Effectiveness of Splinting After Collagenase Injection

NCT04874870 | Completed Phase 3 FDA Drug

• 1 other identifier: FORE- CHI 2021
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Improvement in active extension deficit of MCP joint, in degrees, if applicable

  Clinical measurement of MCP joint extension with goniometer, in degrees, of treated finger

  Baseline, 1 month, and 4 months

• Improvement in active extension deficit of PIP joint, in degrees, if applicable

  Clinical measurement of PIP joint extension with goniometer, in degrees, of treated finger

  Baseline, 1 month, and 4 months

• Improvement in total active extension of each digit, in degrees

  Sum of MCP and PIP joint extension, in degrees, of treated finger

  Baseline, 1 month, and 4 months

Secondary Outcomes (3)

• Compliance of Splint wearing (Splint group only)

  1 month and 4 months

• Functional Outcomes

  Baseline, 1 month, and 4 months

• Patient Satisfaction

  1 month and 4 months

Study Arms (2)

No Splint Group

ACTIVE COMPARATOR

This group will receive Xiaflex injection only

Drug: Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex]

Splint Group

ACTIVE COMPARATOR

This group will receive Xiaflex injection and hand-based custom orthosis to maintain finger extension

Combination Product: Xiaflex + Hand-Based Custom Orthosis

Interventions

Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] DRUG

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

Also known as: Xiaflex

No Splint Group

Xiaflex + Hand-Based Custom Orthosis COMBINATION_PRODUCT

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

Splint Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Contracture of 1 or more digits caused by palpable cord
• PIP joint flexion contracture of 20 degrees or more or;
• MCP joint flexion contracture of 20 degrees or more

You may not qualify if:

• Age less than 18 years
• Prior CCH injection for contracture less than 1 year before start of study
• Prior surgical intervention for contracture less than 1 year before start of study

Sponsors & Collaborators

• Foundation for Orthopaedic Research and Education: lead
• Endo, Inc.: collaborator

Study Sites (1)

Florida Orthopaedic Institute

Tampa, Florida, 33637, United States

Location

Related Publications (3)

• Rayan GM. Dupuytren disease: Anatomy, pathology, presentation, and treatment. J Bone Joint Surg Am. 2007 Jan;89(1):189-98. doi: 10.2106/00004623-200701000-00026. No abstract available.

  PMID: 17256226 BACKGROUND

• Hurst LC, Badalamente MA, Hentz VR, Hotchkiss RN, Kaplan FT, Meals RA, Smith TM, Rodzvilla J; CORD I Study Group. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N Engl J Med. 2009 Sep 3;361(10):968-79. doi: 10.1056/NEJMoa0810866.

  PMID: 19726771 BACKGROUND

• Bowers NL, Merrell GA, Foster T, Kaplan FTD. Does Use of a Night Extension Orthosis Improve Outcomes in Patients With Dupuytren Contracture Treated With Injectable Collagenase? J Hand Surg Glob Online. 2021 Jun 26;3(5):272-277. doi: 10.1016/j.jhsg.2021.05.001. eCollection 2021 Sep.

  PMID: 35415567 BACKGROUND

MeSH Terms

Conditions

Dupuytren Contracture

Interventions

Microbial Collagenase

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Contracture; Muscular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Collagenases; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Study Officials

• Jason Nydick, DO

  Florida Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jason Nydick DO

Model Details: Randomized, Controlled

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: May 6, 2021
• Study Start: July 12, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)