Perform Humeral System Study

Stryker Trauma and Extremities300 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Osteoarthritis Shoulder Avascular Necrosis Post-traumatic Arthrosis of Other Joints, Shoulder Region Rotator Cuff Tear Arthropathy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Baptist Healthcare

Lexington, Kentucky, United States

RECRUITING

Summit Orthopedics

Eagan, Minnesota, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

TERMINATED

Washington University

St Louis, Missouri, United States

RECRUITING

Orthopedic Institute

Sioux Falls, South Dakota, United States

RECRUITING

University of Utah

Salt Lake City, Utah, United States

RECRUITING

Roth McFarlane Hand and Upper Limb Centre

London, Ontario, Canada

RECRUITING

Orthopedic Center Santy

Lyon, France

RECRUITING

Schulthess Klinik

Zurich, Switzerland

RECRUITING

Wrightington Hospital

Wigan, Lancashire, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

Change from Baseline to last follow-up visit in ASES scores

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

Time frame: Baseline through Follow-Up visits through 24 months Post-Op

Secondary Outcomes

Change from Baseline to last follow-up visit in Constant Murley scores

Combination of physician-completed and patient-reported portions to assess functional state of shoulder including range of motion; total score reported out of 100 measuring where lower scores indicate less function of the evaluated shoulder