Quantitative and Clinical Assessment of Flexor Tendon Gliding Following Application of a Bioresorbable Hydrogel: A Prospective, Randomized Study in Patients Undergoing Distal Radius Fracture Repair
NCT ID: NCT04976335
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2021-09-13
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
DOUBLE
Study Groups
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Versawrap
Versawrap membrane
Versawrap membrane will be placed between distal radius plate and flexor tendons
No Versawrap
No interventions assigned to this group
Interventions
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Versawrap membrane
Versawrap membrane will be placed between distal radius plate and flexor tendons
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with a closed, distal radius fracture treated with open reduction and internal fixation using a volar distal radius plating system.
Exclusion Criteria
* concomitant injury to the contralateral wrist;
* history of flexor tendon repair involving one or both hands or wrists;
* use of a trans-carpal fixation device (bridge plate or external fixator) that would preclude wrist motion post-operatively;
* concomitant fracture / injury to the thumb or index finger of one or both hands;
* concomitant carpal tunnel release.
18 Years
ALL
No
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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Locations
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University of Colorado Health Hospital
Aurora, Colorado, United States
Denver Health Hospital
Denver, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Fraser L Leversedge, MD
Role: primary
Other Identifiers
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20-2659
Identifier Type: -
Identifier Source: org_study_id
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