E-MAX 2nd Gen Vit E Poly On BIOLOX Delta Ceramic Heads
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|
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.
E-Max liner wear rate
time frame: Change from baseline to 10 years post-operative
Patient Function and Mobility
time frame: Change from Pre-operative to 10 years post-operative
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
|Official title||E-MAX 2nd Generation Vitamin E Polyethylene On BIOLOX Delta Ceramic Heads|
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