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

Launched by ZIMMER BIOMET · Feb 12, 2021

Keywords

ClinConnect Summary

The G7 Acetabular System study is looking at a specific type of hip implant used in surgeries to replace or fix damaged hips. This includes patients with conditions like osteoarthritis, rheumatoid arthritis, or hip fractures. The main goal is to see how safe and effective the G7 Acetabular Shell works with two different liners over the long term. This is important for both first-time hip surgeries and for patients who may need a second surgery because their previous treatment didn’t work.

To join this study, participants need to be adults who have certain hip conditions and are willing to attend follow-up visits. However, there are some people who can’t participate, like those with severe bone loss or certain infections. If someone is eligible, they can expect to receive the new hip implant and will be monitored to ensure it works well over time. This trial is currently recruiting patients, so it’s a great opportunity for those needing hip surgery to potentially benefit from a newer treatment option.

Gender

ALL

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.