Phase
Condition
Osteoarthritis
Bone Neoplasm
Rheumatoid Arthritis
Treatment
TITAN™ Reverse Shoulder System (TRS)
Clinical Study ID
Ages > 21 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects with grossly deficient rotator cuff with severe arthropathy or Subjectswith failed joint replacement with grossly deficient rotator cuff
Subjects with a shoulder joint anatomically and structurally suited to receive thedevice
Subjects at least 21 years of age and skeletally mature at the time of surgery
Subject provided consent to participate in the clinical study (having signed theInformed Consent Form)
Exclusion
Exclusion Criteria:
Subjects without a functional deltoid muscle
Subjects with active local or systemic infection
Subjects with inadequate bone stock in the proximal humerus or glenoid fossa forsupporting the components
Subjects with poor bone quality such as osteoporosis where there could beconsiderable migration of the prosthesis and/or a chance of fracture of the humerusor glenoid
Subjects with muscular, neurologic, or vascular deficiencies that compromise theaffected extremity
Subjects with known metal allergies
Subjects are known to be at risk for lost to follow-up, or failure to return forscheduled visits
Subjects who are prisoners
Female subject who are pregnant, nursing, or of childbearing potential while notpracticing effective contraceptive methods
Study Design
Connect with a study center
Clinique Bizet
Paris,
FranceSite Not Available
Clinique Bizet
Paris 2988507,
FranceSite Not Available
Hospital de Manacor - Llevant
Manacor, 07500
SpainSite Not Available
Hospital de Manacor - Llevant
Manacor 2514216, 07500
SpainSite Not Available
Barts Health NHS Trust
London,
United KingdomSite Not Available
Barts Health NHS Trust
London 2643743,
United KingdomSite Not Available
University of Florida
Gainesville, Florida 32607
United StatesSite Not Available
University of Florida
Gainesville 4156404, Florida 4155751 32607
United StatesSite Not Available
Johns Hopkins University
Columbia, Maryland 21044
United StatesSite Not Available
Johns Hopkins University
Columbia 4352053, Maryland 4361885 21044
United StatesSite Not Available
Mississipi Bone and Joint Clinic
Starkville, Mississippi 39759
United StatesSite Not Available
Mississipi Bone and Joint Clinic
Starkville 4447161, Mississippi 4436296 39759
United StatesSite Not Available
Active Orthopedics
Glen Ridge, New Jersey 07028
United StatesSite Not Available
Active Orthopedics
Glen Ridge 5098430, New Jersey 5101760 07028
United StatesSite Not Available
The Orthopedics Foundation
New Albany, Ohio 43054
United StatesSite Not Available
Westphal Orthopaedics
Lancaster, Pennsylvania 17601
United StatesSite Not Available
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
The Rothman Institute
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Westphal Orthopaedics
Lancaster 5197079, Pennsylvania 6254927 17601
United StatesSite Not Available
Hospital of the University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesSite Not Available
The Rothman Institute
Philadelphia 4560349, Pennsylvania 6254927 19107
United StatesSite Not Available
University of Virginia Health
Charlottesville, Virginia 22911
United StatesSite Not Available

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