Osteoarthritis, HipRheumatoid ArthritisNon-Union FractureTrochanteric FracturesFemoral Neck FracturesAvascular NecrosisDislocation, Hip
Investigational drug(s) / intervention(s)
Total Hip Arthroplasty with G7 Freedom Constrained Vivacit-E Liners
Total Hip Arthroplasty with G7 Freedom Constrained Vivacit-E Liners: Primary and/or Revision total hip arthroplasty with the G7 Freedom Constrained Vivacit-E Liners
Study summary
The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Freedom Constrained Vivacit-E Acetabular Liners in primary and revision total hip arthroplasty.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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 and medical history including at least one of the following:
* Non-inflammatory degenerative joint disease, including osteoarthritis and avascular 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 trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
* Patient is willing and able to complete scheduled follow-up evaluations as described in the protocol and Informed Consent
* Patient, or the patient's legally authorized representative, has participated in the Informed Consent process and is willing and able to sign an IRB approved informed consent
Exclusion Criteria:
* Patient is septic, has an active infection or has osteomyelitis at the affected joint
* 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 on pre-operative radiographs
* Patient underwent contralateral THA within 3 months of planned index procedure or has 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 or neuromuscular disease which might jeopardize the outcome of the surgery.
* In the opinion of the investigator, patient has any concomitant disease which is likely 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 study entails
Primary outcome measure(s)
Survival of the study device — 10 years Survival (whether or not it is still implanted in the subject) determined using Kaplan Meier method.
Trial sites (10)
Facility
City
Region
Status
University of Alabama at Birmingham
Birmingham
Alabama
University of Southern California
Los Angeles
California
University of Florida Board of Trustees
Gainesville
Florida
Jersey City Medical Center, Inc
Livingston
New Jersey
The Ohio State University
Columbus
Ohio
TOA Research Foundation
Knoxville
Tennessee
The University of Texas Health Science Center of Houston
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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