Hip OsteoarthritisNCT04326010
Prospective Clinical Follow-up of the Echo Bi-Metric Microplasty Stem for Total Hip Arthroplasty
An observational study of Hip Osteoarthritis, run by Zimmer Biomet at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Surgery
- Type of treatment
- Medical device
- How many people
- 206 participants
- Where
- 6 sitesUnited States
- Study dates
- 20 Feb 2017to 4 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Growth Ortho
Austin, Texas, 78751
OrthoSports Associates
Birmingham, Alabama, 35211
Tidewater Orthpaedics
Hampton, Virginia, 23666
Southern Joint Replacement Institute
Nashville, Tennessee, 37203
University of CA - San Diego
San Diego, California, 92037
Jordan-young Institute
Virginia Beach, Virginia, 23462
About this 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.
Read the 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.
- Conditions
- Hip Osteoarthritis
- Being tested
- Surgery
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryDevice
THA surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survival
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.
Measured: 5 years postoperatively / Life of Study
Secondary outcomes (5)
Clinical Outcomes
Clinical Outcomes will be measured using the Harris Hip Score and Physical Exam form.
Measured: 7 Years Post-Operative.
Functional Outcomes
Functional ability will be measured using the EQ-5D-3L.
Measured: 7 Years Post-Operative
Radiographic Outcomes
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
Measured: 7 Years Post-Operative
Quality of Life Outcomes
Will be measured by UCLA Activity Score
Measured: 7 Years Post-Operative
Safety Outcomes
Will be evaluated by monitoring the frequency and incidence of adverse events over time of the study
Measured: 10 Years Post-Operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start20 Feb 2017
- Primary completion14 Jun 2024
- Study completion4 Dec 2024
Why it stopped: Data collected up to this point has provided sufficient follow-up and will allow for a reasonable estimate of the five-year survivorship rate for the Echo Bi-Metric Microplasty stem in primary total hip arthroplasty.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hillary Overholser, BS, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326010
- Sponsor's protocol ID
- H.CR.I.AM.16.6
- Status last verified
- Jan 2025
- First submitted
- 24 Jan 2020
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Follow-up of the Echo Bi-Metric Microplasty Stem for Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT04326010
- Acronym / sponsor ID
- H.CR.I.AM.16.6
- Conditions
- Hip Osteoarthritis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Data collected up to this point has provided sufficient follow-up and will allow for a reasonable estimate of the five-year survivorship rate for the Echo Bi-Metric Microplasty stem in primary total hip arthroplasty.
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 14 Jun 2024 (actual)
- Study completion
- 4 Dec 2024 (actual)
- First posted
- 30 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- Subjects are eligible for this trial if they satisfy all of the following criteria:
Key exclusion criteria (8 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryTHA surgery | Device | – |
Primary outcome
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 secondary outcomes
Clinical Outcomes
Time frame: 7 Years Post-Operative.
Functional Outcomes
Time frame: 7 Years Post-Operative
Radiographic Outcomes
Time frame: 7 Years Post-Operative
Quality of Life Outcomes
Time frame: 7 Years Post-Operative
Safety Outcomes
Time frame: 10 Years Post-Operative
Results and safety
The study was stopped early (reason given: Data collected up to this point has provided sufficient follow-up and will allow for a reasonable estimate of the five-year survivorship rate for the Echo Bi-Metric Microplasty stem in primary total hip arthroplasty.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Hip Osteoarthritis
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
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PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hillary Overholser, BS study director
Zimmer Biomet
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Osteoarthritis, run by Zimmer Biomet at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Data collected up to this point has provided sufficient follow-up and will allow for a reasonable estimate of the five-year survivorship rate for the Echo Bi-Metric Microplasty stem in primary total hip arthroplasty.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Survival (time frame: 5 years postoperatively / Life of Study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.