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TerminatedNCT04326010Updated Feb 5, 2025

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

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

Why this study was terminated
Data collected up to this point has provided sufficient follow-up and will allow for a reasonable estimate of the five-year survivorship rate for the Echo Bi-Metric Microplasty stem in primary total hip arthroplasty.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
206
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Hip Osteoarthritis

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03

In context

Osteoarthritis, Hip

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.

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Lead sponsor

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.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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.

Inclusion criteria

  • Subjects are eligible for this trial if they satisfy all of the following criteria:

    • Patient is 18 to 65 years of age, inclusive
    • Patient is skeletally mature
    • Patient qualifies for primary unilateral or bilateral total hip arthroplasty based on physical exam and medical history including at least one of the following:
    • Osteoarthritis
    • Avascular necrosis
    • Rheumatoid arthritis
    • Correction of functional deformity
    • Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
    • Patient has no history of previous total hip arthroplasty or arthrodesis of the affected hip joint(s)
    • Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent
    • Patient, or the patient's legally authorized representative, has participated in the Informed Consent process and is willing and able to sign an IRB- approved informed consent

Exclusion 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:

    • Patient has a total prosthetic hip replacement device (including surface replacement arthroplasty, endoprosthesis, etc.) in the affected hip joint(s)
    • Patient is septic or has an active infection
    • Patient is uncooperative patient or is incapable of following directions
    • Patient is diagnosed with osteoporosis
    • Patient is diagnosed with a metabolic disorder which may impair bone formation
    • Patient is diagnosed with osteomalacia
    • Patient has distant foci of infections which may spread to the implant site
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
206 participants (actual)
Patient registry
No

Interventions

  • DeviceSurgery

    THA surgery

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Clinical Outcomes

    Clinical Outcomes will be measured using the Harris Hip Score and Physical Exam form.

    Time frame: 7 Years Post-Operative.

  2. Functional Outcomes

    Functional ability will be measured using the EQ-5D-3L.

    Time frame: 7 Years Post-Operative

  3. 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

  4. Quality of Life Outcomes

    Will be measured by UCLA Activity Score

    Time frame: 7 Years Post-Operative

  5. 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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Study locations

6 sites
  • OrthoSports Associates
    Birmingham, Alabama 35211, United States
  • University of CA - San Diego
    San Diego, California 92037, United States
  • Southern Joint Replacement Institute
    Nashville, Tennessee 37203, United States
  • Growth Ortho
    Austin, Texas 78751, United States
  • Tidewater Orthpaedics
    Hampton, Virginia 23666, United States
  • Jordan-young Institute
    Virginia Beach, Virginia 23462, United States
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04326010
Lead sponsor
Zimmer Biomet
Responsible party
Sponsor
First posted
Mar 30, 2020
Start date
Feb 20, 2017
Primary completion
Jun 14, 2024
Completion
Dec 4, 2024
Last update
Feb 5, 2025

Study contacts

Hillary Overholser, BS
study director · Zimmer Biomet

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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