Prospective Clinical Follow-up of the Echo Bi-Metric Microplasty Stem for Total Hip Arthroplasty

Study Overview
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Brief Summary
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The primary objective of this study is to characterize survivorship of the Echo Bi-Metric Microplasty stem in unilateral or bilateral primary total hip arthroplasty at 5 years postoperative.

Detailed Description
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Primary objective The primary objective of this study is to characterize survivorship of the Echo Bi-Metric Microplasty stem in unilateral or bilateral primary total hip arthroplasty at 5 years postoperative. Secondary Objectives Safety will be evaluated by monitoring the frequency and incidence of adverse events over time to 10 years postoperative. Clinical, functional, radiographic, and quality of life outcomes will be assessed over time to 7 years postoperative. Clinical Outcomes will be measured using the Harris Hip Score and Physical Exam form. Radiographs will be reviewed to assess alignment, radiolucencies and other radiographic parameters. Health status and functional ability will be measured using the EQ-5D-3L and the UCLA Activity score.

Official Title
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Prospective Clinical Follow-up of the Echo Bi-Metric Microplasty Stem for Total Hip Arthroplasty

Conditions
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Hip Osteoarthritis

Intervention / Treatment
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* Device: Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects are eligible for this trial if they satisfy all of the following criteria: Patient is 18 to 65 years of age, inclusive Patient is skeletally mature Patient qualifies for primary unilateral or bilateral total hip arthroplasty based on physical exam and medical history including at least one of the following: Osteoarthritis Avascular necrosis Rheumatoid arthritis Correction of functional deformity Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques Patient has no history of previous total hip arthroplasty or arthrodesis of the affected hip joint(s) Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent Patient, or the patient's legally authorized representative, has participated in the Informed Consent process and is willing and able to sign an IRB- approved informed consent Exclusion Criteria: Subjects will be excluded from this trial if they satisfy any of the following criteria as determined by the research staff or in the judgment of the treating physician: Patient has a total prosthetic hip replacement device (including surface replacement arthroplasty, endoprosthesis, etc.) in the affected hip joint(s) Patient is septic or has an active infection Patient is uncooperative patient or is incapable of following directions Patient is diagnosed with osteoporosis Patient is diagnosed with a metabolic disorder which may impair bone formation Patient is diagnosed with osteomalacia Patient has distant foci of infections which may spread to the implant site

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Surgery|THA surgery|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Survival | The primary objective of this study is to characterize survivorship of the Echo Bi-Metric Microplasty stem in unilateral or bilateral primary total hip arthroplasty at 5 years postoperative. | 5 years postoperatively / Life of Study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcomes | Clinical Outcomes will be measured using the Harris Hip Score and Physical Exam form. | 7 Years Post-Operative. | 
| Functional Outcomes | Functional ability will be measured using the EQ-5D-3L. | 7 Years Post-Operative | 
| Radiographic Outcomes | Standard AP and lateral Hip radiographics of the implanted hip device will be assess the positioning of the device as well as lucencies and other potential anomalies | 7 Years Post-Operative | 
| Quality of Life Outcomes | Will be measured by UCLA Activity Score | 7 Years Post-Operative | 
| Safety Outcomes | Will be evaluated by monitoring the frequency and incidence of adverse events over time of the study | 10 Years Post-Operative |