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AR-5106

Knee

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Der GrafBolt wurde für die tibiale Fixierung eines Weichgewebstransplantats bei Kreuzbandrekonstruktionen entwickelt. Er ist aus PEEK gefertigt und besteht aus einer Hülse und einer passenden Schraube, die beide vollständig kanüliert sind. Das GraftBolt-Instrumentenset beinhaltet Dilatatoren und Instrumente für das Einsetzen und Entfernen der Hülse sowie einen Sechskant-Schraubendreher für das Einbringen der Schraube.

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Fixation Strength of the Arthrex GraftBolt and the Mitek INTRAFIX Objective Methods and Materials Porcine tibias, potted in fi berglass, were used for this study. Double-stranded, 8 mm diameter, bovine extensor tendons were prepared by whipstitching each arm of the double strand confi guration. 45 mm tunnels were drilled into the tibias using an 8 mm drill for a line-to-line fi t. A C-ring and 2.4 mm drill pin were used to maintain tunnel placement accuracy. The samples were prepared by pulling a graft into the socket. With the strands held separated and in tension, the grafts were dilated with a 6 mm Dilator, followed by a 6 mm/ 7 mm stepped Dilator. The 8 mm GraftBolt sheath was inserted between the four tensioned graft strands using the custom driver. A 7 x 28 mm Delta Tapered PEEK Interference Screw was inserted to engage the barbs on the sheath. Mitek INTRAFIX samples were prepared by dilating with the 9 mm INTRAFIX Trial (REF: 254651). The potted tibias were secured to an adjustable angle fi xture positioned in the materials testing machine (Instron 8871), to create pull-to-failure in line with the tunnel, to simulate worst case loading conditions. The tendon loop was secured to the cross-head with a clevis and dowel fi xture. The test set-up is shown in Figure 1. Arthrex Research and Development The purpose of this testing is to determine and compare the mechanical strength characteristics of the Arthrex GraftBolt and the Mitek INTRAFIX. © 2010 Arthrex Inc. All rights reserved. LA0152A Conclusion The mechanical strength characteristics of the Arthrex GraftBolt are, on average, superior to those of the Mitek INTRAFIX. Results The results of the biomechanical testing are listed in Table 1. The lower video tracking displacement of the GraftBolt samples was signifi cantly different than that of the INTRAFIX samples (p = 0.019), as shown in Figure 2. No other comparisons were signifi cantly different, although on average, the GraftBolt had higher values for ultimate load, yield load and the load at 5 mm displacement than the INTRAFIX. Figure 2: The graft displacement at the tibial orifi ce was signifi cantly lower for the GraftBolt. Table 1: Biomechanical testing results of the Arthrex GraftBolt and the Mitek INTRAFIX. Xp and Xe refer to the plastic and elastic displacement, respectively, as measured from the Instron cross-head. The video tracking measured only the displacement of the graft at the tibial tunnel orifi ce. Figure 1: A porcine tibia sample positioned in the Instron for mechanical testing with the digital video camera recording the graft position. The graft was precycled from 10 to 50 N at 1 Hz for 10 cycles, followed by cycling from 50 to 250 N at 1 Hz for 500 cycles. Post-cycling, pull-to-failure was conducted at 20 mm/ min. The ultimate load, yield load, load at 5 mm displacement, stiffness, plastic (Xp) and elastic (Xe) cyclic displacement, Device Samples Size Ultimate Load (N) Yield Load (N) Load @ 5 mm (N) GraftBolt 14 1181 ± 308 1117 ± 301 732 ± 164 Mitek INTRAFIX 13 1004 ± 272 961 ± 273 650 ± 223 Device Stiffness (N/mm) Cyclic Displacement (mm) Video Track (mm)Xp Xe GraftBolt 206 ± 49 1.8 ± 0.4 0.8 ± 0.1 1.0 ± 0.3 Mitek INTRAFIX 201 ± 53 2.2 ± 0.8 0.8 ± 0.1 1.5 ± 0.7 and the mode of failure were recorded for each sample. Additionally, digital video tracking was used to determine the displacement at the fi xation site, as shown in Figure 1. 1.0 1.5 0.0 0.5 1.0 1.5 2.0 2.5 D is pl ac em en t ( m m ) Video Tracking Displacment GraftBolt Mitek Intrafix Video Tracking ement ftBolt itek INTRAFIX

Fixation Strength of the Arthrex GraftBolt® and the Mitek INTRAFIX

GraftBolt®

Driver Shaft, Long, BioComposite Interference Screw, Quick Connect

Schraubendreherschaft für BioComposite Interferenzschraube 235 mm lang

Driver Shaft, Long, BioComposite Interference Screw, Qick Connect

Vástago de destornillador, largo, tornillo interferencial de BioComposite, conexión rápida

Haste de chave, parafuso de interferência BioComposite, conexão rápida

Dilatator, 6 mm, GraftBolt

AR-5106

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AR-5100S

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GraftBolt^®

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