Perform Humeral System Study
Start Date
9/12/2021
Completion Date
12/1/2036
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.
Detailed Description
This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study. Data will be collected for the commercially available PERFORM™ Humeral System. The objective of this study is to demonstrate the safety and performance of the PERFORM™ Humeral System devices after implantation over a standard follow-up period using Patient Reported Outcome Measures related to quality of life, pain and functional improvements, safety of the implants, as well as radiographic assessments. Safety and performance measures will be evaluated throughout the patient's participation in the study.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Tornier Perform Humeral - Stem
Conditions
Locations
Baptist Healthcare
Lexington, Kentucky 40503
United States
Summit Orthopedics
Eagan, Minnesota 55121
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
Washington University
St Louis, Missouri 63110
United States
Orthopedic Institute
Sioux Falls, South Dakota 57105
United States
University of Utah
Salt Lake City, Utah 84108
United States
Roth McFarlane Hand and Upper Limb Centre
London, Ontario N6A 4L6
Canada
Orthopedic Center Santy
Lyon, 69008
France
Schulthess Klinik
Zurich, CH-8008
Switzerland
Wrightington Hospital
Wigan, Lancashire WN6 9EP
United Kingdom