Evaluating the performance of a modular hip stem in revision hip surgeries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Emily Hord, CCRP
• Email: ehord@medacta.us.com
• Phone: 331-208-4284

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tipmed Revision Hip Prosthesis: 24-Month Post-Market Follow-Up

  This PMCF study tests the safety and how well the Tipmed Revision Hip Prosthesis works in adults undergoing hip revision surgery.

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• Prospective follow-up of the Prevision hip stem with comparison of implant variants

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• Wearing a straight knee brace for 10 days after revision knee replacement to improve motion.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.