1.1 This guide covers the clinical evaluation of the tissues surrounding metal-on-metal (MOM) hip replacement devices in patients using Magnetic Resonance Imaging (MRI). MOM devices must have articulating components manufactured from cobalt-28% chromium-6% molybdenum (Co28Cr6Mo) alloy (ASTM F 75,ASTM F 799, or ASTM F 1537). This guide does not address devices manufactured from any other alloys. 1.2 This guide describes the recommended protocol for MRI studies of patients implanted with MOM devices to determine if the periprosthetic tissues are likely to be associated with an adverse local tissue reaction (ALTR). 1.3 This guide assumes that the MRI protocol is implemented on MOM devices while they are implanted inside the body.
This standard will be used by clinicians to evaluate the periposthetic tissues surrounding metal-on-metal hip implants using MRI.
Keywordsmuskuloskeletal joint replacement; orthopedic device; metal-on-metal hip prosthesis; metal-on-metal total hip arthroplasty; modular acetabular system; cobalt-28 % chromium-6 % molybdenum alloy; magnetic resonance imaging; MRI
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top
Ballot Item Approved as F2978-2013 and Pending Publication