Ultrasound-guided Regenerative Medicine Procedures:Pandora or Panacea

Ken Mautner, MDDirector, Primary Care Sports MedicineEmory Sports Medicine

Goal of talk “I would like you to talk about stem

cells and PRP, the evidence for them in tendons and joints, and why ultrasound guidance is important”

Jon Finnoff, DO

Do it less than 20 minutes !

Outline Ultrasound guidance for regenerative

medicine procedures Dangers of steroids in treating tendinopathy Regenerative injections for recalcitrant

tendons Needle Tenotomy PRP Stem cells

Regenerative Medicine for Cartilage/OA (knee) 1-2:30 pm today!

Is ultrasound guidance needed for regenerative medicine procedures ?

Accuracy

Efficacy

Cost-effectiveness

Reactive vs

Degenerative Tendon

What is ideal way to treat tendinopathy?

“Old School” Treatments Rest Ice Immobilization NSAIDS Physical Therapy/ biomechanics Possible corticosteroid Injection (CSI) RTP when pain free/ functional

But is tissue healed? If symptoms persist

Surgery

LACK OF EVIDENCE FOR TRADITIONAL TREATMENTS

Lancet, 2010

Lancet, 2010

JAMA, 2013

What is ideal wayto treat tendinopathy?

Evolving algorithm -- “New School” Pathology specific conservative treatments

NSAIDS If inflammatory Mechanotransduction for tendinosis

Eccentrics exercises IASTM/ CFM/ART Nitric Oxide ESWT

Regenerative intervention Percutaneous needle tenotomy (PNT) High Volume Injection (HVIGI) Scraping PRP TENEX (FAST) ADSC +/- PRP BMAC

TIMING OF INTERVENTION AND TYPE OF INTERVENTION HAS NOT BEEN FIGURED OUT

Percutaneous Needle Tenotomy (PNT) and

Platelet Rich Plasma (PRP)

PNT (needle tenotomy) for lateral epicondylosis

McShane et al, Journal of Ultrasound Med. 2006

Ultrasound guided PNT with steroid for chronic lat. epicondylitis Failed conservative tx

58 pts-- avg f/u 28 mo. 80 % Good or

Excellent Outcome 85% would refer friend

or family for procedure

McShane et al, Journal of Ultrasound Med 2008

Ultrasound guided PNT without steroid for chronic lat. Epicondylitis Failed conservative tx

57 pts --avg f/u 22 mo. 92% Good or

Excellent Outcome 90% would refer friend

or close relative for procedure

PRP for chronic lateral epicondylosis

140 pts evaluated for lateral epicondylosis 20 had refractory pain an avg. of 15 months later

15 in treatment group, 5 in bupivicaine control group

Intervention– Injection w/ autologous PRP once into common

extensor tendon followed by gradual increase in rehab program through 4 weeks after which full activity allowed

Outcome– A 46%, 60% and 81% improvement in VAS pain scores

at 1, 2 and 6 months respectively in tx group– 3/5 in bupivicaine group withdrew/ sought other tx– At final F/U (12-38 months) 93% pain free (<10/100

VAS)– No complications, no one got worse

AJSM, 2006

Pts age 16-70 (avg 48 yrs) Greater than 6 months of pain (avg 36 months) Diagnosed by clinical exam plus MRI or

diagnostic US Failed conventional treatments

Medications Bracing Stretching Strengthening CFM Modalities

PRP done under US guidance

PMR journal, 2013

Data of PRP procedures

325 patients with isolated tendinopathy sent questionnaire

Eliminated all non tendons and regional PRP treatments

180 responded (55%) All retrospective data analyzed with following

questions: Overall improvement

Not at all, slightly, moderately, mostly, completely VAS score –pre and post Overall satisfaction Nirchl phase scale

Distribution of Tendons Lateral Epicondyle 30Patella Tendon 27Achilles 27Rotator Cuff 21 Hamstring 17 Gluteus Medius 16 Medial Epicondyle 11 Plantar Fascia 9 13 other tendons <5 each

Improvement

82% reported moderate to complete improvement

– 50%- 100% relief of symptoms70 % reported mostly to complete improvement

-- 75-100% relief of symptoms

Pain Score pre and post PRP

➤ 74% Reduction in VAS

7.3

2.1

Why are we still debating if orthobiologics works?

Need to define what we are injecting ? Platelet counts

MSC counts Leukocyte +/ -

Differential RBC +/ RBC – Autologous/ Allogenic

Need to define the procedure US guidance Needle tenotomy?

Rehabilitation methods Immobilization ? Timing of eccentrics

Do different body regions require different formulas ?

Slide from 2011

____________________________1 If WBC are present (+) the % of neutrophils should also be reported.2 The method of exogenous activation should be reported.

April, 2015

• 80 patients randomized

• PRP vs Placebo• ACP vs saline

• 2 injections 5 days apart• 5 days after injury

• End point was RTP• No difference• Average 42 days

2014, Reurink

RehabilitationL+ PRP

42 days vs 26 days

Why the difference ?

MY TAKE:L+ PRP may reduce recovery from acute hamstring muscle injury

Is it the Needle?

AJSM, 2013

PRP vs PNT for RTC pathology

DBRCT comparing 2 PNT vs 2 PRP injections under US guidance for RTC tendinosis or small, partial tear

Measured results using Shoulder Pain and Disability Index

Clinical Rehabiliation, 2012

60 patients randomized to US- guided injection of PRP vs no injection on POD 7, 14

Outcomes tracked through 16 wks MRI done at 16 wks RESULTS:

PRP did NOT improve early fxnl recovery, ROM, or strength

NO difference in structural integrity at 16 wks. Did not look at long term outcomes….

AJSM, 2015

Stem cells for Tendinopathy

April, 2015

Stem Cells for soft tissue

Surprisingly few clinical studies examining stem cells use for soft tissue injuries Many more studies looking at cartilage Soft tissue studies predominantly

involve PRP Early clinical studies promising but

much more work needed in the area.

46 pts, 60 patellar tendons

Dermal fibroblasts Cultured for 4 wks

Injected in autologous plasma

US guidance usedCompared to autologous

plasma only

AJSM, 2011

• Is it worth it?• High cost• Lag time (4

wks)• Regulatory

issues

45 patients in received BMC during single-row arthroscopic RTC repair 51,000 MSC +/- 25,000

45 age matched controls Up to 10 years follow up with MRI imaging RESULTS:

6 mo 100% of MSC group healed 67% of control group healed

10 years 87% of MSC group with intact RTC 44% of control group

Results most correlated with MSC concentration

Conclusions Needle tenotomy is effective for tendinosis

US guidance will improve accuracy Tenotomy helpful no matter the injectate

Saline, WB, ACP, PRP, Stem Cells PRP may have better results than needling

alone Unsure if related to pathology (tendinosis vs tear)

Stem cells may have better results than PRP/ needling No head to head studies Is it worth the cost and increased risk to perform

this procedure for tendons ? I rarely utilize stem cells as a first line treatment

for recalcitrant tendinopathy

Ken.mautner@emory.org