- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04326010
Prospective Clinical Follow-up of the Echo Bi-Metric Microplasty Stem for Total Hip Arthroplasty
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35211
- OrthoSports Associates
-
-
California
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San Diego, California, United States, 92037
- University of CA - San Diego
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Tennessee
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Nashville, Tennessee, United States, 37203
- Southern Joint Replacement Institute
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Texas
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Austin, Texas, United States, 78751
- Growth Ortho
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Virginia
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Hampton, Virginia, United States, 23666
- Tidewater Orthpaedics
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Virginia Beach, Virginia, United States, 23462
- Jordan-young Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
Investigators
- Study Director: Hillary Overholser, BS, Zimmer Biomet
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H.CR.I.AM.16.6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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