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 18–70ObservationalIntegrity 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
Where it's being run
3 sites across 2 statesTexas2
North Carolina1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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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.