Effectiveness of Splinting After Collagenase Injection

NCT ID: NCT04874870

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-12
• Study Completion Date: 2023-12-01

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.

Detailed 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.

Conditions

Dupuytren Contracture; Dupuytren's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No Splint Group

This group will receive Xiaflex injection only

Group Type: ACTIVE_COMPARATOR

Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex]

Intervention Type: DRUG

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

Splint Group

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

Group Type: ACTIVE_COMPARATOR

Xiaflex + Hand-Based Custom Orthosis

Intervention Type: 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

Interventions

Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex]

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

Intervention Type: DRUG

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

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Xiaflex

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Endo, Inc.

UNKNOWN

Sponsor Role: collaborator

Foundation for Orthopaedic Research and Education

OTHER

Sponsor Role: lead

Responsible Party

Jason Nydick DO

Jason Nydick DO

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason Nydick, DO

Role: PRINCIPAL_INVESTIGATOR

Florida Orthopaedic Institute

Locations

Florida Orthopaedic Institute

Tampa, Florida, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 17256226 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19726771 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35415567 (View on PubMed)

Other Identifiers

FORE- CHI 2021

Identifier Type: -

Identifier Source: org_study_id