Bioactive Bone Glass Substitute

Transcription

1 Bioactive Bone Glass Substitute Injectable Putty

2 BIOMATERIALS IMPROVING THE BONE REGENERATION Noraker has been involved in biomaterial development since It s today an innovative manufacturer of medical implants for bone regeneration, with its core technology: the bioactive glass, a synthetic bioresorbable Composition Avantages Performances The bone substitutes GlassBONE TM and GlassBONE TM Putty 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 Bioactive glass has been classified by Larry Hench as Class A bone substitute, whereas inert materials, such as hydroxyapatites or calcium phosphate, are Class B. 8 Bioactive glass has already proven its clinical performances. Especially its ability to fill a bone defect and to gradually replaced by a functionnal tissue. 4 Diagram of bioactivity according to the composition of the ceramics 5 10 Biological properties according to quantity of silicon, sodium and calcium with 6% of Phosphorous. Soft Tissue bonding Bone bonding %SiO 2 Non bonding : Bioactivity too high Na 2 O : 24,5 % SiO 2 : 45% %CaO Non bonding : Bioactivity too low No glass forming CaO : 24,5 % %Na 2 O

3 The products range of GlassBONE TM consists of Injectable Putty and. Injectable Putty The ergonomics of the syringe has been especially studied to have a good grip. Two tips are available. When mixed with patient s blood or physiological saline solution, it forms a cohesive mass enabling easy implantation. MECHANISM OF ACTION 1. Easy to use : cohesive mass when mixed with serum, blood or autologous bone. Injectable Putty: Ready to use, can be injected through the syringe. 2. Ionic exchanges At 14 days: formation of an active biological mineral layer of calcium phosphate, with similar composition and structure as human bone

4 Did you know? Bone substitutes are classified into an Index of Bioactivity. 8 Class A Matrix for the bone colonization + Stimulation of stem cells Bioactive Glass 45S5 Class B Matrix for the bone colonization HA, βtcp Adhesion and Proliferation of mesenchymal stem cells hmsc GlassBONE TM. 10 (in vitro study) SEM - Day 2 Stem cells adhesion on the surface of GlassBONE TM (dark dots) SEM - Day 7 Multiplication and differentiation of the stem cells(dark spider web) SEM - Day 14 Extracellular matrix and natural hydroxyapatite in formation SEM - Day 21 Dense extracellular matrix; cells differentiated in osteoblasts 3. Genetic activation 4. Bone Regeneration At 21 days: The increased concentration of minerals improves the differenciation and proliferation of osteoblasts in the defect; and starts the formation of the extra-cellular matrix of collagen At 4 weeks: Fibrous collagenous tissue (blue) is spread in the defect and surrounds the bone substitute. A centripetal bone neoformation (dark pink) is already observed. 7 (In vivo study) At 12 weeks: New bone (dark pink) is present in most of the initial defect, with adipocytic bone marrow, an indicator of mature trabecular 7(In vivo study) bone.

5 Clinical Cases 1: Cervical posteral arthrodesis Pr C Barrey, HCL Lyon This case is a 47-years-old female, with major osteophytic arthritis at C1-C2 joint confirmed on CT scan. She is a smoker with a 50 pack year history. The patient underwent posterior C1-C2 laminectomy with posterior fusion. Bone substitute GlassBONE TM (16cc) was mixed with patient s local bone and then placed between C1 and C2 posterior arches. As early as 3 months post-op, cervical pain decreased by 80%. CT scan demonstrated early fusion with formation of a bone bridge between posteral C1 and C2 vertebras. At 8 and 12 months post-op, a bone bridge of excellent quality was observed with the decreasing of radio-opacity of GlassBONE TM and progressive creation of a bony bridge. No complication was reported. CT scan Post op CT scan at 1 year follow up 2: Ginvivoperiostoplasty Dr M-E Gatibelza, CHU Sud Rennes This case is a 9-years-old female, with an alveolar left cleft of 4,6mm, confirmed on conebeam. Gingivoperiostoplasty was realized in ambulatory, with 1cc of GlassBONE TM mixed with 0,5cc of patient s blood. School could start again 1 week after surgery, and sports 1 month after. Clinical follow up at 1 month and 1 year showed good gingival continuity, stable ConeBeam before surgery ConeBeam at 6 months follow up ConeBeam at 1 year follow up bone volume, no persistent palate or alveolar fistula. Radio follow up at 6 months with cone beam showed progressive integration of the bone substitute. At 1 year follow up, cone beam confirmed a mature bone bridge with same density as adjacent maxillaire and complete resorption of GlassBONE TM. 3: Medio foot Arthodesis Dr F Molinier, Clinique des Cèdres Toulouse This case is a 63-years-old male, with invalidating pain on medio-foot for 6 months. Patient showed arthrosis on torsion movement. Arthrodesis was realized, by using GlassBONE TM bone substitute (5cc). At 6 months follow up, fusion was acquired as shown on XRay. XRay before surgery XRay after surgery XRay at 6 months follow up

6 Substituts osseux bioactifs Reference Granule size Volume GB /05-U mm 0.5 cc GB /1-U mm 1,0 cc GB05.1/05-U 0,5 1,0 mm 0,5 cc GB05.1/1-U 0,5 1,0 mm 1,0 cc GB05.1/5 0,5 1,0 mm 5,0 cc GlassBONE is intended to provide bone substitution to fill, rebuild, merge (fuse) when autologous solutions are not applicable or sufficient, pending the regeneration of the bone. 9 Main indications : ORTHOPAEDIC SURGERY SPINAL SURGERY CMF SURGERY DENTAL SURGERY GB1.3/1-U 1,0 3,0 mm 1,0 cc GB1.3/5 1,0 3,0 mm 5,0 cc GB1.3/10 1,0 3,0 mm 10,0 cc GB1.3/16 1,0 3,0 mm 16,0 cc Injectable Putty GB-IP mm à 0.7 mm 1,0 cc GB-IP mm à 0.7 mm 2,5 cc GB-IP mm à 0.7 mm 5,0 cc GB-IP mm à 0.7 mm 10,0 cc 1. Tsigkou, O. et al. Biomaterials. 2009;30: Oonishi, H. et al. J. Biomed. Mater Res. 2000;51: Jones, J.R. Acta Biomaterialia. 2013;9: Xynos, I.D. et al. Calcif Tissue Int. 2000;67: Hench, L.L. J. Mater Sci: Mater Med. 2006;17: Jell, G. et al. J. Mater Sci : Mater Med. 2006;17: Data on file at Noraker, study on sheep. 8. Hench, L.L. Biomaterials 1998;19: Clinicals and technicals datas on file at Noraker. 10. Datas on file at Noraker : In vitro study GlassBONE, bone graft substitutes are a medical devices class III (CE 0459), manufactured by NORAKER. GlassBONE products are indicated for filling bone defects. Read the instructions supplied with the product for complete information on indications, cons-indications, warnings and precautions, and adverse effects. Last update : 01/2019 = = 1 cc granules 1 cc Putty BIOACTIVE 100% MATERIAL NORAKER is a French manufacturer specialized in the research and development of innovative products based on the 45S5 bioactive glass technology for medical applications. Distributed by: NORAKER 13 Av. Albert Einstein Villeurbanne France Tél : +33 (0) Fax : +33 (0) contact@noraker.com GLB-Brochure-EN-2.3