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

Study Overview
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Brief Summary
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Evaluate E1 wear, Clinical Performance of E1 liner in THA in Korean Patient Population

Detailed Description
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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.

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

Conditions
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Avascular Necrosis, Osteoarthritis, Traumatic Arthritis, Rheumatoid Arthritis, Legg-perthes Disease

Intervention / Treatment
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* Device: E1-Hip Bearing


Participation Criteria
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Eligibility Criteria
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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, Osteoarthritis Avascular necrosis Legg Perthes Rheumatoid Arthritis Diastrophic variant Fracture of the pelvis Fused hip Slipped capital epiphysis Subcapital fractures 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: uncooperative patient or patient with neurologic disorders who are incapable of following directions, osteoporosis, metabolic disorders which may impair bone formation, osteomalacia, distant foci of infections which may spread to the implant site, rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and vascular insufficiency, muscular atrophy, or neuromuscular disease. pregnancy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| E1-Hip Bearing<br>E1-Hip Bearing, Evaluate E1 Wear, Clinical Performance of E1 Liner in THA in Korean Patient Population | Device: E1-Hip Bearing<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HHS score | Comparison in clinical outcomes scores between preoperative and various postoperative time points | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip Functions | Harris Hip Score at post follow-up visit | 6 Months | 
| EQ5D | Standardised instrument for use as a measure of health outcome | 6 Months | 
| Modified University of California Los Angeles (UCLA) Activity Score | 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. | 6 Months | 
| Radiographic Assessment | Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop | Immediate post-op(2 - 4 Weeks) | 
| Hip Functions | Harris Hip Score at post follow-up visit | 1 year | 
| Hip Functions | Harris Hip Score at post follow-up visit | 2 years | 
| Hip Functions | Harris Hip Score at post follow-up visit | 5 years | 
| EQ5D | Standardised instrument for use as a measure of health outcome | 1 year | 
| EQ5D | Standardised instrument for use as a measure of health outcome | 2 years | 
| EQ5D | Standardised instrument for use as a measure of health outcome | 5 years | 
| Modified University of California Los Angeles (UCLA) Activity Score | 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. | 1 year | 
| Modified University of California Los Angeles (UCLA) Activity Score | 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. | 2 years | 
| Modified University of California Los Angeles (UCLA) Activity Score | 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. | 5 years | 
| Radiographic Assessment | Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop | 6 Months | 
| Radiographic Assessment | Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop | 1 year | 
| Radiographic Assessment | Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop | 2 years | 
| Radiographic Assessment | Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop | 5 years |