Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
516 participants
INTERVENTIONAL
2002-10-31
2008-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Primary
Primary shoulder
Reverse Shoulder Prosthesis
For subjects with rotator cuff arthropathy and no previous shoulder device implanted.
Revision
Revision shoulder
Reverse Shoulder Prosthesis
For subjects with rotator cuff arthropathy and a failed hemi or total shoulder implant.
Continued Access
Primary shoulder subjects enrolled at a later date in order to collect more data.
Reverse Shoulder Prosthesis
For subjects with rotator cuff arthropathy and no previous shoulder device implanted.
Interventions
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Reverse Shoulder Prosthesis
For subjects with rotator cuff arthropathy and no previous shoulder device implanted.
Reverse Shoulder Prosthesis
For subjects with rotator cuff arthropathy and a failed hemi or total shoulder implant.
Eligibility Criteria
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Inclusion Criteria
* Evidence of upward displacement of the humeral head with respect to the glenoid
* Loss of glenohumeral joint space
* Functional deltoid muscle
* Patient is likely to be available for evaluation for the duration of the study
* Visual Analog Pain Scale 5 or greater
Exclusion Criteria
* Active sepsis
* Excessive glenoid bone loss
* Pregnancy
* Neurological abnormalities, which could hinder patient's ability or willingness to follow study procedures. For example, any that may restrict physical activities such as Parkinson's, Multiple Sclerosis, or previous stroke, which affects upper extremity.
* Mental conditions that may interfere with ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the patient cannot understand the informed consent process, global dementia, prior strokes that interfere with the patient's cognitive abilities, senile dementia, and Alzheimer's Disease.
* Prisoners
* Conditions that place excessive demand on the implant (i.e. Charcot's joints, muscle deficiencies, refusal to modify postoperative physical activities, skeletal immaturity).
* Known metal allergy (i.e., jewelry).
* Visual Analog Pain Scale \<5.
18 Years
ALL
No
Sponsors
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Encore Medical, L.P.
INDUSTRY
Responsible Party
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DJO Surgical
Principal Investigators
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Mark Frankle, M.D.
Role: PRINCIPAL_INVESTIGATOR
Florida Orthopedic Institute
Locations
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Arthritis Orthopedics and Sports Medicine
Glendale, California, United States
Orthopaedic Specialty Institute
Orange, California, United States
University of Colorado
Denver, Colorado, United States
Orthopedic Center of the Rockies
Fort Collins, Colorado, United States
Advanced Orthopedic and Sports Medicine Specialists, P.C.
Lonetree, Colorado, United States
Steadman Hawkins SPT Medical Foundation
Vail, Colorado, United States
Atlantis Orthopaedics
Atlantis, Florida, United States
Orthopaedic Surgery & Sports Medicine
Jupiter, Florida, United States
Palm Beach Orthopaedic Institute
Palm Beach Gardens, Florida, United States
Florida Orthopedic Institute
Temple Terrace, Florida, United States
Atlanta, Georgia, United States
Cincinnati Sports Medicine & Orthopaedic Center
Crestview, Kentucky, United States
Lutherville, Maryland, United States
Orthopedic Specialists
Towson, Maryland, United States
TRIA Orthopaedic Center
Bloomington, Minnesota, United States
Hospital for Special Surgery
New York, New York, United States
UNC School of Medicine
Chapel Hill, North Carolina, United States
Crystal Clinic
Akron, Ohio, United States
Bone & Joint Hospital, LLC
Oklahoma City, Oklahoma, United States
Orthopedic Research Foundation of the Carolinas
Spartanburg, South Carolina, United States
The Carrell Clinic
Dallas, Texas, United States
Orthopedic Associates of Dallas
Dallas, Texas, United States
Orthopedic Specialty Associates, P.A.
Fort Worth, Texas, United States
Unlimited Research
San Antonio, Texas, United States
Orthopedic Institute
Tyler, Texas, United States
Countries
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Related Links
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Sponsor company home page
Other Identifiers
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Study 300
Identifier Type: -
Identifier Source: org_study_id
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