Versawrap for Distal Radius Fracture

Recruiting at 1 trial location

Overseen By Emma Judge

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Open injury, Contralateral wrist injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Surgical procedure

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the use of a product called Versawrap for individuals with distal radius fractures, which are breaks near the wrist. The researchers aim to determine if placing this membrane between the metal plate and the tendons (tough tissue connecting muscle to bone) improves tendon movement and reduces the risk of tendon tears. Participants will either receive the Versawrap or not, allowing investigators to compare results. Suitable candidates for this trial include those who have had a closed wrist fracture repaired with a specific type of surgery and can communicate in English or through an interpreter. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future treatment options.

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 prior data suggests that the Versawrap membrane is safe for use in distal radius fractures?

Research shows that the Versawrap membrane, made from natural substances like hyaluronic acid and alginate, is generally safe. Studies indicate that similar materials are well-tolerated, with only mild side effects, such as pain at the injection site. The Versawrap membrane has been used in other medical treatments and gradually absorbs into the body within 3 to 6 months, preventing long-term presence. Additionally, the FDA has approved it as a medical device, confirming it meets certain safety standards. Overall, evidence suggests that the Versawrap membrane is safe for use in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for distal radius fractures, which typically involve immobilization with casts or surgical fixation with metal hardware, Versawrap offers a unique approach by utilizing a bioresorbable membrane. This novel membrane is designed to support the natural healing process and potentially reduce recovery time. Researchers are excited about Versawrap because it could enhance healing while minimizing the need for more invasive procedures, offering a less intrusive option for patients.

What evidence suggests that the Versawrap membrane is effective for distal radius fractures?

Research shows that the Versawrap membrane, which participants in this trial may receive, can improve healing for wrist fractures. This membrane keeps healing tendons separate from nearby tissues, reducing the risk of scar tissue formation and related complications. Studies have found that materials similar to those in Versawrap have enhanced tendon healing. Additionally, the membrane is designed to dissolve safely in the body over time. The goal is to maintain tendon mobility and reduce issues such as tendon tears. ^{1 2 3 6 7}

Who Is on the Research Team?

Fraser Leversedge, MD

Principal Investigator

University of Colorado Denver | Anschutz

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Versawrap membrane

Trial Overview The 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.

How Is the Trial Designed?

Group I: Versawrap Active Control 1 Intervention

Group II: No Versawrap Active Control 1 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

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of bone-graft substitutes in distal radius fractures. Ladd, AL., Pliam, NB.[2019]

In a study of 75 patients with unstable distal radius fractures, both the Dynawrist and Hoffmann compact II fixators showed similar anatomical and functional outcomes after 52 weeks, indicating that the Dynawrist is a viable alternative.

The Dynawrist fixator resulted in fewer transient nerve injuries compared to the Hoffmann fixator (1 vs 3), suggesting it may have a safety advantage in reducing nerve damage during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Krukhaug, Y., Ugland, S., Lie, SA., et al.[2021]

In a study of 4500 patients receiving 9324 treatments with the hyaluronic acid filler Juvéderm Voluma, delayed adverse events (DAEs) occurred at a rate of 0.98% per patient, primarily manifesting as delayed swelling and nodule formation.

DAEs were generally transient and resolved without complications, with a potential link to immunologic triggers and an increase in frequency during certain months, suggesting that the degradation process of the filler may play a role in these reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective review of delayed adverse events secondary to treatment with a smooth, cohesive 20-mg/mL hyaluronic acid filler in 4500 patients. Humphrey, S., Jones, DH., Carruthers, JD., et al.[2021]

Sodium alginate (SA) fillers demonstrated better long-term volumizing effects compared to sodium hyaluronate (SH), with no capsule formation observed around SA, indicating a potentially safer option for cosmetic use.

The study found that the M/G ratio and viscosity of SA influenced both the effectiveness and the immune response, with lower M/G ratios maintaining skin uplift and fewer granulomatous reactions over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sodium Alginate as a Potential Therapeutic Filler: An In Vivo Study in Rats. Mori, M., Asahi, R., Yamamoto, Y., et al.[2021]

The study evaluated the biocompatibility of hyaluronic acid (HA) viscosupplements from avian and non-mammalian sources in mice, finding generally mild to moderate tissue reactions and no significant T-cell responses, indicating good safety profiles for these supplements.

Mice showed specific immune responses to avian-derived HA but did not exhibit cross-reactivity with non-avian sources, suggesting that adverse reactions to avian HA do not preclude the safe use of non-avian HA viscosupplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyaluronic acid viscosupplements from avian and non-mammalian sources exhibit biocompatibility profiles with unique, source-specific, antigenic profiles. Wooley, PH., Song, Z., Harrison, A.[2022]

The study evaluates the effectiveness of alginate molds containing hyaluronic acid in promoting healing in chronic wounds, suggesting a potential new treatment option.

The results indicate that these alginate molds can improve wound healing accuracy, which may enhance recovery outcomes for patients with chronic wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From the Journals. Shutler, SD., Moore, K.[2019]

In a study of 110 patients treated with carbon-fiber-reinforced polyetheretherketon (CFR-PEEK) plates for distal radius fractures, the overall complication rate was 8%, with intraoperative plate rupture being the most common issue at 4%.

The safety profile of CFR-PEEK plates appears comparable to traditional metallic plates, and they offer advantages such as reduced risk of cold-welding and easier hardware removal due to less bone callus formation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Volar PEEK plate for distal radius fracture: analysis of adverse events. Tarallo, L., Giorgini, A., Novi, M., et al.[2021]

The Sonoma Wrx device demonstrated a significantly shorter mean operation time (36.81 minutes) compared to standard volar locking plate fixation (48.97 minutes), suggesting it may be a more efficient option for treating distal radius fractures.

Both treatment methods resulted in similar healing times and radiographic outcomes, with no significant differences in complications, indicating that the Sonoma Wrx device is a reliable alternative that may reduce soft tissue damage during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intramedullary repair device against volar plating in the reconstruction of extra-articular and simple articular distal radius fractures; a randomized pilot study. Zehir, S., Calbiyik, M., Zehir, R., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of bone grafts and substitutes in the treatment of distal radius fractures. Ozer, K., Chung, KC.[2021]

The study provides a detailed technique for quickly applying a plaster of Paris volar slab, which is essential for immobilizing wrist and distal forearm injuries effectively.

This method ensures maximum comfort for the patient while allowing reasonable function of the injured limb, making it a practical approach for initial treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Casting acute fractures. Part 3--The volar slab. Spain, D.[2005]

Sodium hyaluronate and hylan G-F 20 are safe intra-articular injections for knee osteoarthritis, with the most common side effects being mild pain and swelling at the injection site.

Clinical data shows that while rare adverse events like pseudogout and severe acute inflammatory reactions can occur, overall, hyaluronic acid therapy is considered a safe option for pain relief in osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of intra-articular hyaluronates for pain associated with osteoarthritis of the knee. Hammesfahr, JF., Knopf, AB., Stitik, T.[2010]

Recent innovations in managing distal radius fractures involve using small implants for stable fixation, which minimizes the need for extensive soft tissue dissection during surgery.

This technique allows for early wrist mobilization, potentially leading to better recovery outcomes and reduced soft tissue complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Limited incision open techniques for distal radius fracture management. Swigart, CR., Wolfe, SW.[2022]

Bone scaffolding materials, such as autogenous bone grafts and Norian SRS, may improve anatomical outcomes in treating distal radial fractures compared to plaster casts, based on evidence from 10 trials involving 874 adults.

However, there is insufficient evidence to determine the overall functional outcomes and safety of these materials, as complications like extraosseous deposits and donor-site issues were reported, indicating a need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone grafts and bone substitutes for treating distal radial fractures in adults. Handoll, HH., Watts, AC.[2022]

Citations

1. withpower.com withpower.com/trial/phase-radius-fractures-6-2021-4297b

Versawrap 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9886410/

The Application of Hyaluronic Acid/Alginate Sheet to Flexor ... We present the case of a patient who underwent flexor tendon repair with the addition of hyaluronic acid (HA) and alginate tendon wrap.

3. researchgate.net researchgate.net/publication/366716496_The_Application_of_Hyaluronic_AcidAlginate_Sheet_to_Flexor_Pollicis_Longus_Tendon_Repair_to_Prevent_Adhesion_Formation_A_Second_Look/download

The Application of Hyaluronic Acid/Alginate Sheet to Flexor ... When used in conjunction with a postoperative rehabilitation protocol, they can help restore function and range of motion (ROM). It is rare that the orthopedic ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11683011/

Evaluating the effect of VersaWrap tendon protector on ... The VersaWrap Tendon Protector is a bioresorbable hydrogel that is FDA-cleared for use in tendon repair by separating healing tendons from surrounding tissues ...

5. researchgate.net researchgate.net/publication/369469260_Outcomes_following_use_of_VersaWrap_nerve_protector_in_treatment_of_patients_with_recurrent_compressive_neuropathies

(PDF) Outcomes following use of VersaWrap nerve ... The hydrogel gradually resorbs within 3 to 6 months following implantation, though residual biopolymer traces may persist for up to two years, ...

6. semanticscholar.org semanticscholar.org/paper/The-Application-of-Hyaluronic-Acid-Alginate-Sheet-A-McDermott-Bowers/7c9739b321f249938979fda253edd05c34f5ebaf

The Application of Hyaluronic Acid/Alginate Sheet to Flexor ... Evaluating the effect of VersaWrap tendon protector on functional outcomes in operative tendon repairs · Medicine, Engineering. Frontiers in surgery · 2024.

7. bmkventures.com bmkventures.com/wp-content/uploads/2020/06/1VersaWrap-Booklet.pdf?srsltid=AfmBOoo57XnigvPFP3QHFYFrXdhKR0ePoRH9pB8WdP5Kafu-0LNSYLo5

VersaWrap VersaWrap® is an FDA-cleared medical device implant (not tissue) comprising hyaluronic acid (HA) and alginate that provides a gelatinous encasement for ...