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)
Change from Baseline to last follow-up visit in ASES scores — Baseline through Follow-Up visits through 24 months Post-Op 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
Trial sites (11)
Facility
City
Region
Status
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
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.
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