Clinical Trial: Taperloc Complete Microplasty vs Taperloc Complete Standard: Randomized Controlled Study on Bone Mineral Density

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

Official Title: Taperloc Complete Microplasty vs Taperloc Complete Standard: Randomized Controlled Study on Bone Mineral Density

Brief Summary: The primary purpose of this study is to measure the postoperative changes in bone mineral density, comparing the Taperloc Complete Reduced Distal Microplasty stem and the standard length Taperloc Complete Reduced Distal stem.

Detailed Summary:

The Taperloc Microplasty cementless stem is designed to transmit load to the proximal femur, thereby preserving bone density, and preventing long term instability and loosening secondary to proximal bone resorption. The primary aim of this study is therefore to compare the postoperative changes in bone density with the Taperloc Microplasty stem, using the standard length Taperloc stem as a control.

In addition, the Taperloc stem has historically had a neck angle of 138°. There have been criticisms that this neck angle is too high for the typical Korean population. The newer Taperloc Complete system (both Microplasty and standard length) has a neck angle of 133°. A secondary aim is Occurrence ratio of thigh pain difference between Microplasty and standard stem in Korean Population


Sponsor: Zimmer Biomet

Current Primary Outcome: Bone Mineral Density [ Time Frame: 1 year ]

evaluate bone mineral density around the implant


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Radiographic Evaluation, [ Time Frame: 2 years ]
    Radiographic measurements of stability and fixation
  • VAS Score [ Time Frame: 2 years ]
    The measurement of pain intensity
  • Modified Harris Hip Score [ Time Frame: 2 years ]
    • Over all Survivorship
    • Harris Hip Score
  • Radiographic Evaluation [ Time Frame: 1 year ]
    Radiographic measurements of stability and fixation
  • Radiographic Evaluation [ Time Frame: 6 Weeks ]
    Radiographic measurements of stability and fixation
  • VAS Score [ Time Frame: 1 year ]
    The measurement of pain intensity
  • VAS Score [ Time Frame: 6 Weeks ]
    The measurement of pain intensity
  • VAS Score [ Time Frame: 6 Months ]
    The measurement of pain intensity
  • Modified Harris Hip Score [ Time Frame: 1 year ]
    • Over all Survivorship
    • Harris Hip Score
  • Modified Harris Hip Score [ Time Frame: 6 Months ]
    • Over all Survivorship
    • Harris Hip Score
  • Bone Mineral Density [ Time Frame: Immediate post-op(2 - 4Weeks) ]
    • Two X-ray beams with different energy levels are aimed at the patient's bones.
    • DEXA
    • evaluate the bone mineral density around the implant


Original Secondary Outcome: Same as current

Information By: Zimmer Biomet

Dates:
Date Received: January 14, 2014
Date Started: March 2013
Date Completion: June 2021
Last Updated: March 20, 2017
Last Verified: March 2017