Zimmer Maxera acetabular system in total hip arthroplasty: a multi-center, prospective, non-controlled post marktet clinical follow-up study

Recruiting

• Conditions: hip osteoarthritis; hip wear; 10023213

• Registration Number: NL-OMON53064
• Lead Sponsor: Zimmer Biomet GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 25

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 G

Study & Design

• Study Type: Interventional
• Study Design: Not specified