NCT02087449

Evaluate E1 Wear, Clinical Performance of E1 Liner in THA in Korean Patient Population

A Prospective Multi-center Study on E1 Acetabular Liner in THA

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Evaluate E1 wear, Clinical Performance of E1 liner in THA in Korean Patient Population

Detailed description

Total hip arthroplasty (THA) is one of the most successful surgical procedures in general. Yet, a few problems remain unsolved, and aseptic loosening is probably the most important of them. One of the main reasons for aseptic loosening in THA is the foreign body reaction caused by the wear particles. Since the late 1990s, the orthopedic industry has been developing highly crosslinked polyethylene (HXLPE) materials to capitalize on the increased wear resistance. In 2007, E1® Antioxidant Infused Technology was developed to reduce wear rate, maintain mechanical properties and prevent oxidative degradation.

Conditions

• Osteoarthritis
• Avascular Necrosis
• Traumatic Arthritis
• Rheumatoid Arthritis
• Legg-perthes Disease

Interventions

Type	Name	Description
DEVICE	E1-Hip Bearing	Vitamin E doping of highly cross-linked polyethylene is a proposed method for insuring long-term oxidative stability of highly cross-linked ultra-high molecular weight polyethylene for use in total joint arthroplasty. In vitro research and development studies have shown that this material has improved wear performance, retention of mechanical properties, and a high resistance to oxidation due to the anti-oxidative properties of Vitamin E.

Timeline

• Start date: 2013-02-01
• Primary completion: 2017-12-01
• Completion: 2024-12-12
• First posted: 2014-03-14
• Last updated: 2025-04-02

Locations

1 site across 1 country: South Korea