Prospective Post-market Study Examining the Effectiveness of the EcoFit®

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and effectiveness of the EcoFit Hip with implacross E polyethylene for total hip replacement surgery.

Detailed Description
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This study will assess the performance and success rate of the EcoFit Total Hip System. Survivorship and clinical outcomes will help determine implant success 36 months as defined by specific scoring systems and compared to other published data.

Official Title
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Prospective Post-market Study Examining the Effectiveness of the EcoFit® Total Hip System With Implacross® E Polyethylene

Conditions
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Degenerative Joint Disease, Femoral Fracture, Osteoarthritis, Hip, Traumatic Arthritis

Intervention / Treatment
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* Device: EcoFit® Total Hip System with implacross® E Polyethylene


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be a candidate for a total primary hip replacement. Subject must have degenerative joint disease, including osteoarthritis or traumatic arthritis, OR a femoral fracture which can be treated by a primary hip replacement and no other hardware Subject has a BMI of 40.00 kg/m2 or less at the time of enrollment Subject is likely to be available for evaluation for the duration of the study Subject is able and willing to sign the informed consent and follow study procedures Subject is not pregnant Exclusion Criteria: Subject has had a prior hip replacement in the subject hip Subject has an active cancer or is a survivor for <5 years except for squamous cell or basal cell skin cancer Subject has a chronic disease(s) where, in the opinion of the investigator, the disease will interfere with the patient's ability to follow the protocol Subject is currently a documented substance abuser (alcohol or other addictions) Subject has an infection, or history of infection (within the last 3 months), acute or chronic, local or systemic Subject has a history of muscular, neurological or vascular deficiencies which compromise the affected extremity Subject has a BMI > 40.00 kg/m2 Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease) Subject is a prisoner Subject is pregnant Subject has known materials sensitivity (to metals)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EcoFit® Total Hip System with implacross® E Polyethylene<br>Subjects who meet the indications for use for the EcoFit® Total Hip System with implacross® E Polyethylene and are candidates for a primary hip replacement. | Device: EcoFit® Total Hip System with implacross® E Polyethylene<br>* The EcoFit® Total Hip System is a primary hip replacement system indicated for patients who are candidates for a primary cementless hip replacement. implacross® E Polyethylene is one of the components in the EcoFit® system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of the EcoFit Hip with implacross E polyethylene for total hip replacement surgery | Evaluate the overall survivorship of the devices. Observed product-related complications and revisions are recorded and documented. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the pre to post-op change in the Harris Hip Score | The Harris Hip Score tracks pain, function/gait, performance in functional activities, and range of motion as interpreted by the surgeon. The responses determine a score which can be compared in different intervals. | Pre-op, 6 months, 12 months, 24 months, 36 months | 
| Evaluate the pre to post-op change in the WOMAC Score | The Western Ontario McMaster Arthritis Index, a questionnaire completed by the patient, tracks pain, stiffness, and difficulty with daily activities. | Pre-op, 6 months, 12 months, 24 months, 36 months | 
| Device related complications | Detect any device related complications via the adverse events reporting | Through completion of study, an average of 3.5 years |