Perform® Humeral System - Fracture Study (PFX)
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- ASES Score = American Shoulder and Elbow Surgeons Score — 24 Month
11 items with total score reported out of 100 measuring pain and activity of patient's evaluated shoulder where lower scores indicate more pain and less function
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| More Foundation | Phoenix | Arizona | |
| University of Arkansas Medical Sciences | Little Rock | Arkansas | |
| Eisenhower Health Desert Orthopedic Center | Rancho Mirage | California | |
| California Pacific Orthopaedics | San Francisco | California | |
| The Center for Bone and Joint Disease | Hudson | Florida | |
| Loyola University Chicago | Maywood | Illinois | |
| Washington University | St Louis | Missouri | |
| Tennessee Orthopaedic Alliance | Columbia | Tennessee | |
| University of Texas/UT Health | Houston | Texas |
More Stryker Trauma and Extremities trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05773352 on ClinicalTrials.gov ↗ ← All trials in the USA