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

NCT ID: NCT01098604

Last Updated: 2014-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2009-12-31

Brief Summary

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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

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Conditions

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Arthroplasty, Replacement, Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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32mm ceramic head group

patients performed with THA using 32mm ceramic head

Group Type ACTIVE_COMPARATOR

32mm ceramic head group

Intervention Type DEVICE

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

28mm ceramic head group

patients performed with THA using 28mm ceramic head

Group Type ACTIVE_COMPARATOR

28mm ceramic head group

Intervention Type DEVICE

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

Interventions

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32mm ceramic head group

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

Intervention Type DEVICE

28mm ceramic head group

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seoul National University Bundang Hospital

Principal Investigators

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Kyung-Hoi Koo, professor

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul national University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SNU 08-01

Identifier Type: -

Identifier Source: org_study_id

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