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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 16, 2021
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Tracking Information
First Submitted Date January 24, 2020
First Posted Date March 30, 2020
Last Update Posted Date December 16, 2021
Actual Study Start Date February 20, 2017
Estimated Primary Completion Date February 20, 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 27, 2020)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 27, 2020)
  • Clinical Outcomes [ Time Frame: 7 Years Post-Operative. ]
    Clinical Outcomes will be measured using the Harris Hip Score and Physical Exam form.
  • Functional Outcomes [ Time Frame: 7 Years Post-Operative ]
    Functional ability will be measured using the EQ-5D-3L.
  • 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
  • Quality of Life Outcomes [ Time Frame: 7 Years Post-Operative ]
    Will be measured by UCLA Activity Score
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Clinical Follow-up of the Echo Bi-Metric Microplasty Stem for Total Hip Arthroplasty
Official Title Prospective Clinical Follow-up of the Echo Bi-Metric Microplasty Stem for Total Hip Arthroplasty
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Hip Osteoarthritis
Intervention Device: Surgery
THA surgery
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: March 27, 2020)
206
Original Actual Enrollment Same as current
Estimated Study Completion Date February 20, 2030
Estimated Primary Completion Date February 20, 2029   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04326010
Other Study ID Numbers H.CR.I.AM.16.6
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Zimmer Biomet
Study Sponsor Zimmer Biomet
Collaborators Not Provided
Investigators
Study Director: Kacy Arnold, MS Zimmer Biomet
PRS Account Zimmer Biomet
Verification Date December 2021