Avascular Necrosis, Legg-perthes Disease, Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
Conditions
Brief 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.
Interventions
DEVICEE1-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.
Sponsors
Zimmer Biomet
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HHS score | 1 year | Comparison in clinical outcomes scores between preoperative and various postoperative time points |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hip Functions | 6 Months | Harris Hip Score at post follow-up visit |
| EQ5D | 6 Months | Standardised instrument for use as a measure of health outcome |
| Modified University of California Los Angeles (UCLA) Activity Score | 6 Months | It asks patients to rate their activity level from 1 to 10, with 1 defined as no physical activity and 10 defined as regular participation in impact sports. The UCLA scale has demonstrated construct validity, excellent reliability, and the best completion rates. |
| Radiographic Assessment | Immediate post-op(2 - 4 Weeks) | Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop |
Countries
South Korea
Outcome results
None listed