Is Microfracture a thing of the past? “MFX 2.0” Microfracture a thing of the past? ... Namdari AJSM…

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    Is Microfracture a thing of the past?Augmentation Approaches

    MFX 2.0Bert R. Mandelbaum MD DHL (hon)

    FIFA Medical CommitteeCONCACAF Medical Committee

    Asst Medical Director MLSF-MARC Member

    Team Physician US Soccer, LA Galaxy, Pepperdine University,

    MicrofractureBackground

    Microfracture Utilization:

    European Survey: Microfracture most frequent technique (76%)

    Microfracture most frequent treatment method in NFL (43%)

    Salzmann, Arch Orthop Trauma Surg 2010Brophy J Knee Surg 2009

    Cartilage RepairProcedure Frequency

    Life Science Intelligence Market Report, 2009

  • 2

    Cartilage Repair Algorithm

    Cartilage LesionCartilage Lesion

    SizeSize < 2cm< 2cm

    Deep (>1cm)Deep (>1cm) SuperficialSuperficial SuperficialSuperficial

    SizeSize > 2cm> 2cm

    Deep (>1cm)Deep (>1cm)

    MicrofractureMicrofracture

    OATS/ACTOATS/ACT

    OATSOATSMosaicplastyMosaicplasty

    OATS/ACTOATS/ACT

    ChondrocyteChondrocyteTransplantTransplant

    OCOC--AllograftAllograftACTACT

    RedoRedo--ACTACT ACTACT

    ArthroplastyArthroplasty

    MicrofractureSurgical Technique

    Hybrid FibroHybrid Fibro--Hyaline Repair Tissue with Hyaline Repair Tissue with Limited ColLimited Col--II and II and AggrecanAggrecan ContentContent

    MicrofractureClinical Efficacy

    Microfracture Efficacy

    Improvement 2 yrs 67-86%

    Gudas AJSM 2012Mithoefer, AJSM 2009

    p y Functional Deterioration 47-80% Improvement over Baseline at 10 yrs

  • 3

    MicrofractureClinical Efficacy

    FactorsFactors Better Results with Better Results with

    Mithoefer, AJSM 2009Mithoefer, AJSM 2009

    AgeAgeDuration of SymptomsDuration of SymptomsLesion SizeLesion SizeBody Mass IndexBody Mass IndexPreoperative Activity LevelPreoperative Activity LevelPrior SurgeryPrior SurgeryRepair Cartilage VolumeRepair Cartilage Volume

  • 4

    MicrofractureDecrease of Function

    KonKon, AJSM 2009+2011, AJSM 2009+2011

    MicrofractureFill Grade and Functional Score Decrease

    %%*P

  • 5

    Microfracture Complications/Failures

    Failure/Revision

  • 6

    MicrofractureBone Overgrowth

    MicrofractureIndications and Contraindications

    IndicationsGrade 3Grade 3--4 Defects4 DefectsLesions 2 cmLesions 2 cm22Acute LesionsAcute Lesions

    ContraindicationsDegenerative DefectsDegenerative DefectsUncontained LesionsUncontained LesionsBMI> 30 kg/mBMI> 30 kg/m22

    Age < 40 yearsAge < 40 yearsIncidental LesionsIncidental LesionsNo Prior SurgeryNo Prior Surgery

    ggDefects > 2 cmDefects > 2 cm22Multiple DefectsMultiple DefectsRevision SurgeryRevision Surgery

    MicrofractureStrengths and Weaknesses

    StrengthsMinimally InvasiveMinimally InvasiveLow MorbidityLow MorbidityTechnically SimpleTechnically SimpleCost EffectiveCost Effective

    LimitationsFibroFibro--Hyaline RepairHyaline RepairSmall Defects Only Small Defects Only Unpredictable FillUnpredictable FillLimited IntegrationLimited Integration

    Short RehabilitationShort RehabilitationIncidental DefectsIncidental DefectsFast ImprovementFast Improvement

    ggBone OvergrowthBone OvergrowthDecreasing FunctionDecreasing Function

  • 7

    MicrofractureTechnique Modification

    MicrofractureMicrofractureSealing EffectSealing Effect

    Chen J Chen J OrthopOrthop Res 2009Res 2009

    Microfracture 2.0Innovation

    Drilling and Nanofracture

    Drilling: No Bone CompactionNo Bone Compaction No Fracture No Sealing Effect Less Necrosis

    Nanofracture: Deeper Marrow Access

    MASS Technology 2.0The Only Constant is change

    Mesenchymal Augmentation Scaffold Stimulation

    Scaffold-Guided MSC-based ChondroinductionScaffold Guided MSC based Chondroinduction Techniques

    Applying novel tissue engineering techniques to address limitations of 1st generation MFx

  • 8

    Microfracture Plus 2.0Second Generation Technologies

    Marrow Augmentations and Scaffold Stimulation ( MASS) Clinical and Trials

    AMIC (Collagen Matrix) AMIC (Collagen Matrix) Biocartilage BST CarGel(Chitosan) PEG Hydrogel

    CS Adhesive Fibrinogen

    PRP

    Does MFx plus work with allograft tissue? In vivo supportive evidence:

    Medial femoral condyle defects created within a rabbit model

    Control group = microfracture performed Treatment group = MFx plus lyophilized

    cartilage fagments formed into a scaffold

    Control Group

    BioCartilageArthrexMicronized Cartilage Matrix

    Chadha N et al. Porous Cartilage-Derived Matrix Scaffolds for Repair of Articular Cartilage Defects. ORS 2012; Poster No. 0735.

    cartilage fagments formed into a scaffold Treatment group had persistent

    upregulation of cartilage phenotypic markers: Type II Collagen and Aggrecan

    Treatment Group

    The Use of Micronized Allograft Articular Cartilage (BioCartilage) and Platelet Rich

    Plasma to Augment Marrow Stimulation in an Equine Model of Articular Cartilage Defects

    Cole, Fortier et al 2015

    Microfx

    2 mo 6 mo 13 mo

  • 9

    Case Biocartilage 22 y/o female soccer player

    Does the principle of MFx plus work? BST CarGel

    (Piramal Healthcare)

    Sheep Pre-Clinical Model

    BST CarGelHoemannHoemann JBJS 2005JBJS 2005

    Strauss, Cartilage 2010Strauss, Cartilage 2010

    Chitosan based scaffold mixed with blood

    Shrimp exoskeleton Received CE mark

    approval April 2012 Conducting randomized

    pivotal trial in Canada

    Microfracture Chitosan + Blood

    Gross 6 month Histo 6 month

  • 10

    CoCo--Primary Endpoint Met MRI: Primary Endpoint Met MRI: Quantity of Repair Tissue by Lesion % Fill at 12 monthsQuantity of Repair Tissue by Lesion % Fill at 12 months

    90

    95

    100

    % F

    ill 92.81p=0.0105

    * Means adjusted for lesion volume+SEBST-CarGel, n = 41; MFX, n= 37

    75

    80

    85

    Lesi

    on

    0BST-CarGel MFX

    85.22

    MASSAutologous Matrix Induced Chondrogenesis (AMIC)

    AMIC Single stage procedure Bilayer Membrane (Type I/III or II ovine Collagen) Facilitates cell migration and adhesion Stimulates Chondrogenic Differentiation Stabilizes MSC clot Fibrin Glue Fixation +/- PRP Augmentation High tensile strength Membrane resorbes

    GilleGille KSSTA 2010KSSTA 2010PascarellaPascarella KSSTA 2010KSSTA 2010GilleGille ActaActa OrthopOrthop Trauma Trauma SurgSurg 20132013Fuss 1999Fuss 1999

    MASSAutologous Matrix Induced Chondrogenesis (AMIC)

  • 11

    MASSAutologous Matrix Induced Chondrogenesis (AMIC)

    AMIC Results/Registry

    Increased repair tissue quantity N ff t i ti lit No effect on repair tissue quality

    No effect on biomechanical properties Subchondral bone overgrowth

    GilleGille KSSTA 2010KSSTA 2010PascarellaPascarella KSSTA 2010KSSTA 2010GilleGille ActaActa OrthopOrthop Trauma Trauma SurgSurg 20132013

    MicrofractureMicrofracture--Based (MSC)Based (MSC)ChondroitinChondroitin Sulfate AdhesiveSulfate Adhesive

    MASSPEG-Scaffold (Chondux)

    Liquid 3Liquid 3--D PEGDAD PEGDA--HydrogelHydrogel ScaffoldScaffold

    MASSPEG-Scaffold (Chondux)

  • 12

    MASSPEG-Scaffold (Chondux)

    Advantages

    Adaptation to Defect Geometry Immediate Complete Defect Fill AdhesiveIntegration AdhesiveIntegration Ingrowth/Migration of MSC MSC Stimulation ( GAG, Col 1) Stimulation of intact Chondrocytes Limitation of Fibroblast Growth

    Clinical Results:Clinical Results:European Cohort Study (30 pts) European Cohort Study (30 pts) vsvs MfxMfx (12 Mo):(12 Mo):

    Improved Repair Cartilage Volume (MRI)Improved Repair Cartilage Volume (MRI)

    MASSPEG-Scaffold (Chondux)

    p o ed epa Ca age o u e ( )p o ed epa Ca age o u e ( )Better T2 Relaxation ValuesBetter T2 Relaxation ValuesImproved Histology (HyalineImproved Histology (Hyaline--like)like)Improved BiomechanicsImproved Biomechanics100% Integration grade 1100% Integration grade 1--22No Bony OvergrowthNo Bony Overgrowth

    MASSPEG-Fibrinogen (Gelrin C)

    Procedure One-step procedure (Microfracture) Injectable hydrogel conforms to defect UV-Polymerization in situ (90 sec) Chemotactic scaffold (cell invasion)Chemotactic scaffold (cell invasion)

    Advantages Off-the-shelf Minimally Invasive Applicable to all lesion geometries Immediate Implant Stability Tight integration Controlled biodegradation (enhancing)

  • 13

    EFFECTS OF PLATELET-RICH PLASMA ON TISSUE ENGINEERED CARTILAGE

    Massimo Petrera*, MD - J. N. Amritha De Croos, PhD - Jonathan Iu, BSc - Mark Hurtig, DVM - Rita A. Kandel, MD - John S.

    Theodoropoulos*, MD* University of Toronto Orthopaedic Sports Medicine

    Department of Pathology and Laboratory Medicine, CIHR-Bio Engineering of Skeletal Tissues Team, Mount Sinai Hospital,

    University of Toronto Department of Biomedical Sciences, University of Guelph

    Formation of Articular Cartilage in vitro

    EFFECTS OF PLATELET-RICH PLASMA ON TISSUE ENGINEERED CARTILAGE

    Courtesy: Dr. Rita Kandel

    Results

    Intact cartilage layer and increased extracellular matrix in constructs cultured with 20% PRP

    Samples cultured in Hams F-12 supplemented with 20% PRP had significantly thicker tissue

    EFFECTS OF PLATELET-RICH PLASMA ON TISSUE ENGINEERED CARTILAGE

    Immunostaining: prevalence of type II collagen

  • 14

    Results Mechanical testing

    Tissue engineered cartilage cultured with 20% PRP showed superior compressive mechanical properties with an equilibrium modulus of 38.13.6

    kPa versus 15.61.5kPa for 20% PPP (p=0.0002) and 20.43.5 kPa for 20% FBS (p=0.007)

    Biochemistry Proteoglican

    EFFECTS OF PLATELET-RICH PLASMA ON TISSUE ENGINEERED CARTILAGE

    Biochemistry - Proteoglican

    Samples supplemented with 20% PRP had significantly

    higher GAG content (176.118.8g GAG/mg dry

    wt) compared to those supplemented with 20% FBS (11210.6g GAG/mg dry wt,

    p=0.01 ) or 20% PPP (131.514.8g GAG/mg dry wt,

    p=0.11 )

    Conclusions

    The presence of PRP in the culture media enhances the in vitro formation of cartilage with increased ECM and greater compressive

    mechanical properties, while maintaining features of hyaline phenotype

    EFFECTS OF PLATELET-RICH PLASMA ON TISSUE ENGINEERED CARTILAGE

    phenotype

    This treatment may be a way to generate better tissue suitable to use for cartilage repair

    Further study to evaluate this tissue in vivo is required

    Repeated platelet concentrate injections Repeated platelet concentrate injections 5 injections of ACP post 5 injections of ACP post microfxmicrofx: : macroscopically, histologically, and biomechanically superior to macroscopically, histologically, and biomechanically superior to microfxmicrofx alone after alone after 3, 6, and 12 months3, 6, and 12 months

    ACP 12 mo

    Enhance reparative response of Enhance reparative response of microfracturesmicrofractures in the treatment of in the treatment of chondralchondraldefects of the knee: An experimental study in an animal modeldefects of the knee: An experimental study in an animal model

    Milano et al. Milano et al. ArthroscopyArthroscopy. 2012.. 2012.

    ACP 12 mo

    No ACP 12 mo

    ACP 12 mo

    No ACP 12 mo

  • 15

    PRP improves healing of Microfracture of Articular Cartilage

    defectSchneider, Klein, Dewitz

    Koln, Germany ICRS 2013

    36 pts 2 groups MFX vs MFX + 6 ACP injections WOMAC, Tegner, IKDC, Cincinnati score all significantly

    better of MFX+ACP No adverse events related to this application were noted

    during the procedure The results of our study showed that periodical intra-

    articular injections of autologous conditioned plasma after cartilage repair with microfracture improve cartilage regeneration and may prevent further degenerative changes

    MicrofractureConclusions MicrofractureMicrofracture is effective firstis effective first--line treatment of acute line treatment of acute

    small articular cartilage defects in young patients in small articular cartilage defects in young patients in short term.short term.

    Limited repair tissue quality, quantity, and integration Limited repair tissue quality, quantity, and integration and and subchondralsubchondral bone changes may limit durability bone changes may limit durability and success of 2and success of 2ndnd repair proceduresrepair procedures

    Correct indications for Correct indications for microfracturemicrofracture help to optimize help to optimize outcome after outcome after articulararticular cartilage repair cartilage repair

    22ndnd Generation MASS Technology seems to improve Generation MASS Technology seems to improve prior limitations and outcome . 2.0 prior limitations and outcome . 2.0

    MicrofractureImprovement

    Augmentation Strategies Hyaluronic Acid Injection PRP Growth Factor Augmentation

    Factors: BMP-2, BMP-7, BMP-4, FGF-18, IGF-1 Stimulation of: MSC Differentiation, Proliferation, Metabolism

    Cytokine Modulation IL-Ira + IGF-1 Inhibition of Inflammatory Response

    Kruger J Orthop Res 2011Fortier CORR 2011McIlwraith Arthroscopy 2011Yamaoka Cell Prol 2010Strauss AJSM 2009Kuo OA Cartilage 2006 Steinert J Orthop Res 2003

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