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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT04976335
Status
Recruiting
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Conditions

  • Distal Radius Fracture
  • Tendon Rupture

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Versawrap membrane — DEVICE
    Versawrap membrane will be placed between distal radius plate and flexor tendons

Study Details

The investigators will be evaluating the use of versawrap in the setting of distal radius fractures by placing membrane between plate and flexor tendons. Investigators will then evaluate tendon gliding morphology and number of tendon ruptures

Key Dates

Start date
Sep 13, 2021
Status verified
Sep 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Active Comparator: Versawrap
  • No Intervention: No Versawrap

Primary Outcome Measure

Range of Motion: Thumb Interphalangeal and Index Finger Distal Interphalangeal Joints [ Time Frame: 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Colorado Health HospitalAuroraColorado80045
Fraser L Leversedge, MD
919-316-0616
Denver Health HospitalDenverColorado80204
Alexander Lauder, MD
[email protected]

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By research site
University of Colorado Health Hospital· Aurora, CODenver Health Hospital· Denver, CO

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