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Not listed No phase listed Observational

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

ClinicalTrials.gov ID: NCT01943149

Public ClinicalTrials.gov record NCT01943149. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 7, 2026, 10:22 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

E-MAX 2nd Generation Vitamin E Polyethylene On BIOLOX Delta Ceramic Heads

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01943149
Recruitment status
Not listed
Study type
Observational
Phase
Not listed
Enrollment
50 participants

Conditions and interventions

Interventions

Not listed

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2013
Primary completion
Dec 31, 2023
Completion
Not listed
Last update posted
Oct 27, 2015

Started 2014

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Cornerstone Orthopedics Louisville Colorado 80027

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01943149, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 27, 2015 · Synced Sep 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01943149 live on ClinicalTrials.gov.

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