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Completed

NCT Number: NCT02087436

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

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital, Gyeonggi-do, South Korea

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients suitable for primary Total Hip Replacement

Patients with degenerative joint disease (inflammatory or non-inflammatory) or any of the composite diagnoses of:

  • Osteoarthritis
  • Avascular necrosis
  • Legg Perthes
  • Rheumatoid Arthritis
  • Diastrophic variant
  • Fused hip
  • Sequelae of Slipped capital epiphysis
  • Traumatic arthritis
  • Patients aged over 20
  • Patients must be able to understand instructions and be willing to return for follow-up

Exclusion criteria

  • Absolute contraindications include: infection, sepsis, and osteomyelitis.

Relative contraindications include:

  • uncooperative patient or patient with neurologic disorders who are incapable of following directions,
  • Small Femoral canal
  • Severe osteoporosis (Patients over 65 years old) 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 9) Fracture of the pelvis 10) Subcapital fractures

Treatment and study plan

Taperloc Complete Microplasty

Device

Taperloc Complete Microplsty 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.

Taperloc Complete Standard

Device

Taperloc Complete Standard is designed after the philosophy of a flat tapered wedge. It has evolved to incorporate the Reduced Distal and Microplasty stems to better address all patient anatomies, and facilitate multiple surgical techniques.

Primary outcomes

  1. Bone Mineral Density

    Time frame: 1 year

    evaluate bone mineral density around the implant

Secondary outcomes

  1. Radiographic Evaluation,

    Time frame: 2 years

    Radiographic measurements of stability and fixation

  2. VAS Score

    Time frame: 2 years

    The measurement of pain intensity

  3. Modified Harris Hip Score

    Time frame: 2 years

    • Over all Survivorship
    • Harris Hip Score
  4. Radiographic Evaluation

    Time frame: 1 year

    Radiographic measurements of stability and fixation

  5. Radiographic Evaluation

    Time frame: 6 Weeks

    Radiographic measurements of stability and fixation

  6. VAS Score

    Time frame: 1 year

    The measurement of pain intensity

  7. VAS Score

    Time frame: 6 Weeks

    The measurement of pain intensity

  8. VAS Score

    Time frame: 6 Months

    The measurement of pain intensity

  9. Modified Harris Hip Score

    Time frame: 1 year

    • Over all Survivorship
    • Harris Hip Score
  10. Modified Harris Hip Score

    Time frame: 6 Months

    • Over all Survivorship
    • Harris Hip Score
  11. 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

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Acronym: taperloc

Important dates

Study start
2013
Primary completion
2014
Study completion
2019
First posted
Mar 14, 2014
Registry last updated
Jan 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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