Phase
Condition
Osteoarthritis
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
CanadaActive - Recruiting
Orthopedic Center Santy
Lyon, 69008
FranceActive - Recruiting
Schulthess Klinik
Zürich, CH-8008
SwitzerlandActive - Recruiting
Wrightington Hospital
Wigan, Lancashire WN6 9EP
United KingdomActive - Recruiting
Baptist Healthcare
Lexington, Kentucky 40503
United StatesActive - Recruiting
Summit Orthopedics
Eagan, Minnesota 55121
United StatesActive - Recruiting
Mayo Clinic
Rochester, Minnesota 55905
United StatesTerminated
Washington University
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Orthopedic Institute
Sioux Falls, South Dakota 57105
United StatesActive - Recruiting
University of Utah
Salt Lake City, Utah 84108
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.