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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Versawrap membrane.
- Who it may be relevant to
- Registry conditions: Distal Radius Fracture, Tendon Rupture. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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
Interventions
- Device Versawrap membrane
Versawrap membrane will be placed between distal radius plate and flexor tendons
Primary outcome measures
- Range of Motion: Thumb Interphalangeal and Index Finger Distal Interphalangeal Joints [Time frame: 6 months]
- Range of Motion: Thumb and Index Finger [Time frame: 6 months]
- Range of Motion: Wrist [Time frame: 6 months]
- Ultrasound Assessment of Flexor Pollicis Longus and Index Finger Flexor Digitorum Profundus Tendon Excursion [Time frame: 6 Months]
Secondary outcome measures (10)
- Complications [Time frame: 6 months]
- Patient-Rated Wrist Evaluation (PRWE) [Time frame: 6 Months]
- Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) [Time frame: 6 Months]
- Visual Analog Scale (VAS) pain scores [Time frame: 6 Months]
- Subjective Reporting Specific to Tendon Function [Time frame: 6 Months]
- Ultrasound Assessment of Flexor Pollicis Longus and Index Finger Flexor Digitorum Profundus Tendon Morphology [Time frame: 6 Months]
- Key Pinch [Time frame: 6 Months]
- Three-Jaw Pinch [Time frame: 6 Months]
- Grip Strength [Time frame: 6 Months]
- Soong Classification [Time frame: 6 Months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
United States · 2 centers
- University of Colorado Health Hospital — Aurora
- Denver Health Hospital — Denver
Identifiers
NCT: NCT04976335 · 20-2659