The Comparison of 32mm and 28mm Head Components in Alumina-alumina Total Hip Arthroplasty (THA)

March 19, 2014 updated by: Seoul National University Bundang Hospital

The Comparison of 32mm and 28mm Head Components in Alumina-alumina Total Hip Arthroplasty: A Randomized Clinical Trial

It has been postulated that use of a larger femoral head could reduce the risk of dislocation after total hip arthroplasty, but only limited clinical data have been presented in third generation alumina bearings.

The purpose of this study is to evaluate the effect of femoral head size for total hip arthroplasty using third generation alumina bearings on the joint stability and clinical results.

The investigators hypothesized that larger ceramic head group has a similar rate of dislocation and clinical results in smaller ceramic head group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

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

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-Si, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang 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 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • osteonecrosis of femoral head
  • primary or secondary osteoarthritis of the hips
  • femoral neck fracture

Exclusion Criteria:

  • previous hemi- or total hip arthroplasty
  • highly dislocated or severe ankylosed hip
  • patients who are considered potentially unreliable or who may not reliably attend study visits

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 32mm ceramic head group
patients performed with THA using 32mm ceramic head
Device: 32mm ceramic head group
we performed THA using 32mm ceramic head in this group.
Active Comparator: 28mm ceramic head group
patients performed with THA using 28mm ceramic head
Device: 28mm ceramic head group
we performed THA using 28mm ceramic head in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of dislocation in each head size
Time Frame: 6 weeks
to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.
6 weeks
rate of dislocation in each head size
Time Frame: 3 months
to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.
3 months
rate of dislocation in each head size
Time Frame: 6 months
to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.
6 months
rate of dislocation in each head size
Time Frame: 9 months
to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.
9 months
rate of dislocation in each head size
Time Frame: 12 months
to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.
12 months
rate of dislocation in each head size
Time Frame: 24 months
to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical results using Harris Hip Score
Time Frame: 6 weeks
to compare the clinical results such as pain, function, range of motion between both groups.
6 weeks
clinical results using Harris Hip Score
Time Frame: 3 months
to compare the clinical results such as pain, function, range of motion between both groups.
3 months
clinical results using Harris Hip Score
Time Frame: 6 months
to compare the clinical results such as pain, function, range of motion between both groups.
6 months
clinical results using Harris Hip Score
Time Frame: 9 months
to compare the clinical results such as pain, function, range of motion between both groups.
9 months
clinical results using Harris Hip Score
Time Frame: 12 months
to compare the clinical results such as pain, function, range of motion between both groups.
12 months
clinical results using Harris Hip Score
Time Frame: 24 months
to compare the clinical results such as pain, function, range of motion between both groups.
24 months

Collaborators and Investigators

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

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Kyung-Hoi Koo, Professor, 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

May 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

April 1, 2010

First Submitted That Met QC Criteria

April 2, 2010

First Posted (Estimate)

April 5, 2010

Study Record Updates

Last Update Posted (Estimate)

March 20, 2014

Last Update Submitted That Met QC Criteria

March 19, 2014

Last Verified

March 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • SNU 08-01

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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