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NCT Number: NCT04976335

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

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Key information

Conditions

Distal Radius Fracture Arm Injuries Fractures, Bone Tendon Rupture Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Health Hospital, Aurora, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Versawrap membrane

Device

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

Primary outcomes

  1. 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.

  2. 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

  3. Range of Motion: Wrist

    Time frame: 6 months

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

  4. 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.

Secondary outcomes

  1. Complications

    Time frame: 6 months

    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

  2. Patient-Rated Wrist Evaluation (PRWE)

    Time frame: 6 Months

    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.

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

    Time frame: 6 Months

    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).

  4. Visual Analog Scale (VAS) pain scores

    Time frame: 6 Months

    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.

  5. Subjective Reporting Specific to Tendon Function

    Time frame: 6 Months

    The number of participants reporting the following: 1) pain with resist pinch, 2) perceived tendon triggering, catching, or locking

  6. Ultrasound Assessment of Flexor Pollicis Longus and Index Finger Flexor Digitorum Profundus Tendon Morphology

    Time frame: 6 Months

    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.

  7. Key Pinch

    Time frame: 6 Months

    Standardized clinical examination (relative to wrist and digital positioning) of key pinch.

  8. Three-Jaw Pinch

    Time frame: 6 Months

    Standardized clinical examination (relative to wrist and digital positioning of three-jaw pinch.

  9. Grip Strength

    Time frame: 6 Months

    Standardized clinical examination (relative to wrist and digital positioning) of grip strength.

  10. Soong Classification

    Time frame: 6 Months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Judge

CONTACT

[email protected]

720-872-4850

Fraser J Leversedge, MD

CONTACT

[email protected]

919-316-0616

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jul 26, 2021
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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