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PMCF Study on the Safety and Performance of the Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty | Clinical Trials | Clareo Health

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

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

NCT03372278•Zimmer Biomet

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

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.
+4 more criteria

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.
+19 more criteria

Locations (8)

The Mater Hospital, Concord Hospital

Sydney, Australia

UZ Leuven

Pellenberg, Belgium

Center Maisonneuve-Rosemont Hospital

Montreal, Canada

Jokilaakson terveys oy

Jämsä, Finland

Centre Hospitalier de Perpignan

Perpignan, France

Reinier de Graaf Groep

Delft, Netherlands

Hospital Son Llatzer

Palma de Mallorca, Spain

Royal Liverpool and Broadgreen University Teaching Hospitals

Liverpool, United Kingdom

Key Dates

Start Date

January 1, 2013

Primary Completion Date

January 1, 2027

Completion Date

December 1, 2028

Last Updated

June 15, 2025

Enrollment

250

ACTUAL participants

Conditions

Rheumatoid Arthritis With Adequate Bone QualityInflammatory ArthritisOsteoarthritis, HipAvascular NecrosisPost-traumatic; ArthrosisCongenital Hip Dysplasia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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