CT-Bone®: real bone from the 3D Printer
Patients requiring skeletal augmentation, for example those with facial asymmetry resulting from either trauma or congenital defects, would be helped best with a bony implant made to match their anatomy. Typical bone augmentation implants are made from alloplastic materials (like PEEK or titanium) or the patient’s own bone is cut and repositioned. CT-Bone® is a bone-like customized implant that can be 3D printed and is converted to real bone by the patient.
After taking a CT-scan of the patient, a patient-specific implant is designed by our biomedical engineers in collaboration with the surgeon. This design perfectly fits on the anatomy of the patient, ensuring good bone-to-implant contact and facilitating bony ingrowth. The design is 3D printed in calcium phosphate, the main constituent of natural bone. The 3D printing process has a very high accuracy, resulting in implants that fit perfectly onto the bone of the patient, as designed. Even very complex shapes and designs can be 3D printed; for example 3D printing enables the production of implants with engineered (controlled) porosity, similar to natural bone. When implanted, CT-Bone® unifies with the patient’s own bone in the next months.
Unlike other 3D printed ceramics (like Hydroxyapatite or Beta-TCP), CT-Bone® does not require a thermal process (sintering) to increase mechanical strength and therefore also displays better bony fusion (sintering increases crystallinity which adversely affects biodegradability). Sintering also causes shrinkage of ceramics which results in a non-optimal fit. Since CT-Bone® does not require sintering it displays better bony fusion and is dimensionally stable, so it keeps a perfect fit.
Other manufacturing methods typically produce random porosity, whereas the process of 3D printing allows complex shapes and 100% interconnected porosity.
CT-Bone® is brought to you by Xilloc in collaboration with Next21 (Tokyo, Japan) and is awaiting regulatory approval under the new MDR in Europe.
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A pre-clinical study clearly shows the difference between an implant from Hydroxyapatite and an implant from CT-Bone®. The CT-Bone® implant really fuses with the original bone. Clinical studies confirm excellent bony fusion (results available upon request).
|4 weeks post-op|
|24 weeks post-op|
Further histological investigations showed that in the hydroxyapatite, bone-like tissue was only found in some micropores close to the surface. In CT-Bone®, large bone-like tissues penetrated into the macropores, containing activated osteoclasts, fibroblasts and even blood vessels. In addition, bone marrow formation was observed containing erythroblasts and megakaryocytes.
CT-Bone® is biodegradable by the patient’s osteoclasts and after 3 months CT-Bone® will be fused with the patient’s bone and will remodel in the osteo-cycle. CT-Bone® does not loose shape/volume over time and therefore should not be confused with a bioresorbable material that will be resorbed over time.