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

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

Study Overview

• Status: Recruiting
• Conditions: Distal Radius Fracture; Tendon Rupture
• Intervention / Treatment: Device: Versawrap membrane

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jason L Koerner, MD; Phone Number: 303-724-8472; Email: Jason.koerner@cuanschutz.edu
• Study Contact Backup: Name: Samantha F Bereny; Phone Number: 818-277-0352; Email: samantha.bereny@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Health Hospital
      • Contact: Jason L Koerner, MD; Phone Number: 720-848-0000
    • Denver, Colorado, United States, 80204
      • Recruiting
      • Denver Health Hospital
      • Contact: Jason L Koerner, MD; Phone Number: 303-436-6000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Versawrap	Device: Versawrap membrane; Versawrap membrane will be placed between distal radius plate and flexor tendons
No Intervention: No Versawrap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months
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.	6 Months
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).	6 Months
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.	6 Months
Subjective Reporting Specific to Tendon Function	The number of participants reporting the following: 1) pain with resist pinch, 2) perceived tendon triggering, catching, or locking	6 Months
Ultrasound Assessment of Flexor Pollicis Longus and Index Finger Flexor Digitorum Profundus Tendon Morphology	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.	6 Months
Key Pinch	Standardized clinical examination (relative to wrist and digital positioning) of key pinch.	6 Months
Three-Jaw Pinch	Standardized clinical examination (relative to wrist and digital positioning of three-jaw pinch.	6 Months
Grip Strength	Standardized clinical examination (relative to wrist and digital positioning) of grip strength.	6 Months
Soong Classification	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.	6 Months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Fraser Leversedge, MD, University of Colorado Denver | Anschutz

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2021
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: July 14, 2021
• First Posted (Actual): July 26, 2021

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Wrist Injuries; Rupture; Fractures, Bone; Radius Fractures; Wrist Fractures
• Other Study ID Numbers: 20-2659

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes