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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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In Need of a Total Hip Arthroplasty

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patient is under 65 years of age
* Patient's health status qualifies as ASA 1 or ASA 2
* Patient is willing to commit to long term follow (study duration is 10 yrs)

Exclusion Criteria

* Allergy to any materials used in hip implant
* Unwillingness to participate in long term follow-up
* Diagnosis of inflammatory arthritis
* Simultaneous bilateral total hip arthroplasty is recommended.
* Patient's health status qualifies as ASA 3 or greater.
* Patient is over the age of 65 of age

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No