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

• Conditions: In Need of a Total Hip Arthroplasty

• Registration Number: NCT01943149
• Lead Sponsor: Renovis Surgical Technologies, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-06
• Study First Submitted QC: 2013-09-11
• Study First Posted: 2013-09-16
• Study Start: 2014-01
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-26
• Last Update Posted: 2015-10-28
• Primary Completion: 2024-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
E-Max liner wear rate	Change from baseline to 10 years post-operative	This measure's purpose it to look at the longevity of our product. Radiographs will be taken at standard checkpoints over the course of 10 years. Radiographic analysis will be done to assess wear rates of the E-Max liner over the course of the 10 year study. Wear rates will then be compared to other products that have already been studied and published in hopes of finding that E-Max's wear rates are at least as good if not better than comparative products on the market.

Secondary Outcome Measures

Name	Time	Method
Patient Function and Mobility	Change from Pre-operative to 10 years post-operative	This measure will assess patient function and mobility preoperatively and compare this at standard checkpoints over 10 years post-operatively. This will be done through use of the Harris Hip Score and UCLA Functional Assessment with the hope of seeing improvement in both over the course of time.

Trial Locations

Locations (1)

Cornerstone Orthopedics; 🇺🇸 Louisville, Colorado, United States