Effectiveness of Splinting After Collagenase Injection

Dupuytren Contracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04874870
• Other study ID #: FORE- CHI 2021
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 12, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: September 2023
• Source: Foundation for Orthopaedic Research and Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Contracture
• Dupuytren Contracture
• Dupuytren's Disease

Intervention

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

Locations

Country	Name	City	State
United States	Florida Orthopaedic Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Foundation for Orthopaedic Research and Education	EndoPharmceuticals

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Compliance of Splint wearing (Splint group only)	By compliance survey composed of 4 items; Items 1 and 2 scored from 1-5; 1 - not at all, 2 - slightly, 3- moderately, 4- very, 5- extremely; How comfortable was your splint?; Was the splint easy to use?; Items 3 and 4 scored from 1-5; 1 - not at all, 2 - occasionally, 3- half of the time, 4 - most of the time, 5 - all of the time; Did you wear your splint every night?; Did you have any issues with your splint?	1 month and 4 months
Secondary	Functional Outcomes	Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire score will be used to measure clinical outcomes. The QuickDASH is scored in two components: the disability/symptom section (11 items, scored 1-5) and the optional high performance sport/music or work modules (four items, scored 1-5). From the item scores, scale scores are calculated, ranging from 0 (no disability) to 100 (most severe disability).	Baseline, 1 month, and 4 months
Secondary	Patient Satisfaction	By satisfaction scale composed of 3 items (each of them scored from 1-5; 1 - not at all, 2 - slightly, 3- moderately, 4- very, 5- extremely); How satisfied are you with the progress of your hand?; How satisfied are you with your treatment?; Has your quality of life improved?	1 month and 4 months