Assessing tendon movement after using a special hydrogel in wrist fracture surgery
Official title: 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.
Run by University of Colorado, Denver · NCT04976335 · Data updated 2026-11-12
This study is testing whether a special gel used during wrist fracture surgery can help tendons move better and reduce the chance of injuries after the operation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Status | Recruiting |
| Started | September 13, 2021 |
| Main results expected | July 2027 |
| Study ends | July 2027 |
| Registry record updated | October 2, 2025 |
| Trial ID | NCT04976335 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals diagnosed with a closed distal radius fracture requiring surgical fixation.
✕Probably not a fit
Patients with open injuries or prior flexor tendon repairs may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of a bioresorbable hydrogel, Versawrap, in improving tendon gliding in patients undergoing surgery for distal radius fractures. The hydrogel is placed between the surgical plate and the flexor tendons to potentially reduce tendon ruptures and enhance recovery. Participants will be monitored for tendon gliding morphology and any occurrences of tendon ruptures post-surgery. The study aims to provide insights into the benefits of this innovative approach in orthopedic surgery.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery outcomes and reduced complications for patients with distal radius fractures.
How similar studies have gone: While this specific approach is novel, similar studies exploring tendon gliding improvements have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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University of Colorado Health Hospital
Aurora, Colorado, United States Recruiting -
Denver Health Hospital
Denver, Colorado, United States Recruiting
Study contacts
- Study coordinator: Fraser J Leversedge, MD
- Email: fraser.leversedge@cuanschutz.edu
- Phone: 919-316-0616
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Optimal Duration of Mechanical Traction for Displaced Distal Radius Fractures
This study tests whether 1 minute of mechanical traction can align a displaced distal radius as well as 5 or 10 minutes in adults who come to the emergency department.
-
ESWT added to rehabilitation for CRPS-I after a distal radius fracture
This trial tests whether adding extracorporeal shock wave therapy to standard rehab helps adults with CRPS-I after a distal radius fracture.
-
Wrist Injury Strengthening Exercise added to usual care for improving pain and function after a wrist fracture
This trial tests whether a therapist-guided strengthening program helps people 50 and older recover better from a wrist fracture than standard self-management advice.
-
Home-use photobiomodulation (light) therapy to help recovery after distal radius (wrist) fracture surgery
This test will see if a home-use light therapy device plus twice-daily home exercises helps adults 18–65 recover wrist function after surgical repair of a distal radius fracture.
-
Fear of movement and recovery after a non-surgical broken wrist
This project will see if fear of movement (kinesiophobia) predicts recovery in people treated without surgery for a broken wrist.
-
Casting without prior reduction versus closed reduction for displaced wrist (distal radius) fractures in people 65 and older
This trial will test whether simply putting a cast on displaced wrist fractures in people 65 and older works as well as doing a closed reduction before casting by measuring wrist pain and function at 12 months.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.