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PAN1-00020-DE | A | Rekonstruktionen von Knorpeldefekten - Mikrofrakturierung

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Rekonstruktionen von Knorpeldefekten - Mikrofrakturierung

Orthobiologics

Product

Procedure

Die extrazelluläre Matrix BioCartilage wurde entwickelt, um eine reproduzierbare, einfache und kostengünstige Methode zur Ergänzung traditioneller Verfahren der Mikrofrakturierung bereitzustellen. Die aus Allograft-Knorpel entwickelte BioCartilage-Matrix enthält die extrazelluläre Matrix, die natürlicherweise in Gelenkknorpel vorkommt, sowie einige Hauptkomponenten wie Typ-II-Kollagen, Proteoglykane und zusätzliche kartilaginäre Wachstumsfaktoren. Die BioCartilage-Matrix dient als Gerüst, das über einem mikrofrakturierten Defekt platziert wird und als Bindegewebe autologe zelluläre Interaktionen auslösen sowie den Grad und die Qualität der Gewebeheilung in einem sorgfältig präparierten Gelenkknorpeldefekt verbessern kann.

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BioCartilage® Extracellular Matrix 02 I BioCartilage Extracellular Matrix 03BioCartilage Extracellular Matrix I *The tissue was stained after dehydration, before micronization Figure 1. Immunohisto- chemistry staining for type II collagen* Figure 2. Proteoglycan content as evidenced by the presence of interterritorial granular matrix via toluidine blue staining* Figure 3 Attachment of Progenitor Cell to BioCartilage ECM Figure 4 Composition ■ BioCartilage extracellular matrix (ECM) contains the ECM that is native to articular cartilage including key components such as type II collagen (Figure 1), proteo- glycans (Figure 2), and additional cartilaginous growth factors ■ After processing, the dehydrated allograft cartilage has a particle size of 100-300 microns: • The small particle size improves its injectable nature after it is mixed with an autologous blood solution, allowing easier delivery to the defect site • The small particle size also increases the surface area, providing attachment sites for the patient’s bone marrow cells (Figures 3 and 4 depict the ability of progenitor cells to attach to BioCartilage ECM) ■ The principle of BioCartilage ECM is to serve as a scaffold over a microfractured defect, providing a tissue network that can potentially signal autologous cellular interactions ■ Marrow elements will travel through the microfracture holes and interact with the scaffold created by BioCartilage ECM instead of being expected to create its own fibrin scaffold as typically anticipated from a marrow stimulation procedure Processing ■ BioCartilage ECM goes through a specialized, gentle dehydration process (hypothermic dehydration) that allows the water content to be removed, while remaining in a liquid state instead of requiring the tissue, including the water, to be frozen before removal (lyophilization) ■ After dehydration, the cartilage goes through a number of proprietary processing steps, resulting in a very consistent particle size range ■ BioCartilage ECM is then aseptically processed and packaged to allow for ambient temperature storage with a shelf life of 5 years Features and Benefits BioCartilage® Extracellular Matrix 04 I BioCartilage Extracellular Matrix BioCartilage® Technique Guide Perform the following steps using aseptic technique. Please refer to the directions for use packaged with the product for a full list of warnings and instructions on BioCartilage ECM. Pull back on the mixing element to bring it back to its starting position. Snap the pushrod back onto the mixing element. Remove the funnel and add an autologous blood solution into the mixing syringe with a 1:0.8 ratio (BioCartilage ECM to blood). Twist on the syringe cap and luer cap. Unsnap the pushrod from the mixing element by pressing on the tip of the mixing element with counter- pressure on the tip of the pushrod. To mix the BioCartilageECM and autologous blood solution, push and pull the mixing element back and forth while rotating it in a repeated left-to-right motion. Continue until thoroughly mixed. Apply a delivery needle and dispense the BioCartilage mixture out of the mixing syringe into the needle. Use the obturator to deliver the mixture from the needle to the defect. Remove the syringe cap and snap on the funnel to the end of the syringe. Make sure the plunger is at the end of the syringe, then empty the BioCartilage ECM from its container into the funnel. 5 6 2 3 4 7 1 Ankle Delivery Needle ABS-1000-S Hip Delivery Needle ABS-1000-H Knee Delivery Needle ABS-1000-L Mixing and Delivery Syringe Perform bone marrow stimulation using standard microfracture technique. A PowerPick™ device may be used to perform this procedure while applying irrigation fluid to avoid thermal necrosis. Dry the defect thoroughly. After mixing the BioCartilage ECM with an autologous blood solution (1:0.8 ratio) within the mixing syringe, apply the mixture into the defect. Smooth out BioCartilage ECM within the defect. Ensure that the BioCartilage ECM is flush or slightly recessed when compared to the surrounding articular cartilage. BioCartilage® Knee Arthrotomy Surgical Technique 3 4 2 Debride the articular cartilage defect to a stable border with perpendicular margins. A scalpel can be used to create the vertical margins and a curette can be used to debride the calcified cartilage layer at the base of the defect. 1 05 The BioCartilage knee techniques were developed in collaboration with Brian Cole, MD, MBA (Chicago, IL) BioCartilage Extracellular Matrix I At the completion of surgery, a knee immobilizer locked in extension is placed and the patient is made non weight-bearing or protected weight- bearing with delayed onset of range- of-motion for up to one week post- operatively. Thereafter, standard rehabilitation protocols may be implemented. 6 Apply fibrin over the top of the BioCartilage ECM. Use enough to cover the defect, but prevent over- usage as this will cause the construct to sit proud in the joint. Do not manipulate for 5 minutes after application. The knee may be gently ranged before closure to assure BioCartilage ECM adherence. 5 06 Perform bone marrow stimulation using the PowerPick™ device. After microfracture, ensure the use of a tourniquet, aspirate the arthroscopic fluid, and dry the cartilage defect with the cannulated swabs. A Gemini™ cannula should be used in the portal that resides over the defect. The BioCartilage ECM can be applied over the defect with the arthroscopic delivery needle (mixing in a 1:0.8 ratio with autologous fluid). The elevator component on the arthroscopic delivery needle can be used to smooth out the BioCartilage ECM within the defect so that it remains flush or slightly recessed to the surrounding cartilage. 3 4 2 Debride the articular cartilage defect to a stable border with perpendicular margins. A ring curette and Cobb elevator can be used to also debride the calcified cartilage layer at the base of the defect. Optionally, the fat pad retractor may be used to contain the fat pad and aid in distracting the joint. 1 I BioCartilage Extracellular Matrix BioCartilage® Knee Arthroscopic Surgical Technique Apply a light layer of fibrin over the BioCartilage ECM through a dual- lumen applicator tip; prevent over usage as this will cause the construct to sit proud. Do not manipulate for 5 minutes after application. The knee may be gently ranged before closure to assure BioCartilage ECM adherence. 5 At the completion of surgery, a knee immobilizer locked in extension is placed and the patient is made non weight-bearing or protected weight- bearing as determined by defect location with delayed onset of range- of-motion for up to 1 week post- operatively. Thereafter, standard rehabilitation protocols may be implemented. 6 07BioCartilage Extracellular Matrix I Perform bone marrow stimulation using PowerPick™ device. Aspirate all arthroscopic fluid and dry the cartilage defect with the cannulated swabs. After mixing the BioCartilage ECM with an autologous blood solution (1:0.8 ratio) within the mixing syringe, apply the mixture into the defect using the arthroscopic delivery needle. The elevator component on the arthroscopic delivery needle can be used to smooth out the BioCartilage ECM within the defect. Ensure that the BioCartilage ECM remains flush or slightly recessed when compared to the surrounding cartilage. BioCartilage® Ankle Arthroscopic Surgical Technique 3 4 2 Under tourniquet control, apply 4 mm of distraction to the tibiotalar joint. Debride the articular cartilage defect to create stable margins. A ring curette can be used to create vertical margins and debride the base. Optionally, the fat pad retractor may be used to aid in distracting the joint. 1 The BioCartilage ankle technique was developed in collaboration with Eric Giza, MD (Sacramento, CA), and James McWilliam, MD (New York, NY) At the completion of surgery, the ankle is immobilized in neutral position and the patient is made non weight-bearing. Thereafter, standard rehabilitation protocols may be implemented. 6 Apply fibrin over the BioCartilage ECM through a dual-lumen applicator tip. Avoid applying too much fibrin to prevent the construct from sitting proud. The ankle may be gently ranged before closure to assure BioCartilage ECM adherence. 5 08 I BioCartilage Extracellular Matrix Complete recipient site preparation by creating stable borders with perpendicular margins. Various curettes may be used to create vertical margins and remove the calcified cartilage layer. A standard microfracture pick may be utilized to perform the marrow stimulation procedure. BioCartilage® Hip Arthroscopic Surgical Technique 3 2 Debride the articular cartilage defect using an arthro- scopic shaver in oscillate mode. Use the GraftNet™ device, in line with shaver and suction, to capture the articular cartilage fragments for subsequent steps in the procedure. 1 Withdraw the recovered autograft tissue and mix in a 1:1:1 ratio with BioCartilage ECM and autologous fluid to prepare the composite articular cartilage graft. Assemble the mixing syringe with the hip delivery cannula and fill the cannula with the BioCartilage mixture. 4 09BioCartilage Extracellular Matrix I BioCartilage® Hip Arthroscopic Surgical Technique (Cont.) Aspirate the arthroscopic fluid using the provided suction adapter. Using the ArthroPaddle™ feature of the delivery device, deliver and smooth the BioCartilage mixture into the defect, taking care not to overfill the defect. 6 Apply a thin layer of fibrin over the BioCartilage graft. Maintain a dry joint and do not manipulate the joint for approximately 5 minutes. Standard microfracture rehabilitation protocols may be used. 7 10 Product Description Item Number BioCartilage® Extracellular Matrix, 0.75 cc ABS-1007-BC BioCartilage Extracellular Matrix, 1 cc ABS-1010-BC Mixing and Delivery Kit, large joint (Includes mixing syringe and arthroscopic delivery needle, obturator, funnel, fat pad retractor, and cannulated swabs) ABS-1000-L Mixing and Delivery Kit, small joint (Includes mixing syringe and cap, arthroscopic delivery needle, obturator, funnel, fat pad retractor, and cannulated swabs) ABS-1000-S Mixing and Delivery Kit, hip joint (Includes mixing syringe and cap, arthroscopic delivery needle, obturator, funnel, fat pad retractor, and cannulated swabs) ABS-1000-H Recommended Accessories GraftNet™ Autologous Tissue Collector ABS-1050 PowerPick™ XL, 45°, 6 mm depth AR-8150PX-45 Gemini™ SR8 Cannula AR-6572 Switching Stick, 2.6 mm × 305 mm AR-6572S Chondral Pick, straight 30° tip AR-8655-05 Ring Curette, reverse angle AR-8655-04 Noninvasive Ankle Distractor Set AR-1713S Ankle Arthroscopy Distractor Strap AR-1712 Ankle Arthroscopy Set AR-8655S Ordering Information I BioCartilage Extracellular Matrix 11 1. Cheng N, Estes B, Awad H,et al. Chondrogenic differentiation of adipose-derived adult stem cells by a porous scaffold derived from native articular cartilage extracellular matrix. Tissue Engineering. 2009;15(2):231-41. doi:10.1089/ten.tea.2008.0253 2. Chadha N, Dang A, Sampson E, et al. Porous cartilage-derived matrix scaffolds for repair of articular cartilage defects. ORS 2012 Annual Meeting. Poster No. 0735, Volume: Transactions Vol 36. 3. Malinin T, Temple HT, Carpenter EM. Induction of regeneration of articular cartilage defects by freeze-dried particulate cartilage allografts. Cartilage. Aug, 2009;(1 Suppl):93-164. doi:10.1177/194760350900101S03 References BioCartilage Extracellular Matrix I 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 or outcomes. View U.S. patent information at www.arthrex.com/corporate/virtual-patent-marking © 2020 Arthrex, Inc. All rights reserved. | www.arthrex.com | LB1-0850-EN_H BioCartilage is manufactured and distributed by UMTB Biomedical, Inc. www.umtb.com

BioCartilage® Extracellular Matrix

BioCartilage® extracellular matrix provides a reproducible, simple and inexpensive method to augment marrow stimulation procedures. BioCartilage matrix is developed from allograft cartilage and contains the extracellular matrix that is native to articular cartilage. This animation shows how BioCartilage matrix may interact and potentially signal autologous cellular interactions to improve the degree and quality of tissue healing within a properly prepared articular cartilage defect.

Brian J. Cole, MD, MBA (Chicago, IL), presents recent published data on multicenter, prospective, and clinically significant outcomes of using BioCartilage® extracellular matrix to treat cartilage defects in the knee, including a two year postoperative success rate of 97.9%.1 Dr. Cole discusses how BioCartilage extracellular matrix can be used in conjunction with microfracture to improve patient outcomes and how it fits into treatment algorithms for patients with articular cartilage defects.
Reference:
1. Cole BJ, Haunschild ED, Carter T, et al. Clinically significant outcomes following the treatment of focal cartilage defects of the knee with microfracture augmentation using cartilage allograft extracellular matrix: a multicenter prospective study. Arthroscopy. 2021;37(5):1512-1521. doi:10.1016/j.arthro.2021.01.043

Treatment of Cartilage Defects in the Knee Using BioCartilage® Allograft

Jack Farr II, MD, (Indianapolis, IN) and Brian Cole, MD, MBA, (Chicago, IL) review the treatment options for small articular cartilage lesions. The available treatment options include debridement, marrow stimulation with the PowerPick™ instrument, Osteochondral Autograft Transplantation (OATS® technique) and BioCartilage® Cartilage Extracellular Matrix to augment a traditional microfracture or marrow stimulation procedure.

Treatment Options for Small Articular Cartilage Lesions

Asheesh Bedi, MD, (Ann Arbor, MI) demonstrates the use of BioCartilage® extracellular matrix to treat acetabular cartilage defects. Several technical pearls are demonstrated including the ideal portals and approach, intraoperative surgical planning, as well as implantation techniques of BioCartilage extracellular matrix.

BioCartilage® Extracellular Matrix Mixing and Delivery Advancements in the Hip

BioCartilage® extracellular matrix was designed to provide a reproducible, simple, and inexpensive method to augment traditional microfracture procedures. It is developed from allograft cartilage that has been dehydrated and micronized. BioCartilage matrix contains the extracellular matrix that is native to articular cartilage, including key components such as type II collagen, proteoglycans, and additional cartilaginous growth factors. The principle of BioCartilage matrix is to serve as a scaffold over a microfractured defect, providing a tissue network that can potentially signal autologous cellular interactions and improve the degree and quality of tissue healing within a properly prepared articular cartilage defect.

BioCartilage® Allograft Repair of the Ankle

BioCartilage® Extracellular Matrix Scientific Update BioCartilage extracellular matrix was designed to provide a reproducible, simple and inexpensive method to augment traditional microfracture procedures. BioCartilage matrix is developed from allograft cartilage and contains the extracellular matrix that is native to articular cartilage including key components such as type II collagen, proteoglycans and additional cartilaginous growth factors. The principle of BioCartilage matrix is to serve as a scaffold over a microfractured defect providing a tissue network that can potentially signal autologous cellular interactions and improve the degree and quality of tissue healing within a properly prepared articular cartilage defect. Scientific articles highlighting the benefits of BioCartilage extracellular matrix: 2016 BioCartilage improves cartilage repair compared with microfracture alone in an equine model of full-thickness cartilage loss. Am J Sports Med. 2016;44(9):2366-2374. doi:10.1177/ 0363546516648644. • In an equine animal study comparing microfracture to BioCartilage extracellular matrix, it was shown that BioCartilage matrix with PRP safely improved the cartilage repair. • Outcome measures in the study included ICRS repair score, histologic scores for repair-host integration, base integration, and formation of type II collagen, as well as MRI analysis. The histological scores comparing BioCartilage extracellular matrix to microfracture indicated how it can improve the quality of repair tissue in a properly prepared articular cartilage defect. 2014 Treatment of osteochondral lesions of the talus with marrow stimulation and micronized allograft cartilage matrix: an all arthroscopic technique. Techniques Foot Ankle Surg. 2014;13(3):167-173. doi:10.1097/BTF.0000000000000056. • This publication is a case series that highlights several key aspects of the procedure, technique pearls, rehabilitation protocol and clinical outcomes. • With an average follow-up of 12 months, 7 of 9 patients reported “excellent” outcomes with no functional limitations. Two patients reported “good” results but had occasional pain; however, neither required further surgical intervention. 2013 BioCartilage: background and operative technique. J Operative Techniques in Sports Medicine. 2013;21(2):116-124. doi:10.1053/j.otsm.2013.03.008. • This article highlights the limitations of microfracture and the premise of using a biologic, allogeneic scaffold to augment microfracture procedures. • Key discussion points are introduced, including the product features and handling characteristics; surgical technique pearls, rehabilitation protocols, and frequently asked questions. 2009 Clinical efficacy of the microfracture technique for articular cartilage repair in the knee: an evidence-based systematic analysis. Am J Sports Med. 2009;37(10):2053-2063. doi:10.1177/ 0363546508328414. • In this review article, the authors present 28 studies describing 3122 patients treated with microfracture. The average follow-up was 41 months, with 5 studies reporting outcomes of 5 years or more. • Mithoefer, et al found that microfracture alone provides effective short-term functional improvement of knee function with several shortcomings including limited hyaline repair tissue, variable repair cartilage volume and tissue deterioration over time. While underreported in low level studies, Level 1 clinical studies indicate microfracture failure rates are greater than 25%. • The authors further state the following, leading us to conclude that BioCartilage extracellular matrix is an excellent option that may improve the long term outcomes of microfracture by improving the tissue quality that forms in an articular cartilage defect. —“Repair cartilage quality significantly reduced the risk for subsequent revision and no revisions were required in knees with the best histological repair cartilage quality.” Fortier LA, Chapman HS, Pownder SL, et al. Desai S Abrams GD, Mall NA, Fortier LA, Roller BL, Cole BJ Mithoefer K, McAdams T, Williams RJ, Kreuz PC, Mandelbaum BR Procedure Videos BioCartilage® Mixing and Delivery Advancements in the Knee • Jason M. Scopp, MD, (Salisbury, MD) demonstrates the updated BioCartilage Extracellular Matrix Mixing and Delivery Kit. The new components aid in the visualization of the joint, preparation of the lesion and arthroscopic delivery of BioCartilage extracellular matrix. BioCartilage® Mixing and Delivery Advancements in the Ankle • James McWilliam, MD, (New York, NY) demonstrates the updated BioCartilage Mixing and Delivery Kit. The new components aid in the visualization of the joint, preparation of the lesion and arthroscopic delivery of BioCartilage extracellular matrix. Surgical Technique Animations BioCartilage® Cartilage Extracellular Matrix • This animation shows how BioCartilage extracellular matrix may interact and potentially signal autologous cellular interactions to improve the degree and quality of tissue healing within a properly prepared articular cartilage defect. BioCartilage® Utilization within the Knee • The principle of BioCartilage extracellular matrix is to serve as a scaffold over a microfractured defect, providing a tissue network that can potentially signal autologous cellular interactions and improve the degree and quality of tissue healing within a properly prepared articular cartilage defect. Product and Technique Highlights Fat Pad Retractor • The Fat Pad Retractor is compatible with the PassPort Button™ cannula and is an ideal tool for creating working space when implanting BioCartilage extracellular matrix or performing other arthroscopic procedures in the knee or ankle. Patient Education Animations Ankle Cartilage Repair with BioCartilage® Technique Knee Cartilage Repair with BioCartilage® Technique © 2017 Arthrex, Inc. All rights reserved. LA1-00065-EN_A

BioCartilage® Extracellular Matrix Scientific Update

Extrazelluläre Matrix BioCartilage®

Child (D)

Knee

Die Mikrofrakturierung ist eine chirurgische Technik zur Rekonstruktion von Gelenkknorpel, bei der feine Frakturen erzeugt werden, um die Bildung von Faserknorpel zu initiieren. Arthrex bietet Produkte wie u. a. den PowerPick für eine effektive, sichere und reproduzierbare Durchführung der Mikrofrakturierung.

Mikrofrakturierung

Imaging and Resection

Mit dem für das APS II-Shaversystem entwickelten PowerPick und PowerPick XL lassen sich Mikrofrakturierungen schnell und einfach durchführen. Der PowerPick weist eine Bohrtiefe von 4 mm, der PowerPick XL eine Bohrtiefe von 6 mm auf. Diese zusätzliche Tiefe von 2 mm erlaubt eine ausreichende Penetration des subchondralen Knochens, falls eine senkrechte Positionierung der Bohrspitze nicht möglich sein sollte. Der PowerPick eignet sich außerdem hervorragend zur Ausmessung osteochondraler Defekte, da die Vorderkante der Lasermarkierung, die sich 5 mm vom Schaftende entfernt befindet, als Referenzpunkt verwendet werden kann. Weiterhin kann bei ACL-Rekonstruktionen mit der Bohrspitze die Position des femoralen Bohrkanals in der Femur-Notch markiert werden. Mithilfe der 2 mm breiten Lasermarkierung kann durch Platzierung des Schaftendes in Over The Top-Position die ungefähre Position des Bohrkanals durch das mediale Portal festgelegt werden. Die Hinterkante der Lasermarkierung, die sich 7 mm vom Schaftende entfernt befindet, dient als Referenzpunkt für das Zentrum des Bohrkanals bei Durchführung einer ACL-Rekonstruktion in Single Bundle-Technik. Die Vorderkante der Lasermarkierung, die sich 5 mm vom Schaftende entfernt befindet, dient als Referenzpunkt für das Zentrum des posterioren Bohrkanals bei Durchführung einer ACL-Rekonstruktion in Double Bundle-Technik. Nach Markierung der Position wird dieselbe Messmethode angewendet, um ausgehend von dem zuvor markierten posterioren Bohrkanal die Position des Zentrums des anterioren Tunnels zu ermitteln. Alle PowerPick-Ausführungen haben eine Arbeitslänge von 13 cm und einen Bohrdurchmesser von 1.5 mm. Der PowerPick ist mit um 30° und 45° abgewinkelten Spitzen erhältlich. Der PowerPick XL verfügt über eine um 45° abgewinkelte Spitze.

Stephen S. Burkhart, MD, (San Antonio, TX) uses knotless BioComposite™ SwiveLock® with FiberTape® to complete a strong, low profile, double-row supraspinatus repair that reconstructs the rotator cuff footprint and maximizes contact between the tendon and bone. He demonstrates the use of FiberLink® sutures to address potential dog ears. Dr. Burkhart also highlights the use of the side-loading FastPass Scorpion™ SL to easily pass and retrieve sutures and uses a PowerPick™ to prepare a bleeding bone bed in the rotator cuff footprint.

SpeedBridge™ Rotator Cuff Repair Cadaveric Demonstration

The OrthoIllustrated® animation for bone marrow stimulation - knee microdrilling is an educational tool to help patients better understand this procedure.

Microfracture with PowerPick™ Device

Thomas M. DeBerardino, MD, (San Antonio, TX) chooses the PowerPick™ device for all lesions prior to placing BioCartilage® matrix to enhance healing. Dr. DeBerardino prefers the PowerPick device because of the quick and repeatable one-handed process. He also shares that the PowerPick device reduces skiving as opposed to the typical dull, reusable pick that requires assistance with a mallet.

Articular Cartilage Preparation Using the PowerPick™ Instrument

In this surgical technique video, Peter Millett, MD, (Vail, CO) discusses the use of the PowerPick in the treatment of an articular cartilage lesion of the femoral condyle. The PowerPick produces 1.5 mm holes rapidly and in close proximity to one another, helping to prevent damage to surrounding bone and healthy cartilage, making it the ideal tool for treating articular cartilage defects.

Arthrex PowerPick™ Microfracture of a Femoral Condyle Lesion

Chris Dougherty, DO, FAOAO, (Bentonville, AR) provides an in-depth review of options and techniques for treating cartilage defects of the patella and why he uses BioCartilage in his practice. BioCartilage was designed to provide a reproducible, simple and inexpensive method to augment traditional microfracture procedures. The principle of BioCartilage is to serve as a scaffold over a microfractured defect, providing a tissue network that can potentially signal autologous cellular interactions.

Rekonstruktionen von Knorpeldefekten - Mikrofrakturierung

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Orthobiologie

Extrazelluläre Matrix BioCartilage^®

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Knie

Mikrofrakturierung

Operationsverfahren

Bildgebung & Resektion

PowerPick™

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