GlassBone" Bioactive Bone Substitute

Product catalog summary

Introduction
NORAKER® is a French manufacturer specializing in the development of medical implants for bone regeneration using bioactive glass technology. Their GlassBone™ products are synthetic, bioactive, and absorbable bone substitutes designed for filling, reconstruction, and fusion of bone defects.

Composition and Technology
GlassBone™ substitutes are composed of bioactive glass, a synthetic bioresorbable ceramic made from Silicium, Calcium, Sodium, and Phosphorous. This composition ensures excellent biocompatibility and is classified as a Class A bone substitute, superior to inert materials like hydroxyapatites.

Mechanism of Action
The bioactive glass facilitates bone regeneration through a series of stages: ionic exchanges, scaffold formation, and bone regeneration. Within 14 days, a biological mineral layer forms, and by 21 days, a carbonated hydroxyapatite layer develops. By 4 weeks, fibrous collagenous tissue spreads, and by 12 weeks, new bone is present in the defect.

Advantages and Performance
GlassBone™ products are easy to use, with granules being cohesive and hydrophilic, and the injectable putty ready for syringe application. Clinical studies show high fusion rates and significant pain reduction, with no complications related to the products.

Indications and Target Population
GlassBone™ is indicated for bone defects due to trauma, pathology, or surgery when autologous solutions are insufficient. It is suitable for orthopedic, spinal, cranio-maxillofacial, and ENT surgeries in both children and adults.

Clinical Results
Studies demonstrate that GlassBone™ products achieve excellent fusion rates comparable to autologous bone grafts, with significant improvements in patient outcomes and reduced operative complications.

Product Range
The GlassBone™ range includes granules and injectable putty available in various sizes and volumes to suit different surgical needs.

Conclusion
GlassBone™ products offer a safe and effective alternative to traditional bone grafts, providing reliable bone regeneration and improved patient quality of life.

Catalog excerpts

Synthetic Bone Substitutes Bioactive Glass Technology

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BIOMATERIALS FOR TRUE BONE REGENERATION NORAKER® has been involved in biomaterial development since 2005. It’s today an innovative manufacturer of medical implants for bone regeneration, with its core technology: the BIOACTIVE GLASS, a synthetic bioresorbable ceramic. GlassBone™ Substitutes are made of bioactive glass. This ceramic is composed of Silicium, Calcium, Sodium and Phosphorous, minerals naturally present in the human body. The natural composition allows an excellent biocompatibility. 1, 2, 3 The Bioactive glass has been classified by Dr Larry Hench Class A bone substitute, whereas...

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GlassBone™ range : Injectable Putty and Granules GlassBone'Granules To mix with patient's blood, patient's bone or saline solution 1. Easy to use Granules: very cohesive and hydrophylic when mixed with saline serum, patient blood or autologous bone. Injectable Putty: Ready to use, can be injected through the syringe. At 14 days: formation of an active biological mineral layer of calcium phosphate, with similar composition and structure as human bone. 1 3, 5

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Did you know? Bone substitutes are classified into an Index of Bioactivity (only demonstrated by in-vitro study).8 Bioactivity study - In vitro evaluation for apatite-forming ability. 10 (in vitro study) (a) GlassBone™ Granules (b) GlassBone™ Injectable Putty SEM images of (a) GlassBone™ Granules 05.1 and (b) GlassBone™ Injectable Putty a magnification of x50 (left) and X 10,000 (right) after 28 days of immersion in SBF (testing according to ISO 23317:2014). The surface of the granules presents cracks at x50 and needle-like structures at X 10,000. This is characteristic of hydroxyapatite formation....

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Clinical Results Examples 1_ C linical and radiographic evaluation of bioactive glass in posterolateral cervical or lumbar spinal fusion. European Journal of Orthopaedic Surgery & Traumatology (2019) Barrey C, Broussolle T METHOD: Retrospective case series. 30 consecutive patients with indications for a posterolateral spinal fusion procedure were operated. Appropriate decompressive surgery was performed with subsequent fixation using posterior instrumentation as appropriate and filled with bioactive glass. GlassBone™ Granules (1 – 3.15 mm) were mixed with local autograft harvested from the surgical...

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Bioactive Bone Substitutes Granule size GlassBone™ Granules Loss or lack of bone substance for bone defects of traumatic, pathological or surgical origin when autologous solutions are not applicable or sufficient in orthopedics, neurosurgery, cranio maxillo facial and otorhinolaryngology surgery in children and adult population. Main indications: • ORTHOPAEDIC SURGERY • SPINAL SURGERY GlassBone™ Injectable Putty 2. Oonishi, H. et al. J. Biomed. Mater Res. 2000;51:37-48. 3. Jones, J.R. Acta Biomaterialia. 2013;9:4457-4486. 4. Xynos, I.D. et al. Calcif Tissue Int. 2000;67:321-9. 5. Hench, L.L....

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