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

Not Applicable

Recruiting

• Conditions: Tendon Rupture; Distal Radius Fracture
• Interventions: Device: Versawrap membrane

• Registration Number: NCT04976335
• Lead Sponsor: University of Colorado, Denver

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-14
• Study First Submitted QC: 2021-07-14
• Study First Posted: 2021-07-26
• Study Start: 2021-09-13
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-25
• Primary Completion: 2025-07
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Versawrap	Versawrap membrane	-

Primary Outcome Measures

Name	Time	Method
Range of Motion: Thumb Interphalangeal and Index Finger Distal Interphalangeal Joints	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	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	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	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 Outcome Measures

Name	Time	Method
Complications	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
Patient-Rated Wrist Evaluation (PRWE)	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.
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)	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).
Visual Analog Scale (VAS) pain scores	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.
Subjective Reporting Specific to Tendon Function	6 Months	The number of participants reporting the following: 1) pain with resist pinch, 2) perceived tendon triggering, catching, or locking
Key Pinch	6 Months	Standardized clinical examination (relative to wrist and digital positioning) of key pinch.
Three-Jaw Pinch	6 Months	Standardized clinical examination (relative to wrist and digital positioning of three-jaw pinch.
Grip Strength	6 Months	Standardized clinical examination (relative to wrist and digital positioning) of grip strength.
Soong Classification	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.
Ultrasound Assessment of Flexor Pollicis Longus and Index Finger Flexor Digitorum Profundus Tendon Morphology	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.

Trial Locations

Locations (2)

University of Colorado Health Hospital; 🇺🇸 Aurora, Colorado, United States

Denver Health Hospital; 🇺🇸 Denver, Colorado, United States