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

Rheumatoid Arthritis Clinical Trial

— E1Hip  

Official title:

A Prospective Multi-center Study on E1 Acetabular Liner in THA

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02087449
• Other study ID #: INT.CR.GH5.13
• Status: Active, not recruiting
• Start date: February 2013
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2026
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook National University Hospital	Daegu	Kyungsangbuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HHS score	Comparison in clinical outcomes scores between preoperative and various postoperative time points	1 year
Secondary	Hip Functions	Harris Hip Score at post follow-up visit	6 Months
Secondary	EQ5D	Standardised instrument for use as a measure of health outcome	6 Months
Secondary	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.	6 Months
Secondary	Radiographic Assessment	Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop	Immediate post-op(2 - 4 Weeks)
Secondary	Hip Functions	Harris Hip Score at post follow-up visit	1 year
Secondary	Hip Functions	Harris Hip Score at post follow-up visit	2 years
Secondary	Hip Functions	Harris Hip Score at post follow-up visit	5 years
Secondary	EQ5D	Standardised instrument for use as a measure of health outcome	1 year
Secondary	EQ5D	Standardised instrument for use as a measure of health outcome	2 years
Secondary	EQ5D	Standardised instrument for use as a measure of health outcome	5 years
Secondary	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.	1 year
Secondary	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.	2 years
Secondary	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.	5 years
Secondary	Radiographic Assessment	Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop	6 Months
Secondary	Radiographic Assessment	Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop	1 year
Secondary	Radiographic Assessment	Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop	2 years
Secondary	Radiographic Assessment	Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop	5 years