Overview

This trial is active, not recruiting.

Conditions osteoarthritis, avascular necrosis, traumatic arthritis, rheumatoid arthritis, legg-perthes disease
Treatment e1-hip bearing
Sponsor Biomet, Inc.
Start date February 2013
End date June 2017
Trial size 100 participants
Trial identifier NCT02087449, INT.CR.GH5.13

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
E1-Hip Bearing, Evaluate E1 Wear, Clinical Performance of E1 Liner in THA in Korean Patient Population
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.

Primary Outcomes

Measure
HHS score
time frame: 1 year

Secondary Outcomes

Measure
Hip Functions
time frame: 6 Months
EQ5D
time frame: 6 Months
Modified University of California Los Angeles (UCLA) Activity Score
time frame: 6 Months
Radiographic Assessment
time frame: Immediate post-op(2 - 4 Weeks)
Hip Functions
time frame: 1 year
Hip Functions
time frame: 2 years
Hip Functions
time frame: 5 years
EQ5D
time frame: 1 year
EQ5D
time frame: 2 years
EQ5D
time frame: 5 years
Modified University of California Los Angeles (UCLA) Activity Score
time frame: 1 year
Modified University of California Los Angeles (UCLA) Activity Score
time frame: 2 years
Modified University of California Los Angeles (UCLA) Activity Score
time frame: 5 years
Radiographic Assessment
time frame: 6 Months
Radiographic Assessment
time frame: 1 year
Radiographic Assessment
time frame: 2 years
Radiographic Assessment
time frame: 5 years

Eligibility Criteria

Male or female participants from 20 years up to 65 years old.

Inclusion Criteria: Patients will be included in this study if they received Ringloc acetabular system with E1 liner per the approved indications for use by KFDA in Korea. Specifically, 1. Osteoarthritis 2. Avascular necrosis 3. Legg Perthes 4. Rheumatoid Arthritis 5. Diastrophic variant 6. Fracture of the pelvis 7. Fused hip 8. Slipped capital epiphysis 9. Subcapital fractures 10. Traumatic arthritis Patients aged over 20 Patients with limited co-morbidity - ASA I - III Exclusion Criteria: Exclusion Criteria for this study should comply with the stated contraindications on package inserts of Ringloc acetabular system with E1 liner. These indications are stated below: Absolute contraindications include: infection, sepsis, and osteomyelitis Relative contraindications include: 1. uncooperative patient or patient with neurologic disorders who are incapable of following directions, 2. osteoporosis, 3. metabolic disorders which may impair bone formation, 4. osteomalacia, 5. distant foci of infections which may spread to the implant site, 6. rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and 7. vascular insufficiency, muscular atrophy, or neuromuscular disease. 8. pregnancy

Additional Information

Official title A Prospective Multi-center Study on E1 Acetabular Liner in THA
Principal investigator Shin Yoon Kim, PHD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Biomet, Inc..