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 & Instrumentation
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Total Hip Arthroplasty
- Sponsor
- Zimmer Biomet
- Enrollment
- 300
- Locations
- 11
- Primary Endpoint
- Adverse Event (safety)
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
Brief Summary
The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Acetabular Shells when used with the Vivacit-E and Longevity HXLPE liners and instrumentation in primary and revision total hip arthroplasty.
Detailed Description
The primary endpoint is defined by the survival of the implant system at 10 years, which is based on removal or intended removal of the study device and will be determined using Kaplan Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to either implant or instrumentation should be specified. The secondary endpoints are the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs) as well as radiographic outcomes (if available).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient must be a legal adult who has reached full skeletal maturity.
- •Patient must be treated for one of the following indications:
- •Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- •Rheumatoid arthritis
- •Correction of functional deformity
- •Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
- •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 Institutional Review Board or Ethics Committee (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 prisoner.
- •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.
Outcomes
Primary Outcomes
Adverse Event (safety)
Time Frame: At 10 years
Safety will be evaluated by monitoring the frequency and incidence of device related adverse events or unanticipated adverse device effects in investigational subjects.
Survival of the study device (liner); whether or not it is still implanted in the subject
Time Frame: At 10 years
Survivorship will be based on revision or intended revision of the study device (liner).
Secondary Outcomes
- Pain and Function using Modified Harris Hip Score(At 10 years)
- Patient Quality of Life using EQ-5D-5L Descriptive System(At 10 years)
- Pain and Function using Oxford Hip Score(At 10 years)
- Patient Quality of Life using EQ-5D-5L EQ visual analogue scale(At 10 years)