NCT04976335NARecruiting
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
University of Colorado, Denver
Start Date
9/13/2021
Completion Date
7/1/2027
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
Eligibility Criteria
Age Range: 18 years to No maximum
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.
Interventions
DEVICE
Versawrap membrane
Conditions
Distal Radius FractureTendon Rupture
Locations
University of Colorado Health Hospital
Aurora, Colorado 80045
United States
Denver Health Hospital
Denver, Colorado 80204
United States