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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-13

Study Completion Date

2027-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Distal Radius Fracture Tendon Rupture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Versawrap

Group Type ACTIVE_COMPARATOR

Versawrap membrane

Intervention Type DEVICE

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

No Versawrap

Group Type NO_INTERVENTION

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Colorado Health Hospital

Aurora, Colorado, United States

Site Status RECRUITING

Denver Health Hospital

Denver, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Fraser J Leversedge, MD

Role: CONTACT

919-316-0616

Emma Judge

Role: CONTACT

720-872-4850

Facility Contacts

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Fraser L Leversedge, MD

Role: primary

919-316-0616

Alexander Lauder, MD

Role: primary

Other Identifiers

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20-2659

Identifier Type: -

Identifier Source: org_study_id

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