OsteoarthritisE1HipNCT02087449
Evaluate E1 Wear, Clinical Performance of E1 Liner in THA in Korean Patient Population
An observational study of Osteoarthritis and Avascular Necrosis, run by Zimmer Biomet at 1 site in South Korea.
Trial summary
Evaluate E1 wear, Clinical Performance of E1 liner in THA in Korean Patient Population Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Osteoarthritis, Avascular Necrosis, Traumatic Arthritis
- What is being tested?
- E1-Hip Bearing
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2013to 12 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
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- 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
Who cannot join
- 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:
- uncooperative patient or patient with neurologic disorders who are incapable of following directions,
- osteoporosis,
- metabolic disorders which may impair bone formation,
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Kyungpook National University Hospital
Daegu, Kyungsangbuk-do, 700-721
About this study
Official title: 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
Read the 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.
- Conditions
- Osteoarthritis, Avascular Necrosis, Traumatic Arthritis, Rheumatoid Arthritis, Legg-perthes Disease
- Being tested
- E1-Hip Bearing
- Medical subject headings
- Osteoarthritis, Osteonecrosis, Arthritis, Rheumatoid, Legg-Calve-Perthes Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E1-Hip BearingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| E1-Hip Bearing | E1-Hip Bearing, Evaluate E1 Wear, Clinical Performance of E1 Liner in THA in Korean Patient Population Receives: Device: E1-Hip Bearing |
What is being measured
The primary outcome is the main question the study is designed to answer.
HHS score
Comparison in clinical outcomes scores between preoperative and various postoperative time points
Measured: 1 year
Secondary outcomes (17)
Hip Functions
Harris Hip Score at post follow-up visit
Measured: 6 Months
EQ5D
Standardised instrument for use as a measure of health outcome
Measured: 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.
Measured: 6 Months
Radiographic Assessment
Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop
Measured: Immediate post-op(2 - 4 Weeks)
Hip Functions
Harris Hip Score at post follow-up visit
Measured: 1 year
Hip Functions
Harris Hip Score at post follow-up visit
Measured: 2 years
Hip Functions
Harris Hip Score at post follow-up visit
Measured: 5 years
EQ5D
Standardised instrument for use as a measure of health outcome
Measured: 1 year
EQ5D
Standardised instrument for use as a measure of health outcome
Measured: 2 years
EQ5D
Standardised instrument for use as a measure of health outcome
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 years
Radiographic Assessment
Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop
Measured: 6 Months
Radiographic Assessment
Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop
Measured: 1 year
Radiographic Assessment
Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop
Measured: 2 years
Radiographic Assessment
Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startFeb 2013
- Primary completionDec 2017
- Study completion12 Dec 2024
Why it stopped: Sponsor decided to terminate study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shin Yoon Kim, PHD, Principal investigator, Kyung Pook Nat'l Univ. Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087449
- Sponsor's protocol ID
- INT.CR.GH5.13
- Acronym
- E1Hip
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2014
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-center Study on E1 Acetabular Liner in THA
- ClinicalTrials.gov ID
- NCT02087449
- Acronym / sponsor ID
- E1Hip / INT.CR.GH5.13
- Conditions
- Osteoarthritis, Avascular Necrosis, Traumatic Arthritis, Rheumatoid Arthritis, Legg-perthes Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor decided to terminate study.
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Feb 2013 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 14 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E1-Hip Bearing | – | Device: E1-Hip BearingE1-Hip Bearing, Evaluate E1 Wear, Clinical Performance of E1 Liner in THA in Korean Patient Population |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- 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
- uncooperative patient or patient with neurologic disorders who are incapable of following directions,
- osteoporosis,
- metabolic disorders which may impair bone formation,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E1-Hip BearingVitamin 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. | Device | E1-Hip Bearing |
Primary outcome
HHS score
Time frame: 1 year
Comparison in clinical outcomes scores between preoperative and various postoperative time points
17 secondary outcomes
Hip Functions
Time frame: 6 Months
EQ5D
Time frame: 6 Months
Modified University of California Los Angeles (UCLA) Activity Score
Time frame: 6 Months
Radiographic Assessment
Time frame: Immediate post-op(2 - 4 Weeks)
Hip Functions
Time frame: 1 year
Hip Functions
Time frame: 2 years
Hip Functions
Time frame: 5 years
EQ5D
Time frame: 1 year
EQ5D
Time frame: 2 years
EQ5D
Time frame: 5 years
Modified University of California Los Angeles (UCLA) Activity Score
Time frame: 1 year
Modified University of California Los Angeles (UCLA) Activity Score
Time frame: 2 years
Modified University of California Los Angeles (UCLA) Activity Score
Time frame: 5 years
Radiographic Assessment
Time frame: 6 Months
Radiographic Assessment
Time frame: 1 year
Radiographic Assessment
Time frame: 2 years
Radiographic Assessment
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Sponsor decided to terminate study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shin Yoon Kim, PHD principal investigator
Kyung Pook Nat'l Univ. Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Avascular Necrosis, run by Zimmer Biomet at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor decided to terminate study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HHS score (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.