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

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.

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Key information

Conditions

Osteonecrosis Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Necrosis Osteoarthritis Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases

Age range

20 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ewha Womans University Mokdong Hosptial

Seoul, 158-710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Total hip arthroplasty

Device

Total Hip Arthroplasty

Other names: Proxima

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

Time frame: At least 5 years after surgery

The change in the hip range motion compared to the initial and the last measurement.

Sponsors and collaborators

Lead sponsor

Ewha Womans University

Other

Registry information

Important dates

Study start: 2004
Primary completion: 2006
Study completion: 2011
First posted: Apr 29, 2011
Registry last updated: May 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed