Prospective Observational Multicenter Evaluation of the Use of the G7 BiSpherical Shell - G7 PMCS study

Zimmer GmbH0 sites35 target enrollmentStarted: TBDLast updated: April 15, 2024

Conditions

Trial Snapshot

No summary available.

•- 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.
•- Patients aged of 18 years or more whose skeleton reached bone maturity.
•- Noninflammatory degenerative joint disease, including osteoarthritis and avascular
•- 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.;Inclusion criteria specific for patients receiving the G7 BiSpherical Shell with the Freedom
•Constrained Liner:
•- 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 constrained
•acetabular components have been considered.

•- Infection, sepsis, osteomyelitis.
•- Uncooperative patient or patient with neurologic disorders who is incapable of
•following directions.
•- Osteoporosis.
•- Metabolic disorders which may impair bone formation.
•- Osteomalacia.
•- Distant foci of infections which may spread to the implant site.
•- Rapid joint destruction, marked bone loss or bone resorption apparent on
•roentgenogram.
•- Vascular insufficiency, muscular atrophy, neuromuscular disease.
•- Patient unwilling or unable to give consent, or to comply with the follow-up program
•- Patient known to be pregnant or breastfeeding.
•- Patient presenting any condition that would, in the judgment of the Investigator,
•place the patient at undue risk or interfere with the study.
•- Patient institutionalized or known drug abuser or alcoholic or anyone who cannot
•understand what is required of them.
•- Patient belonging to a vulnerable population: individual whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate. ;Exclusion criteria specific for patients receiving the G7 BiSpherical Shell with the G7
•Freedom Constrained Liner:
•- Bone or musculature compromised by disease, infection, or prior implantation that
•cannot provide adequate support or fixation for the prosthesis.

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