NCT07764614 Tornier Perform™ Reversed Monopost Study
| NCT ID | NCT07764614 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stryker Trauma and Extremities |
| Condition | Non-inflammatory Degenerative Joint Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-10-22 |
| Primary Completion | 2030-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2026-10-22 with a primary completion date of 2030-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Rebecca Gibson
STUDY DIRECTOR
Stryker Trauma & Extremities
Frequently Asked Questions
Who can join the NCT07764614 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-inflammatory Degenerative Joint Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07764614 currently recruiting?
Yes, NCT07764614 is actively recruiting participants. Contact the research team at Monica.Fleeman@stryker.com for enrollment information.
Where is the NCT07764614 trial being conducted?
This trial is being conducted at Rancho Mirage, United States, Columbus, United States.
Who is sponsoring the NCT07764614 clinical trial?
NCT07764614 is sponsored by Stryker Trauma and Extremities. The principal investigator is Rebecca Gibson at Stryker Trauma & Extremities. The trial plans to enroll 150 participants.