An observational study in Hip Osteoarthritis, sponsored by Zimmer Biomet. Terminated at 6 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-02-05.
Sponsored by Zimmer Biomet · Observational
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.
628 studies on the registry are indexed under Osteoarthritis, Hip; 121 are open to participants now.
This study's enrollment of 206 is above the median of 141 across 154 observational studies indexed under Osteoarthritis, Hip.
Browse Osteoarthritis, Hip studies →Zimmer Biomet is the lead sponsor of 271 studies on the registry; 28 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 19 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population will comprise a cohort of a minimum of 200, and no more than 225, hips enrolled across up to 10 centers from subjects who require primary total hip arthroplasty. Subjects must be willing and able to attend required follow-up appointments. Candidates who express interest in study participation will undergo an informed consent procedure, be required to sign an IRB-approved informed consent with required HIPAA authorization1, and eligibility will be determined based upon the inclusion/exclusion criteria.
Subjects are eligible for this trial if they satisfy all of the following criteria:
Exclusion Criteria:
Subjects will be excluded from this trial if they satisfy any of the following criteria as determined by the research staff or in the judgment of the treating physician:
THA surgery
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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Zimmer Biomet