50 Participants Needed

Versawrap for Distal Radius Fracture

Recruiting at 1 trial location
JL
SF
FL
FJ
EJ
Overseen ByEmma Judge
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Colorado, Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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?

Research on similar materials like hyaluronic acid and sodium alginate shows they are generally safe, with mild side effects like injection site pain and swelling. Rarely, more serious reactions like pseudogout or immune responses can occur, but these are uncommon.678910

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

FL

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

I had surgery to fix a broken wrist bone using plates and screws.
I can communicate in English or through a certified interpreter.

Exclusion Criteria

I am having or have had surgery for carpal tunnel syndrome.
I use a device on my wrist that limits its movement after surgery.
I have a fracture or injury in my thumb or index finger on one or both hands.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Application of a bioresorbable hydrogel (Versawrap) during distal radius fracture repair and evaluation of tendon gliding morphology

Surgical procedure
1 visit (in-person)

Follow-up

Participants are monitored for range of motion, pain, tendon function, and complications over a 6-month period

6 months
Multiple visits (in-person and virtual)

Treatment Details

Interventions

  • Versawrap membrane
Trial OverviewThe study tests Versawrap membrane use during surgery to repair a broken wrist. The membrane is placed between the metal plate and tendons to see if it improves how tendons move and reduces ruptures after surgery.
Participant Groups
2Treatment groups
Active Control
Group I: VersawrapActive Control1 Intervention
Group II: No VersawrapActive Control1 Intervention

Versawrap membrane is already approved in United States for the following indications:

🇺🇸
Approved in United States as VersaWrap for:
  • 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

Trials
1,842
Recruited
3,028,000+

Findings from Research

The rise in unstable distal radius fractures has led to advancements in surgical techniques and technologies aimed at achieving early stability and better outcomes for patients.
Although rigorous comparisons of bone graft substitutes are challenging due to their diversity and lack of standardized studies, existing data indicates that these substitutes can enhance treatment methods and improve patient outcomes.
The role of bone graft and alternatives in unstable distal radius fracture treatment.Ladd, AL., Pliam, NB.[2019]
The development of biomaterials for enhancing fracture healing is increasing, with new products aiming to promote quicker recovery and reduce complications, although their specific indications for use are still not well-defined.
An ideal bone graft material should not only stimulate bone healing and provide stability but also be biocompatible, bioresorbable, user-friendly, and cost-effective, highlighting the essential criteria for effective treatment options in distal radius fractures.
The use of bone grafts and substitutes in the treatment of distal radius fractures.Ozer, K., Chung, KC.[2021]
Bone-graft substitutes offer potential advantages over traditional bone grafting by minimizing the risks associated with harvesting autografts, with various FDA-approved products available that differ in composition and effectiveness.
Current evidence, although limited, suggests that bone-graft substitutes may lead to better treatment outcomes for patients with distal radius fractures, highlighting the need for further research to establish standardized comparisons among these products.
Use of bone-graft substitutes in distal radius fractures.Ladd, AL., Pliam, NB.[2019]

References

The role of bone graft and alternatives in unstable distal radius fracture treatment. [2019]
The use of bone grafts and substitutes in the treatment of distal radius fractures. [2021]
Use of bone-graft substitutes in distal radius fractures. [2019]
Limited incision open techniques for distal radius fracture management. [2022]
Bone grafts and bone substitutes for treating distal radial fractures in adults. [2022]
Retrospective review of delayed adverse events secondary to treatment with a smooth, cohesive 20-mg/mL hyaluronic acid filler in 4500 patients. [2021]
Safety of intra-articular hyaluronates for pain associated with osteoarthritis of the knee. [2010]
Sodium Alginate as a Potential Therapeutic Filler: An In Vivo Study in Rats. [2021]
Hyaluronic acid viscosupplements from avian and non-mammalian sources exhibit biocompatibility profiles with unique, source-specific, antigenic profiles. [2022]
From the Journals. [2019]
External fixation of fractures of the distal radius: a randomized comparison of the Hoffman compact II non-bridging fixator and the Dynawrist fixator in 75 patients followed for 1 year. [2021]
Volar PEEK plate for distal radius fracture: analysis of adverse events. [2021]
Intramedullary repair device against volar plating in the reconstruction of extra-articular and simple articular distal radius fractures; a randomized pilot study. [2022]
Casting acute fractures. Part 3--The volar slab. [2005]