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

NCT04976335 | Recruiting FDA Device

• 1 other identifier: 20-2659
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Distal Radius Fracture; Tendon Rupture

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  6 months

• Range of Motion: Wrist

  Standardized clinical examination (relative to wrist and digital positioning): active and passive wrist range of motion.

  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.

  6 Months

Secondary Outcomes (10)

• Complications

  6 months

• Patient-Rated Wrist Evaluation (PRWE)

  6 Months

• Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)

  6 Months

• Visual Analog Scale (VAS) pain scores

  6 Months

• Subjective Reporting Specific to Tendon Function

  6 Months

Study Arms (2)

Versawrap

ACTIVE COMPARATOR

Device: Versawrap membrane

No Versawrap

NO INTERVENTION

Interventions

Versawrap membrane DEVICE

Versawrap membrane will be placed between distal radius plate and flexor tendons

Versawrap

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (2)

University of Colorado Health Hospital

Aurora, Colorado, 80045, United States

RECRUITING

Denver Health Hospital

Denver, Colorado, 80204, United States

RECRUITING

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Central Study Contacts

Fraser J Leversedge, MD

CONTACT

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

Emma Judge

CONTACT

720-872-4850; emma.judge@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: July 26, 2021
• Study Start: September 13, 2021
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)