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

January 31, 2025 updated by: Zimmer Biomet
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
206

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Implant Survival
Time Frame: 5 years postoperatively / Life of Study
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.
5 years postoperatively / Life of Study

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Outcomes
Time Frame: 7 Years Post-Operative.
Clinical Outcomes will be measured using the Harris Hip Score and Physical Exam form.
7 Years Post-Operative.
Functional Outcomes
Time Frame: 7 Years Post-Operative
Functional ability will be measured using the EQ-5D-3L.
7 Years Post-Operative
Radiographic Outcomes
Time Frame: 7 Years Post-Operative
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
7 Years Post-Operative
Quality of Life Outcomes
Time Frame: 7 Years Post-Operative
Will be measured by UCLA Activity Score
7 Years Post-Operative
Safety Outcomes
Time Frame: 10 Years Post-Operative
Will be evaluated by monitoring the frequency and incidence of adverse events over time of the study
10 Years Post-Operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zimmer Biomet

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Hillary Overholser, BS, Zimmer Biomet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 14, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 4, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H.CR.I.AM.16.6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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