Graftys. Cross-selling. Indications. Comparison. Basic Science. Graftys 415 rue Claude Nicolas Ledoux Aix en Provence Cedex 4

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1 2015 Graftys Cross-selling Indications Comparison Graftys 415 rue Claude Nicolas Ledoux Aix en Provence Cedex 4 Basic Science Graftys QuickSet Training 1

2 Where to use QuickSet? Revision Fracture To fill osteolytic lesions and bone defects. Use of a primary prothesis instead of an augmented prothesis. to fill voids around and under fixation or compression defects. Lower prevalence of loss of fracture reduction. Geodic lesion in revision knee Multi-fragment proximal humeral fracture Less pain. Cavity filling Material removal Osteonecrosis of talus and calcaneum To reach deep cavities To fill osteonecrotic bone defects and benign bone cysts. Dynamic Hip Screw To fill defects after material removal. such as screws, or pins used with navigation or cutting instruments. Graftys QuickSet Training 2 Surgery performed by Pr Sébastien PARRATTE, MD, PhD, Pr JN ARGENSON Department of Orthopedic Surgery, Ste Marguerite Universitary Hospital, Marseille, France

3 QuickSet properties Graftys QuickSet Training 3

4 QuickSet Main advantages Transfer Mix Inject Easy to use Quality bone formation Full range of porosity Helps insure Resorbability Composition close to natural bone Helps insure Osseointegration The unique self-hardening injectable Macroporous Bone graft substitute on the market Graftys QuickSet Training 4

5 QuickSet Main advantages Graftys Resorbability Composition Safe reaction Calcium Phosphate Mix + Water (+ Polymer) Calcium Deficient Apatite Similar to Natural bone crystals Graftys QuickSet Training 5

6 QuickSet Main advantages Full remodelling : Porosity and permeability Pore size Cells size QuickSet Micro <10µm / 88% Meso µm / 2% Macro >100µm Osteoblast : µm Osteoclast : until 100 µm 10% Total 70% Graftys QuickSet Training 6

7 Permeability (preclinical study) QuickSet Main advantages Implante d defect Defect Bone tissue Section level A 10mm long and 9mm diameter defect was created in sheep condyle. The Graftys BGS and Norian SRS was implanted. 1 mm ROI 2 9 mm Bone tissue ROI 1 24 weeks postoperative Photomicrograph - Norian SRS 24 weeks postoperative Photomicrograph - QuickSet Graftys QuickSet Training 7

8 Permeability (preclinical study) QuickSet Main advantages Implante d defect 100,0% 0,4% 1,3% 6,7% 1 mm ROI 2 9 mm Bone tissue ROI 1 30,1% 0,7% Lacuna area density 50,0% 91,6% 27,5% soft tissue area density Bone area density Implant area density 41,7% significant difference 0,0% Norian QuickSet Graftys QuickSet Training 8

9 Compressive strength (MPa) Graftys QuickSet Main advantages Secondary fixation- Mechanical resistance Cancellous Bone StrucSure PMMA 6, 7 cortical bone Compressive strength 4-12 MPa 24 MPa MPa MPa 35,00 30,00 25,00 20,00 15,00 10,00 5,00 0, In the OR Hardening time (Hours) Graftys QuickSet Training 9

10 QuickSet Preparation Transfer Inject Mix Graftys QuickSet Training 10

11 QuickSet Preparation Flexible - Mechanical and chemical phases of the cement Mixing time is the time required for mixing the powder and liquid together in order to obtain a cohesive paste. Working time is the time you can inject and work the product. Hardening time is the time the bone substitute needs to reach its full mechanical properties. 2 min 4 min DO NOT TOUCH 24H Hardening time =24 H (linked to the porosity) Graftys QuickSet Training 11

12 Clinical cases / Tibial plateau Graftys QuickSet Training 12

13 Clinical cases / Tibial plateau Graftys By Pr Sebastien Parratte A complex plateau tibial fracture due to a fall in ski Hypothesis: Using an injectible calcium phosphate bone substitutes Graftys Quickset & HBS may fulfill the plateau tibial defects as a bone void filler and allow early mobilization and functional recovery. Pre operative scan Graftys QuickSet Training 13

14 By Pr Sebastien Parratte Clinical cases / Tibial plateau Post operative AP X-ray Post operative Scan Graftys QuickSet Training 14

15 Clinical cases / Tibial plateau Graftys By Pr Sebastien Parratte Histology at 4 months Graftys QuickSet Training 15

16 Clinical cases / Tibial plateau Graftys By Pr Sebastien Parratte Clinical Good osteointegration of the Graftys HBS and Quickset (in blue) in direct contact with new bone trabeculae (no fibrous interface) A very close intertwining between biomaterial (in blue) in degradation process and mineralized lamellar bone (in brown) Presence of osteoblastic cells (cuboid) in relation to osteoid borders in mineralizing process In direct contact, osteoclastic cells (multinuclear cells) are resorbing the biomaterial Presence of numerous blood vessels Graftys QuickSet Training 16

17 Clinical cases / Tibial plateau Graftys By Pr Sebastien Parratte Clinical results: Painfree for the ADL Cycling OK Flexion 120 Extension 0 Stable Radiological results: Fracture healing Restoration of the articular congruency 8 months post operative AP & ML X-Rays Graftys QuickSet Training 17

18 By Pr Sebastien Parratte Biopsy at 1year and 10 months Clinical cases / Tibial plateau X 10 Biomaterial Mineralized lamellar bone Osteoid border 200 µm Graftys QuickSet Training 18

19 Clinical cases / Tibial plateau Graftys By Pr Sebastien Parratte 2 years postoperative AP & ML X-Ray Graftys QuickSet Training 19