Global, Multicenter, and Prospective Post-Market Clinical Follow-Up Study of the G7® Acetabular System with Vivacit-E® and Longevity® Highly Crosslinked Polyethylene (HXLPE) Liners & Instrumentatio

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

- Patient must be a legal adult who has reached full skeletal maturity;
- Patient must be treated for one of the following indications;
o Noninflammatory degenerative joint disease including osteoarthritis and
avascular necrosis;
o Rheumatoid arthritis;
o Correction of functional deformity;
o Treatment of non-union, femoral neck fracture and trochanteric fractures of
the proximal femur with head involvement, unmanageable by other techniques;
o Revision procedures where other treatment or devices have failed
- Patient must be able and willing to complete the protocol required follow-up
visits;
- Patient must be able and willing to sign the IRB/EC approved informed
consent.

Exclusion Criteria

- Patient presents with osteoporosis, which in the opinion of the Principal
Investigator, may limit the subject*s ability to support total hip arthroplasty
using the study device;
- Patient has a metabolic disorder that may impair bone formation;
- Patient has osteomalacia;
- Patient has distant foci of infections which may spread to the implant site
or patient with infection, sepsis or osteomyelitis;
- Patient has rapid joint destruction, marked bone loss or bone resorption
apparent on roentgenogram;
- Patient has a vascular insufficiency, muscular atrophy, or neuromuscular
disease;
- Patient is a current alcohol or drug abuser;
- Uncooperative patient or patient with neurologic disorders who is incapable
or unwilling to follow directions;
- Patient is pregnant.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is defined by the survival of the implant system at 10<br /><br>years which is based on removal or intended removal of the study device and<br /><br>will be determined using Kaplan Meier method. The safety of the system will be<br /><br>assessed by monitoring the frequency and incidence of adverse events. Relation<br /><br>of the events to implant, instrumentation and/or procedure should be specified.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoint is defined by the functional performance and clinical<br /><br>benefits of the study device and is assessed by:<br /><br>- Pain and functional performance will be measured by the Modified Harris Hip<br /><br>Score, and Physical Exam (up to 5 years), and the Oxford Hip Score (up to 10<br /><br>years);<br /><br>- Subject quality-of-life will be measured by the EQ-5D-5L (up to 10 years);<br /><br>- Radiographs will be evaluated (up to 5 years) for radiolucency, osteolysis,<br /><br>atrophy, hypertrophy, component migration, device fracture, heterotopic<br /><br>ossification, etc.</p><br>