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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

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

Detailed Summary: 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.
Sponsor: Zimmer Biomet

Current Primary Outcome: HHS score [ Time Frame: 1 year ]

Comparison in clinical outcomes scores between preoperative and various postoperative time points


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Hip Functions [ Time Frame: 6 Months ]
    Harris Hip Score at post follow-up visit
  • EQ5D [ Time Frame: 6 Months ]
    Standardised instrument for use as a measure of health outcome
  • 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.

  • 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
  • Hip Functions [ Time Frame: 1 year ]
    Harris Hip Score at post follow-up visit
  • Hip Functions [ Time Frame: 2 years ]
    Harris Hip Score at post follow-up visit
  • Hip Functions [ Time Frame: 5 years ]
    Harris Hip Score at post follow-up visit
  • EQ5D [ Time Frame: 1 year ]
    Standardised instrument for use as a measure of health outcome
  • EQ5D [ Time Frame: 2 years ]
    Standardised instrument for use as a measure of health outcome
  • EQ5D [ Time Frame: 5 years ]
    Standardised instrument for use as a measure of health outcome
  • 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.

  • 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.

  • 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.

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


Original Secondary Outcome: Same as current

Information By: Zimmer Biomet

Dates:
Date Received: March 5, 2014
Date Started: February 2013
Date Completion: August 2026
Last Updated: March 20, 2017
Last Verified: August 2016