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.
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.
Study Type
OBSERVATIONAL
Enrollment
500
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.
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.
Time frame: 36 months
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.
Time frame: 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.
Time frame: Pre-op, 6 months, 12 months, 24 months, 36 months
Device related complications
Detect any device related complications via the adverse events reporting
Time frame: Through completion of study, an average of 3.5 years
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