Evaluate E1 Wear, Clinical Performance of E1 Liner in THA in Korean Patient Population (E1Hip)

Zimmer Biomet

Status: Terminated

Conditions: Traumatic Arthritis; Osteoarthritis; Legg-perthes Disease; Avascular Necrosis; Rheumatoid Arthritis

Treatments: Device: E1-Hip Bearing

Study type: Observational

Funder types: Industry

Identifiers

NCT02087449

INT.CR.GH5.13

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

E1-Hip Bearing

Description:

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

Treatment:

Device: E1-Hip Bearing