Injectable Collagenase and Percutaneous Needle Fasciotomy for Dupuytren's Contracture

Jeppe Lange, MD

Status: Completed

Conditions: Dupuytrens Contracture

Treatments: Drug: Xiapex; Procedure: Percutaneous needle fasciotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01538017

M-20110233

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Collagenase injection

Active Comparator group

Description:

Injection of collagenase obtained from Clostridium Histolyticum in contracture string

Treatment:

Drug: Xiapex

Percutaneous needle fasciotomy

Active Comparator group

Description:

PNF ad modum Lermusiaux and Debeyre

Treatment:

Procedure: Percutaneous needle fasciotomy