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

January 10, 2024 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

Active, not recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

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

    • 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

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

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

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

Investigators

  • 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)

February 20, 2017

Primary Completion (Estimated)

February 20, 2029

Study Completion (Estimated)

February 20, 2030

Study Registration Dates

First Submitted

January 24, 2020

First Submitted That Met QC Criteria

March 27, 2020

First Posted (Actual)

March 30, 2020

Study Record Updates

Last Update Posted (Actual)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID 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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