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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03372278




Registration number
NCT03372278
Ethics application status
Date submitted
30/11/2017
Date registered
13/12/2017
Date last updated
18/10/2019

Titles & IDs
Public title
PMCF Study on the Safety and Performance of the Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty
Scientific title
Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty. A Multicenter, Prospective, Non-controlled Post Market Clinical Follow-up Study
Secondary ID [1] 0 0
CIE2011-01H
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis With Adequate Bone Quality 0 0
Inflammatory Arthritis 0 0
Osteoarthritis, Hip 0 0
Avascular Necrosis 0 0
Post-traumatic; Arthrosis 0 0
Congenital Hip Dysplasia 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients who received the Maxera Cup - Subjects in need of a total hip arthroplasty, who met the inclusion/exclusion criteria and who received the Maxera Cup.

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method
Timepoint [1] 0 0
10 years post-surgery
Secondary outcome [1] 0 0
Pain and functional performance based on the Harris Hip Score
Timepoint [1] 0 0
10 years post-surgery
Secondary outcome [2] 0 0
Pain and functional performance based on the UCLA Score
Timepoint [2] 0 0
10 years post-surgery
Secondary outcome [3] 0 0
Subject quality-of-life determined by the EQ-5D (EuroQoI) score
Timepoint [3] 0 0
10 years post-surgery
Secondary outcome [4] 0 0
X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc
Timepoint [4] 0 0
10 years post-surgery
Secondary outcome [5] 0 0
Safety based on eventual complications occurred including dislocations and revisions/removals
Timepoint [5] 0 0
10 years post-surgery

Eligibility
Key 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:

- Osteoarthritis

- Avascular necrosis (AVN)

- Inflammatory arthritis

- Rheumatoid arthritis with adequate bone quality

- Post-traumatic arthritis

- 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.

- Patient has participated in the Informed Consent process and has signed the Ethics
Committee approved informed consent.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- The patient is:

- A prisoner

- Mentally incompetent or unable to understand what participation in the study
entails.

- A known alcohol or drug abuser

- 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.

- 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Mater Hospital, Concord Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Pellenberg
Country [2] 0 0
Canada
State/province [2] 0 0
Montréal
Country [3] 0 0
Finland
State/province [3] 0 0
Jämsä
Country [4] 0 0
France
State/province [4] 0 0
Perpignan
Country [5] 0 0
Netherlands
State/province [5] 0 0
Delft
Country [6] 0 0
Spain
State/province [6] 0 0
Palma De Mallorca
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Liverpool

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Zimmer Biomet
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is a multicenter, prospective, non-controlled post market clinical follow-up
study. The objectives of this study are to confirm the safety and performance of the
commercially available Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty.
Trial website
https://clinicaltrials.gov/show/NCT03372278
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paola Vivoda
Address 0 0
Zimmer Biomet
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications