Perform Humeral System Study (PHS)

Stryker Trauma and Extremities

Status

Enrolling

Conditions

Post-traumatic Arthrosis of Other Joints, Shoulder Region

Osteoarthritis Shoulder

Rotator Cuff Tear Arthropathy

Avascular Necrosis

Treatments

Device: Tornier Perform Humeral - Stem

Study type

Observational

Funder types

Industry

Identifiers

NCT05067543

20D-W-PHS-RM

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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