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

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Arthroplasty, Replacement, Hip

Treatments: Device: 32mm ceramic head group; Device: 28mm ceramic head group

Study type: Interventional

Funder types: Other

Identifiers

NCT01098604

SNU 08-01

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

32mm ceramic head group

Active Comparator group

Description:

patients performed with THA using 32mm ceramic head

Treatment:

Device: 32mm ceramic head group

28mm ceramic head group

Active Comparator group

Description:

patients performed with THA using 28mm ceramic head

Treatment:

Device: 28mm ceramic head group