Demineralized Bone Matrix
                Alan M. Hirahara, M.D., FRCS(C)
       Board Certified in Orthopaedic Surgery & Orthopaedic Sports Medicine
                    Specializing in arthroscopic shoulder surgery




     Medical Director               Team Physician              Consultant
Sacramento State Athletics       Sacramento River Cats          Oakland A’s
                                      MiLB - AAA
STIMUBLAST
Demineralized Bone Matrix
• Allograft bone with inorganic mineral removed, leaving only organic
   collagen matrix


• Increased osteoinductivity
    – Exposed growth factors (BMP’s)


• Requires a carrier


• Many clinical studies showing efficacy but each product has different
   characteristics
DBM

                                                         Osteoinduction
                              Carrier       Terminal
 Product     Distributor                                  Assay – Test
                           % DBM (by wt)    Sterility?
                                                           Every Lot?

                               RPM            Yes             In Vivo
StimuBlast    Arthrex
                               (36)         E-Beam              Yes

              Wright          CaSO4           Yes            In Vitro
AlloMatrix
              Medical          (40)         E-Beam             Yes

                           Na Hyaluronate                In Vivo / In Vitro
  DBX         Synthes                          No
                                (32)                            Yes

                              Glycerol                        In Vivo
 Grafton     Medtronic                         No
                                (17)                            No
Reverse Phase Medium (RPM)
•   Mod Pluronic F127 (Poloxamer PPO PEO)
                                                         5 min
•   More viscous at body temp

•   Resists irrigation, can use arthroscopically

•   Permeable to blood, resorbed

•   Metabolized readily



                                                   RPM           Glycerol
Composite Grafting
The Problem
Etiology of ACL Tunnel Widening
          Biological                     Mechanical

• Synovial fluid propagation   • Graft position

• Increased cytokine levels    • Fixation method

• Sterilization methods

• Implant material

• Graft type

• Graft donor
                                           Maak et al. JAAOS. 2010; 18: 695-706.
                                           Fauno et al. Arthoscopy. 2005; 21(11): 1337-41.
                                           Wilson et al. AJSM. 2004; 32(2): 543-9.
                                           Darabos et al. Knee Surg Sports Traum Arthrsc; 2011; 19: S36-46.
                                           Rodeo et al. AJSM. 2006; 34(11): 1790-800.
Potential Consequences

• Delaying incorporation of the soft tissue graft
  into bone

• Decreasing graft stability

• Causing difficulty with future revision surgery
Saw Bones Testing
A Pilot Study:
Effect of DBM on tunnel size
   in ACL reconstruction

      Alan M Hirahara, MD, FRCSC
Study Design
Study                               Control

• 11 patients                       • 6 patients
    – 6 male / 5 female
                                       – 3 male / 3 female
    – Age mean: 28.9 (15 – 45 yo)
                                       – Age mean: 26.6 (16 – 48 yo)
• 4 revisions
    – 2 staged / 2 primary          • No revisions
• Associated pathology
                                    • Associated pathology
    – 2 meniscus repair
                                       – 2 menisectomy
    – 4 menisectomy
    – 3 chondroplasty                  – 2 microfx chondroplasty
VAS Results
6.0

5.0

4.0

3.0

2.0

1.0

0.0
      Pre-op   Month 1    Month 2       Month 3        Month 4   Month 5   Month 6




                                    Study    Control
Technique
Control
Preliminary Results
FLEXIGRAFT
FlexiGraft

• Partially demineralized cancellous sponges
  – Ground

  – Cubes

  – Strips

• Demineralized cortical fibers
FlexiGraft DBM Sponge
•   Osteoconductive
•   Bioactive
•   Natural architecture
•   Freeze dried
•   Sterile (SAL of 10-6)
•   Hydrophilic
•   Biocompatible
•   Customizable hydration
•   Malleable / Elastic / Compressible
•   Contains no fillers or carriers commonly used in bone putties and gels
FlexiGraft DBM Cortical Fibers
•    Osteoconductive
•    Osteoinductive potential
•    100% cortical
•    Natural architecture
•    Freeze dried
•    Sterile (SAL of 10-6)
•    Hydrophylic
•    Biocompatible
•    Customizable hydration
•    Malleable / Elastic / Compressible
•    Contains no fillers or carriers commonly used in bone putties and gels
FlexiGraft – PASTA Bridge
FlexiGraft – RC Repair
Thank You!

Demineralized Bone Matrix

  • 1.
    Demineralized Bone Matrix Alan M. Hirahara, M.D., FRCS(C) Board Certified in Orthopaedic Surgery & Orthopaedic Sports Medicine Specializing in arthroscopic shoulder surgery Medical Director Team Physician Consultant Sacramento State Athletics Sacramento River Cats Oakland A’s MiLB - AAA
  • 2.
  • 3.
    Demineralized Bone Matrix •Allograft bone with inorganic mineral removed, leaving only organic collagen matrix • Increased osteoinductivity – Exposed growth factors (BMP’s) • Requires a carrier • Many clinical studies showing efficacy but each product has different characteristics
  • 4.
    DBM Osteoinduction Carrier Terminal Product Distributor Assay – Test % DBM (by wt) Sterility? Every Lot? RPM Yes In Vivo StimuBlast Arthrex (36) E-Beam Yes Wright CaSO4 Yes In Vitro AlloMatrix Medical (40) E-Beam Yes Na Hyaluronate In Vivo / In Vitro DBX Synthes No (32) Yes Glycerol In Vivo Grafton Medtronic No (17) No
  • 5.
    Reverse Phase Medium(RPM) • Mod Pluronic F127 (Poloxamer PPO PEO) 5 min • More viscous at body temp • Resists irrigation, can use arthroscopically • Permeable to blood, resorbed • Metabolized readily RPM Glycerol
  • 6.
  • 7.
  • 8.
    Etiology of ACLTunnel Widening Biological Mechanical • Synovial fluid propagation • Graft position • Increased cytokine levels • Fixation method • Sterilization methods • Implant material • Graft type • Graft donor Maak et al. JAAOS. 2010; 18: 695-706. Fauno et al. Arthoscopy. 2005; 21(11): 1337-41. Wilson et al. AJSM. 2004; 32(2): 543-9. Darabos et al. Knee Surg Sports Traum Arthrsc; 2011; 19: S36-46. Rodeo et al. AJSM. 2006; 34(11): 1790-800.
  • 9.
    Potential Consequences • Delayingincorporation of the soft tissue graft into bone • Decreasing graft stability • Causing difficulty with future revision surgery
  • 10.
  • 11.
    A Pilot Study: Effectof DBM on tunnel size in ACL reconstruction Alan M Hirahara, MD, FRCSC
  • 12.
    Study Design Study Control • 11 patients • 6 patients – 6 male / 5 female – 3 male / 3 female – Age mean: 28.9 (15 – 45 yo) – Age mean: 26.6 (16 – 48 yo) • 4 revisions – 2 staged / 2 primary • No revisions • Associated pathology • Associated pathology – 2 meniscus repair – 2 menisectomy – 4 menisectomy – 3 chondroplasty – 2 microfx chondroplasty
  • 13.
    VAS Results 6.0 5.0 4.0 3.0 2.0 1.0 0.0 Pre-op Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Study Control
  • 14.
  • 15.
  • 16.
  • 17.
  • 18.
    FlexiGraft • Partially demineralizedcancellous sponges – Ground – Cubes – Strips • Demineralized cortical fibers
  • 19.
    FlexiGraft DBM Sponge • Osteoconductive • Bioactive • Natural architecture • Freeze dried • Sterile (SAL of 10-6) • Hydrophilic • Biocompatible • Customizable hydration • Malleable / Elastic / Compressible • Contains no fillers or carriers commonly used in bone putties and gels
  • 20.
    FlexiGraft DBM CorticalFibers • Osteoconductive • Osteoinductive potential • 100% cortical • Natural architecture • Freeze dried • Sterile (SAL of 10-6) • Hydrophylic • Biocompatible • Customizable hydration • Malleable / Elastic / Compressible • Contains no fillers or carriers commonly used in bone putties and gels
  • 21.
  • 22.
  • 23.