Phase
Condition
Arthritis And Arthritic Pain
Osteomyelitis
Dermatomyositis (Connective Tissue Disease)
Treatment
Total Hip Arthroplasty with G7 Freedom Constrained Vivacit-E Liners
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient is 18 to 80 years of age, inclusive
Patient is skeletally mature
Patient qualifies for unilateral total hip arthroplasty based on physical exam andmedical history including at least one of the following:
Non-inflammatory degenerative joint disease, including osteoarthritis andavascular necrosis
Rheumatoid arthritis
High risk for dislocation
Undergoing revision hip arthroplasty
Correction of functional deformity
In need of treatment of non-union, femoral neck fracture, and trochantericfractures of the proximal femur with head involvement, unmanageable by othertechniques
Patient is willing and able to complete scheduled follow-up evaluations as describedin the protocol and Informed Consent
Patient, or the patient's legally authorized representative, has participated in theInformed Consent process and is willing and able to sign an IRB approved informedconsent
Exclusion
Exclusion Criteria:
Patient is septic, has an active infection or has osteomyelitis at the affectedjoint
Patient has significant osteoporosis as defined by treating surgeon
Patient has metabolic disorder(s) which may impair bone formation
Patient has osteomalacia
Patient has distant foci of infections which may spread to the implant site
Patient has rapid joint destruction, marked bone loss or bone resorption onpre-operative radiographs
Patient underwent contralateral THA within 3 months of planned index procedure orhas a contralateral THA planned within 3 months of the index procedure
Patient is undergoing simultaneous bilateral THA
Patient has vascular insufficiency, muscular atrophy at the implant site orneuromuscular disease which might jeopardize the outcome of the surgery.
In the opinion of the investigator, patient has any concomitant disease which islikely to jeopardize the functioning or success of the implant
Patient is known to be pregnant
The patient is in the vulnerable population group, such as
a prisoner
a known alcohol or drug abuser
mentally incompetent or unable to understand what participation in this studyentails
Study Design
Study Description
Connect with a study center
University of Alabama at Birmingham
Birmingham, Alabama 35205
United StatesSite Not Available
University of Alabama at Birmingham
Birmingham 4049979, Alabama 4829764 35205
United StatesSite Not Available
University of Southern California
Los Angeles, California 90033
United StatesSite Not Available
University of Southern California
Los Angeles 5368361, California 5332921 90033
United StatesSite Not Available
University of Florida Board of Trustees
Gainesville, Florida 32611
United StatesSite Not Available
University of Florida Board of Trustees
Gainesville 4156404, Florida 4155751 32611
United StatesSite Not Available
Jersey City Medical Center, Inc
Livingston, New Jersey 07039
United StatesSite Not Available
Jersey City Medical Center, Inc
Livingston 5100572, New Jersey 5101760 07039
United StatesSite Not Available
The Ohio State University
Columbus, Ohio 43201
United StatesSite Not Available
The Ohio State University
Columbus 4509177, Ohio 5165418 43201
United StatesSite Not Available
TOA Research Foundation
Knoxville, Tennessee 37923
United StatesSite Not Available
TOA Research Foundation
Knoxville 4634946, Tennessee 4662168 37923
United StatesSite Not Available
The University of Texas Health Science Center of Houston
Houston, Texas 77030
United StatesSite Not Available
Medical City Plano
Plano, Texas 75075
United StatesSite Not Available
The University of Texas Health Science Center of Houston
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
Medical City Plano
Plano 4719457, Texas 4736286 75075
United StatesSite Not Available
University of Utah
Salt Lake City, Utah 84108
United StatesSite Not Available
University of Utah
Salt Lake City 5780993, Utah 5549030 84108
United StatesSite Not Available
West Virginia University
Morgantown, West Virginia 26506
United StatesSite Not Available
West Virginia University
Morgantown 4815352, West Virginia 4826850 26506
United StatesSite Not Available

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