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Trial record 8 of 10 for:    "Legg-Calve-Perthes disease"

Evaluate E1 Wear, Clinical Performance of E1 Liner in THA in Korean Patient Population (E1Hip)

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ClinicalTrials.gov Identifier: NCT02087449
Recruitment Status : Active, not recruiting
First Posted : March 14, 2014
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

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

Condition or disease Intervention/treatment
Osteoarthritis Avascular Necrosis Traumatic Arthritis Rheumatoid Arthritis Legg-perthes Disease Device: E1-Hip Bearing

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Multi-center Study on E1 Acetabular Liner in THA
Study Start Date : February 2013
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : August 2026


Group/Cohort 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.




Primary Outcome Measures :
  1. HHS score [ Time Frame: 1 year ]
    Comparison in clinical outcomes scores between preoperative and various postoperative time points


Secondary Outcome Measures :
  1. Hip Functions [ Time Frame: 6 Months ]
    Harris Hip Score at post follow-up visit

  2. EQ5D [ Time Frame: 6 Months ]
    Standardised instrument for use as a measure of health outcome

  3. Modified University of California Los Angeles (UCLA) Activity Score [ Time Frame: 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.


  4. Radiographic Assessment [ Time Frame: Immediate post-op(2 - 4 Weeks) ]
    Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop

  5. Hip Functions [ Time Frame: 1 year ]
    Harris Hip Score at post follow-up visit

  6. Hip Functions [ Time Frame: 2 years ]
    Harris Hip Score at post follow-up visit

  7. Hip Functions [ Time Frame: 5 years ]
    Harris Hip Score at post follow-up visit

  8. EQ5D [ Time Frame: 1 year ]
    Standardised instrument for use as a measure of health outcome

  9. EQ5D [ Time Frame: 2 years ]
    Standardised instrument for use as a measure of health outcome

  10. EQ5D [ Time Frame: 5 years ]
    Standardised instrument for use as a measure of health outcome

  11. Modified University of California Los Angeles (UCLA) Activity Score [ Time Frame: 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.


  12. Modified University of California Los Angeles (UCLA) Activity Score [ Time Frame: 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.


  13. Modified University of California Los Angeles (UCLA) Activity Score [ Time Frame: 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.


  14. Radiographic Assessment [ Time Frame: 6 Months ]
    Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop

  15. Radiographic Assessment [ Time Frame: 1 year ]
    Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop

  16. Radiographic Assessment [ Time Frame: 2 years ]
    Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop

  17. Radiographic Assessment [ Time Frame: 5 years ]
    Radiographic Assessment at Immediate post-op(2 - 4 Weeks), 6 months, 1 year, 2 year, 5 year postop



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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,

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02087449


Locations
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Korea, Republic of
Kyungpook National University Hospital
Daegu, Kyungsangbuk-do, Korea, Republic of, 700-721
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Principal Investigator: Shin Yoon Kim, PHD Kyung Pook Nat'l Univ. Hospital
  Study Documents (Full-Text)

Documents provided by Zimmer Biomet:

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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT02087449     History of Changes
Other Study ID Numbers: INT.CR.GH5.13
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Legg-Calve-Perthes Disease
Arthritis
Osteoarthritis
Necrosis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes
Femur Head Necrosis
Osteonecrosis
Bone Diseases