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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01098604
Other study ID # SNU 08-01
Secondary ID
Status Completed
Phase Phase 4
First received April 1, 2010
Last updated March 19, 2014
Start date May 2006
Est. completion date December 2009

Study information

Verified date March 2010
Source Seoul National University Bundang Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date December 2009
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 85 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
32mm ceramic head group
we performed THA using 32mm ceramic head in this group.
28mm ceramic head group
we performed THA using 28mm ceramic head in this group.

Locations

Country Name City State
Korea, Republic of Seoul national University Bundang Hospital Seongnam-Si Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 weeks Yes
Primary 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. 3 months Yes
Primary 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. 6 months Yes
Primary 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. 9 months Yes
Primary 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. 12 months Yes
Primary 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. 24 months Yes
Secondary clinical results using Harris Hip Score to compare the clinical results such as pain, function, range of motion between both groups. 6 weeks No
Secondary clinical results using Harris Hip Score to compare the clinical results such as pain, function, range of motion between both groups. 3 months No
Secondary clinical results using Harris Hip Score to compare the clinical results such as pain, function, range of motion between both groups. 6 months No
Secondary clinical results using Harris Hip Score to compare the clinical results such as pain, function, range of motion between both groups. 9 months No
Secondary clinical results using Harris Hip Score to compare the clinical results such as pain, function, range of motion between both groups. 12 months No
Secondary clinical results using Harris Hip Score to compare the clinical results such as pain, function, range of motion between both groups. 24 months No
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