Perform® Humeral System - Fracture Study (PFX)
NCT05773352 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 118
Last updated 2026-04-15
Summary
This study is an international, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF), which is designed to collect safety and performance data on commercially available Perform® Fracture.
Data collected from this study will be used for purposes, including but not limited to, PMS, peer-reviewed publications, education materials, future regulatory submissions, and/or product development.
Conditions
- Traumatic Arthropathy of Shoulder
- Fracture Humerus
- Traumatic Arthritis
- Revision of Other Devices if Sufficient Bone Stock Remains
Interventions
- DEVICE
-
Tornier Perform® Humeral System - Fracture
A replacement of shoulder joints for anatomic and reverse shoulder arthroplasty. A replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains.
Sponsors & Collaborators
-
Stryker Trauma and Extremities
lead INDUSTRY
Principal Investigators
-
Rebecca Gibson · Stryker Trauma and Extremities
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-31
- Primary Completion
- 2026-10-01
- Completion
- 2034-09-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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