Enrolling by invitation
Not applicable
G7 Freedom Constrained Vivacit-E Liners
Condition(s) studied
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
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 |
Houston |
Texas |
|
| Medical City Plano |
Plano |
Texas |
|
| University of Utah |
Salt Lake City |
Utah |
|
| West Virginia University |
Morgantown |
West Virginia |
|
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