New stitching device aims to heal torn shoulder tendons better

NCT ID NCT06868108

ENROLLING_BY_INVITATION Disease control Sponsor: Integrity Orthopaedics, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a new flexible suturing system with anchors (FSSA) to repair full-thickness rotator cuff tears. About 100 people who have had this surgery will get an MRI one year later to check if the tendon has healed. The goal is to see if this device helps tendons heal more reliably.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Flexible Suturing System with Anchors (FSSA) device
What this could lead to: If successful, this device could improve tendon healing after rotator cuff surgery, potentially reducing re-tear rates and improving shoulder function.
What could go wrong: This is a single-arm study with no comparison group, so benefits may not be proven. Results depend on MRI findings at one year, and individual healing varies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

Rotator Cuff Injuries rotator cuff syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ROTATOR CUFF TEARS

Contacts and locations

Locations

Houston Methodist The Woodlands

The Woodlands, Texas, 77385, United States
OrthoCarolina Research Institute

Charlotte, North Carolina, 28207, United States
Texas Orthopedic Specialist

Bedford, Texas, 76021, United States

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