An observational study in Osteoarthritis, Avascular Necrosis and Traumatic Arthritis, sponsored by Zimmer Biomet. Terminated at 1 site in Korea, Republic of. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-02.
Sponsored by Zimmer Biomet · Observational
Evaluate E1 wear, Clinical Performance of E1 liner in THA in Korean Patient Population
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 100 is below the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →Zimmer Biomet is the lead sponsor of 271 studies on the registry; 28 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 19 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
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,
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:
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.
HHS score
Comparison in clinical outcomes scores between preoperative and various postoperative time points
Time frame: 1 year
Hip Functions
Harris Hip Score at post follow-up visit
Time frame: 6 Months
EQ5D
Standardised instrument for use as a measure of health outcome
Time frame: 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.
Time frame: 6 Months
Radiographic Assessment
Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop
Time frame: Immediate post-op(2 - 4 Weeks)
Hip Functions
Harris Hip Score at post follow-up visit
Time frame: 1 year
Hip Functions
Harris Hip Score at post follow-up visit
Time frame: 2 years
Hip Functions
Harris Hip Score at post follow-up visit
Time frame: 5 years
EQ5D
Standardised instrument for use as a measure of health outcome
Time frame: 1 year
EQ5D
Standardised instrument for use as a measure of health outcome
Time frame: 2 years
EQ5D
Standardised instrument for use as a measure of health outcome
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 5 years
Radiographic Assessment
Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop
Time frame: 6 Months
Radiographic Assessment
Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop
Time frame: 1 year
Radiographic Assessment
Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop
Time frame: 2 years
Radiographic Assessment
Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop
Time frame: 5 years
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is terminated, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Zimmer Biomet