Clinical Trials in the Netherlands / NCT03266874
Active, not recruiting Observational

G7 BiSpherical Acetabular Shell PMCF Study

NCT03266874 · tracked via the Priya Life Science Netherlands tracker
Phase
Observational
Started
2017-12-10
Last updated
2025-06-25

Condition(s) studied

Rheumatoid ArthritisOsteoarthritisNoninflammatory Degenerative Joint DiseaseAvascular NecrosisCorrection of Functional DeformityNon-Union FractureFemoral Neck FracturesTrochanteric Fractures

Study summary

The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available G7 BiSpherical Acetabular Shell.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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. * 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. Inclusion criteria specific for patients receiving the G7 BiSpherical Shell with the G7 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 con-strained acetabular components have been considered. Exclusion Criteria: Absolute exclusion criteria include: * 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 or 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.

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Cabinet du Dr. Miazzolo Perpignan France
Orthopädische Chirurgie Müchen OCM Munich Bavaria
Herzogin Elisabeth Hospital Braunschweig Lower Saxony
Reinier de Graaf Groep Delft Netherlands
Orthoprax AG Bern Switzerland

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03266874 on ClinicalTrials.gov ↗ ← All trials in the Netherlands