Clinical trial NCT04874870: Effectiveness of Splinting After Collagenase Injection
Official title: Clinical Effectiveness of Splinting After Collagenase Clostridium Histolyticum Injection for Dupuytren Contracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dupuytren Contracture
Dupuytren's Disease
Lead sponsor: Foundation for Orthopaedic Research and Education
Sponsor class: OTHER
Collaborators: name: Endo, Inc.
First posted: 2021-05-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Controlled
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Improvement in active extension deficit of MCP joint, in degrees, if applicable
timeFrame: Baseline, 1 month, and 4 months
measure: Improvement in active extension deficit of PIP joint, in degrees, if applicable
timeFrame: Baseline, 1 month, and 4 months
measure: Improvement in total active extension of each digit, in degrees
timeFrame: Baseline, 1 month, and 4 months
Secondary outcomes:
measure: Compliance of Splint wearing (Splint group only)
timeFrame: 1 month and 4 months
measure: Functional Outcomes
timeFrame: Baseline, 1 month, and 4 months
measure: Patient Satisfaction
timeFrame: 1 month and 4 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Florida Orthopaedic Institute
state: Florida
Study officials:
affiliation: Florida Orthopaedic Institute
name: Jason Nydick, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.