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Effectiveness of Splinting After Collagenase Injection

NCT04874870 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-02-26

No results posted yet for this study

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.

Conditions

  • Dupuytren Contracture
  • Dupuytren's Disease

Interventions

DRUG

Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex]

1 injection of 0.58mg will be injected into applicable cord.

COMBINATION_PRODUCT

Xiaflex + Hand-Based Custom Orthosis

1 injection of 0.58mg will be injected into applicable cord followed by use of hand-based custom orthosis to maintain finger extension

Sponsors & Collaborators

  • Endo, Inc.

    collaborator UNKNOWN

  • Foundation for Orthopaedic Research and Education

    lead OTHER

Principal Investigators

  • Jason Nydick, DO · Florida Orthopaedic Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-12
Primary Completion
2023-12-01
Completion
2023-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04874870 on ClinicalTrials.gov