Versawrap for Distal Radius Fracture
Trial Summary
What is the purpose of this trial?
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
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Versawrap membrane, VersaWrap, Hyaluronic Acid/Alginate Sheet for distal radius fracture?
The research suggests that bone graft substitutes, which are similar to the components in Versawrap, can improve treatment outcomes for distal radius fractures by providing structural stability and promoting bone healing. Although specific data on Versawrap is not available, the use of similar materials in bone graft substitutes has shown promise in achieving better outcomes.12345
Is Versawrap safe for use in humans?
How is the Versawrap treatment for distal radius fracture different from other treatments?
Versawrap is unique because it uses a membrane made from hyaluronic acid and alginate, which are materials that can promote healing and reduce scarring. Unlike traditional metal plates or external fixators, this treatment is a soft, flexible sheet that can be applied directly to the injury site, potentially offering a less invasive option with fewer complications.111121314
Research Team
Fraser Leversedge, MD
Principal Investigator
University of Colorado Denver | Anschutz
Eligibility Criteria
This trial is for people who can communicate in English or with an interpreter, have a closed distal radius fracture (a type of broken wrist), and are getting surgery with a specific plating system. It's not for those using certain wrist motion-limiting devices, having thumb/index finger injuries, past tendon repairs in hands/wrists, carpal tunnel release surgeries, open wounds, or similar injuries on the other wrist.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Application of a bioresorbable hydrogel (Versawrap) during distal radius fracture repair and evaluation of tendon gliding morphology
Follow-up
Participants are monitored for range of motion, pain, tendon function, and complications over a 6-month period
Treatment Details
Interventions
- Versawrap membrane
Versawrap membrane is already approved in United States for the following indications:
- Tendon repair and protection in hand, wrist, elbow, and other upper extremity procedures
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor