lermusiaux and Debeyre

Primary Outcome Measures

Name	Time	Method
Clinical improvement	2 years	Clinical improvement is defined as a contracture reduction 50% or more from baseline.

Trial Locations

Locations (1)

Center for Planned surgery - Regionalhospital Silkeborg; 🇩🇰 Silkeborg, Denmark