Perform Humeral System Study
Condition(s) studied
Investigational drug(s) / intervention(s)
Tornier Perform Humeral - Stem: The PERFORM Humeral System - Stem is a non-constrained prosthesis intended for the total or partial replacement of the glenohumeral articulation.
Study summary
This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study, which is designed to collect safety and performance data at baseline, surgery, immediate post-op and annually through 10 years post-operation.
Data collected from this study will be used for purposes, including but not limited to, Post-Market Surveillance, peer-reviewed publications, education materials, regulatory submissions, and/or product development.
Eligibility
Primary outcome measure(s)
- Change from Baseline to last follow-up visit in ASES scores — Baseline through Follow-Up visits through 24 months Post-Op
ASES Score = American Shoulder and Elbow Surgeons Score, 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 (11)
| Facility | City | Region | Status |
|---|---|---|---|
| Baptist Healthcare | Lexington | Kentucky | Recruiting |
| Summit Orthopedics | Eagan | Minnesota | Recruiting |
| Mayo Clinic | Rochester | Minnesota | Terminated |
| Washington University | St Louis | Missouri | Active Not Recruiting |
| Ohio State University | Columbus | Ohio | Recruiting |
| Orthopedic Institute | Sioux Falls | South Dakota | Recruiting |
| University of Utah | Salt Lake City | Utah | Recruiting |
| Roth McFarlane Hand and Upper Limb Centre | London | Ontario | Active Not Recruiting |
| Orthopedic Center Santy | Lyon | France | Active Not Recruiting |
| Schulthess Klinik | Zurich | Switzerland | Active Not Recruiting |
| Wrightington Hospital | Wigan | Lancashire | Active Not Recruiting |
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 NCT05067543 on ClinicalTrials.gov ↗ ← All trials in the USA