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

January 6, 2020 updated by: Zimmer Biomet
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.

Study Overview

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Gyeonggi-do, Korea, Republic of
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of
        • Chung-Ang University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  1. Osteoarthritis
  2. Avascular necrosis
  3. Legg Perthes
  4. Rheumatoid Arthritis
  5. Diastrophic variant
  6. Fused hip
  7. Sequelae of Slipped capital epiphysis
  8. Traumatic arthritis
  9. Patients aged over 20
  10. 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:

  1. uncooperative patient or patient with neurologic disorders who are incapable of following directions,
  2. Small Femoral canal

2) 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Taperloc Complete Standard
Group one will receive a total hip replacement with Taperloc Complete Standard. 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.
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.
Active Comparator: Taperloc Complete Microplasty
Group one will receive a total hip replacement with Taperloc Complete Microplasty.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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone Mineral Density
Time Frame: 1 year
evaluate bone mineral density around the implant
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Evaluation,
Time Frame: 2 years
Radiographic measurements of stability and fixation
2 years
VAS Score
Time Frame: 2 years
The measurement of pain intensity
2 years
Modified Harris Hip Score
Time Frame: 2 years
  • Over all Survivorship
  • Harris Hip Score
2 years
Radiographic Evaluation
Time Frame: 1 year
Radiographic measurements of stability and fixation
1 year
Radiographic Evaluation
Time Frame: 6 Weeks
Radiographic measurements of stability and fixation
6 Weeks
VAS Score
Time Frame: 1 year
The measurement of pain intensity
1 year
VAS Score
Time Frame: 6 Weeks
The measurement of pain intensity
6 Weeks
VAS Score
Time Frame: 6 Months
The measurement of pain intensity
6 Months
Modified Harris Hip Score
Time Frame: 1 year
  • Over all Survivorship
  • Harris Hip Score
1 year
Modified Harris Hip Score
Time Frame: 6 Months
  • Over all Survivorship
  • Harris Hip Score
6 Months
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
Immediate post-op(2 - 4Weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Yong-Chan Ha, PHD, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
  • Principal Investigator: Young-Kyun Lee, PHD, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

January 14, 2014

First Submitted That Met QC Criteria

March 13, 2014

First Posted (Estimate)

March 14, 2014

Study Record Updates

Last Update Posted (Actual)

January 9, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

July 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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