ASTM F2978-13
Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging

Standard No.

ASTM F2978-13

Release Date

2013

Published By

American Society for Testing and Materials (ASTM)

Status

Be replaced

Replace By

ASTM F2978-20

Latest

ASTM F2978-20

Scope

5.1 Magnetic resonance imaging is ideally suited to image MOM hip arthroplasty due to its superior soft tissue contrast, multiplanar capabilities and lack of ionizing radiation. MR imaging is the most accurate imaging modality for the assessment of peri-prosthetic osteolysis and wear-induced synovitis (17-19).

5.2 Before scanning a patient with a specific implant, the MR practitioner shall confirm that the device is MR Conditional and that the scan protocol to be used satisfies the conditions for safe scanning for the specific implant.

5.3 This guide can be used to identify the following adverse events.

5.3.1 Osteolysis—Magnetic resonance imaging is superior to conventional radiographs and CT in the assessment of peri-prosthetic osteolysis and has been shown to be the most accurate method to locate and quantify the extent of peri-prosthetic osteolysis (17, 18). On MR imaging, osteolysis appears as well marginated intraosseous intermediate to slightly increased signal intensity lesions that contrast with the high signal intensity of the intramedullary fat. A characteristic line of low signal intensity surrounds the area of focal marrow replacement, distinguishing the appearance of osteolysis from tumoral replacement of bone or infection (20).

5.3.2 Component Loosening—While the data are preliminary, MR imaging can identify circumferential bone resorption that may indicate component loosening. Loosening may result from osteolysis, circumferential fibrous membrane formation or poor osseous integration of a non-cemented component. On MR imaging, component loosening typically manifests as circumferential increased signal intensity at the metallic-bone or cement-bone interface on fat-suppressed techniques (19). The finding of circumferential fibrous membrane formation or osteolysis also indicates potential loosening; this is in contrast to a well-fixed component, with high signal intensity fatty marrow directly opposed to the implant interface.

5.3.3 Wear-Induced Synovitis—Magnetic resonance imaging is the most useful imaging modality to assess the intracapsular burden of wear-induced synovitis surrounding MOM arthroplasty (21). Preliminary data indicate that the signal characteristics of the synovial response on MR imaging correlate with the type of wear-induced synovitis demonstrated on histology at revision surgery (22). Low signal intensity debris is suggestive of metallic debris on histology. Mixed intermediate and low signal debris correlates with the presence of mixed polymeric (polyethylene and/or polymethyl methacrylate) and metallic debris at histology. Magnetic resonance imaging can demonstrate decompression of synovitis or fluid into adjacent bursae, such as the iliopsoas or trochanteric bursa, which can present as soft tissue masses or with secondary nerve compression. On occasion, wear-induced synovitis can result in a chronic indolent pattern of erosion of the surrounding bone, even in the absence of focal osteolytic lesions (6).

5.3.4 Infection—In the setting of infection, the synovium often demonstrates a hyperintense, lamellated appearance with adjacent extracapsular soft tissue edema. These appearances help to distinguish the synovial pattern of infection from wear-induced synovitis, although aspiration is still required for definitive diagnosis (14). The presence of a soft tissue collection, draining sinus or osteomyelitis further supports the diag......

ASTM F2978-13 Referenced Document

• ASTM A340 Standard Terminology of Symbols and Definitions Relating to Magnetic Testing
• ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

ASTM F2978-13 history

• 2020 ASTM F2978-20 Standards Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging
• 2013 ASTM F2978-13 Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging