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

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

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

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis; Rheumatoid Arthritis; Avascular Necrosis; Traumatic Arthritis; Legg-perthes Disease
• Intervention / Treatment: Device: E1-Hip Bearing

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Korea, Republic of
  • Kyungsangbuk-do
    • Daegu, Kyungsangbuk-do, Korea, Republic of, 700-721
      • Kyungpook National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Device: E1-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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Principal Investigator: Shin Yoon Kim, PHD, Kyung Pook Nat'l Univ. Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 12, 2024

Study Registration Dates

• First Submitted: March 5, 2014
• First Submitted That Met QC Criteria: March 13, 2014
• First Posted (Estimated): March 14, 2014

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathologic Processes; Joint Diseases; Femur Head Necrosis; Osteonecrosis; Arthritis; Necrosis; Legg-Calve-Perthes Disease
• Other Study ID Numbers: INT.CR.GH5.13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO