Recruiting

Tornier Perform™

Sponsor:

Stryker Trauma and Extremities

Code:

NCT07764614

Conditions

Non-inflammatory Degenerative Joint Disease

Rhematoid Arthritis

Correction of Functional Deformity

Fracture of the Humeral Head

Traumatic Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tornier Perform™ Reversed MonoPost

Study Details

Brief 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.

Conditions

Non-inflammatory Degenerative Joint Disease

Rhematoid Arthritis

Correction of Functional Deformity

Fracture of the Humeral Head

Traumatic Arthritis

Study ID

NCT07764614

Start date

Oct 22, 2026

Status verified date

Oct, 2026

Completion date

Aug 30, 2031

Anticipated

Primary completion date

Dec 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

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. The Tornier Perform™ Reversed MonoPost Glenoid includes new range of glenoid baseplates for Bony Increased Offset -Reversed Shoulder Arthroplasty (BIO-RSA) and a new range of glenoid baseplates with metallic augmentation to accommodate specific patterns of glenoid wear in patients.

Interventions

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.

Primary outcome measure

  • Performance: American Shoulder and Elbow Surgeons (ASES) score- change in functional ability of the treated shoulder [ Time Frame: from baseline to 2 years ]

Central Contacts and Locations

Central contacts

Monica Fleeman

251-465-5969Monica.Fleeman@stryker.com

Rebecca Gibson

Rebecca.Gibson@stryker.com

Locations

Eisenhower Health

Recruiting

Rancho Mirage, California, United States, 92270

Contacts

Christian Gaxiola

760-340-3911CGaxiola@eisenhowerhealth.org

Principal Investigator:

David Savin

Ohio State University

Recruiting

Columbus, Ohio, United States, 43202

Contacts

Kate Agan

6143667598kate.agan@osumc.edu

Principal Investigator:

Julie Bishop

More Information

Sponsor

Stryker Trauma and Extremities

Last update posted

Oct 23, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Stryker Trauma and Extremities on 2026-10-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.