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M-Vizion™ Macroscopic Radiographic Study for Revision Hip Arthroplasty

This study is observing how well the M-Vizion™ modular hip stem performs in patients who need a second hip replacement surgery (revision hip arthroplasty). Researchers will be looking at how much the stem moves or sinks into the bone (subsidence) after surgery. The goal is for patients receiving the M-Vizion™ stem to have less than 5mm of subsidence after two years. You might be able to join if you are between 21 and 80 years old, can understand and sign consent forms, and are willing to follow the study plan and attend follow-up visits. The current recruitment status is unclear, but the study plans to include 70 participants.

Study design
This is an observational study, meaning researchers will watch and collect information without giving specific treatments. It plans to enroll 70 participants.
What's involved
You would need to attend follow-up visits at 6 weeks, 6 months, and 1 year after your surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 1 year after surgery, with measurements taken at 6 weeks, 6 months, and 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05721859

M-Vizion™ Macroscopic Radiographic Study

Recruiting
Not specifiedAges 21–80Observational
Medacta USA
~70 participants
Updated 2025-05-08 on ClinicalTrials.gov
What's tested:revision hip arthroplasty

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
subsidence
Measured over 6 weeks post-op visit (± 2 weeks)
+3 more outcomes measured

Conditions

Revision Hip Arthroplasty

Explore related trials

Revision of hip arthroplasty

NCT05721859

Where you'd take part

This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Beth Israel Deaconess Medical Center

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Dartmouth Health

    Lebanon, New Hampshirestudy coordinator listed

    Recruiting

  • Geisinger Medical Center

    Danville, Pennsylvaniastudy coordinator listed

    Recruiting

  • New England Baptist Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Northwestern Medicine

    Chicago, Illinoisstudy coordinator listed

    Recruiting

  • OrthoCarolina Research Institute, Inc.

    Charlotte, North Carolinastudy coordinator listed

    Recruiting

  • University of Utah Department of Orthopaedics

    Salt Lake City, Utahstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Emily Hord, CCRP
[email protected]
331-208-4284
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • subsidence6 weeks post-op visit (± 2 weeks)

    Occurrence of subsidence \>5mm

  • subsidence6 Months post-op visit (± 2 months)

    Occurrence of subsidence \>5mm

  • subsidence1 year post-op visit (± 4 months)

    Occurrence of subsidence \>5mm

  • subsidence2 year post-op visit (± 6 months)

    Occurrence of subsidence \>5mm