FDMA FLAP - The first dorsal metacarpal artery (FDMA) flap is used mainly for...
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
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.
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
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
–
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
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
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
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
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
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
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
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
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
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