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

Zimmer Biomet8 sites in 8 countries250 target enrollmentJanuary 2013

ConditionsRheumatoid Arthritis With Adequate Bone Quality Inflammatory Arthritis Osteoarthritis, Hip Avascular Necrosis Post-traumatic; Arthrosis Congenital Hip Dysplasia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rheumatoid Arthritis With Adequate Bone Quality
Sponsor: Zimmer Biomet
Enrollment: 250
Locations: 8
Primary Endpoint: Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method
Status: Active, not recruiting
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2013

End Date

December 2028

Last Updated

10 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Zimmer Biomet

Responsible Party

Sponsor

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.

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.

Outcomes

Primary Outcomes

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

Time Frame: 10 years post-surgery

Secondary Outcomes

Subject quality-of-life determined by the EQ-5D (EuroQoI) score(10 years post-surgery)
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)
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)