Distal Radius FractureNCT04976335
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
A study testing Versawrap membrane in people with Distal Radius Fracture and Tendon Rupture, run by University of Colorado, Denver at 2 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fracture, Tendon Rupture
- What is being tested?
- Versawrap membrane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Sep 2021to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Colorado Health Hospital
Aurora, Colorado, 80045
Fraser L Leversedge, MD, 919-316-0616
- Recruiting
Denver Health Hospital
Denver, Colorado, 80204
Alexander Lauder, MD, alexander.lauder@cuanschutz.edu
About this study
Official title: 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.
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
- Conditions
- Distal Radius Fracture, Tendon Rupture
- Being tested
- Versawrap membrane
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Versawrap membraneDevice
Versawrap membrane will be placed between distal radius plate and flexor tendons
| Study group | Role | What they receive |
|---|---|---|
| Versawrap | Active comparator | Not described Receives: Device: Versawrap membrane |
| No Versawrap | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion: Thumb Interphalangeal and Index Finger Distal Interphalangeal Joints
Standardized clinical examination (relative to wrist and digital positioning): active and passive range of motion for thumb interphalangeal and index finger distal interphalangeal joints.
Measured: 6 months
Range of Motion: Thumb and Index Finger
Standardized clinical examination (relative to wrist and digital positioning): active and passive composite digital range of motion for thumb and index fingers
Measured: 6 months
Range of Motion: Wrist
Standardized clinical examination (relative to wrist and digital positioning): active and passive wrist range of motion.
Measured: 6 months
Ultrasound Assessment of Flexor Pollicis Longus and Index Finger Flexor Digitorum Profundus Tendon Excursion
Tendons in the volar forearm will be directly visualized with ultrasound. The distance the tendons are able to travel (excursion) within the forearm will be reported.
Measured: 6 Months
Secondary outcomes (10)
Complications
Incidence of any of the following perioperative complications: infection, neurovascular injury, tendon rupture, hardware failure, delayed fracture union, fracture nonunion, fracture malunion, or revision surgery
Measured: 6 months
Patient-Rated Wrist Evaluation (PRWE)
The Patient-Rated Wrist Evaluation (PRWE) measures pain and wrist function. Possible scores range from 0-100, with a higher score indicating a worse outcome.
Measured: 6 Months
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)
The Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) measures limb function and disability. Possible scores range from 0-100, with a higher score indicating a worse outcome (more severe disability).
Measured: 6 Months
Visual Analog Scale (VAS) pain scores
The Visual Analog Scale measures patient reported pain using a 100mm scale. Possible scores range from 0-100, with higher scores indicating more severe pain.
Measured: 6 Months
Subjective Reporting Specific to Tendon Function
The number of participants reporting the following: 1) pain with resist pinch, 2) perceived tendon triggering, catching, or locking
Measured: 6 Months
Ultrasound Assessment of Flexor Pollicis Longus and Index Finger Flexor Digitorum Profundus Tendon Morphology
Tendons in the volar forearm will be directly visualized with ultrasound and their physical appearance will be grossly described. For this outcome measure, the number of participants with a healthy tendon, as determined by the physician, will be reported.
Measured: 6 Months
Key Pinch
Standardized clinical examination (relative to wrist and digital positioning) of key pinch.
Measured: 6 Months
Three-Jaw Pinch
Standardized clinical examination (relative to wrist and digital positioning of three-jaw pinch.
Measured: 6 Months
Grip Strength
Standardized clinical examination (relative to wrist and digital positioning) of grip strength.
Measured: 6 Months
Soong Classification
Routine (3-view) radiographs of the injured wrist to document Soong grading of distal radius plate positioning. Soong et al (2011) proposed the Soong classification to classify palmar prominence at the watershed line, where flexor tendons lie closest to the plate. Classifications are as follows: 0: Plates do not extend volar to the watershed line; 1: Plates are volar to the line, but proximal to the volar rim; and 2: Plates are directly on or distal to the volar rim.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start13 Sep 2021
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976335
- Sponsor's protocol ID
- 20-2659
- Status last verified
- Sep 2025
- First submitted
- 14 Jul 2021
- Last updated
- 2 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 ID
- NCT04976335
- Acronym / sponsor ID
- 20-2659
- Conditions
- Distal Radius Fracture, Tendon Rupture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 26 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Versawrap | Active comparator | Device: Versawrap membrane |
| No Versawrap | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Versawrap membraneVersawrap membrane will be placed between distal radius plate and flexor tendons | Device | Versawrap |
Primary outcome
Range of Motion: Thumb Interphalangeal and Index Finger Distal Interphalangeal Joints
Time frame: 6 months
Standardized clinical examination (relative to wrist and digital positioning): active and passive range of motion for thumb interphalangeal and index finger distal interphalangeal joints.
Range of Motion: Thumb and Index Finger
Time frame: 6 months
Standardized clinical examination (relative to wrist and digital positioning): active and passive composite digital range of motion for thumb and index fingers
Range of Motion: Wrist
Time frame: 6 months
Standardized clinical examination (relative to wrist and digital positioning): active and passive wrist range of motion.
Ultrasound Assessment of Flexor Pollicis Longus and Index Finger Flexor Digitorum Profundus Tendon Excursion
Time frame: 6 Months
Tendons in the volar forearm will be directly visualized with ultrasound. The distance the tendons are able to travel (excursion) within the forearm will be reported.
10 secondary outcomes
Complications
Time frame: 6 months
Patient-Rated Wrist Evaluation (PRWE)
Time frame: 6 Months
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)
Time frame: 6 Months
Visual Analog Scale (VAS) pain scores
Time frame: 6 Months
Subjective Reporting Specific to Tendon Function
Time frame: 6 Months
Ultrasound Assessment of Flexor Pollicis Longus and Index Finger Flexor Digitorum Profundus Tendon Morphology
Time frame: 6 Months
Key Pinch
Time frame: 6 Months
Three-Jaw Pinch
Time frame: 6 Months
Grip Strength
Time frame: 6 Months
Soong Classification
Time frame: 6 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Versawrap membrane in people with Distal Radius Fracture and Tendon Rupture, run by University of Colorado, Denver at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fraser J Leversedge, MD (919-316-0616, fraser.leversedge@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion: Thumb Interphalangeal and Index Finger Distal Interphalangeal Joints (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.