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
| NCT ID | NCT04976335 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Distal Radius Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2021-09-13 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2021-09-13 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04976335 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Distal Radius Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04976335 currently recruiting?
Yes, NCT04976335 is actively recruiting participants. Contact the research team at fraser.leversedge@cuanschutz.edu for enrollment information.
Where is the NCT04976335 trial being conducted?
This trial is being conducted at Aurora, United States, Denver, United States.
Who is sponsoring the NCT04976335 clinical trial?
NCT04976335 is sponsored by University of Colorado, Denver. The trial plans to enroll 50 participants.