Effectiveness of Splinting After Collagenase Injection

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dupuytren Contracture, Dupuytren's Disease

Intervention / Treatment
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* Drug: Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex]
* Combination Product: Xiaflex + Hand-Based Custom Orthosis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Controlled
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No Splint Group<br>This group will receive Xiaflex injection only | Drug: Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex]<br>* 1 injection of 0.58mg will be injected into applicable cord.<br>* Other names: Xiaflex;|
| Active Comparator: Splint Group<br>This group will receive Xiaflex injection and hand-based custom orthosis to maintain finger extension | Combination Product: Xiaflex + Hand-Based Custom Orthosis<br>* 1 injection of 0.58mg will be injected into applicable cord followed by use of hand-based custom orthosis to maintain finger extension<br>|

What is the study measuring?
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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 |