chronos Bone Void Filler. Beta-Tricalcium Phosphate ( β-tcp) bone graft substitute.

Transcription

1 chronos Bone Void Filler. Beta-Tricalcium Phosphate ( β-tcp) bone graft substitute. Osteoconductive Resorbable Synthetic

2 chronos Bone Void Filler chronos granules and preforms are synthetic, porous, osteoconductive, resorbable calcium phosphate bone substitutes, which can replace autogenous bone. chronos eliminates the need for autologous bone harvesting, thus reducing overall patient morbidity. chronos granules and preforms are manufactured in a clean-room environment from a biocompatible, radiopaque material, beta-tricalcium phosphate (β-tcp). This material contains two of the main mineral constituents of bone, calcium and phosphorous. chronos has been clinically used in Europe for more than 20 years under the name CEROS 82. Replaced with bone in 6-18 months, chronos is ideal for many bone void filler applications. Due to its synthetic manufacturing process, chronos shows reliable and standardized biomechanical properties. The compressive strength of chronos averages ~5 MPa, and is similar to that of human cancellous bone. Postoperative, 6 weeks Postoperative, 12 months High tibial osteotomy treated with a proximal tibial plate and chronos (Dr. Wymengy, Nijmegen, Netherlands) Synthes chronos Bone Void Filler

3 Indications and Contraindications Indications chronos is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. chronos is indicated for use in the treatment of bony defects created surgically or through traumatic injury. chronos is intended to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine, and pelvis) and may be combined with autogenous blood and/ or bone marrow. Following placement into the bony void, chronos resorbs and is replaced with bone during the healing process. Contraindications* chronos should not be used in: The presence of infection, e.g. inflammatory, bacterial bone diseases (post-traumatic or chronic osteomyelitis) and soft-tissue infections Defects in the region of unclosed epiphyseal cartilage (i.e. fractures of the growth plate) Segmental defects of long bones Areas which are subjected to excessive impact or stress Areas where there is significant vascular impairment proximal to the graft site The presence of metabolic or systemic bone disorders that affect bone or wound healing *For complete indications, contraindications, adverse events and cautions, please see the complete Directions for Use. Synthes

4 Features Biocompatible and safe Biocompatibility is defined as a material s property to be compatible with a biological system. The biocompatibility depends primarily on the material s chemical composition, its three-dimensional structure and its surface topography. Histologic verification: Simultaneous resorption and new bone formation osteoblasts (dark blue) osteoid (blue) chronos (gray) bone (purple) Bone is a composite material consisting mainly of calcium and phosphate, the two main components of chronos. Calcium phosphate minerals have been widely used as bone substitute materials. chronos is made from pure β-tcp and is free of any cytotoxic effects. chronos meets the requirements of ASTM standard F1088, Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation. In addition, chronos has passed tests for biocompatibility. chronos at 12 weeks, in a rabbit critical-sized defect model in the advanced stages of resorption. The remaining material is interwoven with osteoid and mineralized bone. Osteoblasts and osteoid seams are visible. Synthes chronos Bone Void Filler

5 Engineered for osteoconductivity 35 Provides scaffold To facilitate the bone healing process, bone void fillers should at least be osteoconductive. This is mainly influenced by three factors: overall porosity, interconnection of macropores and presence of micropores. chronos has been designed to optimize these features so that it can closely mimic cancellous bone and provide an ideal scaffold for bony infiltration. The compressive strength of chronos is approximately 5 MPa, which is similar to cancellous bone. Overall porosity chronos has a total porosity of approximately 60% for the granules and 70% for the preforms. A high porosity enhances the osteoconductivity, although a porosity that is too high weakens the material s compressive strength. chronos benefits from the highest possible degree of porosity without compromising the mechanical strength. Distribution % < Pore Size (μm) Figure 1. Distribution of chronos macropores >500 Macropores The macropores of chronos are mainly distributed within a range of 100 μm 500 μm (Figure 1). This offers the optimal environment for vascularization and bony infiltration. 1 In addition, the macropores are interconnected to allow bone formation throughout the entire implant (Figure 2). Micropores chronos contains micropores, which are spaces within the material smaller than 10 μm. The microporosity increases the surface area where new bone forms and allows circulation of body fluids (Figure 3). 1 mm Figure 2. chronos macrostructure 30 μm Figure 3. chronos microstructure 2 1. Gazdag, A.R, J. M. Lane, D. Glaser and R.A Foster, Alternatives to autogenous bone graft: efficiency and indications. J Am Acad Orthop Surg 3(1): Microstructure of chronos (Source: Dr. M. Bohner, RMS Foundation; Dr. G. Richards, AO Research) Synthes

6 Features continued Feature Benefit Advantage Osteoconductive Provides a scaffold for bony ingrowth Gives bone cells a path upon which to lay down new host bone Fully synthetic No risk of disease transmission Ease of mind for patients; no religious or ethical concerns Standardized pore sizes macropores: 100 μm 500 μm Optimal environment for Promotes bone formation throughout vascularization and bony infiltration the entire implant, not just at the periphery micropores: <10 μm Increases surface area where new bone forms and allows circulation of fluids throughout the implant Resorbs in 6 18 months Resorption rate is similar to the Replaced with bone in a timely manner regeneration of new bone Radiopaque Enables visualization of implant Easy to see on radiograph to verify position correct placement Can be mixed with blood and Osteogenic cells are naturally found Increases biological activity at defect site bone marrow aspirate (BMA) in BMA Ready to use off the shelf Avoids morbidity and risk of complications Less pain to patient from second surgical site Guaranteed sufficient quantity of bone No concerns about quality and graft substitute quantity of harvested autograft Shortens OR time OR cost reduction 60 70% porous Provides optimal structure for bony Three-dimensional integrity of chronos ingrowth without loss of stability is not compromised (~5 MPa compressive strength) Synthes chronos Bone Void Filler

7 Product Information chronos Blocks chronos β-tricalcium Phosphate Blocks, sterile 10 mm S S Dimensions 12.5 mm x 12.5 mm x 10 mm 20 mm x 20 mm x 10 mm 20 mm 20 mm chronos Wedges, rectangular chronos β-tricalcium Phosphate Wedge, rectangular, sterile Angle Dimensions S 10º 6.5 mm x 25 mm x 20 mm S 14º 8 mm x 25 mm x 20 mm S 18º 10 mm x 25 mm x 20 mm S 22º 12 mm x 25 mm x 20 mm 25 mm 6.5 mm 20 mm chronos Wedges, semi-circular chronos β-tricalcium Phosphate Wedge, semi-circular, sterile Angle Dimensions S 7º 7 mm x 25 mm x 35 mm S 10º 10 mm x 25 mm x 35 mm S 13º 13 mm x 25 mm x 35 mm 35 mm 7 mm 25 mm Synthes

8 Product Information continued chronos Granules, medium chronos β-tricalcium Phosphate Granules, medium, sterile Granule Size Volume S 1.4 mm 2.8 mm 5.0 cc S 1.4 mm 2.8 mm 10.0 cc S 1.4 mm 2.8 mm 20.0 cc chronos Granules, large chronos β-tricalcium Phosphate Granules, large, sterile Granule Size Volume S 2.8 mm 5.6 mm 5.0 cc S 2.8 mm 5.6 mm 10.0 cc S 2.8 mm 5.6 mm 20.0 cc Synthes chronos Bone Void Filler

9 Also Available Bone Marrow Aspiration System features A compact, self-contained system for aspirating autologous bone marrow to augment bone graft substitute products Sterile-packaged in a disposable kit for single-procedure use Indications The Bone Marrow Aspiration System is indicated for aspirating bone marrow. Note: Please refer to the Bone Marrow Aspiration System Technique Guide for additional information. Synthes

10 Synthes (USA) 1302 Wrights Lane East West Chester, PA Telephone: (610) To order: (800) Fax: (610) Synthes (Canada) Ltd Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) To order: (800) Fax: (905) Synthes, Inc. or its affiliates. All rights reserved. chronos and Synthes are trademarks of Synthes, Inc. or its affiliates. Printed in U.S.A. 6/12 J8766-C