Actively Recruiting
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
Led by University of Colorado, Denver · Updated on 2025-10-02
50
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Versawrap, a bioresorbable hydrogel membrane, in patients with distal radius fractures. This prospective, randomized study aims to place the membrane between the distal radius plate and the flexor tendons during fracture repair. The goal is to assess tendon gliding morphology and the number of tendon ruptures that occur after treatment. Participants will be randomly assigned to receive either the Versawrap membrane placement or no Versawrap during their distal radius fracture repair. The membrane is positioned between the plate and flexor tendons to potentially improve tendon movement. The study involves a double-blind design to compare these two groups. During the 6-month follow-up, participants will undergo evaluations including range of motion measurements of the thumb, index finger, and wrist, as well as ultrasound assessments of tendon excursion and morphology. Additional measures include patient-rated wrist function, pain scores, grip strength, and complication monitoring. These assessments will help determine the effects of Versawrap on tendon function and recovery after fracture repair.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cognitively able to converse in English or a 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
- Aged 18 years or older
You will not qualify if you...
- Open injury
- Injury to the opposite wrist
- History of flexor tendon repair in one or both hands or wrists
- Use of a trans-carpal fixation device (bridge plate or external fixator) preventing wrist motion after surgery
- Fracture or injury to the thumb or index finger of one or both hands
- Concomitant carpal tunnel release
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to discharge from surgery
Participants undergo distal radius fracture repair surgery with or without the placement of a Versawrap membrane between the distal radius plate and flexor tendons.
1 surgical visit and immediate post-operative care
Duration - 6 months
Participants receive follow-up assessments to monitor tendon function, range of motion, pain, and complications after surgery.
Multiple follow-up visits over 6 months
Trial Site Locations
Total: 2 locations
1
University of Colorado Health Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Denver Health Hospital
Denver, Colorado, United States, 80204
Actively Recruiting
Research Team
F
Fraser J Leversedge, MD
E
Emma Judge
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
2
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