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

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01098604
First received: April 1, 2010
Last updated: April 2, 2010
Last verified: March 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Arthroplasty, Replacement, Hip
 Device: 32mm ceramic head group
Device: 28mm ceramic head group
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Comparison of 32mm and 28mm Head Components in Alumina-alumina Total Hip Arthroplasty: A Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • rate of dislocation in each head size [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.

  • rate of dislocation in each head size [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.

  • rate of dislocation in each head size [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.

  • rate of dislocation in each head size [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.

  • rate of dislocation in each head size [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.

  • rate of dislocation in each head size [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.


Secondary Outcome Measures:
  • clinical results using Harris Hip Score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    to compare the clinical results such as pain, function, range of motion between both groups.

  • clinical results using Harris Hip Score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    to compare the clinical results such as pain, function, range of motion between both groups.

  • clinical results using Harris Hip Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    to compare the clinical results such as pain, function, range of motion between both groups.

  • clinical results using Harris Hip Score [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    to compare the clinical results such as pain, function, range of motion between both groups.

  • clinical results using Harris Hip Score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    to compare the clinical results such as pain, function, range of motion between both groups.

  • clinical results using Harris Hip Score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    to compare the clinical results such as pain, function, range of motion between both groups.


Enrollment: 128
Study Start Date: May 2006
Study Completion Date: December 2009
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01098604

Locations
Korea, Republic of
Seoul national University Bundang Hospital
Seongnam-Si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Kyung-Hoi Koo, professor Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Kyung-Hoi, Koo/professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01098604     History of Changes
Other Study ID Numbers: SNU 08-01
Study First Received: April 1, 2010
Last Updated: April 2, 2010
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on May 19, 2013