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Study of Versawrap for Distal Radius Fracture Repair

This study is looking at how well a device called Versawrap membrane works for people who have a broken wrist bone (distal radius fracture) that needs surgery. The Versawrap membrane will be placed between the bone plate and the tendons in your wrist. Researchers want to see if it helps tendons move better and reduces the number of tendon ruptures (tears). You can join if you are 18 or older, can communicate in English or your native language with an interpreter, and have a closed distal radius fracture treated with a specific type of surgery. The study will measure success by looking at how well you can move your thumb, index finger, and wrist after 6 months. The current status of this study is unclear.

Study design
This is an interventional, randomized study planning to enroll 50 participants. It compares placing the Versawrap membrane with not placing it during surgery.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your range of motion will be measured at 6 months after the intervention.

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NCT04976335

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

Recruiting
NAAges 18+InterventionalPrevention
University of Colorado, Denver
~50 participants
Updated 2025-10-02 on ClinicalTrials.gov
What's tested:Versawrap membrane

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Range of Motion: Thumb Interphalangeal and Index Finger Distal Interphalangeal Joints
Measured over 6 months
+3 more outcomes measured

Conditions

Distal Radius Fracture
Tendon Rupture

Explore related trials

Distal Radius FracturesRupture of tendon

Where it's being run

2 sites across 1 states
Colorado2

Who to contact

Fraser J Leversedge, MD
[email protected]
919-316-0616
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Cognitively able to converse in English or in native language supported by a certified medical interpreter;
Diagnosed with a closed, distal radius fracture treated with open reduction and internal fixation using a volar distal radius plating system.

Exclusion

open injury;
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.

What this trial measures

  • Range of Motion: Thumb Interphalangeal and Index Finger Distal Interphalangeal Joints6 months

    Standardized clinical examination (relative to wrist and digital positioning): active and passive range of motion for thumb interphalangeal and index finger distal interphalangeal joints.

  • Range of Motion: Thumb and Index Finger6 months

    Standardized clinical examination (relative to wrist and digital positioning): active and passive composite digital range of motion for thumb and index fingers

  • Range of Motion: Wrist6 months

    Standardized clinical examination (relative to wrist and digital positioning): active and passive wrist range of motion.

  • Ultrasound Assessment of Flexor Pollicis Longus and Index Finger Flexor Digitorum Profundus Tendon Excursion6 Months

    Tendons in the volar forearm will be directly visualized with ultrasound. The distance the tendons are able to travel (excursion) within the forearm will be reported.