Clinical Trial on the Effect of the Flexible Suturing System With Anchors (FSSA) in Full-thickness Rotator Cuff Tendon Tears

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
Integrity Orthopaedics, Inc.
Study ID
NCT06868108
Status
Enrolling By Invitation

Conditions

  • Rotator Cuff Tears

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Flexible Suturing System with Anchors (FSSA) — DEVICE
    Surgically repaired full-thickness rotator cuff tendon tears with the Flexible Suturing System with Anchors (FSSA).

Study Details

The purpose of this research study is to evaluate tendon healing when using the Flexible Suturing System with Anchors (FSSA) to surgically repair full-thickness rotator cuff tendon tears.

Key Dates

Start date
Feb 20, 2025
Status verified
Sep 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
100 participants (estimated)

Primary Outcome Measure

Healing Rate [ Time Frame: One year ]

Locations (3)

FacilityCityStateZIPSite coordinators
OrthoCarolina Research InstituteCharlotteNorth Carolina28207-
Texas Orthopedic SpecialistBedfordTexas76021-
Houston Methodist The WoodlandsThe WoodlandsTexas77385-

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