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Blood and Beyond!!!
Mark Lavallee, MD, CSCS, FACSMDirector, York Hospital Sports Medicine Fellowship, York PA
Ass’t Clinical Professor, Penn State Univ. College of Medicine, Hershey, PA
Team Physician, Gettysburg College, Gettysburg, PA
Chairman, USA Weightlifting Sports Medicine, Colorado Spring, CO
February 5th , 2015 ACSM Team Physician Course
Introduction / Disclaimer
• Been performing Platelet-Rich Plasma (a.k.a. PRP) Injections on patients in since 2009 and Autologous Blood injection since 1999
• Been perform FAST by TENEX since November 2011. Involve in longitudinal outcome study (self-funded)
• No financial relationships with any biotechnology firm in relation to PRP, ABI, or Percutaneous tenotomy.
Overview
• What are platelets & PRP
• Basic Science
• Platelet function
• Initiate healing
• Growth Factors
• Difference between PRP, ABI, ACS, etc
• Platelet Basic Science
• Preparation Procedures
Role of PRP:
• Muscle injuries
• Tendon injuries
• Cartilage injuries
• Nerve Injuries
• Potential Adverse effects
• Post-injection Recommendations
• NEXT GENERATION: Focused-Aspiration of Scar Tissue/ Percutaneous U/S guided Tenotomy
Terminology
• PRP: Platelet-Rich Plasma
• PEP: Platelet-Enriched Plasma
• PRGF: Plasma-Rich in Growth Factors
• ACS: Autologous Conditioned Serum
(blood is withdrawn from pt, incubated for
6 hours @ 37oC, re-injected cell-free into
injured area.)
• ABI: Autologous Blood Injection (untreated
blood withdrawn from pt and injected into
injured area)
FIRST, there autologous blood
injections (ABI)
• During the 1990’s, 2cc-10cc of autologous
blood was withdrawn from athlete.
• This blood would be the injected into
muscle strains, joints, chronic injuries
• Started with veterinarians
• Then Maxifacial & plastic Surgeons
• Then, Russian and Chinese Sports
Medicine docs in elite athletes
• PROS: Showed some improved healing,
cheap, easy to perform
• CONS: hematoma, painful.
• Not a lot of peer-reviewed evidence to
support, most ancedotal
Autologous Blood Injections (ABI)
• PROS: Showed some improved healing,
cheap, easy to perform
• CONS: hematoma, painful.
• Not a lot of peer-reviewed evidence to
support, most ancedotal
Suresh SP, Ali KE, Connell DA: British Journal of Sports
Medicine 2006;40:935-939.
Kiter E, et al: Journal of the American Podiatric Medical
Association. Vol 96 (4): July/August 2006.
Then came autologous
conditioned serum (ACS)
• The rationale was to:
• remove cells (mostly RBCS and most
WBCs) via centrifuge
• Keep serum WARM (37 degree) at or
just above body temp, to keep healing
factors from denaturing
• Incubate for around 6 hours
• PROS: less painful, some improved
outcomes, retained platelets/GF
• CONS: labor and time intensive, lack of
peer-reviewed support
So what’s all the HYPE with
Platelets
• Hines Ward 2009
• (Pittsburgh Steelers)
• Knee injury 2 weeks before Super
Bowl in 2009
• Had PRP injection
• Played in Super Bowl 1 week later
• Takashi Saito 2009
(L.A. Dodgers)
Pitcher with UCL injury
Received PRP
Was able to pitch in 2008 Playoffs
•http://www.youtube.com/watch?v=rCDrsw3e_U0
What are Platelets?
• Formed from megakaryocytes
• Megakaryocyte (MK) will give rise to
approximately 4,000 platelets which live an
average of 9-12 days.
• The peripheral blood platelet count ranges from
150 - 450 x 10 /L.
• 2/3 of platelets circulate, while 1/3 are in the
splenic pool or other extravascular locations.
• In the steady state:
• Platelet production = platelet destruction
• Daily production is 30,000 - 40,000 /uL.
Platelet-Rich Plasma InjectionsIndiana University School of Medicine
Mini-Medical School Series
Mark Lavallee, MD, CSCS, FACSM
Stephen Simons, MD, FACSM
March 23rd, 2011
Platelets
RBCs
Platelets
What are on Platelets which make them SPECIAL?
• Platelets contain granules that have bioactive
proteins responsible for hemostasis and healing:
• Alpha granules contain
• Platelet Derived Growth Factor (PDGF)
• Vascular Endothelial Growth Factor (VEGF)
• Transforming Growth Factor-B1 (TGFB)
• Insulin Like Growth Factor-1 (IGF-1)
• platelet factor 4,
• Factors V & XIII and fibrinogen.
• Dense bodies contain serotonin, nucleotides (ADP)
and calcium.
• Platelets release their granular contents upon
activation.
• Platelets activate upon exposure to:
• Calcium
• Thrombin
• Tendon derived collagen
What is PRP?
• PRP is defined as a sample of autologous
blood with concentrations of platelets
above baseline values.
• Clinically active PRP typically contains
over 1 million platelets per microliter.
• A part of the medical frontier know as
“orthobiologics.”
Marx R. Platelet Rich Plasma: what is it and what is not PRP?
Implant Dent 2001;10:225-8.
Why PRP?
• Platelets do more than just clot!
• Platelets release bioactive factors
that:
• Attract macrophages;
• Attract mesenchymal stem cells;
• Promote removal of necrotic tissue;
• Stimulate angiogenesis;
• Enhance tissue regeneration and
healing.
• Autologous blood eliminates
concerns about disease
transmission, is easy and cheap!
Platelets ATTRACT stem cells!!
What is PRP?
• PRP is defined as a sample of
autologous blood with
concentrations of platelets above
baseline values.
• Clinically active PRP typically
contains over 1 million platelets per
microliter.
• A part of the medical frontier know
as “orthobiologics.”
Marx R. Platelet Rich Plasma: what is it and what is
not PRP? Implant Dent 2001;10:225-8.
Indications for PRP
Tendinosis/tears
Ligamentosis/laxity/tears
Muscle tears
Osteoarthritis/arthropathy
Cartilage injury (OCD)
Joint effusions
Wound healing
Fracture non-unions
Stress fractures
Contraindications for PRP
Anti-platelet / anti-inflammatory medication
Coumadin, ASA, NSAIDS, heparin, etc
High dose fish oil
Bovine Thrombin Allergy
Bleeding / clotting disorder
Anemia / low platelet count
?cigarette smoking?
?Auto-immune disease?
RA, gout, SLE
PRP does help resolve synovial proliferation!
~Nutritional / Hormonal deficiency
Potential PRP Injection Applications/Sites
Spine
Sacroiliac joints
Iliolumbar ligaments
Facet joints (C-T-L)
Costotransverse (rib) joints
Spinal ligaments
Shoulder
Rotator cuff tears/tendinosis
Biceps tendinosis
Chronic glenohumeral lig. sprains
AC & GH joint arthritis
Labral tears & degeneration
Elbows
Epicondylitis – medial & lateral
Ulnar collateral ligament
Distal biceps tendon – part. tear
Osteoarthritis
Wrist/Hand
Chronic thumb UCL sprain
First CMC / MCP osteoarthritis
Tenosynovitis / tendinosis
wrist or distal RU osteoarthritis
Potential PRP Injection Applications/Sites
Hip/Pelvis
Hip osteoarthritis
Hamstring origin/ischial tuberosity
Symphysis pubis / pubalgia
Adductor / gluteal tendinosis
Knee
Patellar tendinosis
Quadriceps tendinosis & tears
Collateral / cruciate ligament tears
Meniscal tears
Osteoarthritis
Patellofemoral
Post ACL repair
Pes bursitis / tendinosis
Proximal tibfib joint laxity / OA
Ankle/Foot
Achilles tendinosis
Peroneal tendinosis & tear
Tibialis posterior tears &
tendinosis
Plantar fasciitis
Osteochondral defect talus
Sinus tarsi syndrome
Ankle ligament tears and laxity
Bunions
Osteoarthritis ankle, foot, toes
Sesamoids
PRP Preparation
• A: 30-60 ml for pt’s blood is taken
• B: in is then placed into special sterile single-use kit and placed into centrifuge
• C: once successful spin, platelet-rich plasma is withdrawn from kit and placed into via or syringe
• D: Syringe with about 3-6 ml of PRP is injected into injured area.
Most PRP is injected using Ultrasound Guidance
Hip: Greater Trochanteric Bursa Injection
Tendinopathy
Results When Normal Healing Fails
Post Injection Recommendations
• In review of ALL the available literature:
• No census stands on treatment after
PRP
• Most allow exercise 2-5 days after
injections
• Many encourage Rest, ice and limb
elevation for 48 hours
• Fenestration or percutaneous tenotomy
has been used with PRP to treat
tendonosis, which confounds rehab
process b/c of microtrauma has
elongating rest/rehab cycle.
Potential Adverse Effects
• In review of the literature for adverse reactions
• (esp. Oral & Maxillofacial surgery which pioneered PRP in early 1990’s)
• VERY LITTLE ADVERSE EFFECTS
• ORAL, DENTAL, ENT
• Wang-Saugusa et al, Arch orthop Trauma Surg, 2010:
• no adverse events with 800+ patients
• Anitua et al, J Periodontal, 2010:
• no adverse events in 8 year follow-up due to PRP.
• MUSCLE, TENDON, CARTILAGE
• Articles I reviewed for this lecture: only adverse reactions mentioned were 2 for mild pain, 1 for mild effusion
Potential Adverse Effects
• Theoretically:
• Don’t use PRP in pts with low or abnormal platelet fxn, anemia, hypofibrinogenemia, hemodynamic instability, septicemia
• Sensitivity to bovine thrombin for activation may cause a hypersensitivity reaction in a rare individual.
• Development of antibodies against clotting Factors V and IX leading to life-threatening coagulopathies have been noted in those exposed to bovine thrombin (only 7 cases in literature, none associated with PRP)
• Risk of infection/ sepsis is present whenever the skin is punctured, but this is not unique to PRP.
PRP illegal in sport or not?
• World Anti-Doping Agency (WADA)
• Prohibited Substance List: 2010
• A substance is considered for the list when
• 2 of 3 are met:
• Potential for performance enhancement
• Risks to health
• Violates the spirit of sport
• WADA had PRP on their banned list in 2010 but in
January 2011 it removed
• WADA left other recombinant growth factors (i.e.
epogen, hGh, etc) on the list.
PRP Peer-Reviewed Literature
• Studies placed into following groups:
• Muscle Injury
• Animal & Human studies
• Tendon Injury/ Tendinosis
• Animal and Human Studies
• Cartilage injury (OCDs)
• Animal & Human Studies
• Nerve Injuries
• Intra-articular/ DJD
So What is next for treatment of chronic
tendonosis or ligament injury?
• Ultrasound Guided Percutaneous
Tenotomy or Focused Aspiration of Scar
Tissue
Scar Tissue
Tendon
Bone
Skin
Over 10M Chronic Tendonosis Patients / Year
Shoulder
Over-use workers/athletes
est. 2 million pts/yearElbow
tennis + golfers elbow
est. 2.0 million pts/yr
Plantar Fascia
25% “foot” visits
est. 3 million pts/year
Knee
basketball, volleyball
est 0.5 million pts/yr
35%
Over 9000 treated pts since Feb 2012 … (FDA approved July 2012)
35%Achilles
10% of runners
est. 3 million pts/yr
5%
13%
12%
• Optimized ultrasonic frequency -- breaks-down diseased tissue
- spares healthy tissue
• Continuous irrigation -emulsifies tissue; cools probe
• Aspiration of target tissue
Ultrasonic probe
3 functions
Chronic Tendinopathy Treatment by Ultrasound
Safety characteristics = 4
Technique - Treatment
Chronic Tendinopathy Treatment by Ultrasound
Visualize pathology
Effective only with necrotic tissue
Energy sphere ~ 1mm (cavitation)
Energy module shuts off
- irrigation ceases- aspiration ceases
5.5
1.0
Visual Analogue Scale (VAS)
Clinical Experience
US - 4.5
PRP - 3.8
Chronic Tendinopathy Treatment by Ultrasound
Chronic Lateral Epicondylosis
Betadine prep Lidocaine
Post-Lidocaine #11 Blade scalpel
Chronic Lateral Epicondylosis
#11 Blade scalpel Micro-TX probe
Steri-strip ACE wrap
Chronic Patellar Tendinosis
FAST Probe in Patella Tendon
Cost-Effective and Well-Tolerated
• No restrictions before procedure
• Total procedure time from cleaning of
skin to placing band-aid is less than 20 min.
• No pain or discomfort during procedure
• Permitted to go home afterwards +/- PT
•Covered by some insurances (unlike PRP)
•Can be performed in:
• Clinic setting (cheaper)
•Out-patient surgical setting (more revenue)
•Can be used with PRP
• Post-procedure …
• Over-the-counter pain meds and ice as needed
• Refrain from heavy lifting or in boot for 2 weeks
• Return to full activity in 4 to 6 weeks
Summary
• PRP seems to show some promise as a treatment either by
itself or with other treatments (i.e. surgery, percutaneous
tenotomy, etc) for treatment of injuries to Muscles,
Tendons, Ligaments, Nerves, and Cartilage.
• Much more animal and level 1 evidence based human
research needs to be done to proved its short- and long-
term efficacy in the realm of BOTH PRP and TENEX for
acute and chronic injuries to muscles, tendons, ligaments,
articular cartilage and nerves.
• Studies to date show PRP and TENEX as having little
adverse reactions. More studies are needed
PRP / TENEX Peer-Reviewed
Literature
• PRP Studies placed into following groups:
• Muscle Injury
• Animal & Human studies
• Tendon Injury/ Tendinosis
• Animal and Human Studies
• Cartilage injury (OCDs)
• Animal & Human Studies
• Nerve Injuries
• Intra-articular/ DJD
• TENEX research
MUSCLE INJURIES
• Muscle injuries are the leading cause of time loss from injury in Football/Soccer (Ekstrand et al. BJSM 2009)
• Despite advances in rehabilitation of these injuries(Sherry, Best T, J Orthop Sports Phy Therap, 2004) re-injury rates of this injuries remain high (Orchard, Best T, CJSM 2005) (Malliaropoulos et al Am J Sports Med, 2010)
PRP in Muscle Injuries: ANIMAL STUDIES
• Sheep Spinal muscles 4 sheep with spinal muscles cut had wound filled with PRP or wound simply closed.
• RESULTS:
• Histological comparison of wounds was done at 5 days and 3 weeks.
• Enhanced muscle regeneration was noted in the PRP-treated animal
• COMMENT: No analysis of injectate was done to confirm the contents
Carda et al, 2nd Int. Conf. Regenerative Med, 5/18/2005
PRP in Muscle Injuries: ANIMAL STUDIES
• PRP & Injured Rat Calf Muscles
• 72 Rats with injured (large or small injury)
calf muscle.
• ½ got 100ul PRP and ½ got platelet-poor
plasma (PPP) in calf at 0,3,5,7 days
• Max torque before each injection and Days
14, 21.
• RESULTS:
• Elevated myogenesis in treated
rats vs. control
• PRP showed higher levels of
PDGF, IGF at baseline vs. PPP
• Fxnal improvement at Day 3,7,14
vs. control
Hammond et al, AJSM, vol 37, No. 6, 2009 Myogenesis
PRP in Muscle Injuries: HUMAN STUDIES
• PRP & Muscle Strains in Pro Athletes 5ml of ACS (Autologous Conditioned Serum) injected in 18 professional athletes with muscle strains while 11 professional athletes treated with injection of traumeel/actovegin. 5mls/treatment
• RESULTS:
• Mean no. of treatment was 5.4 vs. 8.3 control
• ACS Return to play was 16 days vs. 22 days for T/A group.
• Human Studies:
• Critique: ACS vs. PRP, non-blinded,
atypical control (traumeel/actovegan),
use of local anesthetic, variable injury
site w/ no quantification of injury grade,
no measurements of GF levels in actual
injectate
•Wright-Carpenter et al, Int J Sport Med, 2004
PRP in Muscle Injuries: HUMAN STUDIES
• PRP & Muscle Strain in Pro Athletes (Spain)
• 20 high-level professional athletes with 22 muscle injuries received PRP compared to 25 age-match controls.
• Injury severity assessed w/ U/S, hematoma were evacuated prior to PRP injection.
• No. of injections depend on size of tear.
• All had formal PT
• RESULTS:
• Full recovery in fxnal capacity as restored in ½ the amount of expected time.
• No fibrous or re-injury were noted after resuming their sports.
• Lack of details concerning:
• methodology in this abstract
• outcomes
• length of follow-up
Sanchez et al, Sports Med; 39(5), 2009
PRP in Muscle Injuries: CASE STUDIES
• PRP & Groin Strain
• 35 y.o. bodybuilder w/ groin strain
• 3 weekly U/S guided injections of PRP
• RESULT: Returned to competition @ 4th week
• Comments:
• Lack of details concerning:
• Grading of injury
• Timing of injections
• Associated treatments,
• Follow-up
• Training demands
•Loo, Ann Acad Med Singapore, 2009
PRP in Muscle Injuries: CASE STUDIES
• PRP & Hamstring Injury
• Single grade II Hamstring injury
from waterskiing
• Single PRP (biomet
system)
• Followed w/ serial MRIs
• Start PT after PRP.
• Took sample @ 3 wks
s/p PRP to assess IGF,
HGF,VEGF
• Comments: Lack of details
concerning grading of injury, timing
of injections, associated trmts,
follow-up, training demands
•Hamilton et al, Acta Orthop Belg, 2010
Case Study: 20y.o. college athlete with traumatic
injury to upper thigh resulting pain and numbness.
• DX: Proximal quadriceps tear, small hematoma, and compressed femoral nerve
• TRMT: local anesthetic used to
• numb
• help guide needle placement
• hydrodissection around femoral nerve.
• After hematoma evacuated, PRP used:
• At site of proximal quad tear
• Around femoral nerve
• Pt sxs improved, completed PT and RTP in 3.5 weeks
IOC report (BJSM 12/2010)
• Concluded “Little scientific evidence of
support for use of PRP in muscle
strain/injuries.”
SUMMARY: PRP in Muscle Injuries
• 1) More research needs to be done to tease out if this is
helpful in:
• the highly athletic may speed return to play
• the very old and frail may speed to ADLs
• those with chronic disease improve healing rates
• 2) No significant adverse rxns noted
• 3) Seems to point toward improved muscle healing.
FUTURE QUESTIONS:
PRP in Muscle Injuries
• Does PRP enhance Muscle regeneration?
• Does PRP reduce recovery time from muscle injury?
• What are the indications for use?
• Which are the active GFs in PRP?
• Is timing of PRP important? How many trmts?
• Should PRP be devoid of WBCs?
• Is whole blood as effective?
• Role of exercise and rehab after PRP?
Hamilton B, Best T, CJSM, Jan 2011
TENDON INJURIES
TENDON
PRP in Tendon Injuries
• Tendon disorders include:
• Acute (inflam) or chronic (non-
inflam)
• Location:
• Myotendinous jxn
• Intertendinous
Osteotendinous jxn
• Role of NSAIDs
• 65% of those using NSAIDs for
tendon injury report
improvement of sxs and return to
sport (Magri et al, CJSM, 2006)
PRP in Tendon Injuries: 2 ANIMAL STUDIES
• PRP injected in transected rat achilles tendon showed increased tendon callus strength by 30% after 1 week compared to control.
(Aspenberg et al, Acta Orthop Scand, 2004)
• PRP was injected in sheep rotator cuff muscle repair. MRI and histologic biopsy demonstrated increased new bone and fibrocartilage formation at healing site as compared to controls(Kovacevic et al, Clin Ortho Relat Res, 2008)
H/E stain of Wistar Rat Achilles/Muscle Jxn
BJSM; p1076 December 2010
As of Feb 2011, there have been 9 scientific publications on use of PRP on human tendons
2 Elbow extensors
3 Achilles tendons
2 Rotator Cuff
2 Patellar Tendon
Only 4 of them are considered level 1 studies (prospective RCTs)
PRP and TENDON INJURY (HUMAN)
PRP in Tendon Injuries: HUMAN STUDIES
• BENEFIT (7)
• Elbow Extensor
tendinosis• (Peerbooms et al)
• (Mishra et al)
• Achilles Tendon Repair • (Sanchez et al)
• Achilles Tendinosis• (Gawedal et al)
• Rotator Cuff Tendinosis • (Randelli et al)
• Patellar Tendon• (Filardo et al)
• (Kon et al)
• NO BENEFIT (2)
• Achilles Tendinosis • (De Vos et al)
• Rotator Cuff
Tendinosis• (Castricini et al)
PRP in Tendon Injuries: HUMAN STUDIES
• Interestingly, all 9 studies were devoid of serious complications involving a total of 394 subjects!
• In the RCTs, length of time patients were followed ranged from 24 to 104 weeks. (average: 83 weeks)
• In the RCTs the number of treated patients ranged from 54 to 100 (average. 75)
Case Study: Non-Surgical Repair of Patellar Tendonosis
• Ultrasound preformed 8 weeks after 1st PRP injection.
• The tendon was significantly less thickened and the area of hypoecogenicity was no
longer visible:
Before PRP Injection 16 Weeks After PRP
Injection
CARTILAGE & LIGAMENT INJURIES
• PRP has been used: Ankle, Hip, & Knee
• Multiple injections into affected joint with PRP
Articular Cartilage
Meniscal CartilageACL & PCL
MCL
PRP in Osteochondral Defects: ANIMAL
• Femoral OCDs in Rabbit Model
• 48 OCDs (5mm) created in femur
• 8 CONTROL: untreated B/L OCDs
• 40 EXP (left knee): PRP in poly-lactic-glycolic acid (PLGA)
• 40 EXP (right knee): PLGA only
• Histology assessed at 4 and 12 weeks
• RESULTS: Improved histological healing in PRP-PLGA group over Control or PLGA only group.
PRP CONTROL
Sun et al, Internat Orthop; 34: 589-597, 2010
PRP & LIGAMENT/CARTILAGE INJURIES (Human)
BJSM, December 2010
PRP in Ligament Injuries: HUMAN STUDIES
• PRP & ACL repair,
• 40 ACL reconstruction using double bundle hamstring grafts, 4 groups
• GROUP A: no PRP
• GROUP B: PRP in femoral tunnels
• GROUP C: PRP in femoral tunnels and intra-articular @ 2 & 4 weeks
• GROUP D: PRP (w/ Thrombin) in femoral tunnels
• Evaluated at 3 months with MRI for Fibrous Interzone (FIZ)
• RESULTS: no statistical difference seen on MRI at Fibrous Interzone (FIZ) at 3 months.
• PRP does not seem to accelerate tendon-to-bone integration in the femoral tunnel after hamstring double-bundle ACL reconstruction
Double bundled Hamstring
graft ACL reconstruction
Silva et al, Knee Surg Sports Traumatol Arthrosc 17:676-682 , 2009.
PRP in Ligament Injuries: HUMAN STUDIES
• PRP & ACL repair, Hamstring graft
• (RCT: level 1)
• 108 ACL ruptures
• EXPERIMENT: 54 double-bundle hamstring grafts, PRP around graft and bone plug
• CONTROL: 54 ACL reconst. w/ no PRP
• Followed by MRI for 3.6 months
• RESULTS: looked at Fibrous Interface Zone (FIZ) and incorporation of tendon-to-bone. At 3.6 months:
• 100% graft maturity in PRP group (78% in control)
• PRP did seem to accelerate tendon-to-bone integration in the femoral tunnel after hamstring double-bundle ACL reconstruction
Double bundled Hamstring
graft ACL reconstruction
•Orrego et al, Arthroscopy, 2008
PRP in Ligament Injuries: HUMAN STUDIES
PRP & ACL repair, Bone-patellar tendon-Bone (BTB) graft
• (RCT: level 1)
• 100 ACL BTB grafts,
• EXP: 50 PRP gel around graft, tibial tunnel, and bone plug
• Control: 50 ACL reconst. w/ no PRP
• Followed by for ~18 months with
• MRI at 6 months and KT-1000
• RESULTS: no significant difference in ROM, muscle torque, and pivot-shift test.
• Risk of re-injury was same in both groups
Valenti Nin et al, Athroscopy, 2009
PRP in Cartilage Injuries: HUMAN STUDIES
• PRP vs. Hyaluron injections into knees
• (Case Control: level III)
• 60 knees w/ Osteoarthritis.
• 3 PRP injections, weekly
• Control:
• 3 hyaluron injections, weekly
• Follow-up: 5 weeks using WOMAC pain scale
• RESULTS:
• Pain relief & physical function was better in PRP group vs. Hyaluron group. Though both groups saw improvement over baseline.
•Sanchez et al, Clin Exp Rheumatol, 2008
PRP in Cartilage Injuries: HUMAN STUDIES
• Arthritis of Knee
• Case Series: Level IV• 115 treated knees of 100 patients with:
• Degenerative Chondropathy
• Early Arthritis
• Advanced Osteoarthritis
• 3 injections q 3 weeks
• Evaluated at 2, 6,12 months
• RESULTS: improvement of all clinical scores:
• at 6 month (best)
• at 12 months (slightly less than 6 months, but statistical better than baseline)
• After 12 months: not measured
• Follow-up median duration of benefit: 9 months
• Adverse rxn: 1pt withdrew due to pain, no infxns, mild effusion
• No control group
Kon et al, Knee Surg Sports Traumatol Arthroscop, 2010.
•Fig 5. pp477 of Kon’s article
PRP in Cartilage Injuries: HUMAN STUDIES
• Intra-articular Hip injections
• Case Series: Level IV
• 2 studies involving hip arthroscopy
w/ labral tears, where PRP was
placed intra-articular after surgery.
• RESULTS: modest improvement
in pain at 1, 2 months post-op.
• Confounded by:
• No adequate controls
• Minimal follow-up
• Surgery
(Philippon et al, Sports Med Arthros,2010)
(Philippon et al., Arthoscopy, 2010)
SUMMARY: PRP in Ligament/Cartilage Injuries
• No severe adverse outcomes
• Clinical improvement in 4 of 7 studies showing compared to controls
• None of the 3 ACL reconstruction-PRP studies appeared to have an clinical benefit. Except for Orrego (2008) which showed MRI improvement in FIZ.
• More studies need to address:
• Best procedure, number, frequency, and proper application of PRP
• Storage methods to house PRP between injections
• More studies involving hip, ankle, elbow and knee chronic degenerative vs. acute chondral injuries
• Athletes vs. sedentary patients
NERVE INJURIES
PRP in Nerve Injuries: ANIMAL
• Peripheral Nerve Regeneration
• 45 Rats
• R Sciatic Nerve cut/repaired
• 2 sutures
• 6 sutures
• 2 sutures/PRP
• 6 suture/ PRP
• L Sciatic Nerve: Control
• RESULTS: PRP improved re-myelinization of those with 6 suture repair. Improved EMG and thicker myelin. No improvement in 2 sutures repair
Sariguney et al. J Reconstr. Microsurgery, 2008
Injection Recommendations
• All studies reviewed used aseptic, sterile procedure.
• Many used ultrasound to guide placement of PRP (especially in dealing with muscles, ligaments and tendons)
• No agreement was noted whether needle placementshould inside tendon, in tendon sheath.
• If exudates around tendon or arthroscopy being done, recommended to remove excess fluid prior to introducing PRP.
• Controversy about avoidance of NSAIDs prior to and 2 weeks S/P PRP.
• Controversy about use of local anesthetic around site of PRP.
TENEX Peer-Reviewed Clinical Publications
In Print
Koh – Am. Journal of Sports Medicine, 2013 (elbow)
Hackel – Orthopaedics Today, 2013 (procedure overview / mixed tendons)
Morrey – Techniques in Elbow and Hand Surgery, 2013(elbow)
ElAttrache – Operative Techniques in Sports Medicine, 2013 (knee)
Barnes – Operative Techniques in Sports Medicine, 2012(procedure overview/mixed tendons)
Khanna – Am Academy of Physical Med & Rehab Poster , 2012 (mixed tendons)
Studies revealed at least 90% patients pain-free within 4 to 6 weeks of treatment
No additional treatment or physical therapy – cost effective intervention
Sustained pain relief with long term follow-up (6 – 12 months)
No reported device or patient related complications
Submitted/In Preparation
Barnes – Elbow tendonosis study
Lavallee-TENEX longitudinal effectiveness study (> 12 months)
Patel – Plantar fascia study
Kamineni - Controlled animal model study
Mayo Clinic– Health economic study
Stowers – Achilles tendon study
Yanish – Economic study of Tenex vs Open Surgery
Chronic Epicondylitis Study (AJSM 2013; 41: 636)
Prospective IRB-approved study of 20 pts with chronic epicondylitis who failed
conservative treatment (medical, PT, cortisone)
Single treatment with TX1
Post-procedure care - no PT, OTC pain control, activity modification for 2
weeks
95% (19/20) patients pain free
No device-related complications
No patient-related complications
p<0.00
1
p<0.00
1
