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 (CU Denver)

Status

Enrolling

Conditions

Distal Radius Fracture

Tendon Rupture

Treatments

Device: Versawrap membrane

Study type

Interventional

Funder types

Other

Identifiers

NCT04976335

20-2659

Details and patient eligibility

About

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

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.