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

NCT02087449 | Terminated DMC

• 1 other identifier: INT.CR.GH5.13
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• HHS score

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

  1 year

Secondary Outcomes (17)

• Hip Functions

  6 Months

• EQ5D

  6 Months

• Modified University of California Los Angeles (UCLA) Activity Score

  6 Months

• Radiographic Assessment

  Immediate post-op(2 - 4 Weeks)

• Hip Functions

  1 year

Study Arms (1)

E1-Hip Bearing

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

Device: E1-Hip Bearing

Interventions

E1-Hip Bearing DEVICE

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.

E1-Hip Bearing

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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,
• Osteoarthritis
• Avascular necrosis
• Legg Perthes
• Rheumatoid Arthritis
• Diastrophic variant
• Fracture of the pelvis
• Fused hip
• Slipped capital epiphysis
• Subcapital fractures
• Traumatic arthritis Patients aged over 20 Patients with limited co-morbidity - ASA I - III

You may not qualify if:

• Absolute contraindications include: infection, sepsis, and osteomyelitis
• Relative contraindications include:
• uncooperative patient or patient with neurologic disorders who are incapable of following directions,
• osteoporosis,
• metabolic disorders which may impair bone formation,
• osteomalacia,
• distant foci of infections which may spread to the implant site,
• rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and
• vascular insufficiency, muscular atrophy, or neuromuscular disease.
• pregnancy

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Kyungpook National University Hospital

Daegu, Kyungsangbuk-do, 700-721, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis; Osteonecrosis; Arthritis, Rheumatoid; Legg-Calve-Perthes Disease

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Femur Head Necrosis

Study Officials

• Shin Yoon Kim, PHD

  Kyung Pook Nat'l Univ. Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 14, 2014
• Study Start: February 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 12, 2024
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)