Evaluating the performance of a modular hip stem in revision hip surgeries
Medacta M-Vizion™ Macroscopic Radiographic Study, Multi-center, Post-Market Outcomes Study
This study is testing if a new modular hip stem can stay stable during revision hip surgeries for patients and if it will move less than 5mm over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | Medacta USA Industry-sponsored |
| Locations | 7 sites (Chicago, Illinois and 6 other locations) |
| Trial ID | NCT05721859 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the performance of the M-Vizion modular stem in patients undergoing revision hip arthroplasty. It focuses on measuring the subsidence of the femoral stem within the canal over a two-year period. Participants will be monitored to ensure they meet the inclusion criteria and comply with the study protocol. The study seeks to determine if the M-Vizion stem will result in less than 5mm of subsidence, indicating effective performance.
Who should consider this trial
Good fit: Ideal candidates are patients aged 21 to 80 who require a revision total hip replacement and are receiving the M-Vizion femoral component.
Not a fit: Patients with neuromuscular deficiencies or systemic disorders that affect bone health may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and stability for patients undergoing revision hip arthroplasty.
How similar studies have performed: Other studies have shown promising results with similar modular hip stem approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chicago, Illinois and 6 other locations
- Northwestern Medicine — Chicago, Illinois, United States (Recruiting)
- New England Baptist Hospital — Boston, Massachusetts, United States (Recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
- Dartmouth Health — Lebanon, New Hampshire, United States (Recruiting)
- OrthoCarolina Research Institute, Inc. — Charlotte, North Carolina, United States (Recruiting)
- Geisinger Medical Center — Danville, Pennsylvania, United States (Recruiting)
- University of Utah Department of Orthopaedics — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Emily Hord, CCRP
- Email: ehord@medacta.us.com
- Phone: 331-208-4284
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.