G7 Acetabular System with Vivacit-E or Longevity Liner PMCF Study

Zimmer Biomet

Status: Enrolling

Conditions: Avascular Necrosis of Hip; Total Hip Arthroplasty; Osteoarthritis, Hip; Fracture of Hip; Osteoarthritis of Hip; Rheumatoid Arthritis of Hip; Degenerative Joint Disease of Hip; Fractures, Hip

Treatments: Device: Vivacit-E and Longevity (HXLPE) Liners

Study type: Interventional

Funder types: Industry

Identifiers

NCT04754087

CMG2019-32H

Details and patient eligibility

About

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.

Full 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).

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

G7 Shell with Vivacit-E and Longevity Highly Crosslinked Polyethylene Liners

Other group

Description:

Up to 300 hips globally will be implanted with a G7 Shell and either the Vivacit-E or Longevity Liner. The liner used by each site will be identified at start-up.

Treatment:

Device: Vivacit-E and Longevity (HXLPE) Liners