Clinical trial NCT03372278: PMCF Study on the Safety and Performance of the Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty
Official title: Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty. A Multicenter, Prospective, Non-controlled Post Market Clinical Follow-up Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Rheumatoid Arthritis With Adequate Bone Quality
Inflammatory Arthritis
Osteoarthritis, Hip
Avascular Necrosis
Post-traumatic; Arthrosis
Congenital Hip Dysplasia
Keywords: Total hip arthroplasty
Medical Device
Safety
Prothesis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2017-12-13
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from severe hip pain and disability requiring total hip arthroplasty and who meet the inclusion/exclusion criteria

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.

Detailed description: 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.

In total 250 patients will be enrolled into the study at up to 10 sites.All potential study subjects will be required to participate in the Informed Consent Process.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method
timeFrame: 10 years post-surgery
Secondary outcomes:
measure: Pain and functional performance based on the Harris Hip Score
timeFrame: 10 years post-surgery
measure: Pain and functional performance based on the UCLA Score
timeFrame: 10 years post-surgery
measure: Subject quality-of-life determined by the EQ-5D (EuroQoI) score
timeFrame: 10 years post-surgery
measure: X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc
timeFrame: 10 years post-surgery
measure: Safety based on eventual complications occurred including dislocations and revisions/removals
timeFrame: 10 years post-surgery
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: The Mater Hospital, Concord Hospital
city: Pellenberg
country: Belgium
facility: UZ Leuven
city: Montréal
country: Canada
facility: Center Maisonneuve-Rosemont Hospital
city: Jämsä
country: Finland
facility: Jokilaakson terveys oy
city: Perpignan
country: France
facility: Centre Hospitalier de Perpignan
city: Delft
country: Netherlands
facility: Reinier de Graaf Groep
city: Palma De Mallorca
country: Spain
facility: Hospital Son Llatzer
city: Liverpool
country: United Kingdom
facility: Royal Liverpool and Broadgreen University Teaching Hospitals
Study officials:
affiliation: Zimmer Biomet
name: Hassan Achakri
role: STUDY_DIRECTOR
References: