NCT04326010

Prospective Clinical Follow-up of the Echo Bi-Metric Microplasty Stem for Total Hip Arthroplasty

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 206 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: —

Summary

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.

Detailed 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 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.

Conditions

• Hip Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Surgery	THA surgery

Timeline

• Start date: 2017-02-20
• Primary completion: 2024-06-14
• Completion: 2024-12-04
• First posted: 2020-03-30
• Last updated: 2025-02-05

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study