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RECRUITING
NCT04322370
NA

Prospective Randomized Blinded Trial of VersaWrap Tendon Protector for Zone 2 Flexor Tendon Injuries

Sponsor: University of Florida

View on ClinicalTrials.gov

Summary

To analyze outcomes between patients with Z2FT injuries following repair, randomized to two groups. The first group will be the negative control, with no tendon wrap. The second group will have a VersaWrap Tendon Protector applied over the site of the tendon repair. VersaWrap is current SOC at UF.

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2020-08-21

Completion Date

2027-05-17

Last Updated

2025-03-17

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

Standard of Care Surgical Procedure

Zone 2 Flexor Tendon surgical repair will be performed by the principal investigator per standard of care. The same technique of tendon repair will be performed for all patients.

DEVICE

VersaWrap Treatment

is intended to manage and protect tendon injuries where there is no significant loss of tendon tissue

Locations (1)

University of Florida

Gainesville, Florida, United States