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Recruiting Observational

Tornier Perform™ Reversed Monopost Study

NCT07764614 · tracked via the Priya Life Science USA tracker
Phase
Observational
Started
2026-10-22
Last updated
2026-10-23

Condition(s) studied

Non-inflammatory Degenerative Joint DiseaseRhematoid ArthritisCorrection of Functional DeformityFracture of the Humeral HeadTraumatic ArthritisRevision of the Devices if Sufficient Bone Stock Remains

Investigational drug(s) / intervention(s)

Tornier Perform™ Reversed MonoPost

Tornier Perform™ Reversed MonoPost: The Commercially available Tornier Perform™ Reversed MonoPost Glenoid is intended to replace the glenoid part of the scapulohumeral joint as part of a reverse shoulder prosthesis.

Study summary

This study is a Multi-center, Prospective Follow-up, Non-significant risk, Post-Market Clinical Follow-Up (PMCF) study to Evaluate the Safety and Effectiveness of the Tornier Perform™ Reversed MonoPost System.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 18 years or older at the time of the informed consent. * Informed and willing to sign an informed consent form (ICF) approved by Institutional Review Board (IRB) or Ethics Committee (EC). * Willing and able to comply with the requirements of the study protocol * Considered a candidate or having received shoulder arthroplasty with the device, having a functional deltoid muscle and with massive and non-repairable rotator cuff tear with pain disabled by: * Rheumatoid arthritis * Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) * Correction of functional deformity * Fracture of the Humeral Head * Traumatic arthritis * Revision of the devices if sufficient bone stock remains * Enrollment occurred up to 1 year after date of surgery provided that mandatory data are accessible: including ASES, Constant, and Active ROM. Exclusion Criteria: * Contraindications or hypersensitivity to the use of the Tornier Perform™ Reversed MonoPost System or their components (e.g., metal sensitivity). * Participation in the treatment period of another clinical trial during the clinical investigation. * Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.44. Examples include any subject "with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, children, impoverished

Primary outcome measure(s)

  • Performance: American Shoulder and Elbow Surgeons (ASES) score- change in functional ability of the treated shoulder — from baseline to 2 years
    The average change in functional ability as measured by the American Shoulder and Elbow Surgeons (ASES) score. ASES is an absolute score ranging from 0 to 100 where a higher score indicates better shoulder function.

Trial sites (2)

FacilityCityRegionStatus
Eisenhower Health Rancho Mirage California Recruiting
Ohio State University Columbus Ohio Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07764614 on ClinicalTrials.gov ↗ ← All trials in the USA