Finished Product

AR-1416T

Knee

Product

Das Allograft-OATS-Instrumentarium vereinfacht die Entnahme großer osteochondraler / hyaliner Knorpelzylinder aus Spenderknochen. Nach Platzierung des Kondylus in der Arbeitsstation wird der Kern mit dem Hohlmeißel (Donor) entnommen. Mit dem Hohlmeißel (Recipient) der entsprechenden Größe wird eine Fassung angelegt, die 0.5 mm kleiner (im Durchmesser) ist als der Spenderzylinder. Mit einer Tiefenskala wird die exakte Tiefe des Allografts ermittelt, damit es mit dem Empfängerloch übereinstimmt. Das Allograft wird an die richtige Größe und Neigung angeglichen. Durch Dilatation des Empfängerlochs kann nach Einsetzen des Allografts ein bündiger Abschluss erreicht werden. Das endgültige Einsetzen des Allografts erfolgt mit einem diametrisch größeren Stößel. Das Ergebnis ist ein plan abschließendes Transplantat, das dank der Press-Fit-Technik keine Fixierungsimplantate erforderlich macht.

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Allograft OATS System for Articular Cartilage Restoration ® Surgical Technique Introducing the Allograft OATS® System for Cartilage Resurfacing Surgical Technique There are few treatment options for patients with large, symptomatic lesions of osteoarticular surfaces. The use of fresh osteochondral allografts for osteoarticular resurfacing allows a surgeon to match the contour and cartilage morphology of the recipient site, while avoiding multiple surgical sites and the possible donor-site morbidity associated with recovering an autograft from the knee. Fresh osteochondral allografts are stored in a proprietary storage nutrient media at 4˚ C to maintain chondrocyte viability. The results of fresh osteochondral allografts are well documented and provide reliable outcomes when restoring articular cartilage.1-3 Allograft OATS Instrument Set 02 | Allograft OATS System for Articular Cartilage Restoration Surgical Technique 1 Following standard preoperative examination and diagnostic studies to confirm the size and extent of the lesion, perform a standard parapatellar arthrotomy to expose the defect. Select the appropriate Cannulated Allograft OATS sizers to estimate and approximate coverage of the lesion. 3 Once the appropriate size match has been confirmed with the sizer, return to the recipient site and place the sizer over the defect, staying perpendicular to the condyle surface. Advance a drill-tip guide pin through the sizer into bone. Create a circumferential mark around the cylinder. Remove the sizer and place a reference mark in a superior 12 o’clock position. 2 Place the sizer used to establish the recipient defect size over the allograft condyle to ensure the allograft is large enough for the defect site and then mark it circumferentially. Remove the sizer and place a reference mark in a superior 12 o’clock position on the graft. 4 Select the appropriate recipient site reamer and loosen the wingnut. Advance the reamer to the desired depth of the recipient site and secure the wing nut. Assemble the appropriately sized recipient scorer with the quickconnect t-handle and 2.4 mm guide pin, then use it to score the articular cartilage to the subchondral bone. Allograft OATS System for Articular Cartilage Restoration | 03 Surgical Technique (Cont.) 5 3 Secure the recipient site reamer with depth-stop to the drill and place it over the drill-tip guide pin. Drill the counterbore into the defect and subchondral bone to the desired depth, typically 5 to 8 mm. Confirm bleeding subchondral surfaces. 7 Take depth measurements of the created socket from four quadrants (12, 3, 6, and 9 o’clock) and record them for use when creating the allograft core. 04 | Allograft OATS System for Articular Cartilage Restoration 6 4 Thread the appropriately sized Allograft OATS® dilator onto the slap hammer and insert it into the recipient’s socket site to achieve a 0.5 mm socket dilation. Advance the dilator until it has completely seated fully into the socket. Operate the slap hammer to remove the dilator. 8 Secure the donor allograft in the Allograft OATS workstation. Place the appropriately sized Allograft OATS workstation bushing into the articulating arm housing and secure it. Move the articulating arm over the graft and set to the exact angle necessary to match the recipient’s contour. Use the OATS sizer to confirm you are perpendicular to the graft. Securely fasten the housing using the hexagon bolt and cheater bar. Surgical Technique (Cont.) 9 Connect the Allograft OATS® donor harvester, with a collared guide pin, to a drill and pass it into the proximal graft housing to rest on the graft’s surface. Drill the harvester to a depth of 15 mm to 20 mm and then remove it. Advance a sagittal saw perpendicularly through the condyle at the approximate depth of the reaming and continue until the core releases. An alternative method would be to ream through the entirety of the allograft and use the collared guide pin to gently extract the graft. 11 An alternative approach to adjust the length of the allograft core is to assemble the depth seat post with the depth-stop feature from the recipient site reamer. The appropriately sized cartilage protector pad is assembled with the depth seat post and depth-stop feature. 10 Mark the depths recorded from the recipient socket on the four quadrants of the graft, then draw a circumferential mark on the bone. Secure the graft in the Allograft OATS holding forceps and use a saw to slowly trim it to achieve the appropriate length of bone to ensure a press-fit in the recipient socket. The allograft should be positioned with the articular surface inferior to cut. The bony aspect of the allograft should be pulse lavaged. 12 Place the allograft plug cartilage down, toward the cartilage protector pad, and the rotate the depth-stop feature to the desired depth. Once fixed in the workstation, a saw may be used to remove the excess bone and to achieve the desired length of allograft plug. Allograft OATS System for Articular Cartilage Restoration | 05 Surgical Technique (Cont.) 13 Bulletize the graft with a ronguer to assist with insertion. The allograft bone may be soaked in autologous conditioned plasma prior to implantation. A thin layer of demineralized bone matrix (DBM) may be applied to the recipient socket to make slight adjustments as needed. Match the graft reference mark with the recipient reference mark for orientation. Advance the graft with firm pressure into the socket. A tamp may be used as needed to achieve complete insertion. 14 Advance the graft until flush with the surrounding cartilage. The Allograft OATS® graft retriever may be used to facilitate extraction of the graft in the event minor adjustments need to be made. References 1. Sadr KN, Pulido PA, McCauley JC, Bugbee WD. Osteochondral allograft transplantation in patients with osteochondritis dissecans of the knee. Am J Sports Med. 2016;44(11):2870-2875. doi:10.1177/0363546516657526 2. Krych AJ, Pareen A, King AH, Johnson NR, Stuart MJ, Williams 3rd RJ. Return to sport after the surgical management of articular cartilage lesions in the knee: a meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2017;25(10):3186-3196. doi:10.1007/s00167-016-4262-3 3. Bugbee W, Cavallo M, Giannini S. Osteochondral allograft transplantation in the knee. J Knee Surg. 2012;25(2):109-116. doi:10.1055/s-0032-1313743 06 | Allograft OATS System for Articular Cartilage Restoration Ordering Information Accessories Product Description Item Number Product Description Item Number Allograft OATS® Instrument Set RAR-4058MS Arthrex ACP® Double-Syringe System ABS-10010S Allograft OATS Disposable Set RAR-4058MS-D AlloSync™ DBM Gel, 1 cc ABS-2013-01 AlloSync DBM Gel, 5 cc ABS-2013-05 Disposable Kits provided with RAR-4058MS: Product Description Item Number Allograft OATS Disposable Kit, 15 mm ABS-4057D-15 Allograft OATS Disposable Kit, 18 mm ABS-4057D-18 Allograft OATS Disposable Kit, 20 mm ABS-4057D-20 Allograft OATS Disposable Kit, 22.5 mm ABS-24057D-225 Allograft OATS Disposable Kit, 25 mm ABS-4057D-25 Allograft OATS Disposable Kit, 27.5 mm ABS-4057D-275 Allograft OATS Disposable Kit, 30 mm ABS-4057D-30 Allograft OATS Disposable Kit, 35 mm ABS-4057D-35 Allograft OATS Disposable Kit Allograft OATS Instrument Set Allograft OATS System for Articular Cartilage Restoration | 07 This description of technique is provided as an educational tool and clinical aid to assist properly licensed medical professionals in the usage of specific Arthrex® products. As part of this professional usage, the medical professional must use their professional judgment in making any final determinations in product usage and technique. In doing so, the medical professional should rely on their own training and experience, and should conduct a thorough review of pertinent medical literature and the product’s directions for use. Postoperative management is patient-specific and dependent on the treating professional’s assessment. Individual results will vary and not all patients will experience the same postoperative activity level and/or outcomes. View U.S. patent information at www.arthrex.com/corporate/virtual-patent-marking © 2020 Arthrex, Inc. All rights reserved. | www.arthrex.com | LT1-0175-EN_I

Allograft OATS® System for Articular Cartilage Restoration

S. Clifton Willimon, MD (Atlanta, GA), demonstrates the treatment of a capitellar osteochondral defect using the OATS® 2.0 system and a precut osteochondral allograft core. Dr. Willimon uses an anconeous approach to the defect and shares several technical pearls for achieving excellent fit and congruity with the surrounding articular cartilage.

video

Capitellar OCD Treatment Using the OATS® 2.0 System

Brian D. Giordano, MD, and P. Christopher Cook, MD, FRCSC, (Rochester, NY) provide a cadaveric demonstration of an open allograft OATS® procedure of the femoral head using the Arthrex® Allograft OATS instrumentation. In this demonstration, they outline the technique for an open surgical dislocation with a trochanteric osteotomy to gain access to the joint space. They provide an overview of the necessary steps to perform this procedure to replace the damaged cartilage of a lesion in the anterior superior region of the femoral head.

Femoral Head Allograft OATS® Technique

Brian J. Cole, MD, MBA (Chicago, IL), provides a demonstration of the Allograft OATS® instrumentation and disposable kit features and benefits. Several technical pearls are included, as well as an introduction to a new vice workstation and additional accessories provided in the instrument trays.

Advancements in Fresh OCA Techniques and Instrumentation

Allograft-OATS®, groß

Child (D)

Orthobiologics

Riley J. Williams III, MD, (New York, NY) provides a cadaveric demonstration of a cartilage restoration procedure using 16 mm precut osteochondral allograft (OCA) cores. Dr. Williams highlights the single-use Allograft OATS® instrumentation to prepare the site for placement of the 16 mm core. Dr. Williams also shows a technique for implanting a second 16 mm OCA core next to the primary repair.

Allograft OATS® Technique Femoral Transplantation Using a Fresh, Precut 16 mm OCA Core

Brian D. Giordano, MD, (Rochester, NY) outlines 2 different cases and his rationale for using various surgical techniques to treat cartilage defects of the femoral head. In this case presentation, he describes his reasoning for using biocompression screws to refixate the cartilage versus implanting an allograft femoral plug using the allograft OATS® system.

Allograft OATS® of the Femoral Head

Jeffrey Macalena, MD, (Minneapolis, MN) presents a case study on a patient treated with distal femoral osteotomy, meniscal allograft and fresh osteochondral allograft.

Distal Femoral Osteotomy with Meniscal Allograft and Fresh Osteochondral Allograft Transplantation

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.

White Papers

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

Hudson-Quick-Lock T-Handgriff

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Allograft-OATS^®, groß

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Allograft-OATS^®, groß

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GraftBolt^®

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