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

Phase 4

Completed

• Conditions: Osteonecrosis; Osteoarthritis
• Interventions: Device: Total Hip Arthroplasty

• Registration Number: NCT01345097
• Lead Sponsor: Ewha Womans University

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.

Study Timeline

• Study Start: 2004-05
• Primary Completion: 2006-03
• Study Completion: 2011-03
• Study First Submitted: 2011-04-27
• Study First Submitted QC: 2011-04-28
• Study First Posted: 2011-04-29
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-28
• Last Update Posted: 2019-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Younger Group	Total Hip Arthroplasty	-
Elderly Group	Total Hip Arthroplasty	-

Primary Outcome Measures

Name	Time	Method
Harris hip score	At least 5 years after surgery	This is a verified scoring tool for measuring hip function.

Secondary Outcome Measures

Name	Time	Method
Improvement in the Range of Motion	At least 5 years after surgery	The change in the hip range motion compared to the initial and the last measurement.

Trial Locations

Locations (1)

Ewha Womans University Mokdong Hosptial; 🇰🇷 Seoul, Korea, Republic of