Injectable Collagenase and Percutaneous Needle Fasciotomy for Dupuytren's Contracture

Dupuytrens Contracture Clinical Trial

Official title:

Comparing Injectable Collagenase (CI) and Percutaneous Needle Fasciotomy (PNF) for Dupuytren's Contracture (DC) Affecting Proximal Interphalangeal Joints (PIP). A Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01538017
• Other study ID #: M-20110233
• Status: Completed
• Phase: N/A
• First received: February 18, 2012
• Last updated: October 3, 2016
• Start date: February 2012
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Regionshospitalet Silkeborg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contracture
• Dupuytren Contracture
• Dupuytrens Contracture

Intervention

Drug:
• Xiapex
Collagenase Clostridium Histolyticum

Procedure:
• Percutaneous needle fasciotomy
Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre

Locations

Country	Name	City	State
Denmark	Center for Planned surgery - Regionalhospital Silkeborg	Silkeborg

Sponsors (1)

Lead Sponsor	Collaborator
Jeppe Lange, MD

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical improvement	Clinical improvement is defined as a contracture reduction 50% or more from baseline.	2 years	No