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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT04322370
Status
Recruiting
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Conditions

  • Flexor Tendon

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Standard of Care Surgical Procedure — 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.
  • VersaWrap Treatment — DEVICE
    is intended to manage and protect tendon injuries where there is no significant loss of tendon tissue

Study Details

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 Dates

Start date
Aug 21, 2020
Status verified
Mar 2025
Primary completion
May 17, 2027
Completion
May 17, 2027

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group A
    VersaWrap Treatment Arm- Zone 2 flexor tendon repair with the use of VersaWrap
  • Active Comparator: Group B
    Standard of Care Treatment Arm- Zone 2 flexor tendon repair

Primary Outcome Measure

Strickland modified Total Active Motion (TAM) [ Time Frame: At 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32610
Ellen Satteson, MD (PRINCIPAL_INVESTIGATOR)

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University of Florida· Gainesville, FL