This document discusses demineralized bone matrix (DBM) and its use in orthopedic procedures. It provides information on several DBM products, including StimuBlast, AlloMatrix, DBX, and Grafton. It describes the composition and characteristics of different DBM carriers like reverse phase medium and glycerol. The document also discusses issues like ACL tunnel widening and presents preliminary results of a pilot study examining the effect of DBM on tunnel size in ACL reconstruction. Finally, it introduces the FlexiGraft DBM product line including sponges, cortical fibers, and its applications in procedures like PASTA bridge and RC repair.

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!