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New hydrogel could prevent tendon ruptures after wrist surgery

NCT ID NCT04976335

Disease control Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a special dissolvable hydrogel placed between the metal plate and tendons during wrist fracture repair. The goal is to see if it helps tendons move more smoothly and reduces the chance of tendon rupture. Fifty adults having wrist fracture surgery will be randomly assigned to receive the hydrogel or standard care, and their hand and wrist movement will be measured over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bioresorbable hydrogel membrane (Versawrap)
What this could lead to
If it works, this could reduce tendon scarring and rupture after wrist fracture surgery, improving hand movement and recovery.
What could go wrong
This is a small, early study with only 50 participants, so results may not apply to everyone. The hydrogel is a new device and its long-term safety and effectiveness are not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2021

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Cognitively able to converse in English or in 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. Exclusion Criteria: * open injury; * concomitant injury to the contralateral wrist; * history of flexor tendon repair involving one or both hands or wrists; * use of a trans-carpal fixation device (bridge plate or external fixator) that would preclude wrist motion post-operatively; * concomitant fracture / injury to the thumb or index finger of one or both hands; * concomitant carpal tunnel release.

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Conditions

The condition(s) this trial relates to.

radius fracture Wrist Fractures

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Distal radius fracture Tendon rupture

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Denver Health Hospital

    RECRUITING

    Denver, Colorado, 80204, United States

  • University of Colorado Health Hospital

    RECRUITING

    Aurora, Colorado, 80045, United States

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