E1Hip: Evaluate E1 Wear, Clinical Performance of E1 Liner in THA in Korean Patient Population
Study Details
Study Description
Brief Summary
Evaluate E1 wear, Clinical Performance of E1 liner in THA in Korean Patient Population
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- HHS score [1 year]
Comparison in clinical outcomes scores between preoperative and various postoperative time points
Secondary Outcome Measures
- Hip Functions [6 Months]
Harris Hip Score at post follow-up visit
- EQ5D [6 Months]
Standardised instrument for use as a measure of health outcome
- Modified University of California Los Angeles (UCLA) Activity Score [6 Months]
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 [Immediate post-op(2 - 4 Weeks)]
Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop
- Hip Functions [1 year]
Harris Hip Score at post follow-up visit
- Hip Functions [2 years]
Harris Hip Score at post follow-up visit
- Hip Functions [5 years]
Harris Hip Score at post follow-up visit
- EQ5D [1 year]
Standardised instrument for use as a measure of health outcome
- EQ5D [2 years]
Standardised instrument for use as a measure of health outcome
- EQ5D [5 years]
Standardised instrument for use as a measure of health outcome
- Modified University of California Los Angeles (UCLA) Activity Score [1 year]
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.
- Modified University of California Los Angeles (UCLA) Activity Score [2 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.
- 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 [6 Months]
Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop
- Radiographic Assessment [1 year]
Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop
- Radiographic Assessment [2 years]
Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop
- Radiographic Assessment [5 years]
Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop
Eligibility Criteria
Criteria
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,
-
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
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:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kyungpook National University Hospital | Daegu | Kyungsangbuk-do | Korea, Republic of | 700-721 |
Sponsors and Collaborators
- Zimmer Biomet
Investigators
- Principal Investigator: Shin Yoon Kim, PHD, Kyung Pook Nat'l Univ. Hospital
Study Documents (Full-Text)
More Information
Publications
None provided.- INT.CR.GH5.13