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.
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.
Study Type
OBSERVATIONAL
Enrollment
206
THA surgery
OrthoSports Associates
Birmingham, Alabama, United States
University of CA - San Diego
San Diego, California, United States
Southern Joint Replacement Institute
Nashville, Tennessee, United States
Growth Ortho
Austin, Texas, United States
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.
Time frame: 5 years postoperatively / Life of Study
Clinical Outcomes
Clinical Outcomes will be measured using the Harris Hip Score and Physical Exam form.
Time frame: 7 Years Post-Operative.
Functional Outcomes
Functional ability will be measured using the EQ-5D-3L.
Time frame: 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
Time frame: 7 Years Post-Operative
Quality of Life Outcomes
Will be measured by UCLA Activity Score
Time frame: 7 Years Post-Operative
Safety Outcomes
Will be evaluated by monitoring the frequency and incidence of adverse events over time of the study
Time frame: 10 Years Post-Operative
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Tidewater Orthpaedics
Hampton, Virginia, United States
Jordan-young Institute
Virginia Beach, Virginia, United States