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NCT Number: NCT01098604

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

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.

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Key information

Conditions

Arthroplasty, Replacement, Hip

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul national University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

32mm ceramic head group

Device

we performed THA using 32mm ceramic head in this group.

28mm ceramic head group

Device

we performed THA using 28mm ceramic head in this group.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Acronym: THA

Important dates

Study start
2006
Primary completion
2007
Study completion
2009
First posted
Apr 5, 2010
Registry last updated
Mar 20, 2014

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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