Status:
ACTIVE_NOT_RECRUITING
G7 BiSpherical Acetabular Shell PMCF Study
Lead Sponsor:
Zimmer Biomet
Conditions:
Rheumatoid Arthritis
Osteoarthritis
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available G7 BiSpherical Acetabular Shell.
Detailed Description
The G7 BiSpherical Acetabular Shell belongs to the G7 multi-bearing platform. It was developed to provide an additional surgical option for patients in need of a total hip replacement. The aim of the ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 10 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2031
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03266874
Start Date
December 10 2017
End Date
December 1 2031
Last Update
June 25 2025
Active Locations (5)
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1
Cabinet du Dr. Miazzolo
Perpignan, France, 66000
2
Orthopädische Chirurgie Müchen OCM
Munich, Bavaria, Germany, 81369
3
Herzogin Elisabeth Hospital
Braunschweig, Lower Saxony, Germany, 38124
4
Reinier de Graaf Groep
Delft, Netherlands