Phase
Condition
Orthopedics
Treatment
Reverse Total Shoulder
Clinical Study ID
Ages > 22 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Individuals requiring reverse total shoulder replacement for a severely painful,disabling, arthritic joint (i.e. osteoarthritis, post-traumatic arthritis androtator cuff arthropathy).
Individuals who are anatomically and structurally suited to receive the implants andhave a functional deltoid muscle.
Individuals who are able to read and comprehend the informed patient consentdocument and are willing and able to provide informed patient consent forparticipation in the study and have authorized the transfer of their information toDePuy Synthes.
Individuals who are willing and able to return for follow-up as specified by thestudy protocol.
Individuals who are a minimum age of 22 years at the time of consent.
Individuals who are willing and able to complete the Patient Reported OutcomeMeasure questionnaires (PROMs) as specified by the study protocol.
Exclusion
Exclusion Criteria:
BMI > 40 kg/m2
Individuals have active, uncontrolled local infection or systemic infection.
Patients who have not reached skeletal maturity, regardless of age.
Either preoperatively or intraoperatively and per standard of care medicalassessment, bone stock in the proximal humerus or glenoid fossa is determined to beinadequate for supporting the INHANCE humeral stemless components (NOTE: exclusionapplies to both arms of the study, i.e., bone stock to be evaluated independent ofrandomized treatment assignment).
Intraoperatively and per treating physician's assessment of bone quality, bone isdetermined to be too soft or porous to support the implant or that is too hard orbrittle to allow for proper bone preparation and fixation, i.e. osteoporosis orsclerotic bone, or tumor(s) of the supporting bone structure, where there could beconsiderable migration of the prosthesis and/or a chance of fracture of the humerusor glenoid.
Fractures of the proximal humerus that could compromise the fixation of the INHANCEreverse humeral stemless components.
Patients who have undergone previous treatment on the study shoulder that maycompromise fixation of the INHANCE reverse humeral stemless component.
Revision of a failed hemi, total or reverse shoulder arthroplasty.
Patient is receiving, or is scheduled to receive, treatment that the Investigatorconsiders could affect bone quality, such as chemotherapy or high dosecorticosteroids.
Individuals who are bedridden per the Investigator's determination.
Individuals that have participated in a clinical investigation with aninvestigational product (drug or device) in the last three months.
Individuals currently involved in any personal injury litigation, medical-legal orworker's compensation claims.
Individuals, in the opinion of the Investigator, who are drug or alcohol abusers orhave psychological disorders that could affect their ability to complete patientreported questionnaires or be compliant with follow-up requirements.
Patients with a known medical condition that the Investigator believes would impactthe study outcomes (including, but not limited to osteomyelitis, Paget's disease,neuropathies such as Charcot's disease, metastatic or neoplastic disorders).
Patient has a medical condition with less than 2 years life expectancy.
Patients who are known to be pregnant or breastfeeding.
Known polyethylene and/or metal sensitivity or allergy.
Contralateral side has been enrolled in the study or has received a total shoulderoperation within the last 6 months
Otherwise determined by the investigator to be medically unsuitable forparticipation in this study
Patient is a member of a vulnerable population (i.e., incarcerated individuals -those incarcerated for at least one month and considered to be an inmate)
Study Design
Study Description
Connect with a study center
Hoag Orthopedic Institute
Irvine, California 92618
United StatesSite Not Available
Cedars Sinai Medical Center
Los Angeles, California 90048
United StatesSite Not Available
Orthopedic Center of Palm Beach County
Atlantis, Florida 33462
United StatesSite Not Available
Atlantis Orthopaedics
Lake Worth, Florida 33463
United StatesSite Not Available
Boston Sports & Shoulder Center
Waltham, Massachusetts 02451
United StatesSite Not Available
Trinity Health Grand Rapids
Grand Rapids, Michigan 49503
United StatesSite Not Available
Missouri Orthopaedic Institute (MOI)
Columbia, Missouri 65201
United StatesSite Not Available
OrthoCarolina Research Institute Charlotte
Charlotte, North Carolina 28207
United StatesActive - Recruiting
Duke Orthopaedics of Raleigh
Raleigh, North Carolina 27609
United StatesSite Not Available
Lindner Research Center
Cincinnati, Ohio 45219
United StatesActive - Recruiting
Cleveland Clinic
Cleveland, Ohio 44195
United StatesActive - Recruiting
Slocum Center for Orthopaedics and Sports Medicine
Eugene, Oregon 97401
United StatesSite Not Available
Slocum Center for Orthpaedics and Sports Medicine
Eugene, Oregon 97401
United StatesSite Not Available
St. Luke's University Health Network
Bethlehem, Pennsylvania 18015
United StatesSite Not Available
Rothman Orthopaedics Institute
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
MTBJ a division of Tennessee Orthaepedic Alliance
Columbia, Tennessee 38401
United StatesSite Not Available
TOSH- The Orthopedic Specialty Hospital
Murray, Utah 84107
United StatesSite Not Available
University of Utah
Salt Lake City, Utah 84108
United StatesSite Not Available
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