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Completed

NCT Number: NCT04874870

Effectiveness of Splinting After Collagenase Injection

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Florida Orthopaedic Institute

Tampa, Florida, 33637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex]

Drug

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

Other names: Xiaflex

Xiaflex + Hand-Based Custom Orthosis

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

Primary outcomes

  1. Improvement in active extension deficit of MCP joint, in degrees, if applicable

    Time frame: Baseline, 1 month, and 4 months

    Clinical measurement of MCP joint extension with goniometer, in degrees, of treated finger

  2. Improvement in active extension deficit of PIP joint, in degrees, if applicable

    Time frame: Baseline, 1 month, and 4 months

    Clinical measurement of PIP joint extension with goniometer, in degrees, of treated finger

  3. Improvement in total active extension of each digit, in degrees

    Time frame: Baseline, 1 month, and 4 months

    Sum of MCP and PIP joint extension, in degrees, of treated finger

Secondary outcomes

  1. Compliance of Splint wearing (Splint group only)

    Time frame: 1 month and 4 months

    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?

  2. Functional Outcomes

    Time frame: Baseline, 1 month, and 4 months

    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).

  3. Patient Satisfaction

    Time frame: 1 month and 4 months

    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?

Sponsors and collaborators

Lead sponsor

Foundation for Orthopaedic Research and Education

Other

Collaborators

  • Endo, Inc.

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 6, 2021
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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