Recruiting

Bioresorbable Hydrogel

Sponsor:

University of Colorado, Denver

Code:

NCT04976335

Conditions

Distal Radius Fracture

Tendon Rupture

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Versawrap membrane

Study Details

Brief summary:

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

Conditions

Distal Radius Fracture

Tendon Rupture

Study ID

NCT04976335

Start date

Sep 13, 2021

Status verified date

Sep, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Versawrap

no intervention: No Versawrap

Interventions

Versawrap membrane

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

Primary outcome measure

  • Range of Motion: Thumb Interphalangeal and Index Finger Distal Interphalangeal Joints [ Time Frame: 6 months ]
  • Range of Motion: Thumb and Index Finger [ Time Frame: 6 months ]
  • Range of Motion: Wrist [ Time Frame: 6 months ]
  • Ultrasound Assessment of Flexor Pollicis Longus and Index Finger Flexor Digitorum Profundus Tendon Excursion [ Time Frame: 6 Months ]

Central Contacts and Locations

Central contacts

Fraser J Leversedge, MD

919-316-0616fraser.leversedge@cuanschutz.edu

Emma Judge

720-872-4850emma.judge@cuanschutz.edu

Locations

University of Colorado Health Hospital

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Fraser L Leversedge, MD

919-316-0616

Denver Health Hospital

Recruiting

Denver, Colorado, United States, 80204

Contacts

Alexander Lauder, MD

alexander.lauder@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Oct 2, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-10-02.