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E-MAX 2nd Gen Vit E Poly On BIOLOX Delta Ceramic Heads

NCT01943149 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2015-10-28

No results posted yet for this study

Summary

The purpose of this study is to monitor outcomes of total hip arthroplasties performed with E-MAX polyethylene and BIOLOX Delta Ceramic head. Polyethylene has been used as a bearing surface in total joint replacements for half of a century. Radiation, the most common form of sterilization, unfortunately it results in the creation of free radicals (atoms or molecules that cause chemical reactions with other substances) within the materials which cause the breakdown of the polyethylene. Second generation antioxidant polyethylene, Renovis E-MAX, mechanically blends in Vitamin E as an antioxidant. This helps eliminate free radicals while maintaining mechanical strength. The theory is that E-MAX will be a safe and long lasting bearing surface in total hip arthroplasty that meets or exceeds current wear rates after being placed in a patient.

Conditions

  • In Need of a Total Hip Arthroplasty

Sponsors & Collaborators

  • Renovis Surgical Technologies, Inc.

    lead INDUSTRY

Eligibility

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

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2024-01-31

Countries

  • United States

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 NCT01943149 on ClinicalTrials.gov