This study is a PMCF study to fulfill the post-market surveillance obligations according to Medical Device Directive and MEDDEV 2.12-2. The data collected from this study will serve the purpose of confirming safety and performance of the G7…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Implant survivorship: assessed with the Kaplan-Meier method according to the
implant revisions.
Secondary outcome
Clinical efficacy: Pain and functional performance will be measured using the
Harris Hip Score.
In addition, performance will be evaluated based on the Oxford Hip Score and
evaluation of X-rays. The assessment of safety will be evaluated by monitoring
the frequency and incidence of adverse device effects in investigational
subjects.
Background summary
The Zimmer Biomet 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 G7
BiSpherical Acetabular Shell is to increase hip function while reducing pain.
This study is a PMCF study to fulfill the post-market surveillance obligations
according to Medical Device Directive and MEDDEV 2.12-2.
Study objective
This study is a PMCF study to fulfill the post-market surveillance obligations
according to Medical Device Directive and MEDDEV 2.12-2. The data collected
from this study will serve the purpose of confirming safety and performance of
the G7 BiSpherical Acetabular Shell.
Study design
A multicenter, prospective, non-randomized, non-controlled post market
surveillance study involving orthopedic surgeons skilled in hip arthroplasty
procedures.
Intervention
Implantation of the G7 bispherical acetabular shell
Study burden and risks
There are no anticipated risks specific to study participation other than the
potential loss of confidentiality. There are no experimental procedures in this
study, and participation in this study is not anticipated to affect the medical
treatment of enrolled patients.
When used in accordance with product labeling, the risks associated with the
use of G7 BiSpherical Acetabular Shell are similar to those of standard
acetabular cups used for the same clinical indication or purpose.
Sulzerallee 8
Winterthur CH-8404
CH
Sulzerallee 8
Winterthur CH-8404
CH
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03266874 |
| CCMO | NL64657.098.18 |