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

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

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 Overview

• Status: Active, not recruiting
• Conditions: In Need of a Total Hip Arthroplasty

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Louisville, Colorado, United States, 80027
      • Cornerstone Orthopedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be patients of specified doctors specialized in orthopedic medicine with a specialty in joint replacement.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
E-Max liner wear rate	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.	Change from baseline to 10 years post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Function and Mobility	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.	Change from Pre-operative to 10 years post-operative

Collaborators and Investigators

• Sponsor: Renovis Surgical Technologies, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: September 6, 2013
• First Submitted That Met QC Criteria: September 11, 2013
• First Posted (Estimate): September 16, 2013

Study Record Updates

• Last Update Posted (Estimate): October 28, 2015
• Last Update Submitted That Met QC Criteria: October 26, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: HIP-001