PMCF Study on the Safety and Performance of the Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty

Sponsor

Zimmer Biomet (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03372278

Collaborator

(none)

250

Enrollment

Locations

191

Anticipated Duration (Months)

31.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis With Adequate Bone Quality Inflammatory Arthritis Osteoarthritis, Hip Avascular Necrosis Post-traumatic; Arthrosis Congenital Hip Dysplasia

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.

Study Design

Study Type:

Observational

Actual Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty. A Multicenter, Prospective, Non-controlled Post Market Clinical Follow-up Study

Actual Study Start Date :

Jan 1, 2013

Anticipated Primary Completion Date :

Jan 1, 2027

Anticipated Study Completion Date :

Dec 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method [10 years post-surgery]

Secondary Outcome Measures

Pain and functional performance based on the Harris Hip Score [10 years post-surgery]
Pain and functional performance based on the UCLA Score [10 years post-surgery]
Subject quality-of-life determined by the EQ-5D (EuroQoI) score [10 years post-surgery]
X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc [10 years post-surgery]
Safety based on eventual complications occurred including dislocations and revisions/removals [10 years post-surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country
1	The Mater Hospital, Concord Hospital	Sydney	Australia
2	UZ Leuven	Pellenberg	Belgium
3	Center Maisonneuve-Rosemont Hospital	Montréal	Canada
4	Jokilaakson terveys oy	Jämsä	Finland
5	Centre Hospitalier de Perpignan	Perpignan	France
6	Reinier de Graaf Groep	Delft	Netherlands
7	Hospital Son Llatzer	Palma De Mallorca	Spain
8	Royal Liverpool and Broadgreen University Teaching Hospitals	Liverpool	United Kingdom