RecruitingNot Applicable

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

United States50 participantsStarted 2021-09-13

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 6 months

Range of Motion: Thumb and Index Finger

Timeframe: 6 months

Range of Motion: Wrist

Timeframe: 6 months

Ultrasound Assessment of Flexor Pollicis Longus and Index Finger Flexor Digitorum Profundus Tendon Excursion

Timeframe: 6 Months

Trial details

NCT IDNCT04976335

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07

Contact for this trial

Fraser J Leversedge, MD

919-316-0616 fraser.leversedge@cuanschutz.edu

View on ClinicalTrials.gov More Distal Radius Fracture trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 6 months

Range of Motion: Thumb and Index Finger

Timeframe: 6 months

Range of Motion: Wrist

Timeframe: 6 months

Ultrasound Assessment of Flexor Pollicis Longus and Index Finger Flexor Digitorum Profundus Tendon Excursion

Timeframe: 6 Months