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

Distal Radius Fracture Clinical Trial

Official 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04976335
• Other study ID #: 20-2659
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2021
• Est. completion date: November 2024

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: Fraser Leversedge, MD
• Phone: 9193160616
• Email: fraser.leversedge[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures
• Rupture
• Tendon Rupture
• Wrist Fractures

Intervention

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

Locations

Country	Name	City	State
United States	University of Colorado Health Hospital	Aurora	Colorado
United States	Denver Health Hospital	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Range of Motion: Wrist	Standardized clinical examination (relative to wrist and digital positioning): active and passive wrist range of motion.	6 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Key Pinch	Standardized clinical examination (relative to wrist and digital positioning) of key pinch.	6 Months
Secondary	Three-Jaw Pinch	Standardized clinical examination (relative to wrist and digital positioning of three-jaw pinch.	6 Months
Secondary	Grip Strength	Standardized clinical examination (relative to wrist and digital positioning) of grip strength.	6 Months
Secondary	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