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Clinical Trials in the USA / NCT05067543
Recruiting Observational

Perform Humeral System Study

NCT05067543 · tracked via the Priya Life Science USA tracker
Sponsor
Stryker Trauma and Extremities
Phase
Observational
Started
2021-09-12
Last updated
2026-09-01

Condition(s) studied

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

Investigational drug(s) / intervention(s)

Tornier Perform Humeral - Stem

Tornier Perform Humeral - Stem: The PERFORM Humeral System - Stem is a non-constrained prosthesis intended for the total or partial replacement of the glenohumeral articulation.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
Baptist Healthcare Lexington Kentucky Recruiting
Summit Orthopedics Eagan Minnesota Recruiting
Mayo Clinic Rochester Minnesota Terminated
Washington University St Louis Missouri Active Not Recruiting
Ohio State University Columbus Ohio Recruiting
Orthopedic Institute Sioux Falls South Dakota Recruiting
University of Utah Salt Lake City Utah Recruiting
Roth McFarlane Hand and Upper Limb Centre London Ontario Active Not Recruiting
Orthopedic Center Santy Lyon France Active Not Recruiting
Schulthess Klinik Zurich Switzerland Active Not Recruiting
Wrightington Hospital Wigan Lancashire Active Not Recruiting

More Stryker Trauma and Extremities trials in the USA

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05067543 on ClinicalTrials.gov ↗ ← All trials in the USA