Norian Drillable: A Competitive Analysis

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1 : A Competitive Analysis Evan Jacobson, M.S. ABSTRACT This study demonstrates the functional properties of and other currently marketed calcium phosphate cements. The functional properties of are similar to the other products when evaluating the compressive strength, setting time, and injectability. The material s toughness* is the property that distinguishes from other products. is 2 3 times tougher than other calcium phosphate cements, which allows for the product to be drilled, tapped, and have a screw placed through it. INTRODUCTION Overview is a biocompatible, fiber reinforced calcium phosphate bone void filler that is intended to be placed into bony voids either before or after final fixation. When fully set, it closely approximates the mineral phase of bone. is made of three key components: calcium phosphate powder, polylactide/glycolide copolymer fibers, and sodium hyalu ronate solution. The calcium phosphate converts in vivo to form carbonated apatite, closely resembling the mineral phase of bone. It is gradually resorbed and replaced with bone during the natural healing process. Calcium phosphate has been widely used in clinical applications for decades, resulting in the availability of many publications and clinically demonstrating its safety and efficacy to address bone regeneration. 1 The bioresorbable polylactide/ glycolide copolymer fibers are uniformly distributed and randomly oriented within the material, providing an increase in toughness which reduces crack propagation and allows for the material to be drilled and tapped. Finally, the sodium hyaluronate solution is a ph-neutral solution that increases viscosity, leading to improved mixing and flow properties. INDICATIONS is intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure. Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process. is intended to be placed in bony voids either before or after final fixation. *Toughness is defined as a measure of a material's resistance to fracture when stressed. Data on file with Synthes.

2 CONTRAINDICATIONS The safety and effectiveness of this device for use in the spine has not been established Use of this device is contraindicated in the spine, including use in the pedicle, as this could be associated with leakage of the device material into the bloodstream, which could cause serious adverse events, including death is not intended for use in the spine and should not be used in the presence of active or suspected infection is not for screw augmentation is not for use in: Patients with traumatic open injuries that are predisposed to infection Stress bearing applications Areas where adjacent bone is avascular, or is incapable of supporting or anchoring the implanted rigid fixation hardware 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 are skeletally immature Vertebral compression fractures Intra-articular space (i.e. material injected into the joint space) Please refer to the instructions for use for a complete list of indications, contra indications, warnings and precautions. STUDY OBJECTIVES & METHODS This study characterized the mechanical properties of, Fast Set Putty (FSP),, Fast Set Putty (FSP), and Stryker. There were four (4) tests that were performed to characterize the products: Compression Test* Indentation Test (Setting time)* ion Test* Three Point Bend Test* COMPRESSION TEST A compression test measures the compressive strength of a material. The compressive strength is the capacity of a material to withstand direct axial compressive loading/forces. In this test, a load is imparted on the material until it fails. The compressive strength (stress) is calculated by dividing the maximum compressive load by the cross-sectional area of the sample. Each material was prepared to create compression cylinders. These samples were cured in 37 C phosphate buffered saline (PBS) for 24 hours and tested to measure the compressive strength. Three dies of each material were prepared for a total of 21 samples. *Mechanical test results are not necessarily indicative of clinical performance. Data on file with Synthes.

3 IDENTATION TEST (SETTING TIME) To establish the setting time of these materials, a sample is prepared and at predetermined time points, the load imparted on the sample is measured. The material is considered set when it achieves either 3 lbf (hand mixed materials) or 9 lbf (machine mixed materials). Each material was prepared to create cylindrical samples. These samples were cured in 37 C PBS (time dependant on product s literature) and then the compressive load was measured. Three mixes were prepared for a total of 9 samples. The time points are as follows: : 8 1 minutes FSP: 3 5 minutes : 8 1 minutes FSP: 3 5 minutes : 3 5 minutes INJECTION TEST This test was conducted on those materials that are stated to be injectable (,, ). The injection force is important to the ergonomics of injectable implants. Elevated injection forces may make it difficult to successfully implant the biomaterial. Previous internal studies have demonstrated that a load exceeding 25 lbf is difficult to manually inject. Each material was mixed and loaded into the Delivery Syringe. A 12 gauge, 1 cm delivery needle was then attached to the delivery needle. Testing was conducted after the dwell time listed below. : 5 minutes post mix : 5 minutes post mix : 4 minutes from start of mixing THREE POINT BEND TEST A three point bend test measures the flexural strength of a material. From the flexural test, the material s toughness can also be established. Work of fracture is a quantitative way of expressing a material s toughness, or the ability of a material to resist crack propagation. To determine the work of fracture, a stress-strain curve is generated during the three point bend test. From this curve, the material s toughness or work of fracture can be calculated by integrating the curve and dividing it by the cross-sectional area of the sample. Each of the materials were prepared to create a rectangular block. These samples were cured for 24 hours and tested to measure the work of fracture. Three molds were prepared for a total of 18 samples.

4 RESULTS Compression Test Each product was filled into three compression dies making 21 individual samples. The average compressive strength ranged from a minimum of MPa ( FSP) to a maximum of MPa ( Rotary Mix) (Figure 1). FSP,, and had average compressive strengths of MPa, MPa, and 26.3 MPa, respectively, which are all clinically similar. 6 Comp. Stress (MPa) FSP FSP Figure 1. Compression Test Indentation Testing (Setting Time) The indentation test evaluates the compressive load at the identified setting time of a material. Three mixes from each of the materials were evaluated at three time points defined as the set time in the product literature. FSP, FSP and were all evaluated between 3 and 5 minutes in 37 C PBS. The average loads at this time for FSP, FSP and were lbf, 86.6 lbf, and lbf, respectively (Figure 2). 25 Comp. Load at.5 in (lbf) FSP FSP Figure 2. Indentation Test

5 These three materials would meet the acceptance criterion of 3 lbf at 5 minutes for FSP and are all clinically similar. and were measured at 1 minutes which is identified as the set time. had a load of lbf, whereas had a load of lbf, both of which met the acceptance criterion ( 9 lbf). ion Test The injection test evaluated the maximum load required to deliver the material from the syringe. The first analysis evaluating the peak load demonstrated that and require similar loads to inject the materials out a syringe, ranging from lbf ( ) to lbf ( ) (Figure 3). At bf required to inject, was more than 2x higher than and. All materials were measured in triplicate within the working time defined in the product s literature Peak Load (lbf) Figure 3. ion Test Three Point Bend Test Each product was filled into three molds making 18 individual samples. The average work of fracture ranged from a minimum of J/m2 ( FSP) to a maximum of J/m2 ( ) (Figure 4). 7 Work of Fracture (J/m 2 ) FSP FSP Figure 4. Three Point Bend Test

6 , FSP and were all clinically similar with average work of fractures of J/m2, J/m2, and J/m2, respectively. The products had a magnitude higher work of fracture compared to the other products, 41.5 J/m2 ( FSP) and J/m2 ( ). There is a magnitude difference in the range, which is directly related to the toughness of the materials (Figure 5). Ceramic materials are brittle in flexural loading, but the added fibers in FRN increase the toughness compared to other ceramics.,, Stryker (Stryker) Stress (MPa) Strain (mm) Figure 5. Comparison of Material Toughness CONCLUSIONS The functional testing demonstrated that although the five products have some similar characteristics, there are distinct differences between the products. The compressive strength of and were higher than the other three devices that are mixed by hand. All products were found to be higher than cancellous bone (~5 7 MPa) 2. The setting time test showed at the time defined in the product literature, all of the materials met the standards for setting. All other products were set between 5 and 1 minutes in 37 C PBS. For ergonomic reasons, the amount of load required to inject the material out of syringe should be minimized as much as possible. and required similar loads to inject the material, but required more than 2 times those loads. The three point bend test displayed the largest difference between the products and the other ceramics. The average work of fracture of the products was 2 3 times higher than the other products. This increase demonstrated that the products have a higher material toughness and an increased ability to resist cracking.

7 References 1. Bajammal S, Zlowodzki M, Lelwica A, Tornetta P III, Einhorn T, Buckley R, Leighton R, Russell T, Larsson S, Bhandari M. The Use of Calcium Phosphate Bone Cement in Fracture Treatment. A Meta-Analysis of Randomized Trials. Journal of Bone and Joint Surgery 28; 9: Cowin, S.C., ed. Bone Mechanics Handbook. 2nd ed. New York, NY: CRC Press, Print. 212 Synthes, Inc. or its affiliates. All rights reserved. Stryker and are trademarks of Stryker Corporation or its affiliates. is a trademark of Kensey Nash or its affiliates. Synthes is a trademark of Synthes, Inc. or its affiliates. Printed in U.S.A. 7/12 J11497-A

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