Arthroplasty, Replacement, Hip
Conditions
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.
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.
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rate of dislocation in each head size | 6 weeks | to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical results using Harris Hip Score | 6 weeks | to compare the clinical results such as pain, function, range of motion between both groups. |
Countries
South Korea
Outcome results
None listed