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

Study Overview
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Brief Summary
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The investigators determined whether new short, metaphyseal-fitting cementless anatomical femoral stem provides major functional improvements radiographically secure implant fixation is achieved with this new stem the bone content is preserved at the baseline level or above at the final follow-up these procedures are associated with early failure and complications.

Detailed Description
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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.

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

Conditions
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Osteoarthritis, Osteonecrosis

Intervention / Treatment
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* Device: Total Hip Arthroplasty


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Younger Group<br> | Device: Total Hip Arthroplasty<br>* Total Hip Arthroplasty<br>* Other names: Proxima;|
| Experimental: Elderly Group<br> | Device: Total Hip Arthroplasty<br>* Total Hip Arthroplasty<br>* Other names: Proxima;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris hip score | 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 | The change in the hip range motion compared to the initial and the last measurement. | At least 5 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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short, metaphyseal-fitting femoral stem, cementless anatomical femoral stem, young patient, elderly patient