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

Phase 4

Completed

• Conditions: Arthroplasty, Replacement, Hip
• Interventions: Device: 32mm ceramic head group; Device: 28mm ceramic head group

• Registration Number: NCT01098604
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2007-11
• Study Completion: 2009-12
• Status Verified: 2010-03
• Study First Submitted: 2010-04-01
• Study First Submitted QC: 2010-04-02
• Study First Posted: 2010-04-05
• Last Update Submitted: 2014-03-19
• Last Update Posted: 2014-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
32mm ceramic head group	32mm ceramic head group	patients performed with THA using 32mm ceramic head
28mm ceramic head group	28mm ceramic head group	patients performed with THA using 28mm ceramic head

Primary Outcome Measures

Name	Time	Method
rate of dislocation in each head size	24 months	to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.

Secondary Outcome Measures

Name	Time	Method
clinical results using Harris Hip Score	24 months	to compare the clinical results such as pain, function, range of motion between both groups.

Trial Locations

Locations (1)

Seoul national University Bundang Hospital; 🇰🇷 Seongnam-Si, Gyeonggi-do, Korea, Republic of