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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Versawrap membrane
DeviceVersawrap membrane will be placed between distal radius plate and flexor tendons
Treatment groups
Trial outcomes
Primary outcomes
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.
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
Range of Motion: Wrist
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
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
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
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.
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).
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.
Sponsors and contacts
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