The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Acetabular Shells when used with the Vivacit-E and Longevity HXLPE liners and instrumentation in primary and revision total hip…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is defined by the survival of the implant system at 10
years which is based on removal or intended removal of the study device and
will be determined using Kaplan Meier method. The safety of the system will be
assessed by monitoring the frequency and incidence of adverse events. Relation
of the events to implant, instrumentation and/or procedure should be specified.
Secondary outcome
The secondary endpoint is defined by the functional performance and clinical
benefits of the study device and is assessed by:
- Pain and functional performance will be measured by the Modified Harris Hip
Score, and Physical Exam (up to 5 years), and the Oxford Hip Score (up to 10
years);
- Subject quality-of-life will be measured by the EQ-5D-5L (up to 10 years);
- Radiographs will be evaluated (up to 5 years) for radiolucency, osteolysis,
atrophy, hypertrophy, component migration, device fracture, heterotopic
ossification, etc.
Background summary
Degenerative diseases or trauma of the hip can cause pain and disability. When
conservative treatments like steroids and/or pain-medication have failed, a hip
replacement can be performed as an alternative treatment. This is a surgical
procedure, during which the affected joint is replaced by an artificial hip
implant (prosthesis). There are many different implants available, one is
called the G7 Acetabular System from Zimmer Biomet. The implant is available in
different sizes, which allows the investigator to find the right size for your
anatomy. If you decide to take part in the study, you will help the
investigator, as well as Zimmer Biomet, to provide the scientific basis for a
continuous improvement in the treatment of patients with degenerative diseases
or trauma of the hip.
Study objective
The main objectives of this study are to confirm the long-term safety,
performance, and clinical benefits of the G7 Acetabular Shells when used with
the Vivacit-E and Longevity HXLPE liners and instrumentation in primary and
revision total hip arthroplasty:
The primary endpoint is defined by the survival of the implant system at 10
years, which is based on removal or intended removal of the study device and
will be determined using Kaplan Meier method. The safety of the system will be
assessed by monitoring the frequency and incidence of adverse events. Relation
of the events to implant, instrumentation and/or procedure should be specified.
The secondary endpoints are the assessment of performance and clinical benefits
by recording patient-reported clinical outcomes measures (PROMs) as well as
radiographic outcomes (if available).
Study design
Global, Multicenter, Prospective, Non-randomized, Consecutive series of
patients, Dual cohort study
Study burden and risks
In this study, patients do not experience any additional burden and / or risk.
The only risk, is the same risks that patients receive also with regular care.
Risks such as the surgical procedure, postoperative infections and loosening of
the prosthesis can occur in both study contexts and regular care. Patients
return at the same check-up times with questionnaires and X-rays, both in the
study and in regular care.
Zaehlerweg 4
Zug 6300
CH
Zaehlerweg 4
Zug 6300
CH
Listed location countries
Age
Inclusion criteria
- Patient must be a legal adult who has reached full skeletal maturity;
- Patient must be treated for one of the following indications;
o Noninflammatory degenerative joint disease including osteoarthritis and
avascular necrosis;
o Rheumatoid arthritis;
o Correction of functional deformity;
o Treatment of non-union, femoral neck fracture and trochanteric fractures of
the proximal femur with head involvement, unmanageable by other techniques;
o Revision procedures where other treatment or devices have failed
- Patient must be able and willing to complete the protocol required follow-up
visits;
- Patient must be able and willing to sign the IRB/EC approved informed
consent.
Exclusion criteria
- Patient presents with osteoporosis, which in the opinion of the Principal
Investigator, may limit the subject*s ability to support total hip arthroplasty
using the study device;
- Patient has a metabolic disorder that may impair bone formation;
- Patient has osteomalacia;
- Patient has distant foci of infections which may spread to the implant site
or patient with infection, sepsis or osteomyelitis;
- Patient has rapid joint destruction, marked bone loss or bone resorption
apparent on roentgenogram;
- Patient has a vascular insufficiency, muscular atrophy, or neuromuscular
disease;
- Patient is a current alcohol or drug abuser;
- Uncooperative patient or patient with neurologic disorders who is incapable
or unwilling to follow directions;
- Patient is pregnant.
Design
Recruitment
Medical products/devices used
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 | NCT03456622 |
| CCMO | NL76141.096.21 |