CRANIOS REINFORCED BONE VOID FILLER The tougher bone cement TECHNICAL MONOGRAPH
INTRODUCTION CRANIOS REINFORCED Bone Void Filler contains reinforcing fibers that impart an increase in toughness* to reduce crack propagation during the setting process. CRANIOS REINFORCED Bone Void Filler is a biocompatible, self-setting calcium phosphate cement intended to fill defects in the restoration or augmentation of the cranial skeleton. It contains reinforcing fibers that impart an increase in toughness* to reduce crack propagation during the setting process. CRANIOS REINFORCED Bone Void Filler also incorporates a sodium hyaluronate solution to enhance viscosity, and improve handling and injection properties. When the cement is fully cured, the composition closely approximates the mineral phase of bone. It is gradually resorbed and replaced with bone during the healing process. * Toughness is defined as a measure of a material s resistance to fracture when stressed. Data on file with DePuy Synthes Companies, mechanical test number FRN test 132. 1 DePuy Synthes Companies CRANIOS REINFORCED Bone Void Filler Technical Monograph
CRANIOS REINFORCED BONE VOID FILLER Indications CRANIOS REINFORCED Fast Set Putty and CRANIOS REINFORCED are indicated for repairing or filling cranial defects and craniotomy cuts with a surface area no larger than 25 cm². CRANIOS REINFORCED Fast Set Putty and CRANIOS REINFORCED are also indicated for the restoration or augmentation of bony contours of the cranial skeleton (including fronto-orbital areas), such as burr hole voids and other cranial defects. Contraindications CRANIOS REINFORCED Fast Set Putty and CRANIOS REINFORCED are not intended for use in the spine and should not be used in the presence of active or suspected infection. CRANIOS REINFORCED Fast Set Putty and CRANIOS REINFORCED are not for use in: patients with traumatic open injuries that are predisposed to infection stress-bearing applications, such as the temporomandibular joint areas where adjacent bone is avascular, or is incapable of supporting or anchoring the implant patients with compromised health (e.g., abnormal calcium metabolism, metabolic bone disease, a recent local untreated infection, vascular or severe neurological disease, infection, immunologic deficiencies, or systemic disorders) that result in poor wound healing or will result in tissue deterioration over the implant site patients who have not reached an age at which skull/facial growth is essentially complete defects contiguous with any of the paranasal sinuses defects greater than 25 cm 2 CRANIOS REINFORCED is not intended for use in the spine Burr hole Cranial defect Temporal bone augmentation Orbital rim Suboccipital cranioplasty Please see Directions for Use for full prescribing indications, contraindications, precautions and warnings. CRANIOS REINFORCED Bone Void Filler Technical Monograph DePuy Synthes Companies 2
CRANIOS REINFORCED BONE VOID FILLER CHEMICAL PROPERTIES Sodium Hyaluronate Solution Sodium hyaluronate solution is a ph-neutral viscous solution that provides enhanced mixing and flow properties for a smooth and easy application. Bioresorbable Fibers The bioresorbable poly(lactide co-glycolide) polymer fibers are randomly oriented and uniformly distributed in the material to impart an increase in toughness.* This incorporation of fibers into the matrix increases the material s resistance to cracking during the setting process. * Toughness is defined as a measure of a material s resistance to fracture when stressed. Mechanical test data on file with DePuy Synthes Companies, mechanical test number FRN test 132. Mechanical test results may not necessarily be indicative of clinical results. Calcium Phosphate Calcium phosphate has been widely used in clinical applications for decades. There are a number of publications and clinical cases available which demonstrate its safety and effectiveness to address bone regeneration.¹, ² 3 DePuy Synthes Companies CRANIOS REINFORCED Bone Void Filler Technical Monograph
CRANIOS REINFORCED Bone Void Filler A COMPOSITION SIMILAR TO BONE Approximation to Bone Once CRANIOS REINFORCED Bone Void Filler is fully cured, the resulting biomaterial formed is carbonated apatite, which has a crystallographic characteristic and chemical composition similar to bone. The carbonate content of carbonated apatite distinguishes CRANIOS REINFORCED Bone Void Filler from hydroxyapatite. Hydroxyapatite does not contain any carbonate; however the carbonate content of CRANIOS REINFORCED Bone Void Filler is 4.0 5.0%, which more closely resembles the composition of bone (Figure 1). CRANIOS REINFORCED Bone Void Filler CNTS/SEC Bone 2 THETA CNTS/SEC Figure 1 2 THETA CRANIOS REINFORCED Bone Void Filler Technical Monograph DePuy Synthes Companies 4
CRANIOS REINFORCED Bone Void Filler The tougher bone cement MECHANICAL PROPERTIES Performance in a Physiological Environment In order to set properly, CRANIOS REINFORCED Bone Void Filler requires a warm, wet environment which reduces the need to limit moisture at the operative site. The setting reaction of CRANIOS REINFORCED Bone Void Filler is isothermic, which does not cause thermal damage to the surrounding tissue. Compressive Strength As the carbonated apatite forms, the compressive strength of the material increases. In approximately 24 hours, CRANIOS REINFORCED Bone Void Filler has achieved its full compressive strength (Figure 2). Compression Load Test 60 50 MPa 40 30 20 10 0 Figure 2 CRANIOS REINFORCED Fast Set Putty CRANIOS REINFORCED Norian CRS Fast Set Putty Norian CRS HydroSet TM (Stryker ) CRANIOS REINFORCED CRANIOS REINFORCED Bone 3 Fast Set Putty Compressive Strength ~35MPa ~25MPa Cancellous Bone 5 7 MPa 5 DePuy Synthes Companies CRANIOS REINFORCED Bone Void Filler Technical Monograph
CRANIOS REINFORCED Bone Void Filler The tougher bone cement FIBERS INCREASE THE MATERIAL S RESISTANCE TO CRACKING Toughness* Three-point bend testing confirms CRANIOS REINFORCED Bone Void Filler to be the tougher* bone cement with an increased ability to resist cracking. Comparison of Material Toughness* 9 8 7 CRANIOS REINFORCED Bone Void Filler Norian CRS Bone Void Filler HydroSet (Stryker) Ceramic materials are brittle in flexural loading; however, the incorporation of bioresorbable fibers into CRANIOS REINFORCED Bone Void Filler increases the material s resistance to fracture during flexural loading when compared to calcium phosphate cements without reinforcing fibers (Figure 3). Stress (MPa) 6 5 4 3 2 1 0 0 0.5 1.0 1.5 2.0 2.5 Strain (mm) Figure 3 CRANIOS REINFORCED Bone Void Filler flexes but does not fail. CRANIOS REINFORCED Bone Void Filler also displayed a high Work of Fracture, which is directly related to the toughness* of the material (Figure 4). Work of Fracture Work of Fracture (J/m 2 ) 700 600 500 400 300 200 100 0 CRANIOS REINFORCED Fast Set Putty CRANIOS REINFORCED Norian CRS Fast Set Putty Norian CRS HydroSet (Stryker) Figure 4 * Toughness is defined as a measure of a material s resistance to fracture when stressed. Mechanical test data on file with DePuy Synthes Companies, mechanical test number FRN test 132. Mechanical test results may not necessarily be indicative of clinical results. CRANIOS REINFORCED Bone Void Filler Technical Monograph DePuy Synthes Companies 6
CRANIOS REINFORCED Bone Void Filler The tougher bone cement ADDITIONAL TOUGHNESS*FOR SEVERAL MONTHS CRANIOS REINFORCED Bone Void Filler has an increased toughness* imparted by the reinforcing fibers that is sustained over a period of several months (Figure 5). When the fibers degrade, the material is equivalent in strength to the previous, Norian CRS Bone Void Filler product. Duration of Increased Toughness* 400 Work of Fracture (J/m ) 2 350 300 250 200 150 100 50 CRANIOS REINFORCED Fast Set Putty Norian CRS Fast Set Putty 0 0 2 4 6 8 10 12 14 Figure 5 Time (months) FIBERS ARE SIGNIFICANTLY RESORBED IN 12 MONTHS Fiber Resorption Over time, the reinforcing fibers begin to degrade through hydrolysis (Figure 6). The relationship between Work of Fracture and the fiber molecular weight test was determined to be directly proportional. Fiber Degradation 90,000 * Toughness is defined as a measure of a material s resistance to fracture when stressed. Mechanical test data on file with DePuy Synthes Biomaterials, mechanical test number FRN test 132. Mechanical test results may not necessarily be indicative of clinical results. Fiber Molecular Weight 80,000 CRANIOS REINFORCED Fast Set Putty 70,000 CRANIOS REINFORCED ROTARY Mix 60,000 50,000 40,000 30,000 20,000 10,000 0 0 2 4 6 8 10 12 14 Figure 6 Time (months) 7 DePuy Synthes Companies CRANIOS REINFORCED Bone Void Filler Technical Monograph
CRANIOS REINFORCED Bone Void Filler The tougher bone cement EASIER TO INJECT Injection For ergonomic reasons, the amount of load required to inject the material out of a syringe should be minimized. An elevated injection force may make it difficult to successfully implant the biomaterial. Each material was injected through a 12 gauge, 10 cm delivery needle (available through DePuy Synthes Companies) during the material s working time. The results of the injection test showed the amount of force required to inject both CRANIOS REINFORCED and Norian CRS to be comparable. While, in contrast, HydroSet (Stryker) required more than twice the injection force to inject (Figure 7). Injection Test Peak Load 35 Peak Load (lbf) 30 25 15 10 5 0 CRANIOS REINFORCED Norian CRS HydroSet (Stryker) Figure 7 CRANIOS REINFORCED Bone Void Filler Technical Monograph DePuy Synthes Companies 8
PRODUCT INFORMATION CRANIOS REINFORCED Fast Set Putty, sterile CRANIOS REINFORCED, sterile 615.03.01S 3 cc 616.03.01S 3 cc 615.05.01S 5 cc 616.05.01S 5 cc 615.10.01S 10 cc 616.10.01S 10 cc Delivery Needles, sterile MXR-US-2000 er 612.40.01S 612.41.01S 612.41.05S 612.42.01S 8 gauge x 10 cm, 1/pkg. 10 gauge x 10 cm, 1/pkg. 10 gauge x 10 cm, 5/pkg. 12 gauge x 10 cm, 1/pkg. 9 DePuy Synthes Companies CRANIOS REINFORCED Bone Void Filler Technical Monograph
REFERENCES 1. Cassidy C, Jupiter JB, Cohen M, Delli-Santi M, Fennell C, Leinberry C, et al. Norian SRS cement compared with conventional fixation in distal radial fractures. A randomized study. J Bone Joint Surg Am. 2003 Nov;85-A:2127 2137. 2. Chang BS, Lee CK, Hong KS, Youn HJ, Ryu HS, Chung SS, et al. Osteoconduction at porous hydroxyapatite with various pore configurations. Biomaterials. 2000;21:1291 1298. 3. Cowin, SC, ed. Bone Mechanics Handbook, 2nd ed. New York, NY: RC Press, 2001. CRANIOS REINFORCED Bone Void Filler Technical Monograph DePuy Synthes Companies 10
Limited Warranty and Disclaimer: DePuy Synthes Biomaterials products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed. WARNING: In the USA, this product has labeling limitations. See package insert for complete information. CAUTION: USA Law restricts these devices to sale by or on the order of a physician. Not all products are currently available in all markets. Manufactured by (United States): Synthes USA Products, LLC 1302 Wrights Lane East West Chester, PA 19380 Telephone: (610) 719-5000 To order: (800) 523-0322 Fax: (610) 251-9056 www.depuysynthes.com DePuy Synthes 2015. All rights reserved. Norian and SRS are trademarks of DSM Biomedical or its affiliates. Stryker Orthopaedics and HydroSet are trademarks of Stryker Corp. or its affiliates. DSUS/MOC/1214/0186 12/15 DV