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

• Status: Withdrawn
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alberta

Criteria

Inclusion Criteria:

• 18 years of age or older

• Metacarpophalangeal joint contracture between 20-100 degrees OR proximal interphalangeal joint contracture between 20-80 degrees

• Positive table top test, defined as the inability to simultaneously place the affected finger and palm flat on a table

Exclusion Criteria:

• Use of an anticoagulant within 7 days before the beginning of the study, excluding aspirin

• Bleeding disorder

• Recent stroke

• Allergy to collagenase

• A chronic muscular, neurologic, or neuromuscular disorder affecting the hands

• Previous treatment of the affected joint within 90 days before the beginning of the study

• Use of a tetracycline derivative within 14 days before the beginning of the study

• Pregnancy

• Breast feeding

• Premenopausal woman, not using contraception