Treatment of Tumor Diseases of the Spine
With BlackArmor® Implants
The skeletal system is the third most common site of metastases, after the liver and lungs. Thereof, bone metastases occur most often in the spine (60% to 80 %). Other frequently affected regions of the body are the pelvis, femur, ribs, and humerus. 30% to 50% of all patients who develop a malignant tumor develop bone metastases – very often in the area of the spine.
(Schultheiss, M. 2007. 'Operative Therapieoptionen bei Skelettmetastasen', Orthopädie und Unfallchirurgie up2date, 2: 141-56.)
Benefits in the Tumor Treatment when Using BlackArmor®
Eicker et al. report on the use of the BlackArmor® Carbon/PEEK pedicle system in the treatment of two groups of 5 patients diagnosed with degenerative and metastatic tumor disease respectively. The visualization of the pedicle screw with minimized artifacts is possible on both CT and MRI. The aftercare of the tumor patients is a great advantage through this imaging.
(Eicker et al. 2016. 'First experience with carbon fibers/peek pedicle screws', J Neurosurg Sci, 61: 222-4)
Another study addresses the effects of different pedicle screw materials on the calculation of the dose distribution in photon and proton radiation. The basis for the creation of radiation plans is a CT data set from a phantom study on icotec BlackArmor® Carbon/PEEK and icotec titanium screws. The beam-hardening and partial volume artifacts of the titanium screws interfere with the calculation of the dose distribution. The BlackArmor® Carbon/PEEK screws yielded almost artifact-free imaging which enabled homogenous dose distribution as well as a sufficient dose in the target volume in proton as well as photon radiation.
(Kashua et al. 2016. 'Auswirkung unterschiedlicher Implantatmaterialien auf die Berechnung der Dosisverteilung', 22.Jahrestagung DEGRO, 192 Suppl. 1, 109.)
What do I need to know about icotec products before use? The most important questions regarding the handling of our implants are presented here. Please contact us for further information.
Is there particle abrasion from Carbon/PEEK?
Particulate Debris and Its Formation
In general, particles always form wherever implant parts rub against each other or implants move or rub against tissue. Even micromovements are enough to generate particles. Due to their size, geometry, and chemistry, these particles can trigger various reactions in the body, can become trapped and isolated in the body, can trigger cellular reactions (even including tumor growth), but can also be transported over long distances and deposited in tissues.
Biocompatibility of Carbon Fibers and PEEK
The very good biocompatibility of pure, uncoated carbon fibers was proven in 1982 by Tayton in an animal study with rats (Tayton, Phillips, and Ralis 1982). The biocompatibility of polyetheretherketone (PEEK) was analyzed and confirmed in the investigations by Williams (Williams D.F. 1987). BlackArmor® consists of precisely these materials: pure, uncoated carbon fibers and PEEK polymer which is classified as “medical grade” according to ASTM standard, and is thus suitable as implant material.
Particulate Debris and Wear of Carbon/PEEK Implants
The Carbon/PEEK trauma implants (tibial nail, dynamic compression plate (DCP), proximal humerus plate, and volar distal radius plate) investigated by Steinberg (Steinberg et al. 2013) all underwent dynamic testing of 1 million cycles. The volume of abrasion particles was determined (0.50 mm Carbon/PEEK)and is lower than for titanium implants (1.19 mm3 titanium particles). Tullberg describes a single case (case report) of wear debris from an I/F Brantigan cage (Tullberg 1998). The Brantigan cage is a Carbon/PEEK cage, with 30% fibers of a length in the mm range. Fusion failed due to an infection in the segment and the cage broke due to constant loading. As a result of the persistent movement, and thus friction between the bone and the implant, there was significant formation of particles, which also dispersed into the spinal canal. Histologically, only a minor inflammatory reaction was found; in the case of the present infection, this is not necessarily related to the implant. Togawa, in his analysis of 8 removed Carbon/PEEK cages (short fiber), also comes to similar conclusions (Togawa et al. 2004). Although more wear particles from the Carbon/PEEK cages were found in comparison with the removed titanium cages, there was no demonstrable osteolysis or inflammatory reactions which could be attributed to the debris.
Debris and Abrasive Wear of the Titanium Coating
In the case of cages and pedicle screws from icotec, in which the titanium coating is applied on Carbon/PEEK, no such effects have been observed to date. The layer meets all criteria for adhesive strength with regard to shear and tensile stress, in the static and dynamic case. Since the titanium layer is pure titanium according to the ASTM standard, it can be assumed that the cellular reactions to wear debris from this layer can be easily compared to the reactions to conventional titanium implants and are therefore not critical.
The Following Statements on Particulate Debris and Tissue Reactions to Carbon/PEEK Are Scientifically Proven
The biocompatibility of Carbon/PEEK is very good. Abrasion can occur during the surgery through damage to the material or through any movements between the implants and/or tissue and cause inflammatory reactions. Inflammatory reactions to Carbon/PEEK do not differ from those of titanium implants (Cotic et al. 2015; Gerlach et al. 2004).
How can I assess the intra- or extra-articular position of the screws and/or implants?
Carbon/PEEK as a material is not visible in X-rays and CT. X-ray markers made of tantalum (a very X-ray-opaque metal often used in medicine) are inserted at specific and important sites in the implant; the implants can thus be localized without problems and their correct position assessed. The quantity of X-ray markers and thus the volume of metal in the implant are kept to a minimum so as not to influence the imaging negatively.
Can customer-specific implants be developed and manufactured?
Owing to the special manufacturing procedure, customer-specific implants cannot be manufactured.
Can BlackArmor® implants be sterilized or resterilized?
All BlackArmor® implants from icotec are sterilized with radiation and delivered in sterile packaging. The implants may only be used once.
Cleaning and resterilization are not permitted and can have negative effects on the sterility or biocompatibility of the implant.
What training and workshops are offered by icotec?
We will be happy to provide you with a list of our current training dates on request. Please contact our headquarters in Altstätten directly.
Is there a DRG code for icotec BlackArmor® products?
Code 5-931.2 has existed in Germany since 2017. This is an additional code and should be added to the existing coding (e.g. spondylosis) when using our BlackArmor® Carbon/PEEK material.
Do you want to learn more about our implants, surgical techniques, or the topics of Carbon/PEEK, titanium, the spine, and trauma? We will be happy to provide you with a list of publications.