Dataset Information

Magnetic Resonance Safety Evaluation of a Novel Alumina Matrix Composite Ceramic Knee and Image Artifact Comparison to a Metal Knee Implant of Analogous Design.

ABSTRACT:

Background

Image artifacts caused by metal knee implants in 1.5T and 3T magnetic resonance imaging (MRI) systems complicate imaging-based diagnosis of the peri-implant region after total knee arthroplasty. Alternatively, metal-free knee prostheses could effectively minimize MRI safety hazards and offer the potential for higher quality diagnostic images.

Methods

A novel knee arthroplasty device composed of BIOLOX delta, an alumina matrix composite (AMC) ceramic, was tested in a magnetic resonance (MR) environment. American Society for Testing and Materials test methods were used for evaluating magnetically induced displacement force, magnetically induced torque, radiofrequency-induced heating, and MR image artifact.

Results

Magnetically induced displacement force and magnetically induced torque results of the AMC ceramic knee indicated that these effects do not pose a known risk in a clinical MR environment, as assessed in a 3T magnetic field. Moreover, minimal radiofrequency-induced heating of the device was observed. In addition, the AMC ceramic knee demonstrated minimal MR image artifacts (7 mm) in comparison to a cobalt-chromium knee (88 mm). The extremely low magnetic susceptibility of AMC (2 ppm) underlines that it is a nonmetallic and nonmagnetic material well suited for the manufacturing of MR Safe orthopaedic implants.

Conclusions

The AMC ceramic knee is a novel metal-free total knee arthroplasty device that can be regarded as MR Safe, as suggested by the absence of hazards from the exposure of this implant to a MR environment. The AMC ceramic knee presents the advantage of being scanned with superior imaging results in 3T MRI systems compared to alternative metal implants on the market.

SUBMITTER: Modinger Y

PROVIDER: S-EPMC10374871 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

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Publications

Magnetic Resonance Safety Evaluation of a Novel Alumina Matrix Composite Ceramic Knee and Image Artifact Comparison to a Metal Knee Implant of Analogous Design.

Mödinger Yvonne Y Anttila Eric D ED Baker Grant M GM Gross David C DC Porporati Alessandro A AA

Arthroplasty today 20230723

<h4>Background</h4>Image artifacts caused by metal knee implants in 1.5T and 3T magnetic resonance imaging (MRI) systems complicate imaging-based diagnosis of the peri-implant region after total knee arthroplasty. Alternatively, metal-free knee prostheses could effectively minimize MRI safety hazards and offer the potential for higher quality diagnostic images.<h4>Methods</h4>A novel knee arthroplasty device composed of BIOLOX <i>delta</i>, an alumina matrix composite (AMC) ceramic, was tested i ...[more]

PMID: 37521740

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Project description:We recently developed a recombinant growth factor-free bone regenerative scaffold composed of stoichiometric hydroxyapatite (HA) ceramic particles and human demineralized bone matrix (DBM) particles (HA-DBM). Here, we performed the first pre-clinical comparative evaluation of HA-DBM relative to the industry standard and established positive control, recombinant human bone morphogenetic protein-2 (rhBMP-2), using a rat posterolateral spinal fusion model (PLF). Female Sprague-Dawley rats underwent bilateral L4-L5 PLF with implantation of the HA-DBM scaffold or rhBMP-2. Fusion was evaluated using radiography and blinded manual palpation, while biomechanical testing quantified the segmental flexion-extension range-of-motion (ROM) and stiffness of the fused segments at 8-weeks postoperatively. For mechanistic studies, pro-osteogenic gene and protein expression at 2-days and 1-, 2-, and 8-weeks postoperatively was assessed with another cohort. Unilateral fusion rates did not differ between the HA-DBM (93%) and rhBMP-2 (100%) groups; however, fusion scores were higher with rhBMP-2 (p = 0.008). Both treatments resulted in significantly reduced segmental ROM (p < 0.001) and greater stiffness (p = 0.009) when compared with non-operated controls; however, the degree of stabilization was significantly higher with rhBMP-2 treatment relative to the HA-DBM scaffold. In the mechanistic studies, PLGA and HA scaffolds were used as negative controls. Both rhBMP-2 and HA-DBM treatments resulted in significant elevations of several osteogenesis-associated genes, including Runx2, Osx, and Alp. The rhBMP-2 treatment led to significantly greater early, mid, and late osteogenic markers, which may be the mechanism in which early clinical complications are seen. The HA-DBM scaffold also induced osteogenic gene expression, but primarily at the 2-week postoperative timepoint. Overall, our findings show promise for this 3D-printed composite as a recombinant growth factor-free bone graft substitute for spinal fusion. STATEMENT OF SIGNIFICANCE: Despite current developments in bone graft technology, there remains a significant void in adequate materials for bone regeneration in clinical applications. Two of the most efficacious bone graft options are the gold-standard iliac crest bone graft and recombinant human-derived bone morphogenetic protein-2 (rhBMP-2), available commercially as Infuse™. Although efficacious, autologous graft is associated with donor-site morbidity, and Infuse™ has known side effects related to its substantial host inflammatory response, possibly associated with a immediate, robust osteoinductive response. Hence, there is a need for a bone graft substitute that provides adequate osteogenesis without associated adverse events. This study represents a significant step in the design of off-the-shelf growth factor-free devices for spine fusion.

Dataset Information

Magnetic Resonance Safety Evaluation of a Novel Alumina Matrix Composite Ceramic Knee and Image Artifact Comparison to a Metal Knee Implant of Analogous Design.

Background

Methods

Results

Conclusions

Publications

Magnetic Resonance Safety Evaluation of a Novel Alumina Matrix Composite Ceramic Knee and Image Artifact Comparison to a Metal Knee Implant of Analogous Design.

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