Phase
Condition
N/ATreatment
Alliance Glenoid
Identity Stem
Clinical Study ID
Ages > 20 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient must be 20 years of age or older.
Patient must be anatomically and structurally suited to receive shoulderarthroplasty implants.
Patient is a candidate for shoulder arthroplasty due to one or more of thefollowing:
Non-inflammatory degenerative joint disease including osteoarthritis andavascular necrosis.
Rheumatoid arthritis.
Correction of functional deformity.
Fractures of the proximal humerus, where other methods of treatment are deemedinadequate.
Difficult clinical management problems, where other methods of treatment maynot be suitable or may be inadequate.
Patient must be able and willing to complete the protocol required follow-up.
Patient must be able and willing to sign the IRB/EC approved informed consent.
Patient has grossly deficient rotator, (for reverse application)
With severe arthropathy and/or
Previously failed shoulder joint replacement
Patient must have functional deltoid muscle (for reverse application)
Exclusion
Exclusion Criteria:
Patient is unwilling or unable to give consent or to comply with the follow-upprogram.
Patient has any condition which would in the judgement of the Investigator, placethe patient at undue risk or interfere with the study.
Patient is known to be pregnant or breastfeeding.
Patient is a vulnerable subject (prisoner, mentally incompetent or unable tounderstand what participation to the study entails, a known alcohol or drug abuser,and/or anticipated to be non-compliant).
Patient is uncooperative or patient with neurologic disorders who is incapable orunwilling to follow directions.
Patient has any sign of infection affecting the shoulder joint or in its proximitywhich may spread to the implant site.
Patient has rapid joint destruction, marked bone loss, or bone resorption apparenton roentgenogram.
Patient has any neuromuscular disease compromising the affected limb that wouldrender the procedure unjustifiable.
Patient presents with osteoporosis, which in the opinion of the Investigator, maylimit the subject's ability to support total shoulder arthroplasty using the studydevice.
Patient has osteomalacia.
Patient has a metabolic disorder that may impair bone formation.
Patient has deficient rotator cuff.
Patient presents with significant injury to the upper brachial plexus.
Patient has paralysis of the axillary nerve.
Patient has non-functional deltoid or external rotator muscles.
Study Design
Study Description
Connect with a study center
Fukui General Hospital
Fukui, 910-3113
JapanSite Not Available
Iwaki City Medical Center
Fukushima, 973-8555
JapanSite Not Available
Yuuai Medical Center
Okinawa, 901-0224
JapanSite Not Available
Kichijoji Minami Hospital
Tokyo, 180-0003
JapanSite Not Available
Kensington Private Hospital
Whangarei, 0112
New ZealandSite Not Available
Hoag Orthopedic Institute
Irvine, California 92618
United StatesActive - Recruiting
Panorama Orthopaedic and Spine Center
Golden, Colorado 80401
United StatesActive - Recruiting
Northwestern University
Chicago, Illinois 60208
United StatesActive - Recruiting
Norton Healthcare, Inc
Louisville, Kentucky 40202
United StatesActive - Recruiting
William Beaumont Hospital
Royal Oak, Michigan 48073
United StatesActive - Recruiting
TRIA Orthopaedic Center Research Institute
Bloomington, Minnesota 55431
United StatesSite Not Available
Mississippi Sports Medicine and Orthopaedic Center, PLLC
Jackson, Mississippi 39202
United StatesActive - Recruiting
Washington University
Saint Louis, Missouri 63130
United StatesActive - Recruiting
Advance Bone and Joint
Saint Peters, Missouri 63376
United StatesSite Not Available
University of Buffalo
Buffalo, New York 14215
United StatesSite Not Available
Rothman Institute
Philadelphia, Pennsylvania 19107
United StatesActive - Recruiting
Intermountain Health
Murray, Utah 84107
United StatesActive - Recruiting
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