Collagenase and Needle Aponeurotomy: Single Modality Versus Combination Treatment for Dupuytren's Disease

Dupuytren Contracture Clinical Trial

Official title: Collagenase and Needle Aponeurotomy: Single Modality Versus Combination Treatment for Dupuytren's Disease

Status Withdrawn

Clinical Trial Summary

Dupuytren's disease results in deformity of the hand and this can lead to trouble with daily activities. Treatment traditionally involves cutting out diseased tissue, however this can cause damage to important structures in the hand and results in large scars.

Needle aponeurotomy and collagenase injections are newer treatments that are thought to be safer. These treatments allow quicker return to function. One drawback is that Dupuytren's deformity may return more quickly than when all diseased tissue is surgically cut out.

This research study is designed to compare the effectiveness of needle aponeurotomy and collagenase injection for Dupuytren's disease. This study will determine which procedure gives the best results- either needle aponeurotomy, collagenase injection, or both procedures in combination. Participants will be evaluated to see how they do in the long term.

Clinical Trial Description

Dupuytren's disease is a benign proliferative disorder of the palmar fascia. It results in progressive thickening and contracture of fibrous bands on the volar surface of the palm and fingers as a result of excessive myofibroblast activity. Patients develop longitudinal cords which may lead to progressive joint contractures. Dupuytren's disease limits hand function and can diminish quality of life.

The most commonly used technique for treatment is open limited fasciectomy. The cumulative complication rate ranges from 14-67% and includes nerve division (2-5%), infection (4-12%), neurapraxia (0.4-52%), and regional pain syndrome (2-13%). The recurrence rate of Dupuytren's disease after fasciectomy is approximately 50% at 5 years.

Recently, interest in needle aponeurotomy and collagenase clostridium histolyticum injection have increased as alternative treatment modalities for Dupuytren's disease. Both procedures can be performed in an outpatient clinic, have limited downtime, allow earlier return to work, and are associated with significantly fewer serious complications than open fasciectomy. Needle aponeurotomy and collagenase injection are less invasive than fasciectomy, however they are associated with higher rates of disease recurrence.

Numerous studies investigating the effectiveness and safety of needle aponeurotomy and collagenase injection studies have been published. To date, there is no published literature about the use of these techniques in combination for the treatment of Dupuytren's disease. The investigators propose to follow the patient population of a single surgeon performing needle aponeurotomy in combination with collagenase injection to determine the effectiveness of this combination treatment. Patients treated with combination treatment will be compared to patients treated with a single modality- either needle aponeurotomy or collagenase injection.

Patients will be assessed pre and post operatively to evaluate functional status and the degree of joint contracture. Patient satisfaction, adverse events, recurrence, and repeat treatment rates will also be determined. ;

Study Design

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

Related Conditions & MeSH terms

• Contracture
• Dupuytren Contracture

• NCT number: NCT01776892
• Study type: Interventional
• Source: University of Alberta
• Status: Withdrawn
• Phase: Phase 3
• Start date: May 2013
• Completion date: March 2014