Prospective Clinical Follow-up of the Echo Bi-Metric Microplasty Stem for Total Hip Arthroplasty
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
Summary
- Conditions
- Hip Osteoarthritis
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
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 ...
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.
Tracking Information
- NCT #
- NCT04326010
- Collaborators
- Not Provided
- Investigators
- Study Director: Kacy Arnold, MS Zimmer Biomet
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