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

Zimmer GmbH0 个研究点目标入组 35 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•- 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.

•Absolute exclusion criteria are:
•- Infection, sepsis, osteomyelitis.;Relative exclusion criteria include:
•- 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.;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.

发起方