Void Fillers: White Paste or Bone

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1 J. TRACY WATSON M.D. PROFESSOR OF ORTHOPAEDIC SURGERY CHIEF ORTHOPAEDIC TRAUMA SERVICE ST. LOUIS UNIVERSITY SCHOOL OF MEDICINE Void Fillers: White Paste or Bone Void Fillers: White Paste or Bone INJECTABLE CALCIUM PHOSPHATES AND SULFATES: WHEN I USE THEM AND HOW 1

2 Publications: Disclosures Orthopaedic Knowledge Online, Trauma Editor Journals: Editorial panels: JBJS, JOT, CORR, J of Trauma, Current Orthopaedic Practice. Research / Fellowship support: COTA, Twin Star Medical, Dep. Of Defense, METRC Consultant / Designer Biomet, Smith & Nephew, Ellipse, Medtronic, Stryker, Bioventus, DePuy Boards / Officer: Ota Fund Development And Fellowship Committee No Financial Conflicts Related To Content METAPHYSEAL REQUIRMENTS SUBCHONDRAL SURFACE SUPPORT MAINTAIN ARTICULAR REDUCTION METAPHYSEAL CORTICAL DEFECTS RECONSTRUCT ANATOMY TO MAINTAIN DIA-METAPHYSEAL CONTINUITY METAPHYSEAL DEFECTS VASCULAR REGION BIOLOGICALLY COMPETENT SOLITARY VOID LARGE / CONTAINED UNCONTAINED REQUIRES + /- MECHANICAL SUPPORT 2

3 SUBCHONDRAL SUPPORT SIMPLE CONDUCTIVE SUBSTRATE ONLY RELIABLE SUBCHONDRAL SUPPORT (+HARDWARE) NO OTHER ADJUVANTS INDICATED i.e. BMP S CELLUAR ADJUVANTS METAPHYSEAL DEFECTS ONLY SIMPLE SUBSTITUTE REQUIRED.. CONDUCTIVE SUBSTRATES PRESENTS SPECIFIC 3-D ARCHITECTURE AND SURFACE AREA AS SITE OF CELLULAR ATTACHMENT 3

4 CONDUCTIVE SUBSTRATES 4

5 VARIABLE CEMENT CHEMISTRY CaPO 4 CAN BE FORMULATED AS A CEMENT DUAL COMPONENT MIXED AT TIME OF DELIVERY Adding An Aqueous Solution Dissolves The Calcium, Followed By A Precipitation Reaction Calcium Phosphate Crystals Grow And The Cement Hardens. ( can modify these kenetics) INJECTABLE WHICH ONE IS BEST??? MECHANICAL PROPERTIES..WILL IT ADEQUATELY SUPPORT SURFACE THRU TRANSITION TO FULL Wt. BEARING? INCORPORATION / DEGRADATION TIME???? CAN YOU INSTRUMENT????..FILL AND DRILL?? EASE OF USE.IS IT A FLAIL IN SURGERY???? DOES IT FILL THE DEFECT COMPLETELY??? 5

6 SUBCHONDRAL SUPPORT OPTIONS VOID FILLER STRUCTURAL SUPPORT CaSO 4 RAPID CaPO 4 VARIABLE CaSO 4 CERAMICS BEHAVES AS A TRUE SALT IN A FLUID DYNAMIC A SALT WILL DISSOLVE IN THE JOINT.INTO RESPECTIVE IONS AND ABSORBED WITHOUT SEQUELLA OSMOTIC EFFECT IN UNCONTAINED DEFECT (wound drnage with poor soft tissues) FLOWS EASIER WHEN INJECTED..LESS VISCOUS POROSITY OF MATERIAL CaSO 4 VERY LITTLE INITIAL POROSITIY ON IMPLANTATION DURING DISSOLUTION INCREASED SURFACE AREA EXPOSED RESORBED MATERIAL OR OSTEOINTEGRATION.CHEMICAL DISSOLUTION MEDIATED EVENT RAPID. 6

7 ORIF WITH LOCKING PLATE AND 10cc CaSO 4 1 mo post op RAPID INCORPORATION MAY LEAD TO LOSS OF SUPPORT / REDUCTION 2 mo post op 3 mo post op DELIVERY VEHICLE The use of an antibiotic-impregnated, osteoconductive, bioabsorbable bone substitute in the treatment of infected long bone defects: results of a Randomized prospective trial. McKee.et.al JOT 02, 10 7

8 DELIVERY VEHICLE INDICATIONS CaSO 4 METAPHYSEAL VOID FILLER LACKS SUBCHONDRAL SUPPORT TOO RAPID INCORPORATION? Rapid DECREASE MECHANICAL STRENGTH OVER TIME DELIVERY CARRIER FOR ANTIBIOTICS,,,,ORTHOBIOLOGICS INJECT INTO INFECTED DEFECTS FLOWS AND FILLS COMPLETLY POROSITY OF MATERIAL CaPO 4 POROSITY, FACILITATE CELLULAR PENETRATION INCREASED SURFACE AREA RESORBED MATERIAL OR OSTEOINTEGRATION.CELLULAR MEDIATED EVENT.LONGER INCORPORATION TIME 8

9 CaPO 4 CERAMICS (PARTICULATE) CRYSTALLINE DEPENDENT RATE OF INCORPORATION BEHAVES AS A TRUE CERAMIC IN A FLUID DYNAMIC (porosity) TRUE CERAMIC SLOW TO DISSOLVE IN JOINT 3-D ARCHITECHTURE IMPORTANCE OF POROSITY ABILITY TO FOSTER CELLULAR INTERACTIONS HA ProOsteon ProOsteon CONSIDERED NON-RESORBABLE 9

10 CONDUCTIVE SUBSTRATES CEMENTS COMPOSITE SULFATE/PHOSPHATE Injectable applications MPa COMPRESSIVE STRENGTH (material properties) 200 PO 4 SO 4 Allograft 175 composite PROVIDER DATA / BROCHURE Regenerate Strength: 3X Normal Bone DEFECT REGENERATE: Compressive Strength of Regenerate at 13 Weeks for PRO-DENSE PO 4 + SO 4 graft and Autograft compared to Normal Bone 10 8 MPa POPRO-DENSE 4 + SO 4 graft (N=5) Autograft (N=4) Normal Bone (N=8) 10

11 SETTING TIMES VARIABLE TO ALLOW INSTRUMENTATION.INCOMPLETE FILLING WITH PARTICULATE CONDUCTIVE SUBSTRATES DELIVERY AND CONTAINMENTMAY BE PROBLEMATIC 11

12 Injection Of Cements Difficult and Messy COURTESY.. TONEY RUSSELL M.D. Traditional Injection Techniques Venturi Effect P1=P2 No Flow REDUCE INJECTION PRESSURES DUAL INJECTION INJECT CANNULA ASPIRATION CANNULA ASPIRATION TO DEVELOP VACUMN IN THE CEMENT 12

13 13

14 2 PORTAL TECHNIQUE SUCTION / INJECTION FILL DEFECT.ADD HARDWARE DUAL PORTAL INJECTION 14

15 COMPLETE FILLING FOLLOWED BY RAFT PLATE SUPPORT 28 y/o Sh V with Compartment Syndrome 6 months 15

16 Initial post op CT 3 month CT 1 month 3 month 16

17 DEVELOP POTENTIAL SPACE.LOW PRESSURE AREA CREATE NEGATIVE VOID WITH CANNULATED SYSTEM FLOWABLE FILL INTO NEGATIVE PRESSURE REGION + - SECOND PRESSURE RELIEF BLOW HOLES 55 y/o Sh II Draft PMD BALLOON REDUCTION NEGATIVE SPACE.LOW PRESSURE 17

18 COMPLETELY FILLED LOW PRESSURE VOID PRODUCE NEGATIVE DEFECT INJECTION / ASPIRATION 18

19 COMPLETE FILLING PLAIN BANANA INJECTED BANANA POROUS ARCHITECTURE ABLE TO FILL SPACES COMPLETELY PRESSURE RELIEF ( NEGATIVE PRESSURE VOID). BANANA SPLIT OPEN 19

20 AUGMENTED BANANA 20

21 Traditional Injection Techniques Venturi Effect P1=P2 No Flow N-Force System For Augmented Internal Fixation With Ceramic Cements N-Force System: 1 st FDA Cleared Trauma Implant For Use With Biomaterial Injection Allows Cement Insertion Before, During Or After Definitive Fixation Static Testing ASTM 4 pt Bend Test and Pull-Out 63 21

22 Axial Pullout Test No Cement vs. With B-BSM Cement Mean 475% Increase No Cement 400 N Cement Augment 1900 N Structural Stability of N-Force I-Beam Concept Placement Around Plate 66 22

23 Options for N-Force 67 Through Plate hole Sequential Injection 68 Injectable Fenestrated Screws 69 23

24 Implant SOM Delivery Russell VJO Placement Around Plate 71 Options for N-Force 72 Through Plate hole 24

25 Sequential Injection 73 Tibial Plateau Fracture Closed 25

26 Initial Reduction and Fixation CaPO4 Injection Though N-Force Screws 26

27 Final Construct Depressed Plateau Osteopenic Reduction, Provisional Fixation Courtesy of Dr. J. Weinlein, Memphis 27

28 Rafter Screw Technique with 4.0 mm N-Force Screws Fill of Defect From Top Down Russell TA, Leighton RK. Comparison of autogenous bone graft and endothermic calcium phosphate cement for defect augmentation in tibial plateau fractures. A multicenter, prospective, randomized study. Calcium Phosphate Cement (82 Fractures) Autogenous Iliac Bone Graft (38 Fractures) (P = 0.009) Higher Rate Of Articular Subsidence During The Three To Twelve-month Follow-up Period In The Bone Graft Group 28

29 ALLOPLASTIC GRAFT MATERIALS SUPERIOR TO AUTOGRAFT / DBM Russell TA, JBJS 2008 Oct;90(10): Goff T, Kanakaris NK, Giannoudis PV. Use Of Bone Graft Substitutes In The Management Of Tibial Plateau Fractures. Injury. Jan 2013;44 Suppl 1:S Hydroxyapatite Granules Calcium Sulphate Bioactive Glass Tricalcium Phosphate Demineralized Bone Matrix Allografts Auto Grafts Xenografts. CaPO 4 Cements Meta-analysis Goff T, Kanakaris NK, Giannoudis PV. Use Of Bone Graft Substitutes In The Management Of Tibial Plateau Fractures. Injury. Jan 2013;44 Suppl 1:S Secondary collapse of joint surface 2 mm Highest in the biological substitutes group (Allograft, DBM, Autograft and Xenograft) 8.6% CaSO 4 cases, 11.1% HA treated group, 5.4% CaPO 4 cases 3.7% Primary surgical site and donor site infection (3.6%) AIBG CaPO 4 Cements Meta-analysis 29

30 A Prospective Functional Analysis Of Proximal Tibia Fractures Using A Calcium Sulfate/Calcium Phosphate Composite Graft With An Early Weight Bearing Protocol OTA 2010 J. Tracy Watson, MD 1 ; Joseph Borrelli, MD 2 ; Timothy G. Weber, MD 3 ; Robert H. Choplin, MD, FACR 4 ; Scott A. Persohn, RT 4 ; Rena White 5 ; Emily Haglund 5 1 St. Louis University, St. Louis, MO, USA, 2 University of Texas Southwestern, Dallas, TX, USA, 3 OrthoIndy, Indianapolis, IN, USA, 4 Indiana University, Indianapolis, IN, USA, 5 Wright Medical Technology, Arlington, TN, USA Results: Maintained Articular Reduction In All Patients The Injected Graft Remodeled Over Time And Approached Normal Bone Density By 24 wks Progressed to wt. bearing 4 weeks earlier CURRENT CONDUCTIVE CERAMIC CEMENTS RESIST TENSION POORLY WEAK IN SHEAR STRESS NOT INDICATED FOR DIAPHYSEAL REPLACEMENT METAPHYSEAL LOCATIONS ONLY CONTAINED DEFECTS!!!!!! 30

31 CURRENT INJECTION TECHNIQUE DEFECTS FILL BEST WITH NEGATIVE PRESSURE VOIDS INJECTION / ASPIRATION TECHNIQUES DEVELOPMENT OF NEGATIVE PRESSURE VOIDS (BALLOON) SPECIFIC NEGATIVE PRESSURE SCREWS FOR INJECTION WHICH PASTE IS BEST??? MECHANICAL PROPERTIES..WILL IT ADEQUATELY SUPPORT SURFACE THRU TRANSITION TO FULL Wt. BEARING? INCORPORATION / DEGRADATION TIME???? CAN YOU INSTRUMENT????..FILL AND DRILL?? EASE OF USE.IS IT A FLAIL IN SURGERY???? DOES IT FILL THE DEFECT COMPLETELY? 31

32 Busch Stadium, 32

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