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NCT05067543Recruiting

Perform Humeral System Study

Stryker Trauma and Extremities

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

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 comprehend study questions, inability to keep scheduled assessment times) * Patient belongs to a vulnerable group of patients, including minor patients, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion (patients who may not be acting on their own initiative) (referred as "vulnerable subject" in the section 3.44 of the ISO 14155 norm). * Active local or systemic infection, sepsis, or osteomyelitis * Poor bone quality, where there could be considerable migration of the prothesis and/or a chance of fracture of the humerus or glenoid * Significant injury to the brachial plexus * Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components * Neuromuscular disease (e.g., joint neuropathy) * Patient with known allergy to one of the product materials * Metabolic disorders which may impair bone formation * Patient pregnancy * Planned for two-stage surgery

Interventions

DEVICE

Tornier Perform Humeral - Stem

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Conditions

Osteoarthritis ShoulderAvascular NecrosisPost-traumatic Arthrosis of Other Joints, Shoulder RegionRotator Cuff Tear Arthropathy

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