Update on DBM, August 2012

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. STIMUBLAST

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. Composite Grafting

7. The Problem

8. 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.

9. Potential Consequences
• Delaying incorporation of the soft tissue graft
into bone
• Decreasing graft stability
• Causing difficulty with future revision surgery

10. Saw Bones Testing

11. A Pilot Study:
Effect of 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. Technique

15. Control

16. Preliminary Results

17. FLEXIGRAFT

18. FlexiGraft
• Partially demineralized cancellous 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 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

21. FlexiGraft – PASTA Bridge

22. FlexiGraft – RC Repair

23. Thank You!