RecruitingNot ApplicableNCT04976335

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

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.


Sponsor

University of Colorado, Denver

Enrollment

50 participants

Start Date

Sep 13, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria6

  • 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.

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Interventions

DEVICEVersawrap membrane

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


Locations(2)

University of Colorado Health Hospital

Aurora, Colorado, United States

Denver Health Hospital

Denver, Colorado, United States

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NCT04976335


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