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NCT06868108

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

Enrolling by Invitation
Not specifiedAges 18–70Observational
Integrity Orthopaedics, Inc.
~100 participants
Updated 2025-09-10 on ClinicalTrials.gov
What's tested:Flexible Suturing System with Anchors (FSSA)

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Healing Rate
Measured over One year

Conditions

Rotator Cuff Tears

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Rupture of rotator cuff of shoulder

NCT06868108

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Houston Methodist The Woodlands

    The Woodlands, Texasno site contact published

  • OrthoCarolina Research Institute

    Charlotte, North Carolinano site contact published

  • Texas Orthopedic Specialist

    Bedford, Texasno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Exclusion

Current or prior infection of the ipsilateral shoulder
Known inflammatory arthropathy or history of inflammatory arthropathy
Chronic joint disease
Concomitant labral fixation
Concomitant os acromial fixation
Glenohumeral joint instability (multiple dislocations/subluxations)
Subacromial or intra-articular injection within 3 months prior to surgery
Oral or injected steroid use in the following timeframe: 4 weeks prior to surgery through current date
Hamada 3 or greater rotator cuff arthropathy on X-ray
Goutallier atrophy \> Grade 3
Proximal humeral fracture or scapular fracture
Avascular necrosis of humeral head or glenoid
Immunodeficiency disorders
Chronic inflammatory disorders
Osteoarthritis \>2 (Samilson-Prieto) 8. Has other concurrent medical or other conditions (chronic or acute in nature) that in the opinion of the participating investigator may prevent participation or otherwise render subject ineligible for the study. 9. Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications.

What this trial measures

  • Healing RateOne year

    The cumulative healing rate of the repaired rotator cuff tendon, confirmed through MRI, studied one year after the intervention and using the Sugaya classification (Sugaya H (2005)), where healing is defined as Sugaya Type I, II, or III.