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Below is a collection of resources&nbsp;for you&nbsp;to&nbsp;learn more about the&nbsp;latest innovative products and techniques in minimally invasive orthopedics.

AAOS 2024 Annual Meeting: Orthobiologics Feature Products

Orthobiologics

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A document containing information about Arthrex products and product lines.

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Quick Facts IntraOsseous BioPlasty® Technique (IOBP® Technique) Subchondral bone marrow lesions (BMLs) are important to identify and treat, as they are highly predictive of total knee arthroplasty (TKA)1 BMLs can result from1: Subchondral insufficiency 57% 97% Increased chance of a patient needing TKA within two years if BMLs are left untreated2 Greater intraosseous pressures measured in medial and lateral femoral condyles of patients with BMLs than in patients without BMLs3 fractures Osteoarthritis Avascular necrosis Core decompression (CD) alone is not effective at treating necrotic lesions4 Success at 5-Year Follow-up Acute trauma 77% Chronic trauma Delayed bone union Osteoporosis Bone repair after BMA injection was observed in 88% of patients5 Before and After IOBP Procedure 10 100 90 8 80 70 6 60 5 50 40 4 30 2 0 P ain Visual Analog Scale (VAS) I nternational Knee Documentation Committee (IKDC) Before After 20 10 0 Before After The IOBP technique is associated with clinically significant improvements in pain and function3 arthrex.com © 2021 Arthrex, Inc. All rights reserved. LI1-000152-en-US_B CD and BMA CD alone Achieve Joint Preservation Through Comprehensive Treatment of BMLs: 1.19% At 15-year (on average) follow-up, treatment with cell therapy resulted in per-year revision rates similar to TKA (1.19% versus 1.0%, respectively)6 27% Multiple kit options tailored to treat BMLs of the knee, hip, and talus IOBP core decompression device has a 3.3 mm diameter that can achieve a 7 mm cortex-sparing decompression The IOBP technique includes use of the Arthrex Angel® cPRP and bone marrow processing system and AlloSync™ Pure demineralized bone matrix to encourage bone remodeling and repair Simple procedure with a low complication rate; patients can bear weight as tolerated, allowing them an early return to function and activities of daily living7,8 References 1. Bonadio MB, Filho AGO, Helito CP, Stump XM, Demange MK. Bone marrow lesion: image, clinical presentation, and treatment. Magn Reson Insights. 2017;10:1178623X17703382. doi:10.1177/1178623X17703382 2. Tanamas SK, Wluka AE, Pelletier JP, et al. Bone marrow lesions in people with knee osteoarthritis predict progression of disease and joint replacement: a longitudinal study. Rheumatology (Oxford). 2010;49(12):2413-2419. doi:10.1093/ rheumatology/keq286 3. Kasik CS, Martinkovich S, Mosier B, Akhavan S. Short-term outcomes for the biologic treatment of bone marrow edema of the knee using bone marrow aspirate concentrate and injectable demineralized bone matrix. Arthrosc Sports Med Rehabil. 2019;1(1):e7-e14. doi:10.1016/j. asmr.2019.07.001 4. Gangji V, De Maertelaer V, Hauzeur JP. Autologous bone marrow cell implantation in the treatment of non-traumatic osteonecrosis of the femoral head: five year follow-up of a prospective controlled study. Bone. 2011;49(5):1005-1009. doi:10.1016/j.bone.2011.07.032 5. Hernigou PH, Mathieu G, Poignard A. Percutaneous autologous bone-marrow grafting for nonunions. Surgical technique. J Bone Joint Surg Am. 2006 Sep;88 Suppl 1 Pt 2:322-7. doi:10.2106/JBJS.F.00203 6. Hernigou P, Delambre J, Quiennec S, Poignard A. Human bone marrow mesenchymal stem cell injection in subchondral lesions of knee osteoarthritis: a prospective randomized study versus contralateral arthroplasty at a mean fifteen-year followup. Int Orthop. 2021;45(2):365-373. doi:10.1007/s00264-020-04571-4 7. Martin JR, Houdek MT, Sierra RJ. Use of concentrated bone marrow aspirate and platelet rich plasma during minimally invasive decompression of the femoral head in the treatment of osteonecrosis. Croat Med J. 2013;54(3):219224. doi:10.3325/cmj.2013.54.219 8. Tanamas SK, Wluka AE, Pelletier JP, et al. Bone marrow lesions in people with knee osteoarthritis predict progression of disease and joint replacement: a longitudinal study. Rheumatology. 2010;49(12):2413-2419. doi:10.1093/rheumatology/keq286

IntraOsseous BioPlasty® Technique

Spine

Michael R. Baria, MD (Columbus, OH), discusses the cellular components and growth-factor content of platelet-rich plasma (PRP) prepared using the Angel® cPRP processing system.&nbsp;

video

Surgeons presenting one or more clinical cases

Case Presentation - Videos

Vídeos apresentações de casos

Video presentaciones de casos

Case Presentation Videos

Cellular Components and Growth-Factor Content of PRP From the Angel® cPRP System

This animation demonstrates BoneSync™ calcium phosphate cement for augmentation of poor-quality bone surrounding lateral-row anchors during a FiberTak® SpeedBridge™ rotator cuff repair.&nbsp;

A general overview including the relevant steps of an Arthrex surgical technique. These animations always include a voice-over explaining the process.

OP-Anleitung Animationen

Animações — Técnica cirúrgica

Animaciones de técnicas quirúrgicas

Surgical Technique Animations

BoneSync™ Calcium Phosphate Cement Animation

Knee

SpeedGraft Achilles Tendon ® Product Highlight Product Description Additional Features and Benefits A preshaped, predrilled, and presutured achilles tendon allograft for use in ACL reconstruction procedures. No donor-site morbidity 3-year shelf life 10 -6 sterility assurance level Presutured soft tissue for use with FastThread™ PEEK interference screws Preshaped and predrilled bone block Multiple sizing options available: Diameters: 9 mm-10.5 mm Lengths: 78 mm-113 mm Presutured ACL Tendon Allograft Fixation Options Femoral Fixation TightRope® Attachable Button System (ABS) fixation can be used in connection with any graft type. The TightRope II BTB implant with FiberTape® anchors for use with the InternalBrace™ technique or TightRope II BTB implant with additional flipping suture are great options for femoral fixation. The TightRope constructs can be assembled around closed-end grafts such as the PilotGraft™ BTB tendon and SpeedGraft® Achilles bone block. ACL TightRope II Implant Tibial Fixation Ideal for tibial fixation of soft-tissue and patellar tendon grafts, FastThread interference screws can be inserted quickly, provide strength, and are designed to protect the graft. FastThread BioComposite Interference Screw FastThread PEEK Interference Screw The InternalBrace surgical technique is intended only to augment the primary repair/reconstruction by expanding the area of tissue approximation during the healing period and is not intended as a replacement for the native ligament. The InternalBrace technique is for use during soft tissue-to-bone fixation procedures and is not cleared for bone-to-bone fixation. arthrex.com PilotGraft BTB is a trademark of JRF Ortho. © 2023-02 Arthrex, Inc. All rights reserved. DOC1-000969-en-US_B

SpeedGraft® Achilles Tendon

A list of scientific articles pertaining to a product or procedure.

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Atualizações científicas

Actualizaciones científicas

Scientific Updates

AutoCart™ Procedure Scientific Update A review of design rationale, techniques, and outcomes Cartilage defects primarily occur in areas of articular joints that experience biomechanical joint loading. After a traumatic event or if degeneration progresses, these defects can become painful and may limit daily activities. Since chondrocytes of articular cartilage have limited native healing capacity, autologous chondrocyte transplantation has been described as a potential treatment to repair these defects. The GraftNet™ device for autologous cartilage collection augmented with BioCartilage® extracellular matrix allograft and microfracture—also known as the AutoCart procedure—allows for a single-stage implantation procedure. The limitations of microfracture alone are well known, and chondrocyte differentiation is a risk with other twostage autologous chondrocyte implantation procedures that require cellular expansion in a laboratory setting. The articles below showcase data relating to the principles of the AutoCart procedure, current clinical outcomes, results of competitor two-stage autologous chondrocyte implantation, and the cost analysis of each treatment. Technique Principles of Single-Stage Autologous Cartilage Implantation Cole BJ, Farr J, Winalski CS, et al Outcomes after a single-stage procedure for cell-based cartilage repair: a prospective clinical safety trial with 2-year follow-up. Am J Sports Med. 2011;39(6):1170-1179. doi:10.1177/0363546511399382 Analyzed safety and clinical outcomes of a single-stage cartilage autograft implantation system. At 24 months, the single-stage autograft technique provided significantly improved patient outcomes on the IKDC and KOOS scales compared to microfracture alone. Single-stage autografting showed a decreased incidence of intralesional osteophyte formation at 6- and 12-month follow-ups. Takeaway Compared to microfracture alone, single-stage autograft cartilage implantation provides superior patient outcomes and less negative outcomes associated with osteophyte formation. 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 Determined short-term outcomes of allograft extracellular matrix augmentation for focal cartilage defects of knees with microfracture. Safe and an effective treatment with a 2.1% failure rate, clinically significant minimally clinically important difference (MCID) of 90%, and a patient acceptable symptomatic state (PASS) of 85% at a 2-year follow-up. Patients reported a decrease in incidences of pain that led to a reduction in daily activities and work compared to preoperative values, with an 80% rate of return to functions of daily living at a 2-year follow-up. Takeaway Cartilage allograft extracellular matrix for focal cartilage defects appears to be safe, with a minimal failure rate and satisfactory patient-reported outcomes at a 2-year follow-up. Beletsky A, Naveen NB, Tauro T, et al Microdrilling demonstrates superior patient-reported outcomes and lower revision rates than traditional microfracture: a matched cohort analysis. Arthrosc Sports Med Rehabil. 2021;3(3):e629-e638. doi:10.1016/j.asmr.2020.10.006 Comparison of patient-reported outcomes and revision rates of standard microfracture using an awl versus microdrilling. Microdrilling achieved a significant difference in MCID at 1 year compared to microfracture and >80% for KOOS, QOL, and SF12 PCS scores. Microfracture achieved ≤60% for both categories. At 3-year follow-up, microdrill reoperation rate was half that of microfracture (41.2% and 20.6% respectively). Takeaway The microdrilling technique showed improved patient clinical outcomes up to a 1-year follow-up, and decreases in revision rates and subsequent procedures at a 3-year follow-up. Levinson C, Cavalli E, Sindi DM, et al Chondrocytes from device-minced articular cartilage show potent outgrowth into fibrin and collagen hydrogels. Orthop J Sports Med. 2019;7(9):2325967119867618. doi:10.1177/2325967119867618 Investigated the effect of arthroscopic minced cartilage collection on chondrocyte viability and migration potential of chondrocytes into a surrounding matrix. After 7 days of growth, chondrocyte viability was similar to hand mincing and a biopsy punch of intact cartilage. Chondrocytes had similar migration into the surrounding matrix regardless of collection by device or hand mincing. Takeaway The chondrocytes from resected cartilage maintained their viability at a comparable level to an intact punch of cartilage. Chondrocytes show the ability to migrate to surrounding area regardless of mincing type. Acevedo L, Iselin L, Berkelaar MHM, et al Comparison of human articular cartilage tissue and chondrocytes isolated from peripheral versus central regions of traumatic lesions. Cartilage. 2021;13(2_suppl):68S-81S. doi:10.1177/1947603520958154 Analyzed minced cartilage from the central and peripheral regions of traumatic joint injuries for tissue quality, viability, and proliferation capability. Peripheral cartilage had similar cellularity and proliferation rate as central cartilage samples. Peripheral cartilage had increased cartilage quality, while central cartilage had an increase in cartilage viability. However, peripheral cell viability was still at 96.8%—well above the acceptable percentage for implantation. Takeaway Peripheral cartilage surrounding a traumatic lesion may provide cartilage with high quality, acceptable chondrocyte viability, acceptable cellularity, and proliferative potential. Tsuyuguchi Y, Nakasa T, Ishikawa M, et al The benefit of minced cartilage over isolated chondrocytes in atelocollagen gel on chondrocyte proliferation and migration. Cartilage. 2021;12(1):93-101. doi:10.1177/1947603518805205 Analyzed the capability of minced cartilage and isolated chondrocytes embedded in atelocollagen gel for chondrocyte proliferation, migration, and matrix production potential. Histologically, minced cartilage showed a higher capacity for migration into gel than the isolated chondrocytes. In immunohistochemistry analysis, minced cartilage showed higher matrix content, cellular proliferation, and anabolic potential than isolated chondrocytes. Takeaway Minced cartilage placed into a gel scaffold appears to have greater potential for regenerating tissue from its chondrocytes than isolated cartilage. de Windt TS, Sorel JC, Vonk LA, Kip MMA, Ijzerman MJ, Saris DBF Early health economic modelling of single-stage cartilage repair. Guiding implementation of technologies in regenerative medicine. J Tissue Eng Regen Med. 2017;11(10):2950-2959. doi:10.1002/term.2197 Analyzed cost-effectiveness of a single-stage cartilage regeneration technique. In early modeling, single-stage autologous chondrocyte implantation is more than 2.5x more cost-effective than two-stage procedures when accounting for quality-adjusted life years (QALY). If long-term clinical outcome data continues to show the single-stage procedure is superior, it may prove to be even more cost effective than two-stage procedures. Takeaway Early health economic modeling shows single-stage cartilage repair is significantly more cost effective than two-stage repair when accounting for QALY. Long-term data may increase this discrepancy. Limitations of Two-Stage Autologous Chondrocyte Implantation Darling EM, Athanasiou KA Rapid phenotypic changes in passaged articular chondrocyte subpopulations. J Orthop Res. 2005;23(2):425-432. doi:10.1016/j.orthres.2004.08.008 Investigated the cellular phenotypic differentiation that occurs during cellular expansion of chondrocytes and whether the differentiations revert to native phenotypes when implanted back into a 3D cellular matrix. In an in vitro setting, monolayer expansion of chondrocytes takes more than 4 weeks, resulting in multiple surgical operations. Monolayer expansion is associated with loss of native chondrocyte phenotype and a shift toward a more fibroblastic cell type. 3D encapsulation of expanded cells does not return cell phenotype to a chondrocyte-like state, resulting in the reimplanted chondrocytes having a fibrous phenotype. Takeaway In vitro expansion of chondrocytes and encapsulation into a 3D structure may result in the implantation of a fibrous cellular phenotype and not a chondrocyte cellular phenotype. AS Shekkeris, JR Perera, G Bentley, et al Histological results of 406 biopsies following ACI/MACI procedures for osteochondral defects in the knee. Orthop Proceedings. 2012(94)12-12. Investigated the histological quality of autologous chondrocyte implantation (ACI) and its correlation to functional outcomes. One to two years after implantation, only 42.4% of defects were filled with hyaline-like or mixed cartilage; 53.6% of defects were filled with fibrocartilage or fibrous tissue. Of the hyaline-like and mixed filled defects, 70% of patients achieved fair or excellent functional outcomes. In comparison, 89% of patients with fibrous tissue-filled defects had poor functional outcomes. Takeaway The majority of filled defects with ACI did not demonstrate chondrocyte cellular properties. Defects filled with fibrous tissue were associated with less-favorable functional outcomes for patients. Sochacki KR, Varshneya K, Calcei JG, et al Comparison of autologous chondrocyte implantation and osteochondral allograft transplantation of the knee in a large insurance database: reoperation rate, complications, and cost analysis. Cartilage. 2021;13(1_suppl):1187S-1194S. doi:10.1177/1947603520967065 Large-scale study with 909 subjects compared reoperation rates, complications, and cost differences in ACI and osteochondral allograft (OCA) procedures. ACI and OCA procedures had associated reoperation rates of 67.6% and 40.4%, respectively, with a mean follow-up of 39.2 months. At 2 years postoperative, OCA had an associated cost of $33,426, compared to $56,578 for ACI. Takeaway At early and midterm follow up, OCA procedures have a lower cost and reoperation rate than ACI, providing another cost-effective cartilage restoration option alongside the AutoCart procedure. arthrex.com © 2022-11 Arthrex, Inc. All rights reserved. DOC1-000907-en-US_A

AutoCart™ Procedure Scientific Update

BoneSync BioActive ™ Moldable Strips and Putty 02 I BoneSync™ BioActive Bone Void Filler BoneSync™ BioActive Putty and Strips Mechanism of Action BoneSync BioActive is a second-generation bone void filler that includes bioglass 45S5 and provides an osteoconductive and osteostimulative matrix.1 Available putty and strip versions to fit various application needs. Bioactive glass provides a favorable environment for bone regeneration and osteoblast attachment.2 Ions adhere to the silica gel surface, forming an apatite mineral layer. As bioactive glass interacts with bodily fluids, the dissolution product results in a negatively charged surface and alkaline environment, which is ideal for bone formation. Mesenchymal stem cells and osteoprogenitor cells attach to the surface of the mineral layer of the bioglass. Bioactive Glass Surface Reaction PO 4 Cells HA New bone Ca2+ CO32+ Silica gel HA surface 45S5 bioactive glass Adhesion of Ca2+, PO4, and CO32+ ions to the silica gel surface, forming bone-like hydroxyapatite (HA) Bone-forming cells colonize the surface of the HA-coated bioactive glass Crystallization of the bone-like matrix and maturation of bone cells lead to new bone formation Composition BoneSync BioActive filler is composed of 50% carbonate apatite anorganic bone mineral, 30% 45S5 bioactive glass, and 20% type I collagen. Developed to resemble the composition and pore structure of natural human bone,3,4 BoneSync BioActive bone void filler is slowly resorbed and replaced by new bone tissue during the healing process. 50% Carbonate Apatite 20% Type I Collagen 30% 45S5 Bioactive Glass BoneSync™ BioActive Bone Void Filler I 03 Features and Benefits MAN BONE BO N AT E APA TI Similar-Sized Macro and Micro Pores for Cell Migration T Slow E [ R CA Resorption Profile HU ] Balanced Fast β-TCP Carbonate Apatite Hydroxy Apatite (HA) Carbonate Apatite An anorganic bone mineral that allows for sustained osteoconductivity and remodeling during bone regeneration, carbonate apatite contains similar macro and micro pores to human bone. It has an optimal resorption and remodeling profile when compared to β-tricalcium phosphate (β-TCP) and HA.5 Type I Collagen The collagen in BoneSync™ BioActive filler is highly purified and retains biological factors.6 It is 100% resorbable through normal metabolic pathways7 and binds proteins and cells.6 04 I BoneSync™ BioActive Bone Void Filler 45S5 Bioactive Glass The 30% composition of bioactive glass in BoneSync BioActive filler creates a favorable environment for bone regeneration and osteoblast attachment.¹ Bioactive glass is incorporated within the suggested critical range of 5% to 40% for optimal osteoblast growth and calcium phosphate formation in a composite.8 IB U UN ON IF I C L E D I ST R TI O RM RT PA 45S5 Bioactive Glass Particles Carbonate Apatite Anorganic Bone Mineral Porous Type I Collagen Matrix Uniform Particle Distribution BoneSync™ BioActive bone void filler has a uniform distribution of bioactive glass and mineral particles throughout the matrix, which is achieved through a proprietary manufacturing process.9 Moldable Advantage BoneSync BioActive filler can be combined with either autogenous bone marrow or autograft bone mixed with saline. Upon hydration, the product is moldable, flexible, and absorbent and will resist migration. BoneSync BioActive filler is nearly 2x more absorbent than Vitoss® bioactive foam.9 Vitoss is a registered trademark of Stryker. BoneSync™ BioActive Bone Void Filler I 05 Ordering Information BoneSync™ BioActive Bone Void Filler Product Description Item Number BoneSync BioActive Matrix Strip, 5 cc ABS-3500-05 BoneSync BioActive Matrix Strip, 10 cc ABS-3500-10 BoneSync BioActive Matrix Strip, 20 cc ABS-3500-20 BoneSync BioActive Matrix Strip, 40 cc ABS-3500-40 BoneSync BioActive Matrix Putty, 2.5 cc ABS-3400-02 BoneSync BioActive Matrix Putty, 5 cc ABS-3400-05 BoneSync BioActive Matrix Putty, 10 cc ABS-3400-10 BoneSync BioActive Matrix Putty, 20 cc ABS-3400-20 References 1. Hench LL, Polak JM, Xynos ID, Buttery LDK. Bioactive materials to control cell cycle. Mater Res Innov. 2000;3(6)313-323. doi:10.1007/s100190000055 2. Xynos ID, Hukkanen MV, Batten JJ, Buttery LD, Hench LL, Polak JM. Bioglass 45S5 stimulates osteoblast turnover and enhances bone formation In vitro: implications and applications for bone tissue engineering. Calcif Tissue Int. 2000;67(4):321-9. doi:10.1007/s002230001134 3. Matsuura A, Kubo T, Doi K, et al. Bone formation ability of carbonate apatite-collagen scaffolds with different carbonate contents. Dent Mater J. 2009;28(2):234-242. doi:10.4012/dmj.28.234 4. Ellies LG, Carter JM, Natiella JR, Featherstone JD, Nelson DG. Quantitative analysis of early in vivo tissue response to synthetic apatite implants. J Biomed Mater Res. 1988;22(2):137-148. doi:10.1002/jbm.820220206 5. Spence G, Patel N, Brooks R, Rushton N. Carbonate substituted hydroxyapatite: resorption by osteoclasts modifies the osteoblastic response. J Biomed Mater Res A. 2009;90(1):217-224. doi:10.1002/jbm.a.32083 6. Geiger M, Li RH, Friess W. Collagen sponges for bone regeneration with rhBMP-2. Adv Drug Deliv Rev. 2003;55(12):1613-1629. doi:10.1016/j.addr.2003.08.010 7. Li ST. Biologic biomaterials: tissue-derived biomaterials (collagen). In: Bronzino JD, ed. The Biomedical Engineering Handbook. 1st ed. CRC Press; 2000:740-763. 8. Gerhardt LC, Boccaccini AR. Bioactive glass and glass-ceramic scaffolds for bone tissue engineering. Materials (Basel). 2010;3(7):3867-3910. doi:10.3390/ma3073867 9. Collagen Matrix, Inc. Data on file. Oakland, NJ. 06 I BoneSync™ BioActive Bone Void Filler Notes BoneSync™ BioActive Bone Void Filler I 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 arthrex.com © 2022-09 Arthrex, Inc. All rights reserved. LB1-000388-en-US_A

BoneSync™ BioActive Moldable Strips and Putty

The AutoCart™ procedure provides a simple, reproducible, and cost-effective method for treating symptomatic cartilage defects. Using the GraftNet™ device to collect autologous, particulated cartilage, the AutoCart technique is a single-stage, matrix-augmented approach that can be performed arthroscopically and may improve the degree and quality of tissue healing within a properly prepared articular cartilage defect.1&nbsp;
Reference&nbsp;
1. Salzmann GM, Ossendorff R, Gilat R, Cole BJ. Autologous minced cartilage implantation for treatment of chondral and osteochondral lesions in the knee joint: an overview. Cartilage. 2021;13(1_suppl):1124S-1136S. doi:10.1177/1947603520942952&nbsp;

AutoCart™ Procedure Surgical Technique

The ACP Max™ system provides efficient concentration of platelets and growth factors from platelet-rich plasma (PRP) for use at the patient’s point of care. Expanding on the previous generation of PRP devices, the ACP Max system allows for a larger blood draw and provides increased platelet concentration using a unique double-syringe, double-spin design.&nbsp;

ACP Max™ Platelet-Rich Plasma System

This animation highlights the clinical benefits of SynoJoynt® 1% sodium hyaluronate, a high-molecular-weight, non–cross-linked sodium hyaluronate indicated for osteoarthritis pain of the knee in patients who have failed to adequately respond to conservative, nonpharmacologic therapy and simple analgesics. SynoJoynt sodium hyaluronate is derived from bacterial fermentation and is proven safe and effective in a 3-dose regimen.1&nbsp;
 
Reference&nbsp;
1. US Food and Drug Administration. Summary of safety and effectiveness (SSED) for SynoJoynt. Accessed January 5, 2022. https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170016B.pdf&nbsp;

SynoJoynt® 1% Sodium Hyaluronate

Allograft Tendons A Comprehensive Portfolio Allograft Tendons Overview Since its inception, Arthrex has been committed to one mission: Helping Surgeons Treat Their Patients Better™. We are strategically focused on constant product innovation through scientific research, surgeon collaboration, and medical education to make less invasive surgical procedures simpler, safer, and more reproducible. Our strategic partnerships serve as the industry leaders in procurement, donor screening, and selection criteria. Tissue processing by our partners balances safety with quality by ensuring the preservation of inherent biological properties of the tissue. Our partners provide state-of-the-art processing methods. LifeNet Health’s Allowash XG® has been shown to render a sterility assurance level (SAL) of 10 -6 and to inactivate viruses without compromising the biomechanical or biochemical properties of the tissue.1,2 JRF Ortho’s advanced cleansing technologies maintain tissue integrity with consistent processing, monitored temperature, and limited reagent exposure. Regulatory / Compliance AATB FDA ✔ ✔ CLIA ISO ✔ ✔ The availability of allograft tendons provides surgeons with an invaluable tool for treating a variety of injuries. In the United States, it’s estimated that there are 500,000 knee ligament procedures performed annually,3 including an estimated 300,000 anterior cruciate ligament (ACL) surgeries.4 The Arthrex portfolio of tendons provides surgeons with the widest selection of presutured and standard allograft tendons in the world. Allograft tendons provide many benefits over autograft tendons in reconstructive procedures, such as less donor-site morbidity, fewer incisions, shorter operative time, larger grafts, lower incidence of postoperative arthrofibrosis, and less postoperative pain.4,5 Sterile Tendons Since 2004, Arthrex has been a leading marketer of Allowash XG processed tendons. These tendons have been clinically proven in a variety of surgical applications with an unmatched safety record. The process renders the allografts sterile, without compromising biomechanical or biochemical properties.6-10 Allowash XG Patented and validated process that provides allografts with a SAL of 10 -6 Incorporates 6 steps to ensure sterility Bioburden control Bioburden assessment Minimizing contamination Rigorous cleaning Disinfection and rinsing regimen Terminal sterilization Facilities and environmental controls designed to eliminate cross contamination Uses gentle detergents, antibiotics, and solutions known to be safe on tissue Eliminates blood, lipids, and marrow Flushing Centrifugation Hypotonic processes and ultrasonication Intensive decontamination, disinfection, and scrubbing regimen Designed to eliminate bacteria and viruses Cover histology image courtesy of Dr. Chantelle Bozynski, Thompson Laboratory for Regenerative Orthopaedics, University of Missouri. 02 I Allograft Tendons Tendon Allografts Product Description JRF Ortho Item Number LifeNet Health Item Number Achilles Tendon w/ Bone Block ACT-001 FATB Achilles Tendon w/o Bone Block AWO-001 FAT Anterior Tibialis Tendon, short length, D ≥ 7.5 mm, L = 170 mm-200 mm SAT-001 FANT-SL Posterior Tibialis Tendon, short length, D ≥ 7.5 mm, L = 170 mm-200 mm FPOST-SL Peroneus Longus Tendon, short length, D = 8 mm-11 mm, L = 170 mm-200 mm FPLT-SL Tibialis Tendon, anterior DAT-001 FANT/TIB/T Tibialis Tendon, posterior DPT-001 FPOST.TIBIAL Gracilis, double strand DSG-001 Patellar Tendon, bisected/hemi HPL-001 FBPL WPL-001 FWPL Patellar Tendon, bisected, small block Patellar Tendon, whole FBPLSB Patellar Tendon, whole - small block FWPLSB Patellar Tendon, whole w/ quadriceps FWPLQ Patellar Tendon, whole w/ extensor mechanism FWPLQEXT Peroneus Longus, double strand DSP-001 Peroneus Tendon Preshaped Achilles, 9 mm FPLT ATP-091 Preshaped Achilles, 10 mm ATP-101 FATB10 Preshaped Achilles, 11 mm ATP-111 FATB11 Preshaped Patellar Tendon, 10 mm PLP-101 FPL10 Preshaped Patellar Tendon, 11 mm PLP-111 FPL11 Quadruple Strand Semitendinosus/ Gracilis QSG-001 Quadriceps Tendon w/ Bone QDT-001 Preshaped Quadriceps Tendon, 10 mm QDT-101 Semitendinosus, single strand SST-001 Semitendinosus, double strand DST-001 FQUADB Semitendinosus and Gracilis Tendons 1FST+1FGRACILIS Semitendinosus Tendon, ≥ 230 mm, min D > 4 mm FST Semitendinosus Tendon, L = 160 mm-250 mm, D = 4 mm-6 mm Gracilis Tendon, short length FSTP SSG-001 FGRACILIS Fascia Lata, small, 30 mm × 60 mm FL S Fascia Lata, medium, 30 mm × 150 mm FL M Fascia Lata, large, 80 mm × 200 mm FL L GraftRope FROPE Allograft Tendons I 03 Aseptic Tendons Arthrex offers a full complement of aseptically processed tendons that are never treated with irradiation. Our partner for aseptic tendons, JRF Ortho and its recovery and processing partners, uses extensive evaluation criteria to identify and qualify suitable donors in accordance with American Association of Tissue Banks (AATB) standards. Maximizing safety while providing quality tendons: Aseptically processed allografts are manufactured in a controlled environment with patented methods Use of highly sensitive nucleic acid testing (NAT) Comprehensive donor screening Fluid extraction testing: Advanced cleansing technologies: Designed to cleanse while preserving tissue integrity Proprietary cleansing reduces bioburden without using harsh reagents like hydrogen peroxide Bioburden reduction steps that remove blood and lipids This testing is more accurate because contamination is difficult to detect by swabbing the external surface of the graft Tissue is released after no growth culture results from a validated and highly sensitive fluid membrane filtration test Approximately 35% of all tendons qualify for transplant without the need for ultra-low-dose irradiation Aseptic Tendons Product Description JRF Ortho Item Number Achilles Tendon w/ Bone Block ACT-002 Achilles Tendon w/o Bone Block AWO-002 Achilles Tendon, preshaped, 9 mm (a) ATP-092 Achilles Tendon, preshaped, 10 mm ATP-102 Achilles Tendon, preshaped, 11 mm ATP-112 Hemi-Patellar Ligament HPL-002 Whole-Patellar Ligament WPL-002 Whole-Patellar Ligament w/ Quadriceps WPQ-002 Quadriceps Tendon w/ Bone QDT-001 Quadriceps Tendon w/ Bone, preshaped, 10 mm QDT-102 Patellar Ligament, preshaped, 10 mm (b) PLP-102 Patellar Ligament, preshaped, 11 mm PLP-112 Double Strand Semitendinosus Tendon DST-002 Double Strand Peroneous Longus DSP-002 Double Strand Anterior Tibialis DAT-002 Double Strand Posterior Tibialis DAP-002 Quadruple Strand Semitendinosus/Gracilis QSG-002 Single Strand Semitendinosus Tendon SST-002 Single Strand Anterior Tibialis (c) SAT-002 04 I Allograft Tendons (a) (b) (c) Presutured Tendons Arthrex offers the largest portfolio of presutured tendon allografts for your ligament reconstruction procedures. Presutured tendons are preassembled by qualified tissue technicians for consistency. These tendons are sterilized under low-dose, low-temperature irradiation for patient safety. The convenience of a presutured tendon allows for an off-the-shelf solution with minimal preparation time. Presutured Tendons Product Description JRF Ortho Item Number VersaGraft® Tendon (a) VRG-001 VersaGraft 3.5 Tendon VRG-351 SpeedGraft® Tendon (b) SPD-001 GraftLink® XL Tendon (PCL) GRX-001 LifeNet Health Item Number Allograft GraftLink® Tendon (c) FGL Allograft GraftLink Triple Strand FGLTS QuadLink™ Construct Tendon (d) FQL FlexiGRAFT® Connect Tendon FCON FlexiGRAFT Connect EXT Tendon FCONEXT DualLink Presutured Construct FDL PilotGraft™ BTB Tendon (e) PSP-101 SpeedGraft Achilles Tendon (f) PSA-101 (b) (c) (f) (d) (e) (a) GraftLink Allograft Tendon for All-Inside ACL Reconstruction SpeedGraft Achilles Tendon for ACL Reconstruction VersaGraft Tendon for Lateral Ankle Reconstruction Allograft Tendons I 05 Graft Sizing and Socket Creation Arthrex graft tubes are ideal for sizing and compressing allograft GraftLink® constructs. These full-length, clear tubes facilitate graft compression, sizing, and preparation. Graft Sizing Measure the graft length and diameter. Pass both the femoral and tibial ends of the graft into the sizing block to measure diameter for socket drilling. Socket Creation The length from the end of the femoral socket to the end of the tibial socket should be at least 10 mm longer than the graft to ensure the graft can be tensioned fully. Example: 70 mm length Allograft QuadLink™ Construct The QuadLink construct is a presized and preassembled allograft quadriceps tendon presutured with #2 FiberLoop with FiberTag™ suture, designed to be used with ACL TightRope® implants. The all-inside ACL technique is ideal for quadriceps grafts, as only a graft length of 60 mm to 75 mm is needed. ACL TightRope II implants are used to fixate the graft in minimally invasive sockets created with a FlipCutter® III drill. A standard all-inside technique is used to implant the graft. QuadLink presutured constructs are preassembled by qualified technicians that have trained and certified to ensure construct consistency. The tendons are provided as a sterile allograft construct via the Allowash XG process for patient and surgeon safety. 06 I Allograft Tendons Allograft QuadLink Construct Features and Benefits: Minimal graft preparation time Presized diameter and lengths Allowash XG technology Preassembled with #2 FiberLoop with FiberTag suture Preloaded with passing sutures to facilitate loading with ACL TightRope II implants Allograft GraftLink® Construct Consisting of preconstructed allograft tendon, GraftLink constructs are designed for use with the GraftLink ACL technique and TightRope® implants. Each construct is precisely assembled according to Arthrex specifications by trained tissue technicians to ensure it meets the requirements of the GraftLink technique and allows for an anatomic, minimally invasive, and reproducible ACL reconstruction. Allograft GraftLink Construct Features and Benefits: Allowash XG technology Preassembled with #2 FiberWire® suture Minimal graft preparation time Presized to specifications of GraftLink all-inside ACL technique Preloaded with passing sutures to facilitate loading of ACL TightRope implants The constructs are rendered sterile using the Allowash XG process, a patented and proprietary sterilization process with a high degree of safety that achieves an SAL of 10 -6 without compromising biological and biomechanical properties. Since 1995, more than 6 million bioimplants processed using Allowash technology have been distributed with no disease transmission.1 PilotGraft™ BTB Tendon PilotGraft BTB tendons are preshaped, predrilled, bonetendon-bone allografts that can be used in ACL and PCL reconstruction procedures. Two preshaped 10 mm bone block, each with a 2 mm predrilled hole through the bone, facilitate insertion into bone tunnels. Looped #2 FiberLoop® suture is preinserted through the tunnels to help with suture shuttling. It can be removed if securing the tendon with an interference screw. Bone dowels are available in lengths from 20 mm to 30 mm. Available intra-articular lengths range from 25 mm to 45 mm and can be selected based on surgeon requirements. PilotGraft BTB Tendon Features and Benefits: Multiple size options (65 mm to 95 mm total length) No donor-site morbidity 3-year shelf life Sterile (10 -6 SAL) Allograft Tendons I 07 SpeedGraft® Achilles Tendon This presutured Achilles tendon, which includes a bone block predrilled with a 2 mm tunnel, provides for boneto-bone fixation on the femoral side and efficient softtissue fixation on the tibial side. Looped #2 FiberLoop® suture is preinserted through the tunnel to help with suture shuttling. It can be removed if securing the tendon with an interference screw. SpeedGraft Presutured Double Strand Tendon Designed for use with the ACL TightRope® implant for ACL and PCL reconstructions, the SpeedGraft allograft is a presutured, double strand, sterile tendon with individually sutured tails that can be identified by their color. This design allows for multiple fixation methods, providing flexibility for the surgeon. SpeedGraft Tendon Features and Benefits: Each tendon is assembled according to Arthrex specifications, by trained tissue technicians, ensuring that the presutured tendon meets the requirements of the procedure to allow for an anatomic, minimally invasive, and reproducible ACL or PCL reconstruction. SpeedGraft presutured tendons are processed with a validated and patented cleaning treatment designed to facilitate the removal of cellular elements from tissue while maintaining the structural integrity of the allograft. This process has been proven to reduce the potential danger of disease transmission by removing over 99% of blood, lipids, and marrow from the allograft. The incorporation of a rigorous donorscreening process and terminal sterilization enhances the safety of this allograft tendon. ACL TightRope RT Implant Graft: Sterile allograft tendon ACL/PCL 08 I Allograft Tendons Preassembled with #2 FiberLoop® and #2 TigerLoop® suture Minimal preparation time 10 -6 SAL for patient safety Use with ACL TightRope RT implant Presized lengths and diameters for patient customization Tendon lengths: 175 mm to 295 mm Tendon diameters: 8 mm to 11 mm Double Stranded: FiberLoop suture TigerLoop suture VersaGraft® Tendon The VersaGraft presutured tendon is a preassembled, presized, sterile allograft tendon with simple tensioning and rigid fixation that can be used for anatomic reconstruction of the anterior talofibular (ATFL) and calcaneofibular (CFL) ligaments. All tendons are precisely assembled by highly trained tissue technicians, according to Arthrex specifications, to ensure each construct meets the requirements of the lateral ankle reconstruction technique. Potential Applications Medial patellofemoral ligament (MPFL) Patellar tendon repair Medial collateral ligament (MCL) Elbow ligament repair Lateral collateral ligament (LCL) Lateral ankle stabilization Medial deltoid reconstruction Anterolateral ligament (ALL) reconstruction Acromioclavicular (AC) joint reconstruction Diameter: 4.5 mm ± .5 mm Lengths: 150 mm - 250 mm ALL Reconstruction Allograft Tendons I 09 VersaGraft® 3.5 mm Tendon The VersaGraft 3.5 mm presutured tendon provides time and cost savings to physicians. Presutured tendon constructs are sterile and preassembled with Arthrex sutures for speed and convenience. Each construct is assembled according to Arthrex specifications, by trained technicians, ensuring that the presutured tendon construct meets the requirements of the procedure to allow for anatomic, minimally invasive, and reproducible reconstruction. Commonly used for MPFL reconstructions, the VersaGraft 3.5 tendon comes preassembled with #0 FiberLoop® suture and has a diameter of 3.5 mm to 4.5 mm and length of 190 mm to 240 mm. 10 I Allograft Tendons FlexiGraft® Connect™ Tendon FlexiGraft Connect EXT Tendon The FlexiGraft Connect tendon is presutured with #2 FiberLoop® suture for 15 mm to 19 mm of length on one end and a locking tag stitch on the opposite end. The tendon has a diameter of 4.5 mm ± 0.5 mm and a length of 150 mm to 250 mm. This small-diameter, presutured tendon is can be used for distal extremity procedures such as metatarsophalangeal joint reconstruction, distal extremity tendon transfer, elbow and thumb ulnar collateral ligament (UCL) procedures, hallux varus/ valgus reconstruction, spring ligament reconstruction, and scapholunate ligament reconstruction. It’s similar in design to the FlexiGraft Connect tendon but smaller in diameter and suture size. References 1. Moore MA. Inactivation of enveloped and non-enveloped viruses on seeded human tissues by gamma irradiation. Cell Tissue Bank. 2012;13(3):401-407. doi:10.1007/s10561-011-9266-0 2. LifeNet Health. Data on file (TR-0020, TR-0023). Virginia Beach, VA. 3. SmartTRAK Market Research, Graft Market – US, 2018. 4. Garrett WE, Jr, Swiontkowski MF, Weinstein JN, et al. American Board of Orthopaedic Surgery practice of the orthopaedic surgeon: part II. Certification examination case mix. J Bone Joint Surg Am. 2006;88:660-667. doi:10.2106/JBJS.E.01208 5. Edgar CM, Zimmer S, Kakar S, Jones H, Schepsis AA. Prospective comparison of auto and allograft hamstring tendon constructs for ACL reconstruction. Clin Orthop Relat Res. 2008;466(9):2238-2246. doi:10.1007/s11999008-0305-5 6. Samsell BJ, Moore MA. Use of controlled low dose gamma irradiation to sterilize allograft tendons for ACL reconstruction: biomechanical and clinical perspective. Cell Tissue Bank. 2012;13(2):217-23. doi:10.1007/ s10561-011-9251-7 7. Balsly CR, Cotter AT, Williams LA, Gaskins BD, Moore MA, Wolfinbarger L Jr. Effect of low dose and moderate dose gamma irradiation on the mechanical properties of bone and soft tissue allografts. Cell Tissue Bank. 2008;9(4):289-98. doi:10.1007/s10561-008-9069-0 8. Tejwani SG, Chen J, Funahashi TT, Love R, Maletis GB. Revision risk after allograft anterior cruciate ligament reconstruction: association with graft processing techniques, patient characteristics, and graft type. Am J Sports Med. 2015;43(11):2696-705. doi:10.1177/0363546515589168 9. Greaves LL, Hecker AT, Brown CH Jr. The effect of donor age and low-dose gamma irradiation on the initial biomechanical properties of human tibialis tendon allografts. Am J Sports Med. 2008;36(7):1358-66. doi:10.1177/0363546508314394 10. Rihn JA, Irrgang JJ, Chhabra A, Fu FH, Harner CD. Does irradiation affect the clinical outcome of patellar tendon allograft ACL reconstruction?. Knee Surg Sports Traumatol Arthrosc. 2006;14(9):885-96. doi:10.1007/s00167006-0036-7 Allograft Tendons I 11 Allowash XG technology is a registered trademark of LifeNet Health. 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 arthrex.com © 2024-06 Arthrex, Inc. All rights reserved. LB1-000090-en-US_C

Allograft Tendons: A Comprehensive Portfolio

The BioACL™ technique harnesses the patient’s own biology and combines it with the highest-quality biologic scaffolds to maximize the healing potential of an anterior cruciate ligament (ACL) reconstruction.&nbsp;

BioACL™ Technique Animation

Gian Salzmann, MD (Zurich, Switzerland), presents a case in which he treated a young athlete with a full-thickness cartilage defect of the patella using the AutoCart™ procedure. Prof. Salzmann discusses his rehabilitation protocol and the patient considerations that helped support an excellent outcome.

AutoCart™ Procedure: Case Presentation in a Young Athlete

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Arthrex offers a variety of tendon allografts, including a wide portfolio of presutured tendons, for primary and revision ligament reconstruction procedures. This animation highlights the comprehensive presutured allograft tendon portfolio and potential applications.&nbsp;

AAOS 2024 Annual Meeting: Orthobiologics Feature Products