Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04874870
Status:
COMPLETED
Last Update Posted:
2024-05-01
First Post:
2021-04-23
Brief Title:
Effectiveness of Splinting After Collagenase Injection
Sponsor:
Foundation for Orthopaedic Research and Education
Organization:
Foundation for Orthopaedic Research and Education
Study Overview
Official Title:
Clinical Effectiveness of Splinting After Collagenase Clostridium Histolyticum Injection for Dupuytren Contracture
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 contractures with a standard finger goniometer and QuickDASH scores All patients that participate will receive 1 injection of 058 mg of CCH into cord After 24-48 hours if needed patient will return to clinic for extension manipulation of treated fingers to help facilitate rupture of cord Following injection andor 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 contractures 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None