Clinical trial NCT02087449: Evaluate E1 Wear, Clinical Performance of E1 Liner in THA in Korean Patient Population
Official title: A Prospective Multi-center Study on E1 Acetabular Liner in THA
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoarthritis
Avascular Necrosis
Traumatic Arthritis
Rheumatoid Arthritis
Legg-perthes Disease
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2014-03-14
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are treated to have Total Hip Arthroplasty at Daegu Catholic University Hospital, Kyung Pook Nat'l Univ. Hospital, Yeonsei Univ. College of Medicine, and Gangdong Kyung Hee Univ. Hospital

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.

Eligibility criteria: 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

Primary outcomes:
measure: HHS score
timeFrame: 1 year
Secondary outcomes:
measure: Hip Functions
timeFrame: 6 Months
measure: EQ5D
timeFrame: 6 Months
measure: Modified University of California Los Angeles (UCLA) Activity Score
timeFrame: 6 Months
measure: Radiographic Assessment
timeFrame: Immediate post-op(2 - 4 Weeks)
measure: Hip Functions
timeFrame: 1 year
measure: Hip Functions
timeFrame: 2 years
measure: Hip Functions
timeFrame: 5 years
measure: EQ5D
timeFrame: 1 year
measure: EQ5D
timeFrame: 2 years
measure: EQ5D
timeFrame: 5 years
measure: Modified University of California Los Angeles (UCLA) Activity Score
timeFrame: 1 year
measure: Modified University of California Los Angeles (UCLA) Activity Score
timeFrame: 2 years
measure: Modified University of California Los Angeles (UCLA) Activity Score
timeFrame: 5 years
measure: Radiographic Assessment
timeFrame: 6 Months
measure: Radiographic Assessment
timeFrame: 1 year
measure: Radiographic Assessment
timeFrame: 2 years
measure: Radiographic Assessment
timeFrame: 5 years
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
state: Kyungsangbuk-do
Study officials:
affiliation: Kyung Pook Nat'l Univ. Hospital
name: Shin Yoon Kim, PHD
role: PRINCIPAL_INVESTIGATOR
References: