Taking people in United StatesNo phase
Tornier Perform™ Reversed Monopost Study
Key facts
- Who runs it
- Stryker Trauma and Extremities
- Where
- Columbus and Rancho Mirage, United StatesSee the 2 sites
- Trial code
- Status
- Recruiting
- People taking part
- 150 people, planned
- Started
- 22 Oct 2026
- Expected to end
- 30 Aug 2031
- Type of study
- Observational
- Treatments tested
- Tornier Perform™ Reversed MonoPost
- Record updated
- 23 October 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in United States
- Ohio State UniversityColumbus, United StatesContact: Kate AganTaking people
- Eisenhower HealthRancho Mirage, United StatesContact: Christian GaxiolaTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- 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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 23 October 2026