Prospective Observational Multicenter Evaluation of the Use of the G7 BiSpherical Shell

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 35

Inclusion Criteria

- 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
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.;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.

Exclusion Criteria

- 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Implant survivorship: assessed with the Kaplan-Meier method according to the<br /><br>implant revisions.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p> Clinical efficacy: Pain and functional performance will be measured using the<br /><br>Harris Hip Score.<br /><br>In addition, performance will be evaluated based on the Oxford Hip Score and<br /><br>evaluation of X-rays. The assessment of safety will be evaluated by monitoring<br /><br>the frequency and incidence of adverse device effects in investigational<br /><br>subjects. </p><br>