The objectives of this study are to confirm the safety and performance of the Zimmer Maxera Cup mated with either a BIOLOX delta or BIOLOX OPTION femoral head when used in primary total hip arthroplasty.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is defined as the implant survival at 10 years.
Secondary outcome
Assessment of Outcome Measures:
• Safety (adverse events)
• Performance (implant survival, overall pain and functional performances,
subject quality-of-life and radiographic parameters)
Background summary
Total hip arthroplasty (THA) is a medical procedure where an arthritic,
degenerative or fractured total hip joint is replaced with a prosthetic device.
Since the inception of modern THA in 1961, THA has become a widely accepted
orthopedic procedure.
Over the last several decades, technological advancements have been made to
improve implant strength, fixation, and wear properties of implant surfaces in
THA systems. Due to the friction and wear properties in other systems,
researchers began looking at ceramic on ceramic (COC) systems first introduced
in 1970. Early outcomes associated with COC systems were mixed and failures
were attributed to poor implant design and material quality of alumina ceramic.
Since its original introduction, substantial improvements have been made to
alumina ceramic. It has been a standardized material since 1984 (International
Standard Organization, ISO 6474) and its mechanical properties are largely
dependent on grain size, purity, porosity, and grain distribution. BIOLOX
forte1, the third generation of alumina ceramics, is roughly three times as
hard as metal and thus much more scratch resistant. The wettability of alumina,
or relative degree to which a fluid will spread or coat a solid surface in
relation to its surface energy, is higher than polymers and metals which allows
water to be adsorbed with high bond strength and proteins to cover ceramic
surfaces with a
monolayer (i.e. synovial fluid).
While the tribologic properties of alumina are excellent, there have been many
concerns over the past decades regarding orientation and wear of the ceramic
couple, noise during articulation and eventual fracture of the ceramic
acetabular liner.
Although implant design and correct implant positioning have been a concern in
COC systems, they have some advantages over other alternate bearing systems.
COC systems are accepted as the coupling that produces the lowest wear, and
early to midterm reports demonstrate less osteolysis.
Additionally, dislocation has been reported as one of the most common reasons
for early revision in primary THA. Large-diameter femoral heads theoretically
can reduce dislocation risk.
Study objective
The objectives of this study are to confirm the safety and performance of the
Zimmer Maxera Cup mated with either a BIOLOX delta or BIOLOX OPTION femoral
head when used in primary total hip arthroplasty.
Study design
A multi-centre, prospective, non-controlled post-market clinical follow-up
study.
Intervention
The Zimmer Maxera Cup mated with either a BIOLOX delta or BIOLOX OPTION femoral
head used in primary total hip arthroplasty.
Study burden and risks
The risks associated with the use of the Zimmer Maxera Acetabular System are
similar to those with the use of other standard ceramic on ceramic hip systems
when used for the same clinical indication. These risks are categorized as
those anticipated to be related to general surgical risks, total hip
arthroplasty risks, or those potential risks associated with the
investigational system. Unanticipated adverse events may occur as well. A list
of anticipated adverse device effects (ADE) can be found in the IFU of the
system, a copy of which can be found in the Investigator Binder.
Sulzerallee 8
Winterthur CH-8404
CH
Sulzerallee 8
Winterthur CH-8404
CH
Listed location countries
Age
Inclusion criteria
• Patient is 18 to 75 years of age, inclusive.
• Patient is skeletally mature.
• Patient qualifies for primary unilateral or simultaneous bilateral total hip
arthroplasty
(THA) based on physical exam and medical history including at least one of the
following:
o Osteoarthritis
o Avascular necrosis (AVN)
o Inflammatory arthritis
o Rheumatoid arthritis with adequate bone quality
o Post-traumatic arthritis
o Congenital hip dysplasia.
• Patient has no history of previous total hip replacement or arthrodesis of
the affected hip
joint(s).
• Patient has a Harris Hip Score <70 in the affected hip and a Harris Hip pain
rating of
moderate, marked, or disabled.
• Patient is willing and able to provide written informed consent.
• Patient is willing and able to cooperate in the required post-operative
therapy.
• Patient is willing and able to complete scheduled follow-up evaluations as
described in
the Informed Consent.
Exclusion criteria
• The patient is:
o A prisoner
o Mentally incompetent or unable to understand what participation in the study
entails.
o A known alcohol or drug abuser
o Anticipated to be non-compliant
• The patient has a neuromuscular disorder, vascular disorder or other
condition that
could contribute to prosthesis instability, prosthesis fixation failure, or
complications in
postoperative care.
• The patient has local bone tumors and/or cysts in the portion of bone to be
retained in
the operative hip that could inhibit implant fixation.
• The patient has insufficient bone stock or poor bone quality to fix the
component. Insufficient
bone stock exists in the presence of metabolic bone disease (i.e. osteoporosis),
cancer, and radiation. Note: Dual Energy X-ray Absorptiometry (DEXA) may be
required
to assess the presence of adequate bone stock.
• The patient has rapid disease progression as obvious by joint destruction or
bone absorption
seen on x-ray.
• The patient has osteoradionecrosis in the affected hip.
• The patient has a neuromuscular condition in the ipsilateral or contralateral
limb which
affects lower limb function.
• The patient has loss of abductor musculature in the affected hip.
• The patient has a vascular (large and small vessel disease) insufficiency.
• The patient has had previous prosthetic hip replacement device (any type,
including
surface replacement arthroplasty, endoprosthesis, etc.) in the joint to be
operated.
• The patient has had previous girdlestone procedure (resection arthroplasty)
or surgical
fusion of the hip to be operated.
Emilie Rohmer, 11.05.2012, Rev. 0 page 17 of 57
F WT.30.0108-1 Effective Date 21. Okt. 2010
Clinical Investigation Plan Revision 0
• The patient has an acute femoral neck fracture in the operative hip.
• The patient has had a procedure on the operative hip in the last 6 months
(i.e. arthroscopy,
ORIF femoral neck fracture, etc).
• The patient has undergone a total hip replacement, endoprosthesis, or surface
arthroplasty
of the contralateral (opposite side) hip within the past 6 months regardless of
whether the previous hip was enrolled in this clinical study.
• The patient has a moderate to severe limb length discrepancy greater than 3.2
cm.
• The patient has an active, old or remote infection in or about the affected
hip joint or an
infection distant from the hip joint that may spread to the hip hematogenously.
• The patient has poor skin coverage around the affected hip joint.
• The patient has a diagnosed systemic disease that could affect his/her safety
or the
study outcome.
• The patient is currently receiving, or within the past three months, has
received any drug
known to potentially interfere with bone/soft tissue healing (e.g. long-term
chronic systemic
steroid or inhaler steroid therapy).
• The patient has received an investigational drug or device within the
previous 6 months.
• The patient is known to be pregnant.
• The patient is unwilling or unable to give informed consent, or to comply
with the followup
program.
• The patient is known to have a highly communicable disease that may limit
follow-up.
• The patient has a known sensitivity or allergic reaction to one or more of
the implanted
materials which include metal and ceramic.
• The patient is Grade III obese with a Body Mass Index (BMI) > 35.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 |
|---|---|
| CCMO | NL41295.098.12 |