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28mm Ceramic-on-Ceramic Total Hip Replacement Study

NCT01657435 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 185

Last updated 2019-11-19

No results posted yet for this study

Summary

This study is intended to gather medium (0-5 years) and long-term (6-10 years) information regarding the performance and safety of the commercially available Ceramax™ Ceramic on Ceramic Total Hip System. This is a two-phased study consisting of a clinical follow-up phase and a clinical outcomes phase.

In Phase One (0-5 years), diagnostic, demographic and operative information will be gathered for each subject enrolled in this study. In addition, Harris Hip Evaluations, subjective evaluations and radiographs will be completed annually.

In Phase Two (6 - 10 years), a subjective outcomes questionnaire and a SF-12 Health Survey will be mailed to subjects annually.

Conditions

  • Non-inflammatory Degenerative Joint Disease
  • Osteoarthritis
  • Avascular Necrosis
  • Post-traumatic Arthritis

Interventions

DEVICE

Ceramax Acetabular System

28mm Ceramic-on-ceramic Acetabular Cup System

Sponsors & Collaborators

  • DePuy Orthopaedics

    lead INDUSTRY

Principal Investigators

  • Tammy L ODell, BS CCRC CCRA · DePuy Orthopaedics

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-01
Primary Completion
2019-09-24
Completion
2019-09-24

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT01657435 on ClinicalTrials.gov