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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01345097
• Other study ID #: THRProxima
• Status: Completed
• Phase: Phase 4
• Start date: May 2004
• Est. completion date: March 2011

Study information

• Verified date: April 2019
• Source: Ewha Womans University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2011
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteonecrosis
• Seizures

Intervention

Device:
• Total Hip Arthroplasty
Total Hip Arthroplasty

Locations

Country	Name	City	State
Korea, Republic of	Ewha Womans University Mokdong Hosptial	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ewha Womans University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Harris hip score	This is a verified scoring tool for measuring hip function.	At least 5 years after surgery
Secondary	Improvement in the Range of Motion	The change in the hip range motion compared to the initial and the last measurement.	At least 5 years after surgery