Clinical trial NCT05721859: M-Vizion™ Macroscopic Radiographic Study
Official title: Medacta M-Vizion™ Macroscopic Radiographic Study, Multi-center, Post-Market Outcomes Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Revision Hip Arthroplasty
Keywords: revision
hip
arthroplasty
Lead sponsor: Medacta USA
Sponsor class: INDUSTRY
First posted: 2023-02-10
Enrollment: 70
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients listed for revision THA receiving a M-Vizion femoral component and meeting all inclusion/ exclusion criteria at a research site,

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: subsidence
timeFrame: 6 weeks post-op visit (± 2 weeks)
measure: subsidence
timeFrame: 6 Months post-op visit (± 2 months)
measure: subsidence
timeFrame: 1 year post-op visit (± 4 months)
measure: subsidence
timeFrame: 2 year post-op visit (± 6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
city: Boston
country: United States
facility: New England Baptist Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth Health
state: New Hampshire
city: Charlotte
country: United States
facility: OrthoCarolina Research Institute, Inc.
state: North Carolina
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah Department of Orthopaedics
state: Utah
Study officials:
References: