M-Vizion™ Macroscopic Radiographic Study

Medacta

Status: Enrolling

Conditions: Revision Hip Arthroplasty

Treatments: Device: revision hip arthroplasty

Study type: Observational

Funder types: Industry

Identifiers

NCT05721859

MUSA-H-MV-001

Details and patient eligibility

About

Study of the patient's subsidence after revision hip arthroplasty by assessing gross stem subsidence in the femoral canal.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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.