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Bioresorbable Hydrogel

Versawrap for Distal Radius Fracture

N/A

Recruiting

Led By Fraser Leversedge, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with a closed, distal radius fracture treated with open reduction and internal fixation using a volar distal radius plating system

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial will evaluate the effectiveness of versawrap, a type of membrane, in treating distal radius fractures. The trial will specifically look at the effects on tendon gliding and the number of tendon ruptures.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While the trial description does not specify side effects of Versawrap directly, potential risks may include local irritation at the surgical site, allergic reactions to materials used in Versawrap or increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I had surgery to fix a broken wrist bone using plates and screws.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Range of Motion: Thumb Interphalangeal and Index Finger Distal Interphalangeal Joints

Range of Motion: Thumb and Index Finger

Range of Motion: Wrist

+1 more

Secondary outcome measures

Complications

Grip Strength

Key Pinch

+7 more

Trial Design

2Treatment groups

Active Control

Group I: VersawrapActive Control1 Intervention

Group II: No VersawrapActive Control1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,734 Previous Clinical Trials

2,148,783 Total Patients Enrolled

Fraser Leversedge, MDPrincipal InvestigatorUniversity of Colorado Denver | Anschutz

Media Library

Versawrap membrane (Bioresorbable Hydrogel) Clinical Trial Eligibility Overview. Trial Name: NCT04976335 — N/A

Distal Radius Fracture Research Study Groups: Versawrap, No Versawrap

Distal Radius Fracture Clinical Trial 2023: Versawrap membrane Highlights & Side Effects. Trial Name: NCT04976335 — N/A

Versawrap membrane (Bioresorbable Hydrogel) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04976335 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment seeking to incorporate more participants?

"As per the information made available on clinicaltrials.gov, this medical trial is actively looking for participants in its study. The initial posting was done on July 1st 2021 and the most recent update was published two weeks later on July 14th 2021."

Answered by AI

How many participants are being admitted to this medical trial?

"Yes, the online listing on clinicaltrials.gov verifies that this medical trial is actively recruiting participants. It was initially posted on July 1st 2021 and its most recent update was made on July 14th 2021. The research team is searching for 100 individuals to join at two sites."

Answered by AI

What are the core objectives of this experiment?

"This clinical trial intends to measure Range of Motion: Wrist over a 6-month period, with Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH), Visual Analog Scale (VAS) pain scores, and Soong Classification as secondary endpoints. The former is assessed using a 0-100 score where higher numbers indicate worse outcomes; VAS pain ratings also use a 0-100 scale but signify increased severity due to greater values; finally, Soong Classification grades plate positioning at watershed line on volar rim from zero for plates not extending beyond it up to two for those that do."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04976335.