Hip Fractures Clinical Trial
Official title:
Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Echo FX Stem With the RingLoc Bipolar Acetabular Cup and Femoral Head (Implants and Instrumentation) in Hip Hemiarthroplasty - A Retrospective Enrollment/Prospective Follow-up Consecutive Series Study
The objective of this retrospective enrollment and prospective follow-up study is to confirm safety, performance, and clinical benefits of the Echo FX Stem with the RingLoc Bipolar Acetabular Cup and Femoral Head in hip hemiarthroplasty (implants and instrumentation) at a minimum of 10 years follow-up. All available retrospective data will be collected from each patient and a prospective aspect to the study will be necessary to reach the 10-year time point.
The objective of this retrospective enrollment and prospective follow-up study is to confirm safety, performance, and clinical benefits of the Echo FX Stem with the RingLoc Bipolar Acetabular Cup and Femoral Head in hip hemiarthroplasty (implants and instrumentation) at a minimum of 10 years follow-up. All available retrospective data will be collected from each patient and a prospective aspect to the study will be necessary to reach the 10-year time point. The primary objective is to confirm the safety of the implants. This will be assessed by recording and analyzing the incidence and frequency of revisions, complications and adverse events. Relationship of the events to either implant or instrumentation will be specified. The secondary objective is the assessment of performance and clinical benefits by analyzing recorded Patient Reported Outcomes Measures (PROMs). ;
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