Overview

This trial is active, not recruiting.

Condition in need of a total hip arthroplasty
Sponsor Renovis Surgical Technologies, Inc.
Start date January 2014
End date January 2024
Trial size 50 participants
Trial identifier NCT01943149, HIP-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
E-Max liner wear rate
time frame: Change from baseline to 10 years post-operative

Secondary Outcomes

Measure
Patient Function and Mobility
time frame: Change from Pre-operative to 10 years post-operative

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title E-MAX 2nd Generation Vitamin E Polyethylene On BIOLOX Delta Ceramic Heads
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Renovis Surgical Technologies, Inc..