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Clinical Trials/NCT01345097
NCT01345097
Completed
Phase 4

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

Ewha Womans University1 site in 1 country200 target enrollmentMay 2004
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ConditionsOsteonecrosisOsteoarthritis

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Osteonecrosis
Sponsor
Ewha Womans University
Enrollment
200
Locations
1
Primary Endpoint
Harris hip score
Status
Completed
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
May 2004
End Date
March 2011
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Young Hoo Kim

Professor

Ewha Womans University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Harris hip score

Time Frame: At least 5 years after surgery

This is a verified scoring tool for measuring hip function.

Secondary Outcomes

  • Improvement in the Range of Motion(At least 5 years after surgery)

Study Sites (1)

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