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CompletedNCT01098604THAUpdated Mar 20, 2014

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

A Phase 4 interventional study of 32mm ceramic head group and 28mm ceramic head group in Arthroplasty, Replacement, Hip, sponsored by Seoul National University Bundang Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2014-03-20.

Sponsored by Seoul National University Bundang Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
20 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Arthroplasty, Replacement, Hip
03

In context

Lead sponsor

Seoul National University Bundang Hospital is the lead sponsor of 368 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    32mm ceramic head group

    patients performed with THA using 32mm ceramic head

    Device: 32mm ceramic head group

  • Active comparator
    28mm ceramic head group

    patients performed with THA using 28mm ceramic head

    Device: 28mm ceramic head group

Interventions

  • Device32mm ceramic head group

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

  • Device28mm ceramic head group

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

06

What researchers measure

Primary outcomes

  1. rate of dislocation in each head size

    to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.

    Time frame: 6 weeks

  2. rate of dislocation in each head size

    to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.

    Time frame: 3 months

  3. rate of dislocation in each head size

    to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.

    Time frame: 6 months

  4. rate of dislocation in each head size

    to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.

    Time frame: 9 months

  5. rate of dislocation in each head size

    to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.

    Time frame: 12 months

  6. rate of dislocation in each head size

    to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.

    Time frame: 24 months

Secondary outcomes

  1. clinical results using Harris Hip Score

    to compare the clinical results such as pain, function, range of motion between both groups.

    Time frame: 6 weeks

  2. clinical results using Harris Hip Score

    to compare the clinical results such as pain, function, range of motion between both groups.

    Time frame: 3 months

  3. clinical results using Harris Hip Score

    to compare the clinical results such as pain, function, range of motion between both groups.

    Time frame: 6 months

  4. clinical results using Harris Hip Score

    to compare the clinical results such as pain, function, range of motion between both groups.

    Time frame: 9 months

  5. clinical results using Harris Hip Score

    to compare the clinical results such as pain, function, range of motion between both groups.

    Time frame: 12 months

  6. clinical results using Harris Hip Score

    to compare the clinical results such as pain, function, range of motion between both groups.

    Time frame: 24 months

07

Study locations

1 site
  • Seoul national University Bundang Hospital
    Seongnam-Si, Gyeonggi-do 463-707, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01098604
Lead sponsor
Seoul National University Bundang Hospital
First posted
Apr 5, 2010
Start date
May 2006
Primary completion
Nov 2007
Completion
Dec 2009
Last update
Mar 20, 2014

Study contacts

Kyung-Hoi Koo, professor
principal investigator · Seoul National University Bundang Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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