Perform Humeral System Study
Stryker Trauma and Extremities
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Not specified
Inclusion Criteria: * 18 years or older at the time of the informed consent or non-opposition (when applicable). * Informed and willing to sign an informed consent form approved by IRB or EC (when applicable). * Willing and able to comply with the requirements of the study protocol. * Considered a candidate for shoulder arthroplasty using a study device. * Meets indications for use requirements or other local, regional, or geographic specific regulatory requirements Exclusion Criteria: * Not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehe…
Interventions
- DeviceTornier Perform Humeral - Stem
The PERFORM Humeral System - Stem is a non-constrained prosthesis intended for the total or partial replacement of the glenohumeral articulation.
Locations (10)
- Baptist HealthcareLexington, Kentucky
- Summit OrthopedicsEagan, Minnesota
- Mayo ClinicRochester, Minnesota
- Washington UniversitySt Louis, Missouri
- Orthopedic InstituteSioux Falls, South Dakota
- University of UtahSalt Lake City, Utah