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

Status unconfirmed

Conditions studied: In Need of a Total Hip Arthroplasty

In brief

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.

Key facts

Study ID

NCT01943149

Run by

Renovis Surgical Technologies, Inc.

People needed

50

Starts

2014-01-01

Last updated by the study team

2015-10-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Cornerstone Orthopedics — Louisville, Colorado, United States

Full record on ClinicalTrials.gov

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