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Incorporating Biologic Technology 
Advances into my Practice 
Alan M. Hirahara, M.D., FRCS(C) 
Board Certified in Orthopaedic Surgery & Orthopaedic Sports Medicine 
Specializing in arthroscopic shoulder and knee surgery
How Do I View Technology? 
• Filling a need 
• Expanding a practice 
• Investigational / Experimental 
• Institutional constraints
FILLING A NEED 
Failures 
Technically Challenging Problems 
No Answers
Failures 
• Outcomes 
– 
– Justify your techniques 
• To patients 
• To insurance companies
Systematic Review of Microfracture 
• Goyal et al, Arthroscopy, 2013 (Level I & II studies) 
• Short term clinical outcomes Good for small lesions 
• Long term (> 5 yrs) Failure expected, regardless of lesion size 
• Mithoefer 
• Good / Excellent in 67% 
• Return to sports 66% @ avg 8 mos 
• Decreased function in 42% after 2 5 yrs
BIOCARTILAGE
BioCartilage 
• Inexpensive, easy, 
arthroscopic procedure 
• Covering chondral defects 
• Hyaline-like Cartilage 
PRP 
• Initiating the healing/clotting 
cascade 
• Diminishing inflammation & 
pain 
• Increasing stem cell migration
Why PRP as the Mixing Liquid? 
• Repeated platelet concentrate injections enhance reparative response of 
microfractures in the treatment of chondral defects of the knee 
– 5 injections of ACP post microfx: macroscopically, histologically, and 
biomechanically superior to microfx alone after 3, 6, and 12 months 
ACP 12 mo 
No ACP 12 mo 
ACP 12 mo No ACP 12 mo 
Milano et al. Arthroscopy, 2012.
BioCartilage: The Shoulder
BioCartilage: Trochlea (Knee)
BioCartilage: LFC (Knee)
My Experience 
Shoulders 10 
• 7 - Humeral head lesions 
• 3 - Glenoid lesions 
Knees 5 
• 2 - Trochlear lesions 
• 1 - LFC lesion 
• 2 - MFC lesions 
All procedures performed arthroscopically
Relative Costs 
• ACI 
– $16,000 
• Cost for cultured cells 
– Must add costs of two surgeries 
– Open Procedure 
• DoNovo NT 
– $4,500 Live cells 
– Juvenile, allograft cartilage 
minced into 1 mm cubes 
– Open procedure 
• BioCartilage 
– $770 
– Morselized, dehydrated cartilage 
– Arthroscopic
Case: Reverse Hill-Sachs Lesion
BioCartilage
BioCartilage
BioCartilage Equine Study Update 
BioCartilage 
Implantation 
• Investigators: 
– Lisa Fortier, DVM, PhD 
– Brian Cole, MD, MBA 
– James Cook, DVM, PhD 
• In vivo model: 
– Five horses, two 10 mm defects in each knee 
– Proximal and distal defect in lateral trochlea 
– BioCartilage in one knee, Microfracture in other 
• Outcomes: 
– Arthroscopic scoring at 2, 6, and 13 months 
– MRI, Micro-CT, and Histologic scoring at 13 
months
Arthroscopic Scoring of Defects 
(Higher = Better, both are significant)
Arthroscopic Images of Proximal Defect 
Microfx 
BioCartilage 
Preliminary Results 
2 mo 6 mo 13 mo
Preliminary Results 
Arthroscopic video of Distal Defect at 13 mo 
Microfx BioCartliage
How Should We Do It? 
Open 
• Easy 
• Inexpensive 
• Quick 
Arthroscopy 
• Very challenging 
• Clean margins 
– Curette / Burr 
• Instrumentation 
– Cannulas 
– Double lumen applicator for 
fibrin covering
Tips 
• Use cannula 
– Easier, more reliable instrument insertion 
– Not to disturb fibrin clot or sculpted BioCartilage 
• Make good vertical margins 
– Prefer curette with microfracture 
– BEWARE making divots with burrs 
• Overlay fibrin glue to adhere to native cartilage 
– Use a double lumen syringe system 
– 
– Tisseel has own double lumen syringe avail. 
• Suction out fluid 
– Keep it DRY!!! 
• Do not overhydrate with PRP 
– 0.8 1.0 cc 
–
Case: Failure! 
Intra-Op BioCartilage Placement 4 Months Post-op
Technically Challenging Problems 
• New technology can simplify and overcome 
obstacles 
– Better 
– Easier 
– Faster 
– Cheaper
ALLOGRAFT GRAFTLINK® 
CONSTRUCT
What is the Allograft GraftLink Construct? 
• A pre-sutured, sterile tendon construct 
that was designed for use with the 
GraftLink All-Inside® ACL technique 
• Assembled according to Arthrex 
specifications by allograft tissue 
specialists to ensure the construct meets 
the requirements of the technique
Allograft GraftLink Benefits 
• Reduced OR Time 
– No autograft recovery 
– No construct assembly 
• Minimally invasive 
– No donor site incision 
– No chance of autograft site 
complications 
• Convenience and 
Consistency 
– Graft length or diameter 
– Excellent suture pattern & 
knot strength 
– Consistency in assembly 
• Tendons pre-sutured during 
assembly
Allograft GraftLink Specs 
• Construct consists of a single tendon 
• Tibialis, Peroneus Longus, Semi-tendinosus 
• Construct diameter = 7.5-10.5 mm 
• Construct length = 60-80 mm 
• Donors: 15-60 
• #2 FiberWire ®
Allograft GraftLink Benefits 
• Sterile 
– AlloWash XG ® process 
– Sterility Assurance Level of 10-6 
– Patient safety 
• Reduced risk of disease transmission 
– Facility safety 
• Reduced risk of allograft related infection
Allograft GraftLink Benefits 
• Fixation options 
– BTB TightRope® (for Femur) 
– Open TightRope® ABS (for Tibia)
Sutures 
• Passing sutures for implants 
• Untied sutures connect free ends to 
tendons during assembly 
– Used for backup fixation
GraftLink Biomechanical Testing 
GraftLink pre-sutured tendons demonstrated slightly 
greater ultimate load when compared to unstitched tendons 
GraftLink pre-sutured tendons and unstitched tendons were 
statistically similar for cyclic displacement test results 
http://www.arthrex.com/myarthrex/whitepapers/loader.cfm?url=/commonspot/security/getfile.cfm&pageid=104984
GraftLink Creation
Attaching BTB TightRopes to PGL
No Answers
The Anterolateral Ligament 
Steven Claes, J of Anatomy 2013 
ALL found in 97% of knees (n=41)
Mechanical Advantage 
• 
– Force on ACL = (Force on ALL) x (R / r) 
• For example, if R2 = 30 mm & R1 = 5 mm 
• Force on ACL = 6x the force seen by the ALL
MRI of the Knee
MRI of the Knee 
LCL 
IT Band 
ALL
Ultrasound Evaluation of ALL 
ALL
My Experience 
Since January 2014 
• 13 ACL + ALL Reconstructions 
• 1 ACL Recon + ALL Repair 
• 5 ACL Recon without ALL injury 
• 4 ACL Recon with healing of ALL 
• 3 ALL Recon only 
– With previous ACL Recon 
• 60% 
– Needed ALL surgery with ACL 
• 22% 
– No ALL tear with ACL rupture 
• 18% 
– ALL showed evidence of healing 
* All reconstructions and repairs augmented with Internal Brace
Anterolateral Ligament (ALL) 
Reconstruction 
Ultrasound Guided, Percutaneous Placement Allograft Recon with Internal Brace
EXPANDING YOUR PRACTICE
Marketing 
• Websites 
• Social media 
• Advertising 
• 
•
INVESTIGATIONAL / EXPERIMENTAL
Fear / Faith 
• 
• Scientific Data vs. Clinical Data 
• - 
•
AUTOLOGOUS CONDITIONED PLASMA
AAOS CPG OA Knee 2nd ed. 
June 2013 
• Recommendation 8 
– unable to recommend for or against the use of intraarticular (IA) 
corticosteroids 
• Strength of Recommendation: Inconclusive 
• Recommendation 9 
– cannot recommend using hyaluronic acid for patients with symptomatic 
• Strength of Recommendation: Strong 
• Recommendation 10 
– unable to recommend for or against growth factor injections and/or platelet 
rich plasma 
• Strength of Recommendation: Inconclusive
AAOS CPG OA Knee 2nd ed. 
June 2013 
NO RISK ANALYSIS!!! 
recommendations did not include 
, but rather only evidence of the 
presence or absence of 
Jevsevar, AAOS Now
Risks 
• Cortisone 
– Soften cartilage 
– Weaken tendons 
– AVN of bone 
– Crystal deposition 
• Hyaluronic acid 
– Aseptic inflammatory reactions 
– Allergic reactions 
• PRP 
– NO adverse events reported!!! 
Filardo et al, Knee Surg Sports Traumatol Arthrosc 2013
Degenerative Joint Disease 
Goals 
• Decrease PAIN 
• Decrease INFLAMMATION 
• Increase HA SYNTHESIS 
NOT!!! 
• Rebuild new cartilage 
• Re-establish joint space 
• Eliminate spurs 
• Prevent degradation of joint (?) 
B 
A 
B 
2 
0 
CONTROL ACP HA 
LOG HAS-2 FOLD 
CHANGE OVER 
HA IN 
SYNOVIOCYTES 
MMP 13-IN 
SYNOVIOCYTES 
A 
B 
A 
0 
-2 
CONTROL ACP HA 
LOG MMP-13 
FOLD CHANGE 
OVER CONTROL 
A B B 
20 
0 
CONTROL ACP HA 
Α (PG/ML) 
TNF- Α 
Fortier et al, AJSM, 2014
My Experience with PRP 
as of 7/22/14
Pain Scores DJD Knee 
7.0 
6.0 
5.0 
4.0 
3.0 
2.0 
1.0 
- 
Pre-Injection Week 1 Week 2 Week 3 Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 
ACP Cortisone Supartz 
* No statistical significance between 
groups 
ACP n = 
24 
Cortisone n = 
81 
Supartz n = 
109
Level 1 Evidence: PRP in DJD 
PRP Superior to Hyaluronic Acid 
• Cerza et al, AJSM 2012 
• Sanchez et al, Arthroscopy 2012 
• Vaquerizo et al, Arthroscopy 2013 
• Chang et al, ACRM, 2014 (Meta-analysis) 
• Cole et al, Preliminary data 2014 
PRP Superior to Placebo 
• Patel et al, AJSM 2013 
• Chang et al, ACRM, 2014 (Meta-analysis) 
• Smith et al, Preliminary data 2014
Level 1 Evidence Supporting PRP for OA 
H 
A 
ACP 
Cerza et al., AJSM, 2012
Level 1 Evidence Supporting PRP for OA 
• Sachez et al, Arthroscopy, 2012 
– Randomized, double-blind, HA-controlled, multicenter trial: 176 patients 
– Primary outcome was 50% decrease in knee pain from baseline to week 24 
– Three weekly injections of PRGF 
• Significant reduction in knee pain and stiffness from baseline 
– 38% of patients receiving PRGF had 50% decrease in WOMAC pain score 
– 24% of patients receiving HA had 50% decrease in WOMAC pain score 
– p = 0.044 
Sanchez et al. A randomized clinical trial evaluating plasma rich in growth factors (PRGF-Endoret) versus hyalurnoic acid in the short-term treatment of symptomatic knee osteoarthritis. Arthroscopy. 2012; 28(8): 1070-8.
Level 1 Evidence Supporting PRP for OA 
96 patients: Randomized 
• PRGF: 3 injections 
• Durolane HA: 1 injection 
Vaquerizo et al. Comparison of intra-articular injections of PRGF vs. Durolane HA in the treatment of patients with symptomatic osteoarthritis. Arthroscopy. 2013; 29(10): 1635-43.
Level 1 Evidence Supporting PRP for OA 
• Randomized controlled trial 
• 78 patients (156 knees): Bilateral OA 
divided into 3 groups 
– Group A (52 knees): Single 
injection of PRP 
– Group B (50 knees): Two 
injections of PRP three weeks 
apart 
– Group C (46 knees): Single 
injection of saline 
• PRP: platelet count of 3x; filter was used 
to remove the WBCs 
• WOMAC and VAS: baseline, 6 weeks, 3 
months, 6 months 
Patel et al. Treatment with platelet-rich plasma is more effective than placebo for knee osteoarthritis: a prospective, double-blind, randomized trial. AJSM. 2013; 41(2): 356-64.
Who Gets It? 
• PRP improved effects over HA 
– Younger patients 
– Early OA 
• PRP similar effects to LW HA (not HW) 
– Older patients (> 50 yo) 
– Advanced OA Filardo et al., Knee Surg Sports Traumatol Arthrosc 2011 
Kon et al, Arthroscopy 2011
INSTITUTIONAL CONSTRAINTS
Healthcare Decisions 
Who decides? 
• Doctors 
• Patients 
• Facility 
• Insurance 
company 
• Government 
How to decide? 
• Based on Outcomes / Failures 
• Scientific / Clinical data 
• Technologic advances 
• Prevention 
• Cost 
– Short vs Long term
Prevention 
Can save money by preventing repeat surgery or complications 
• Failures 
• Re-tear 
• Infection 
• Stiffness 
• Less pain 
• Faster rehabilitation 
• Faster return to function 
• Faster return to work
BONE VOID FILLERS 
STIMUBLAST / QUICKSET
ACL Reconstruction: The Problem
Etiology of ACL Tunnel Widening 
Biological 
• Synovial fluid propagation 
• Increased cytokine levels 
• Sterilization methods 
• Implant material 
• Graft type 
• Graft donor 
Mechanical 
• Graft position 
• Fixation method 
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
Options 
StimuBlast FlexiGRAFT Cortical Fibers 
QuickSet
Demineralized Bone Matrix 
• Allograft bone with inorganic mineral removed, leaving only organic 
collagen matrix 
• Increased osteoinductivity 
– 
• Requires a carrier 
• Many clinical studies showing efficacy but each product has different 
characteristics
Reverse Phase Medium (RPM) 
• Mod Pluronic F127 (Poloxamer PPO PEO) 
• More viscous at body temp 
• Resists irrigation, can use arthroscopically 
• Permeable to blood, resorbed 
• Metabolized readily 
5 
min 
RPM 
Glycerol
DBM 
Product Distributor 
Carrier 
% DBM (by wt) 
Terminal 
Sterility? 
Osteoinduction 
Assay – Test 
Every Lot? 
StimuBlast Arthrex 
RPM 
(36) 
Yes 
E-Beam 
In Vivo 
Yes 
AlloMatrix 
Wright 
Medical 
CaSO4 
(40) 
Yes 
E-Beam 
In Vitro 
Yes 
DBX Synthes 
Na Hyaluronate 
(32) 
No 
In Vivo / In Vitro 
Yes 
Grafton Medtronic 
Glycerol 
(17) 
No 
In Vivo 
No
Filling Tunnels
1st Stage for ACL Revision 
StimuBlast / QuickSet
1st Stage for ACL Revision 
StimuBlast / QuickSet 
Pre-op 2 Months post-op
2nd Stage for ACL Revision 
StimuBlast 2nd Look
All-Inside GraftLink Technique 
StimuBlast
GraftLink
Backfill of OATS Donor Site 
StimuBlast
Case: OATS Backfill 
StimuBlast 
October 2012 May 2014
Backfill of Glenoid Rim Anchor Hole 
StimuBlast
1st Stage for MPFL Revision 
QuickSet 
February 2013 May 2014
Arthroscopy 
QuickSet
QuickSet Post-op 
Anterior Anchor Posterior Anchor 
No Gap formation. 
Quickset placed after 
anchor in place 
Gap formation. 
No Quickset 
No Gap formation. 
Quickset placed before 
anchor 
No Gap formation. 
No prior hole
Comparison 
StimuBlast 
• Excellent for filling in bony 
defects 
– Can help fill gaps when placing 
grafts 
• No structural support 
• Can be done arthroscopically 
– Safe 
QuickSet 
• Reinforce anchors in porous bone 
or holes 
– Insert QuickSet first prior to 
anchor placement 
• No immediate structural support 
• Can be done arthroscopically 
– Be careful with placement
So How Do I Incorporate New Technology? 
• Honestly evaluate my outcomes 
• Keep an open mind 
• Trust in my ability & instincts 
• Have a little Faith 
• the future
HiraharaMD.com

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Incorporating Biologic Technology Advances into my Practice

  • 1. Incorporating Biologic Technology Advances into my Practice Alan M. Hirahara, M.D., FRCS(C) Board Certified in Orthopaedic Surgery & Orthopaedic Sports Medicine Specializing in arthroscopic shoulder and knee surgery
  • 2. How Do I View Technology? • Filling a need • Expanding a practice • Investigational / Experimental • Institutional constraints
  • 3. FILLING A NEED Failures Technically Challenging Problems No Answers
  • 4. Failures • Outcomes – – Justify your techniques • To patients • To insurance companies
  • 5. Systematic Review of Microfracture • Goyal et al, Arthroscopy, 2013 (Level I & II studies) • Short term clinical outcomes Good for small lesions • Long term (> 5 yrs) Failure expected, regardless of lesion size • Mithoefer • Good / Excellent in 67% • Return to sports 66% @ avg 8 mos • Decreased function in 42% after 2 5 yrs
  • 7. BioCartilage • Inexpensive, easy, arthroscopic procedure • Covering chondral defects • Hyaline-like Cartilage PRP • Initiating the healing/clotting cascade • Diminishing inflammation & pain • Increasing stem cell migration
  • 8. Why PRP as the Mixing Liquid? • Repeated platelet concentrate injections enhance reparative response of microfractures in the treatment of chondral defects of the knee – 5 injections of ACP post microfx: macroscopically, histologically, and biomechanically superior to microfx alone after 3, 6, and 12 months ACP 12 mo No ACP 12 mo ACP 12 mo No ACP 12 mo Milano et al. Arthroscopy, 2012.
  • 12. My Experience Shoulders 10 • 7 - Humeral head lesions • 3 - Glenoid lesions Knees 5 • 2 - Trochlear lesions • 1 - LFC lesion • 2 - MFC lesions All procedures performed arthroscopically
  • 13. Relative Costs • ACI – $16,000 • Cost for cultured cells – Must add costs of two surgeries – Open Procedure • DoNovo NT – $4,500 Live cells – Juvenile, allograft cartilage minced into 1 mm cubes – Open procedure • BioCartilage – $770 – Morselized, dehydrated cartilage – Arthroscopic
  • 17. BioCartilage Equine Study Update BioCartilage Implantation • Investigators: – Lisa Fortier, DVM, PhD – Brian Cole, MD, MBA – James Cook, DVM, PhD • In vivo model: – Five horses, two 10 mm defects in each knee – Proximal and distal defect in lateral trochlea – BioCartilage in one knee, Microfracture in other • Outcomes: – Arthroscopic scoring at 2, 6, and 13 months – MRI, Micro-CT, and Histologic scoring at 13 months
  • 18. Arthroscopic Scoring of Defects (Higher = Better, both are significant)
  • 19. Arthroscopic Images of Proximal Defect Microfx BioCartilage Preliminary Results 2 mo 6 mo 13 mo
  • 20. Preliminary Results Arthroscopic video of Distal Defect at 13 mo Microfx BioCartliage
  • 21. How Should We Do It? Open • Easy • Inexpensive • Quick Arthroscopy • Very challenging • Clean margins – Curette / Burr • Instrumentation – Cannulas – Double lumen applicator for fibrin covering
  • 22. Tips • Use cannula – Easier, more reliable instrument insertion – Not to disturb fibrin clot or sculpted BioCartilage • Make good vertical margins – Prefer curette with microfracture – BEWARE making divots with burrs • Overlay fibrin glue to adhere to native cartilage – Use a double lumen syringe system – – Tisseel has own double lumen syringe avail. • Suction out fluid – Keep it DRY!!! • Do not overhydrate with PRP – 0.8 1.0 cc –
  • 23. Case: Failure! Intra-Op BioCartilage Placement 4 Months Post-op
  • 24. Technically Challenging Problems • New technology can simplify and overcome obstacles – Better – Easier – Faster – Cheaper
  • 26. What is the Allograft GraftLink Construct? • A pre-sutured, sterile tendon construct that was designed for use with the GraftLink All-Inside® ACL technique • Assembled according to Arthrex specifications by allograft tissue specialists to ensure the construct meets the requirements of the technique
  • 27. Allograft GraftLink Benefits • Reduced OR Time – No autograft recovery – No construct assembly • Minimally invasive – No donor site incision – No chance of autograft site complications • Convenience and Consistency – Graft length or diameter – Excellent suture pattern & knot strength – Consistency in assembly • Tendons pre-sutured during assembly
  • 28. Allograft GraftLink Specs • Construct consists of a single tendon • Tibialis, Peroneus Longus, Semi-tendinosus • Construct diameter = 7.5-10.5 mm • Construct length = 60-80 mm • Donors: 15-60 • #2 FiberWire ®
  • 29. Allograft GraftLink Benefits • Sterile – AlloWash XG ® process – Sterility Assurance Level of 10-6 – Patient safety • Reduced risk of disease transmission – Facility safety • Reduced risk of allograft related infection
  • 30. Allograft GraftLink Benefits • Fixation options – BTB TightRope® (for Femur) – Open TightRope® ABS (for Tibia)
  • 31. Sutures • Passing sutures for implants • Untied sutures connect free ends to tendons during assembly – Used for backup fixation
  • 32. GraftLink Biomechanical Testing GraftLink pre-sutured tendons demonstrated slightly greater ultimate load when compared to unstitched tendons GraftLink pre-sutured tendons and unstitched tendons were statistically similar for cyclic displacement test results http://www.arthrex.com/myarthrex/whitepapers/loader.cfm?url=/commonspot/security/getfile.cfm&pageid=104984
  • 36. The Anterolateral Ligament Steven Claes, J of Anatomy 2013 ALL found in 97% of knees (n=41)
  • 37. Mechanical Advantage • – Force on ACL = (Force on ALL) x (R / r) • For example, if R2 = 30 mm & R1 = 5 mm • Force on ACL = 6x the force seen by the ALL
  • 38. MRI of the Knee
  • 39. MRI of the Knee LCL IT Band ALL
  • 41. My Experience Since January 2014 • 13 ACL + ALL Reconstructions • 1 ACL Recon + ALL Repair • 5 ACL Recon without ALL injury • 4 ACL Recon with healing of ALL • 3 ALL Recon only – With previous ACL Recon • 60% – Needed ALL surgery with ACL • 22% – No ALL tear with ACL rupture • 18% – ALL showed evidence of healing * All reconstructions and repairs augmented with Internal Brace
  • 42. Anterolateral Ligament (ALL) Reconstruction Ultrasound Guided, Percutaneous Placement Allograft Recon with Internal Brace
  • 44. Marketing • Websites • Social media • Advertising • •
  • 46. Fear / Faith • • Scientific Data vs. Clinical Data • - •
  • 48. AAOS CPG OA Knee 2nd ed. June 2013 • Recommendation 8 – unable to recommend for or against the use of intraarticular (IA) corticosteroids • Strength of Recommendation: Inconclusive • Recommendation 9 – cannot recommend using hyaluronic acid for patients with symptomatic • Strength of Recommendation: Strong • Recommendation 10 – unable to recommend for or against growth factor injections and/or platelet rich plasma • Strength of Recommendation: Inconclusive
  • 49. AAOS CPG OA Knee 2nd ed. June 2013 NO RISK ANALYSIS!!! recommendations did not include , but rather only evidence of the presence or absence of Jevsevar, AAOS Now
  • 50. Risks • Cortisone – Soften cartilage – Weaken tendons – AVN of bone – Crystal deposition • Hyaluronic acid – Aseptic inflammatory reactions – Allergic reactions • PRP – NO adverse events reported!!! Filardo et al, Knee Surg Sports Traumatol Arthrosc 2013
  • 51. Degenerative Joint Disease Goals • Decrease PAIN • Decrease INFLAMMATION • Increase HA SYNTHESIS NOT!!! • Rebuild new cartilage • Re-establish joint space • Eliminate spurs • Prevent degradation of joint (?) B A B 2 0 CONTROL ACP HA LOG HAS-2 FOLD CHANGE OVER HA IN SYNOVIOCYTES MMP 13-IN SYNOVIOCYTES A B A 0 -2 CONTROL ACP HA LOG MMP-13 FOLD CHANGE OVER CONTROL A B B 20 0 CONTROL ACP HA Α (PG/ML) TNF- Α Fortier et al, AJSM, 2014
  • 52. My Experience with PRP as of 7/22/14
  • 53. Pain Scores DJD Knee 7.0 6.0 5.0 4.0 3.0 2.0 1.0 - Pre-Injection Week 1 Week 2 Week 3 Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 ACP Cortisone Supartz * No statistical significance between groups ACP n = 24 Cortisone n = 81 Supartz n = 109
  • 54. Level 1 Evidence: PRP in DJD PRP Superior to Hyaluronic Acid • Cerza et al, AJSM 2012 • Sanchez et al, Arthroscopy 2012 • Vaquerizo et al, Arthroscopy 2013 • Chang et al, ACRM, 2014 (Meta-analysis) • Cole et al, Preliminary data 2014 PRP Superior to Placebo • Patel et al, AJSM 2013 • Chang et al, ACRM, 2014 (Meta-analysis) • Smith et al, Preliminary data 2014
  • 55. Level 1 Evidence Supporting PRP for OA H A ACP Cerza et al., AJSM, 2012
  • 56. Level 1 Evidence Supporting PRP for OA • Sachez et al, Arthroscopy, 2012 – Randomized, double-blind, HA-controlled, multicenter trial: 176 patients – Primary outcome was 50% decrease in knee pain from baseline to week 24 – Three weekly injections of PRGF • Significant reduction in knee pain and stiffness from baseline – 38% of patients receiving PRGF had 50% decrease in WOMAC pain score – 24% of patients receiving HA had 50% decrease in WOMAC pain score – p = 0.044 Sanchez et al. A randomized clinical trial evaluating plasma rich in growth factors (PRGF-Endoret) versus hyalurnoic acid in the short-term treatment of symptomatic knee osteoarthritis. Arthroscopy. 2012; 28(8): 1070-8.
  • 57. Level 1 Evidence Supporting PRP for OA 96 patients: Randomized • PRGF: 3 injections • Durolane HA: 1 injection Vaquerizo et al. Comparison of intra-articular injections of PRGF vs. Durolane HA in the treatment of patients with symptomatic osteoarthritis. Arthroscopy. 2013; 29(10): 1635-43.
  • 58. Level 1 Evidence Supporting PRP for OA • Randomized controlled trial • 78 patients (156 knees): Bilateral OA divided into 3 groups – Group A (52 knees): Single injection of PRP – Group B (50 knees): Two injections of PRP three weeks apart – Group C (46 knees): Single injection of saline • PRP: platelet count of 3x; filter was used to remove the WBCs • WOMAC and VAS: baseline, 6 weeks, 3 months, 6 months Patel et al. Treatment with platelet-rich plasma is more effective than placebo for knee osteoarthritis: a prospective, double-blind, randomized trial. AJSM. 2013; 41(2): 356-64.
  • 59. Who Gets It? • PRP improved effects over HA – Younger patients – Early OA • PRP similar effects to LW HA (not HW) – Older patients (> 50 yo) – Advanced OA Filardo et al., Knee Surg Sports Traumatol Arthrosc 2011 Kon et al, Arthroscopy 2011
  • 61. Healthcare Decisions Who decides? • Doctors • Patients • Facility • Insurance company • Government How to decide? • Based on Outcomes / Failures • Scientific / Clinical data • Technologic advances • Prevention • Cost – Short vs Long term
  • 62. Prevention Can save money by preventing repeat surgery or complications • Failures • Re-tear • Infection • Stiffness • Less pain • Faster rehabilitation • Faster return to function • Faster return to work
  • 63. BONE VOID FILLERS STIMUBLAST / QUICKSET
  • 65. Etiology of ACL Tunnel Widening Biological • Synovial fluid propagation • Increased cytokine levels • Sterilization methods • Implant material • Graft type • Graft donor Mechanical • Graft position • Fixation method 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.
  • 66. Potential Consequences • Delaying incorporation of the soft tissue graft into bone • Decreasing graft stability • Causing difficulty with future revision surgery
  • 67. Options StimuBlast FlexiGRAFT Cortical Fibers QuickSet
  • 68. Demineralized Bone Matrix • Allograft bone with inorganic mineral removed, leaving only organic collagen matrix • Increased osteoinductivity – • Requires a carrier • Many clinical studies showing efficacy but each product has different characteristics
  • 69. Reverse Phase Medium (RPM) • Mod Pluronic F127 (Poloxamer PPO PEO) • More viscous at body temp • Resists irrigation, can use arthroscopically • Permeable to blood, resorbed • Metabolized readily 5 min RPM Glycerol
  • 70. DBM Product Distributor Carrier % DBM (by wt) Terminal Sterility? Osteoinduction Assay – Test Every Lot? StimuBlast Arthrex RPM (36) Yes E-Beam In Vivo Yes AlloMatrix Wright Medical CaSO4 (40) Yes E-Beam In Vitro Yes DBX Synthes Na Hyaluronate (32) No In Vivo / In Vitro Yes Grafton Medtronic Glycerol (17) No In Vivo No
  • 72. 1st Stage for ACL Revision StimuBlast / QuickSet
  • 73. 1st Stage for ACL Revision StimuBlast / QuickSet Pre-op 2 Months post-op
  • 74. 2nd Stage for ACL Revision StimuBlast 2nd Look
  • 77. Backfill of OATS Donor Site StimuBlast
  • 78. Case: OATS Backfill StimuBlast October 2012 May 2014
  • 79. Backfill of Glenoid Rim Anchor Hole StimuBlast
  • 80. 1st Stage for MPFL Revision QuickSet February 2013 May 2014
  • 82. QuickSet Post-op Anterior Anchor Posterior Anchor No Gap formation. Quickset placed after anchor in place Gap formation. No Quickset No Gap formation. Quickset placed before anchor No Gap formation. No prior hole
  • 83. Comparison StimuBlast • Excellent for filling in bony defects – Can help fill gaps when placing grafts • No structural support • Can be done arthroscopically – Safe QuickSet • Reinforce anchors in porous bone or holes – Insert QuickSet first prior to anchor placement • No immediate structural support • Can be done arthroscopically – Be careful with placement
  • 84. So How Do I Incorporate New Technology? • Honestly evaluate my outcomes • Keep an open mind • Trust in my ability & instincts • Have a little Faith • the future