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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01345097
Other study ID # THRProxima
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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