chronos BOne VOid Filler Beta-Tricalcium Phosphate (b-tcp) bone graft substitute

Transcription

1 chronos BOne VOid Filler Beta-Tricalcium Phosphate (b-tcp) bone graft substitute

2 chronos Bone Void Filler Osteoconductive Resorbable Synthetic chronos Granules and Preforms are synthetic, porous, osteoconductive, resorbable calcium phosphate bone substitutes, which can replace autogenous bone. chronos Bone Graft Substitute 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 (b-tcp). This material contains two of the main mineral constituents of bone, calcium and phosphorous. chronos Bone Graft Substitute has been clinically used in Europe for more than 20 years under the name CEROS 82. Replaced with bone in 6 to 18 months, chronos Bone Graft Substitute is suitable for many bone void filler applications. Due to its synthetic manufacturing process, chronos Beta-Tricalcium Phosphate shows reliable and standardized biomechanical properties. The compressive strength of chronos Beta-Tricalcium Phosphate 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 Preforms (Dr. Wymengy, Nijmegen, Netherlands) DePuy Synthes Trauma 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: x The presence of infection, e.g. inflammatory, bacterial bone diseases (post-traumatic or chronic osteomyelitis) and soft-tissue infections x Defects in the region of unclosed epiphyseal cartilage (i.e., fractures of the growth plate) x Segmental defects of long bones x Areas which are subjected to excessive impact or stress x Areas where there is significant vascular impairment proximal to the graft site x 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. chronos Bone Void Filler DePuy Synthes Trauma

4 Features Biocompatible 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 osteoid (blue) osteoblasts (dark blue) chronos Beta-Tricalcium Phosphate (gray) bone (purple) Bone is a composite material consisting mainly of calcium and phosphate, the two main components of chronos Beta-Tricalcium Phosphate. Calcium phosphate minerals have been widely used as bone substitute materials. chronos Bone Graft Substitute is made from pure b-tcp and is free of any cytotoxic effects. chronos Beta-Tricalcium Phosphate meets the requirements of ASTM standard F1088, Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation. In addition, chronos Beta-Tricalcium Phosphate has passed tests for biocompatibility. chronos Beta-Tricalcium Phosphate 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. DePuy Synthes Trauma chronos Bone Void Filler

5 Features Engineered for osteoconductivity 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 Beta-Tricalcium Phosphate thas 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 Beta-Tricalcium Phosphate is approximately 5 MPa, which is similar to cancellous bone. Overall porosity chronos Beta-Tricalcium Phosphate 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 Beta-Tricalcium Phosphate benefits from the highest possible degree of porosity without compromising the mechanical strength. Distribution % < >500 Pore Size (µm) Figure 1. Distribution of chronos Beta-Tricalcium Phosphate macropores Macropores The macropores of chronos Beta-Tricalcium Phosphate 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). 1 mm Figure 2. chronos Beta-Tricalcium Phosphate macrostructure Micropores chronos Beta-Tricalcium Phosphate 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). Figure 3. chronos Beta-Tricalcium Phosphate microstructure 2 30 µm 1. Gazdag AR, Lane JM, Glaser D, Foster RA. Alternatives to autogenous bone graft: efficiency and indications. J Am Acad Orthop Surg. 1995;3(1): Microstructure of chronos (Source: Dr. M. Bohner, RMS Foundation; Dr. G. Richards, AO Research) chronos Bone Void Filler DePuy Synthes Trauma

6 Features 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 from Ease of mind for patients human tissue 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 rate of 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 Sufficient quantity of bone graft No concerns about quality and 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 Beta-Tricalcium Phosphate is not (~5 MPa compressive strength) compromised DePuy Synthes Trauma chronos Bone Void Filler

7 PrOduCT information chronos Blocks chronos b-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 b-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 b-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 chronos Bone Void Filler DePuy Synthes Trauma

8 Product information chronos Granules, medium chronos b-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 b-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 DePuy Synthes Trauma chronos Bone Void Filler

9 also available PROCURE Bone Marrow Aspiration Kit features x a compact, self-contained system for aspirating autologous bone marrow to augment bone graft substitute products x Sterile-packaged in a disposable kit for single-procedure use Indications The PrOCure Bone Marrow aspiration Kit is indicated for aspirating bone marrow. Note: Please refer to the PROCURE Bone Marrow Aspiration Kit Technique Guide for additional information. chronos Bone Void Filler DePuy Synthes Trauma

10 CAUTION: USA Law restricts these devices to sale by or on the order of a physician. Manufactured by (United States): Synthes USA Products, LLC 1302 Wrights lane east West Chester, Pa Telephone: (610) To order: (800) Fax: (610) depuy Synthes Trauma, a division of doi all rights reserved. dsus/moc/0514/ /14 dv