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Evaluation Of Osteointegration Of Polyetheretherketone (peek) And Amorphous Magnesium Phosphate (amp-peek) Macroporous Cranioplasty Implants In A Rat Critical-size Defect Calvarial Model
Diwakar Phuyal, MB BS1, Filippo Andrea Giovanni Perozzo, MD
1, Mazen Al-Malak, MD
1, Osama Darras, MD
1, Prabaha Sikder, PhD
2, Varun Kshettry, MD
1, Antonio Rampazzo, MD, PhD
1, Bahar Bassiri Gharb, MD, PhD
1.
1Cleveland Clinic Foundation, Cleveland, OH, USA, 2Cleveland State University, Cleveland, OH, USA.
PURPOSE:Amorphous magnesium phosphate (AMP) coating of PEEK intramedullary nails has shown to enhance osteointegration. We hypothesized that AMP-coating and macroporosity will facilitate osteointegration of PEEK cranioplasty.
METHODS:Animal procedures were approved by the Institutional Animal Care and Use Committee (IACUC) (protocol 00003190). A 9 mm full thickness calvarial critical size defect was created, followed by AMP-PEEK, PEEK or autologous bone placement. Sample size was calculated as 10 rats per group to achieve 80% power. Micro-Computed tomography (CT) and 3D reconstruction with volumetric analysis were performed at 6 weeks and 18 weeks. After euthanasia, pull-out testing of the implant or bone graft was performed.
Mann-Whitney test was used to assess differences in bone volume, bone volume/total volume, bone mineral density (BMD), and tissue mineral density among groups.
RESULTS:Bone formation at the osteotomy site was identified by 6 weeks in all groups. Bone extended into the implant pores in 70% of the AMP-PEEK and 50% of the PEEK (p=0.36). Bone volumes were 0.95 ± 0.73 mm³ in AMP-PEEK versus 0.48 ± 0.38 mm³ in PEEK group (p=0.1). BMD was significantly greater in AMP-PEEK than PEEK (62.06 ± 5.42 vs. 56.39 ± 2.80 mg/mm³, p=0.03). At 18 weeks, bone volume was 2.456 ± 1.71 mm³ in AMP-PEEK versus 1.85 ± 1.17 mm³ in PEEK group (p=0.6). Three-dimensional reconstruction showed bone-implant integration in 80% of AMP-PEEK and 70% of PEEK implants (p=0.61).
CONCLUSION:Macroporous PEEK implants display evidence of osteointegration by 6 weeks, with AMP coating appearing to enhance early bone formation.
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