Assessing tendon movement after using a special hydrogel in wrist fracture surgery
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.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Trial ID | NCT04976335 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with a closed distal radius fracture requiring surgical fixation.
Not a fit: Patients with open injuries or prior flexor tendon repairs may not benefit from this study.
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 performed: While this specific approach is novel, similar studies exploring tendon gliding improvements have shown promising results.
Eligibility criteria
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 this trial is running
Aurora, Colorado and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.