“It can be concluded that implantation of the new radiolucent system is safe and at least comparable with the commonly used titanium implants in terms of intra- and postoperative complications, stability at weight bearing and at functional recovery and provides sufficient long-term results for the requirements of selected tumor patients.”
The Benefits of the BlackArmor® Technology
High-quality imaging enables clear diagnoses and thus effective treatments. Titanium implants create artifacts in CT and MR imaging with significant consequences for therapeutic decisions and options. However, the artifact-free BlackArmor® Carbon/PEEK enables optimized performance of perioperative management,1Fleege et al. (2020): Carbon-Fiber-Reinforced Pedicle Screws Reduce Artifacts in Magnetic Resonance Imaging of Patients with Lumbar Spondylodesis. Scientific Reports. 2020 (PubMed, PMID: 32999385) adjuvant radiation therapy, 2Müller et al. (2020): The Dosimetric Impact of Stabilizing Spinal Implants in Radiotherapy Treatment Planning with Protons and Photons: Standard Titanium Alloy vs. Radiolucent Carbon-Fiber-Reinforced PEEK Systems. Journal of Applied Clinical Medical Physics. (PubMed, PMID: 32476247)3Poel et al. (2020): Assessing the Advantages of CFR-PEEK over Titanium Spinal Stabilization Implants in Proton Therapy – A Phantom Study. Physics in Medicine and Biology. (PubMed, PMID: 32315991)4Shi et al. (2022): Comprehensive Evaluation of Carbon-Fiber-Reinforced Polyetheretherketone (CFR-PEEK) Spinal Hardware for Proton and Photon Planning. Technology in Cancer Research & Treatment. (PubMed, PMID: 35410544) and aftercare.5Ringel et al. (2017): Radiolucent Carbon Fiber-Reinforced Pedicle Screws for Treatment of Spinal Tumors: Advantages for Radiation Planning and Follow-Up Imaging. World Neurosurgery. (PubMed, PMID: 28478252)
Left: BlackArmor® Carbon/PEEK, right: titanium
A successful radiation therapy plan requires accurate planning, precise application, and homogenous distribution of the prescribed radiation dose to the tumor volume.3Poel et al. (2020): Assessing the Advantages of CFR-PEEK over Titanium Spinal Stabilization Implants in Proton Therapy – A Phantom Study. Physics in Medicine and Biology. (PubMed, PMID: 32315991) As a result, the spinal cord and other organs at risk are better protected, and the potential to achieve local tumor control is increased.3Poel et al. (2020): Assessing the Advantages of CFR-PEEK over Titanium Spinal Stabilization Implants in Proton Therapy – A Phantom Study. Physics in Medicine and Biology. (PubMed, PMID: 32315991)4Shi et al. (2022): Comprehensive Evaluation of Carbon-Fiber-Reinforced Polyetheretherketone (CFR-PEEK) Spinal Hardware for Proton and Photon Planning. Technology in Cancer Research & Treatment. (PubMed, PMID: 35410544)6Krätzig et al. (2021): Carbon-Fiber-Reinforced PEEK versus Titanium Implants: An In Vitro Comparison of Susceptibility Artifacts in CT and MR Imaging. Neurosurgical Review. (PubMed, PMID: 32930911)
BlackArmor® Carbon/PEEK is a high-performance composite material consisting of endless carbon fibers in a PEEK matrix. icotec developed proprietary composite flow molding (CFM) manufacturing technology to transform the raw material into complex implant designs with maximum 3D strength. BlackArmor® Carbon/PEEK implants have been shown to be reliably stable and resilient in both mechanical testing and real-world application.7Archavlis & Ringel (2018): Radiolucent Carbon-Fiber-Reinforced Pedicle Screws in Spine Metastases: Middle-Term Radiological and Clinical Results, Abstracts DGNC. Innovative Surgical Sciences. 2018 Mar 14. doi:10.1515/iss-2018-2006.8Wagner et al. (2021): Cement-Augmented Carbon-Fiber-Reinforced Pedicle Screw Instrumentation for Spinal Metastases: Safety and Efficacy. World Neurosurgery. (PubMed, PMID: 34339894)9Lindtner et al. (2018): Pedicle Screw Anchorage of Carbon-Fiber-Reinforced PEEK Screws under Cyclic Loading. European Spine Journal. (PubMed, PMID: 29497852)10Almeida et al. (2022): Carbon Fiber Reinforced PEEK Implants for Spine Tumors: A Single Center Experience. The Spine Journal, Volume 22, Issue 9, Supplement, 2022, Page S185. https://doi.org/10.1016/j.spinee.2022.06.378.
The Ti-iT® titanium coating from icotec leads to high primary stability as well as rapid and targeted osseointegration of BlackArmor® Carbon/PEEK implants.11Hoppe et al. (2018): First Results of a New Vacuum Plasma Sprayed (VPS) Titanium-Coated Carbon/PEEK Composite Cage for Lumbar Interbody Fusion. Journal of Functional Biomaterials. (PubMed, PMID: 29538285)12Burkhardt et al. (2021): The Surgical Treatment of Pyogenic Spondylodiscitis using Carbon-Fiber-Reinforced Polyether Ether Ketone Implants: Personal Experience of a Series of 81 Consecutive Patients. World Neurosurgery. (PubMed, PMID: 33905911)
State-of-the-Art Technology for Treating Spinal Tumors
The Swiss medical technology industry guarantees the best quality and is known for its precision and reliability. icotec is committed to these principles and strives for the highest standard of quality. The technology for BlackArmor® Carbon/PEEK implants was developed at ETH Zurich and is used throughout the world in the optimized treatment of spinal tumors.