Revision Hip ArthroplastyNCT05721859
M-Vizion™ Macroscopic Radiographic Study
An observational study of Revision Hip Arthroplasty, run by Medacta USA at 7 sites in United States.
Trial summary
Study of the patient's subsidence after revision hip arthroplasty by assessing gross stem subsidence in the femoral canal. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Revision Hip Arthroplasty
- What is being tested?
- revision hip arthroplasty
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 7 sitesUnited States
- Study dates
- 12 Oct 2022to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients listed for revision THA receiving a M-Vizion femoral component and meeting all inclusion/ exclusion criteria at a research site,
Who may be able to join
- Must be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF).
- Ability to understand and provide written authorization for use and disclosure of personal health information.
- Subjects who are able and willing to comply with the study protocol and follow-up visits.
- Patients requiring a revision total hip replacement.
- Subjects undergoing revision THA who will receive an M-Vizion femoral component according to the indications for use.
- Male and female patients ages 21 - 80 years of age at the time of surgery.
Who cannot join
- Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
- Patients with a systemic or metabolic disorder leading to progressive bone deterioration.
- Patients bone stock is compromised by disease or infection, which could possibly prevent adequate support and/or fixation to the prosthesis.
- Patients with an active or suspected latent infection in or about the hip joint.
- Patients that are incarcerated.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
New England Baptist Hospital
Boston, Massachusetts, 02120
Michael McTague, 617-754-6609, mmctague@bidmc.harvard.edu
Eric Smith, MD
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Julia Aguiar, 0000000000, hjaguiar2@bidmc.harvard.edu
Michael Baratz, MD
- Recruiting
OrthoCarolina Research Institute, Inc.
Charlotte, North Carolina, 28207
Alexis Ready, Alexis.Ready@orthocarolina.com
Caleb Michalek, caleb.michalek@orthocarolina.com
- Recruiting
Northwestern Medicine
Chicago, Illinois, 60611
Melissa Shauver, melissa.shauver1@nm.org
Megan VanDyke, megan.vandyke@nm.org
- Recruiting
Geisinger Medical Center
Danville, Pennsylvania, 17822
Yagiz Ozdag, MD, 0000000000, yozdag@geisinger.edu
John Mercuri, MD
- Recruiting
Dartmouth Health
Lebanon, New Hampshire, 03756
Holly Symonds, holly.b.symonds@hitchcock.org
Wayne Moschetti, MD
- Recruiting
University of Utah Department of Orthopaedics
Salt Lake City, Utah, 84108
Brenna Blackburn, PhD, MPH, 801-213-7154, brenna.blackburn@hsc.utah.edu
Claire Kepron, 801-213-7154
About this study
Official title: Medacta M-Vizion™ Macroscopic Radiographic Study, Multi-center, Post-Market Outcomes Study
Study of the patient's subsidence after revision hip arthroplasty by assessing gross stem subsidence in the femoral canal.
Read the detailed description
The aim of this study is to evaluate the M-Vizion modular stem performance in patients who undergo total hip replacement according to the standard practice. It is expected that subjects receiving revision hip arthroplasty with the Medacta M-Vizion™ modular hip stem will have less than 5mm of stem subsidence at 2 years.
- Conditions
- Revision Hip Arthroplasty
- Being tested
- revision hip arthroplasty
- Keywords
- revision, hip, arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
revision hip arthroplastyDevice
revision hip arthroplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
subsidence
Occurrence of subsidence >5mm
Measured: 6 weeks post-op visit (± 2 weeks)
subsidence
Occurrence of subsidence >5mm
Measured: 6 Months post-op visit (± 2 months)
subsidence
Occurrence of subsidence >5mm
Measured: 1 year post-op visit (± 4 months)
subsidence
Occurrence of subsidence >5mm
Measured: 2 year post-op visit (± 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start12 Oct 2022
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Revision Hip ArthroplastyStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medacta USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721859
- Sponsor's protocol ID
- MUSA-H-MV-001
- Status last verified
- May 2025
- First submitted
- 27 Jan 2023
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medacta M-Vizion™ Macroscopic Radiographic Study, Multi-center, Post-Market Outcomes Study
- ClinicalTrials.gov ID
- NCT05721859
- Acronym / sponsor ID
- MUSA-H-MV-001
- Conditions
- Revision Hip Arthroplasty
- Keywords
- revision, hip, arthroplasty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Medacta USAIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 10 Feb 2023 (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.
Study of the patient's subsidence after revision hip arthroplasty by assessing gross stem subsidence in the femoral canal.
Detailed description
The aim of this study is to evaluate the M-Vizion modular stem performance in patients who undergo total hip replacement according to the standard practice. It is expected that subjects receiving revision hip arthroplasty with the Medacta M-Vizion™ modular hip stem will have less than 5mm of stem subsidence at 2 years.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients listed for revision THA receiving a M-Vizion femoral component and meeting all inclusion/ exclusion criteria at a research site,
Key inclusion criteria (6 listed)
- Must be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF).
- Ability to understand and provide written authorization for use and disclosure of personal health information.
- Subjects who are able and willing to comply with the study protocol and follow-up visits.
- Patients requiring a revision total hip replacement.
- Subjects undergoing revision THA who will receive an M-Vizion femoral component according to the indications for use.
Key exclusion criteria (5 listed)
- Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
- Patients with a systemic or metabolic disorder leading to progressive bone deterioration.
- Patients bone stock is compromised by disease or infection, which could possibly prevent adequate support and/or fixation to the prosthesis.
- Patients with an active or suspected latent infection in or about the hip joint.
- Patients that are incarcerated.
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 |
|---|---|---|
| revision hip arthroplastyrevision hip arthroplasty | Device | – |
Primary outcome
subsidence
Time frame: 6 weeks post-op visit (± 2 weeks)
Occurrence of subsidence >5mm
subsidence
Time frame: 6 Months post-op visit (± 2 months)
Occurrence of subsidence >5mm
subsidence
Time frame: 1 year post-op visit (± 4 months)
Occurrence of subsidence >5mm
subsidence
Time frame: 2 year post-op visit (± 6 months)
Occurrence of subsidence >5mm
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: No
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ROADMAP Clinical Trial
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Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision Hip Prosthesis System
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Revision Hip Arthroplasty, run by Medacta USA at 7 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Hord, CCRP (331-208-4284, ehord@medacta.us.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subsidence (time frame: 6 weeks post-op visit (± 2 weeks)). The study lists 4 primary outcomes in all. 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 8 May 2025.