Effectiveness of Splinting After Collagenase Injection

Dupuytren Contracture Clinical Trial

Official title: Clinical Effectiveness of Splinting After Collagenase Clostridium Histolyticum Injection for Dupuytren Contracture

Status Completed

Clinical Trial Summary

Dupuytren disease is a fibroproliferative condition of the palmar and digital fascia. A collagen containing cord forms which can lead to fixed flexion contracture of one or more fingers. While there is no cure, many treatment options are available to manage symptoms. One of these options is injectable collagenase clostridium histolyticum (CCH). CCH is a combination of two highly selective microbial collagenases that can disrupt collagen types I and III usually found in cords. Current standard of care after receiving a CCH injection is daily hand exercises and use of a static night brace for four months. However, there is limited evidence that use of a night splint after CCH injection has any benefit post-treatment. The goal of our randomized, controlled trial, is to determine the clinical effectiveness of splinting after CCH injection. Study subjects will be adults 18 years of age or older with Dupuytren disease and contracture of one or more digits. Treatment includes collagenase clostridium histolyticum injection for Dupuytren flexion contraction, with randomization to static night splint or no splint.

Clinical Trial Description

Patients with Dupuytren disease that meet inclusion criteria will be consented to participate. All patients will be randomized to splint or no splint group prior to treatment. Baseline data will be collected prior to treatment and will include demographics, measurement of joint flexion contracture(s) with a standard finger goniometer, and QuickDASH scores. All patients that participate will receive 1 injection of 0.58 mg of CCH into cord. After 24-48 hours, if needed, patient will return to clinic for extension manipulation of treated finger(s) to help facilitate rupture of cord. Following injection and/or manipulation, all patients will be instructed to perform a series of finger exercises daily that they will receive from a hand therapist. In addition, patients assigned to the splint group will be fitted for a static night splint that they will be instructed to wear nightly for 4 months. Splint compliance will be recorded by a survey at each follow up visit. Patients will return to clinic for routine follow up care at 1 month and 4 months during which their degree of contracture(s) and outcomes will be measured and recorded. The primary outcome measures of this study are improvement in active extension deficit of each joint and total active extension of each digit, in degrees. The secondary outcome measures are QuickDASH scores and patient satisfaction. ;

Related Conditions & MeSH terms

• Contracture
• Dupuytren Contracture
• Dupuytren's Disease

• NCT number: NCT04874870
• Study type: Interventional
• Source: Foundation for Orthopaedic Research and Education
• Status: Completed
• Phase: Phase 3
• Start date: July 12, 2021
• Completion date: December 1, 2023