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

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ClinicalTrials.gov Identifier: NCT01098604
Recruitment Status : Completed
First Posted : April 5, 2010
Last Update Posted : March 20, 2014
Sponsor:
Information provided by:
Seoul National University Bundang Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Arthroplasty, Replacement, Hip Device: 32mm ceramic head group Device: 28mm ceramic head group Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : December 2009

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.



Primary Outcome Measures :
  1. 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.

  2. 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. 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.

  4. 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.

  5. 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.

  6. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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. 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.

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: April 5, 2010    Key Record Dates
Last Update Posted: March 20, 2014
Last Verified: March 2010