Trial | NCT01538017  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    50
Comparing injectable collagenase and percutaneous needle fasciotomy for Dupuytren's contracture affecting proximal interphalangeal joints. An open label, medico-independent randomized controlled trial.
Study Started
Feb 29
2012
Primary Completion
Oct 31
2016
Study Completion
Oct 31
2016
Last Update
Oct 04
2016
Estimate

Drug Xiapex

Collagenase Clostridium Histolyticum

  • Other names: XIAPEX® - Pfizer UK

Procedure Percutaneous needle fasciotomy

Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre

Collagenase injection Active Comparator

Injection of collagenase obtained from Clostridium Histolyticum in contracture string

Percutaneous needle fasciotomy Active Comparator

PNF ad modum Lermusiaux and Debeyre

Criteria 

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
No Results Posted