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

NCT03372278 | Active Not Recruiting

• 1 other identifier: CIE2011-01H
• Study Type: observational
• Target: 250
• Locations: 8 countries
• Sites: 8

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.

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

Outcome Measures

Primary Outcomes (1)

• Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method

  10 years post-surgery

Secondary Outcomes (5)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (8)

The Mater Hospital, Concord Hospital

Sydney, Australia

Location

UZ Leuven

Pellenberg, Belgium

Location

Center Maisonneuve-Rosemont Hospital

Montreal, Canada

Location

Jokilaakson terveys oy

Jämsä, Finland

Location

Centre Hospitalier de Perpignan

Perpignan, France

Location

Reinier de Graaf Groep

Delft, Netherlands

Location

Hospital Son Llatzer

Palma de Mallorca, Spain

Location

Royal Liverpool and Broadgreen University Teaching Hospitals

Liverpool, United Kingdom

Location

MeSH Terms

Conditions

Arthritis; Osteoarthritis, Hip; Osteonecrosis; Osteoarthritis; Hip Dislocation, Congenital

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Hassan Achakri

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 13, 2017
• Study Start: January 1, 2013
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

FI (1); AU (1); CA (1); NL (1); FR (1); ES (1); GB (1); BE (1)