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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
50
Versawrap membrane will be placed between distal radius plate and flexor tendons
University of Colorado Health Hospital
Aurora, Colorado, United States
RECRUITINGDenver Health Hospital
Denver, Colorado, United States
RECRUITINGRange 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
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
Range of Motion: Wrist
Standardized clinical examination (relative to wrist and digital positioning): active and passive wrist range of motion.
Time frame: 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.
Time frame: 6 Months
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
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
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
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
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
Time frame: 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.
Time frame: 6 Months
Key Pinch
Standardized clinical examination (relative to wrist and digital positioning) of key pinch.
Time frame: 6 Months
Three-Jaw Pinch
Standardized clinical examination (relative to wrist and digital positioning of three-jaw pinch.
Time frame: 6 Months
Grip Strength
Standardized clinical examination (relative to wrist and digital positioning) of grip strength.
Time frame: 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.
Time frame: 6 Months
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