Follow-up of a reverse shoulder implant in adults with shoulder joint damage
Follows adults with damaged shoulder joints who receive the Tornier Perform Reversed MonoPost implant.
Key facts
- Who runs it
- Stryker Trauma and Extremities
- Where
- Columbus and Rancho Mirage, United StatesSee the 2 sites
- Trial code
- Registry title
- Tornier Perform™ Reversed Monopost Study
- 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
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who will have, or already had, a reverse shoulder replacement with the Tornier Perform™ Reversed MonoPost System. It follows how safe the device is and how well it works.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- A working deltoid (shoulder) muscle and a large rotator cuff tear that cannot be repaired, with disabling pain. The pain comes from rheumatoid arthritis, non-inflammatory joint wear (such as osteoarthritis or avascular necrosis), a deformity needing correction, a fracture of the top of the upper arm bone, or arthritis after an injury. People needing a replacement of earlier devices can also join if enough bone remains.
- Earlier treatment
- People can join before surgery, or up to 1 year after surgery with the device. Those joining after surgery must have the required data available: ASES, Constant and Active ROM scores.
Main reasons for not taking part
- Reasons the device cannot be used, or allergy to it or its parts (such as metal allergy)
- Taking part in the treatment period of another clinical trial
- Vulnerable people, such as those unable to decide for themselves because of mental disability
- People living in nursing homes, children, or people living in poverty
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.
- Official title
- Tornier Perform™ Reversed Monopost Study
- Plain-language title
- Follow-up of a reverse shoulder implant in adults with shoulder joint damageGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 23 October 2026