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

April 28, 2019 updated by: Young Hoo Kim, Ewha Womans University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 158-710
        • Ewha Womans University Mokdong Hosptial

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Younger Group
Device: Total Hip Arthroplasty
Total Hip Arthroplasty
Other Names:
  • Proxima
Experimental: Elderly Group
Device: Total Hip Arthroplasty
Total Hip Arthroplasty
Other Names:
  • Proxima

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Harris hip score
Time Frame: At least 5 years after surgery
This is a verified scoring tool for measuring hip function.
At least 5 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in the Range of Motion
Time Frame: At least 5 years after surgery
The change in the hip range motion compared to the initial and the last measurement.
At least 5 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ewha Womans University

Investigators

  • Study Director: Young-Hoo Kim, MD, Ewha Womans University MokDong Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

April 27, 2011

First Submitted That Met QC Criteria

April 28, 2011

First Posted (Estimate)

April 29, 2011

Study Record Updates

Last Update Posted (Actual)

May 1, 2019

Last Update Submitted That Met QC Criteria

April 28, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THRProxima

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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