G7 BiSpherical Acetabular Shell PMCF Study

Korábbi kezelés

• Patient institutionalized or known drug abuser or alcoholic or anyone who cannot understand what is required of them.
• Bone or musculature compromised by disease, infection, or prior implantation that cannot provide adequate support or fixation for the prosthesis.

Más betegség

• Infection, sepsis, osteomyelitis.
  • Relative exclusion criteria include:
• Uncooperative patient or patient with neurologic disorders who is incapable of following directions.
• Metabolic disorders which may impair bone formation.
• Distant foci of infections which may spread to the implant site.
• Vascular insufficiency, muscular atrophy or neuromuscular disease.
• Patient presenting any condition that would, in the judgment of the Investigator, place the patient at undue risk or interfere with the study.

Egyéb

• Absolute exclusion criteria include:
• Osteoporosis.
• Osteomalacia.
• Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
• Patient unwilling or unable to give consent, or to comply with the follow-up program.
• Patient known to be pregnant or breastfeeding.
• Patient belonging to a vulnerable population.

• Patient capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study.
• Patient aged of 18 years or more whose skeleton reached bone maturity.
• 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.
• The Biomet G7 Freedom Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to con-strained acetabular components have been considered.