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

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03372278
• Other study ID #: CIE2011-01H
• Status: Active, not recruiting
• Start date: January 2013
• Est. completion date: December 2028

Study information

• Verified date: March 2024
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: December 2028
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Avascular Necrosis
• Congenital Hip Dysplasia
• Developmental Dysplasia of the Hip
• Hip Dislocation
• Hip Dislocation, Congenital
• Inflammatory Arthritis
• Necrosis
• Osteoarthritis
• Osteoarthritis, Hip
• Post-traumatic; Arthrosis
• Rheumatoid Arthritis With Adequate Bone Quality

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

Australia,  Belgium,  Canada,  Finland,  France,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method		10 years post-surgery
Secondary	Pain and functional performance based on the Harris Hip Score		10 years post-surgery
Secondary	Pain and functional performance based on the UCLA Score		10 years post-surgery
Secondary	Subject quality-of-life determined by the EQ-5D (EuroQoI) score		10 years post-surgery
Secondary	X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc		10 years post-surgery
Secondary	Safety based on eventual complications occurred including dislocations and revisions/removals		10 years post-surgery