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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Colorado, Denver

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Versawrap membrane

    Device

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: VersawrapActive comparator 1 intervention
Group B: No VersawrapNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months
2

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

Time frame
6 months
3

Range of Motion: Wrist

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

Time frame
6 months
4

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.

Time frame
6 Months

Secondary outcomes

1

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

Time frame
6 months
2

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.

Time frame
6 Months
3

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).

Time frame
6 Months
4

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.

Time frame
6 Months

Other outcomes

Sponsors and contacts

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