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Maxera Large Cups - Canada

NCT04348968 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2021-04-05

No results posted yet for this study

Summary

This study is monocentric, retrospective and prospective, non-controlled, consecutive series Post-Market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Largest Zimmer® Maxera™ Cup (Implants and Instrumentation)

Conditions

  • Degenerative Joint Disease of Hip
  • Osteoarthritis, Hip
  • Avascular Necrosis of Hip
  • Post-Traumatic Osteoarthritis of Hip
  • Congenital Dysplasia of the Hip
  • Joint Diseases
  • Rheumatoid Arthritis of Hip

Interventions

DEVICE

Total hip arthroplasty

The THA surgical procedure involves replacing the head of the femur and acetabulum or socket with an artificial prosthesis. This system is composed of a femoral stem that is inserted into the femoral canal, a ball that attaches to the femoral stem, and an acetabular component or shell that replaces the acetabulum. In this study, the acetabular component is the Zimmer Maxera Cup, which is a monoblock construct consisting of a pre-assembled shell and liner. The ceramic liner articulates with a ceramic femoral head for a ceramic-on-ceramic large diameter head articulation. The Maxera Cup is intended for single use only and is designed for reconstruction of the hip joint for conditions described in the inclusion and exclusion section of this protocol.

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Paola Vivoda · Zimmer Biomet

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2021-03-25
Completion
2021-03-25

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04348968 on ClinicalTrials.gov