A Short Metaphyseal Fitting Total Hip Arthroplasty in Young and Elderly Patients

NCT ID: NCT01345097

Last Updated: 2019-05-01

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2011-03-31

Brief Summary

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The investigators determined whether

1. new short, metaphyseal-fitting cementless anatomical femoral stem provides major functional improvements
2. radiographically secure implant fixation is achieved with this new stem
3. the bone content is preserved at the baseline level or above at the final follow-up
4. these procedures are associated with early failure and complications.

Detailed Description

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To attempt reduction of stress shielding and thigh pain as well as to improve survivorship, a new short, metaphyseal-fitting cementless anatomical femoral stem was developed. The question arises as to whether it is possible to obtain rigid fixation of the stem without diaphyseal fixation in the young as well as in the elderly patients. The purpose of this study was to determine the clinical and radiographic results of the new short, metaphyseal-fitting cementless anatomical femoral stem in the young as well as in the elderly patients.

Conditions

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Osteonecrosis Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Younger Group

Group Type EXPERIMENTAL

Total Hip Arthroplasty

Intervention Type DEVICE

Total Hip Arthroplasty

Elderly Group

Group Type EXPERIMENTAL

Total Hip Arthroplasty

Intervention Type DEVICE

Total Hip Arthroplasty

Interventions

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Total Hip Arthroplasty

Total Hip Arthroplasty

Intervention Type DEVICE

Other Intervention Names

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Proxima

Eligibility Criteria

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Inclusion Criteria

* Osteoarthritis of hip joint requiring total hip arthroplasty

Exclusion Criteria

* Neurologic disorders affecting motor function of lower extremity foot and ankle disorders limiting ambulation of the patient
* Patients with bone metabolic disorders other than osteoporosis which prevents normal bone metabolism
* Multi-systemic inflammatory arthritis which debilitates patients other than hip joint.
Minimum Eligible Age

20 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ewha Womans University

OTHER

Sponsor Role lead

Responsible Party

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Young Hoo Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young-Hoo Kim, MD

Role: STUDY_DIRECTOR

Ewha Womans University Mokdong Hospital

Locations

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Ewha Womans University Mokdong Hosptial

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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THRProxima

Identifier Type: -

Identifier Source: org_study_id

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