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

Terminated

• Conditions: Osteoarthritis; Traumatic Arthritis; Legg-perthes Disease; Avascular Necrosis; Rheumatoid Arthritis
• Interventions: Device: E1-Hip Bearing

• Registration Number: NCT02087449
• Lead Sponsor: Zimmer Biomet

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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-03-13
• Study First Posted: 2014-03-14
• Primary Completion: 2017-12
• Study Completion: 2024-12-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
HHS score	1 year	Comparison in clinical outcomes scores between preoperative and various postoperative time points

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kyungpook National University Hospital; 🇰🇷 Daegu, Kyungsangbuk-do, Korea, Republic of