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

N/ATerminatedNCT02087449

Zimmer Biomet100 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Osteoarthritis Avascular Necrosis Traumatic Arthritis Rheumatoid Arthritis Legg-perthes Disease

Interventions

E1-Hip BearingDEVICE

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Kyungpook National University Hospital

Daegu, Kyungsangbuk-do, South Korea

Outcomes

Primary Outcomes

HHS score

Comparison in clinical outcomes scores between preoperative and various postoperative time points

Time frame: 1 year

Secondary Outcomes

Hip Functions

Harris Hip Score at post follow-up visit

Time frame: 6 Months

EQ5D

Standardised instrument for use as a measure of health outcome

Time frame: 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.

Time frame: 6 Months

Radiographic Assessment

Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop

Time frame: Immediate post-op(2 - 4 Weeks)

Hip Functions

Harris Hip Score at post follow-up visit

Time frame: 1 year

Hip Functions

Harris Hip Score at post follow-up visit

Time frame: 2 years

Hip Functions

Harris Hip Score at post follow-up visit

Time frame: 5 years

Data from ClinicalTrials.gov

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