Phase
Condition
Musculoskeletal Diseases
Dermatomyositis (Connective Tissue Disease)
Bone Diseases
Treatment
G7 Dual Mobility Longevity bearing
G7 Dual Mobility with Vivacit-E bearing
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 (total) hip arthroplasty based on physical exam and medicalhistory including at least one of the following:
Non-inflammatory degenerative joint disease, including osteoarthritis andavascular necrosis
Rheumatoid arthritis
Dislocation risks
Correction of functional deformity
Treatment of non-union, femoral neck fracture, and trochanteric fractures ofthe proximal femur with head involvement, unmanageable by other techniques
Revision procedures where other treatment or devices have failed.
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 (LAR), has participatedin the Informed Consent process and is willing and able to sign an IRB/EC approvedInformed Consent
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 apparent 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 are likely to jeopardize the outcome of the surgery.
Patient has any concomitant disease which is likely to jeopardize the functioning orsuccess of the implant
Patient is known to be pregnant
The patient is in a 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
UZ Leuven
Leuven, 3000
BelgiumSite Not Available
Istituto San Siro
Milano,
ItalySite Not Available
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam 50612
Korea, Republic ofSite Not Available
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do 58128
Korea, Republic ofSite Not Available
Bowen Hefley Orthopedics
Little Rock, Arkansas 72205
United StatesSite Not Available
HCA HealthONE Orthopedic Specialists
Denver, Colorado 80218
United StatesSite Not Available
Jersey City Medical Center
Jersey City, New Jersey 07302
United StatesSite Not Available
Hospital for Special Surgery
New York, New York 10021
United StatesSite Not Available
The Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
Slocum Research & Education Foundation
Eugene, Oregon 97401
United StatesSite Not Available

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