Phase
Condition
Musculoskeletal Diseases
Osteoarthritis
Bone Neoplasm
Treatment
Tornier Perform Humeral - Stem
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
18 years or older at the time of the informed consent or non-opposition (whenapplicable).
Informed and willing to sign an informed consent form approved by IRB or EC (whenapplicable).
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 geographicspecific regulatory requirements
Exclusion
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 assessmenttimes)
Patient belongs to a vulnerable group of patients, including minor patients, thoseunable to decide for themselves to participate or needing a Legally AuthorizedRepresentative (LAR), or others who could be subject to coercion (patients who maynot be acting on their own initiative) (referred as "vulnerable subject" in thesection 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 prothesisand/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 thecomponents
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
Study Design
Study Description
Connect with a study center
Roth McFarlane Hand and Upper Limb Centre
London, Ontario N6A 4L6
CanadaSite Not Available
Roth McFarlane Hand and Upper Limb Centre
London 6058560, Ontario 6093943 N6A 4L6
CanadaSite Not Available
Orthopedic Center Santy
Lyon, 69008
FranceSite Not Available
Orthopedic Center Santy
Lyon 2996944, 69008
FranceSite Not Available
Schulthess Klinik
Zurich 2657896, CH-8008
SwitzerlandSite Not Available
Schulthess Klinik
Zürich, CH-8008
SwitzerlandSite Not Available
Wrightington Hospital
Wigan, Lancashire WN6 9EP
United KingdomSite Not Available
Wrightington Hospital
Wigan 2633948, Lancashire WN6 9EP
United KingdomSite Not Available
Baptist Healthcare
Lexington, Kentucky 40503
United StatesSite Not Available
Baptist Healthcare
Lexington 4297983, Kentucky 6254925 40503
United StatesActive - Recruiting
Summit Orthopedics
Eagan, Minnesota 55121
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Summit Orthopedics
Eagan 5024825, Minnesota 5037779 55121
United StatesActive - Recruiting
Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905
United StatesTerminated
Washington University
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University
St Louis 4407066, Missouri 4398678 63110
United StatesSite Not Available
Orthopedic Institute
Sioux Falls, South Dakota 57105
United StatesSite Not Available
Orthopedic Institute
Sioux Falls 5231851, South Dakota 5769223 57105
United StatesActive - Recruiting
University of Utah
Salt Lake City, Utah 84108
United StatesSite Not Available
University of Utah
Salt Lake City 5780993, Utah 5549030 84108
United StatesActive - Recruiting

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