Effectiveness of Splinting After Collagenase Injection

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

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.

Study Overview

• Status: Completed
• Conditions: Dupuytren Contracture; Dupuytren's Disease
• Intervention / Treatment: Drug: Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex]; Combination product: Xiaflex + Hand-Based Custom Orthosis

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33637
      • Florida Orthopaedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: No Splint Group; This group will receive Xiaflex injection only	Drug: Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex]; 1 injection of 0.58mg will be injected into applicable cord.; Other Names: Xiaflex
Active Comparator: Splint Group; This group will receive Xiaflex injection and hand-based custom orthosis to maintain finger extension	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Foundation for Orthopaedic Research and Education
• Collaborators: EndoPharmceuticals
• Investigators: Principal Investigator: Jason Nydick, DO, Florida Orthopaedic Institute

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2021
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: April 23, 2021
• First Submitted That Met QC Criteria: April 30, 2021
• First Posted (Actual): May 6, 2021

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Muscular Diseases; Neoplasms, Connective Tissue; Neoplasms, Fibrous Tissue; Fibroma; Contracture; Dupuytren Contracture
• Other Study ID Numbers: FORE- CHI 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pending results- the plan would be to submit a poster for presentation and a manuscript for publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes