Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04326010
Recruitment Status : Active, not recruiting
First Posted : March 30, 2020
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Brief 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.

Condition or disease Intervention/treatment
Hip Osteoarthritis Device: Surgery

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 206 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Clinical Follow-up of the Echo Bi-Metric Microplasty Stem for Total Hip Arthroplasty
Actual Study Start Date : February 20, 2017
Estimated Primary Completion Date : February 20, 2029
Estimated Study Completion Date : February 20, 2030

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Surgery
    THA surgery


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Clinical Outcomes [ Time Frame: 7 Years Post-Operative. ]
    Clinical Outcomes will be measured using the Harris Hip Score and Physical Exam form.

  2. Functional Outcomes [ Time Frame: 7 Years Post-Operative ]
    Functional ability will be measured using the EQ-5D-3L.

  3. 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

  4. Quality of Life Outcomes [ Time Frame: 7 Years Post-Operative ]
    Will be measured by UCLA Activity Score

  5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04326010


Locations
Layout table for location information
United States, Alabama
OrthoSports Associates
Birmingham, Alabama, United States, 35211
United States, California
University of CA - San Diego
San Diego, California, United States, 92037
United States, Tennessee
Southern Joint Replacement Institute
Nashville, Tennessee, United States, 37203
United States, Texas
Orthopaedic Specialists of Austin
Austin, Texas, United States, 78751
United States, Virginia
Tidewater Orthpaedics
Hampton, Virginia, United States, 23666
Jordan-young Institute
Virginia Beach, Virginia, United States, 23462
Sponsors and Collaborators
Zimmer Biomet
Investigators
Layout table for investigator information
Study Director: Kacy Arnold, MS Zimmer Biomet
Layout table for additonal information
Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT04326010    
Other Study ID Numbers: H.CR.I.AM.16.6
First Posted: March 30, 2020    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis, Hip
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases