Viscosupplimentation:

Does It Work?

What Do We Do When No

One Will Pay For It?!!

William R. Beach MD

Conflict of Interest Statement

• Fellowship Grants

• Smith Nephew

• Arthrex

• Synthes

• Mitek

• Share Holder

• Tuckahoe Surgery Center & St. Mary’s ASC

• Comp Recovery

• AANA Board of Directors

• AAOS Coding, Coverage and Reimbursement

Committee

Conservative Treatment

Cost vs. Benefit

• Viscosupplimentation – Does it work?

It Doesn’t Matter What We Think!

• YES, but according to the AAOS – not

well enough (MCII) and not long

enough

• AAOS Clinical Practice Guideline –

Strong recommendation against!!

AAOS OA CPG – Conservative Tx.

1. Strong (+) - PT & low impact aerobic

exercise.

2. Moderate (+) - Weight loss for BMI > 25

3. A) Strong (-) - Acupuncture, B)

Inconclusive – Electrotherapeutic modalities,

C) Inconclusive – Manual therapy.

4. Inconclusive – Unloader bracing

5. Moderate (-) – Shoe wedges

6. Strong (-) – Glucosamine/Chondrotin

AAOS OA CPG - Pharmacologic

7. A.) Strong (+) – NSAID (oral/topical) &

Tramadol, B) Inconclusive –

Acetaminophen, opioids, or pain patches

AAOS OA CPG - Procedural

8. Inconclusive – Intra-articular corticosteroids

9. Strong (-) – Viscosupplementation

10. Inconclusive – Growth factor injections and/or

platelet rich plasma

11.Moderate (-) – Needle lavage

12.Strong (-) – Arthroscopic lavage

13.Inconclusive – Arthroscopic partial meniscectomy

or loose body removal in patients with

osteoarthritis of the knee and mechanical

symptoms consistent with a torn meniscus

AAOS OA CPG - Procedural

14.Limited – valgus producing proximal tibial

osteotomy in patients with symptomatic

medial compartment osteoarthritis

15.Consensus (-) – free-floating (un-fixed)

interpositional device

A Randomized Clinical Trial Evaluating

Plasma Rich in Growth

Factors (PRGF-Endoret) Versus

Hyaluronic Acid in the

Short-Term Treatment of Symptomatic

Knee Osteoarthritis

• LEVEL 1 Randomized Clinical Trial!! Mikel Sánchez, Ph.D., Nicolás Fiz, Ph.D., Juan Azofra, Ph.D., Jaime Usabiaga,

Ph.D.,Enmanuel Aduriz Recalde, Ph.D., Antonio Garcia Gutierrez, Ph.D., Javier

Albillos, Ph.D.,Ramón Gárate, Ph.D., Jose Javier Aguirre, Sabino Padilla,

Ph.D.,Gorka Orive, Ph.D., and Eduardo Anitua, M.D., D.D.S., Ph.D. In Vitoria,

Spain.

Purpose: This multicenter, double-blind clinical trial evaluated and

compared the efficacy and safety of PRGF-Endoret (BTI Biotechnology

Institute, Vitoria-Gasteiz, Spain), an autologous biological therapy for

regenerative purposes, versus hyaluronic acid (HA) as a short-term

treatment for knee pain from osteoarthritis. Methods: We randomly

assigned 176 patients with symptomatic knee osteoarthritis to receive

infiltrations with PRGF-Endoret or with HA (3 injections on a weekly

basis).

The primary outcome measure was a 50% decrease in knee pain from

baseline to week 24. As secondary outcomes, we also assessed pain,

stiffness, and physical function using the Western Ontario and

McMaster Universities Osteoarthritis Index; the rate of response using

the criteria of the Outcome Measures for Rheumatology Committee and

Osteoarthritis Research Society International Standing Committee for

Clinical Trials Response Criteria Initiative (OMERACT-OARSI); and

safety.

Results: The mean age of the patients was 59.8 years, and 52% were women. Compared

with the rate of response to HA, the

rate of response to PRGF-Endoret

was 14.1 percentage points higher (95%

confidence interval, 0.5 to 27.6; P .044). Regarding the secondary outcome measures, the rate of response to PRGF-

Endoret was higher in all cases, although no significant differences were

reached. Adverse events were mild and evenly distributed between the groups.

Conclusions: Plasma rich in growth

factors showed superior short-term

results when compared with HA in a

randomized controlled trial, with a comparable safety

profile, in alleviating symptoms of mild to moderate osteoarthritis of the knee. Level of Evidence: Level I, randomized

controlled multicenter trial.

Comparison Between Hyaluronic Acid

and Platelet-Rich Plasma, Intra-articular

Infiltration in the Treatment of

Gonarthrosis

• LEVEL 1 Randomized Clinical Trial!!

Fabio Cerza,*y MD, Stefano Carnı`,z MD, Alessandro Carcangiu,*§ MD, Igino

Di Vavo,* MD, Valerio Schiavilla,* MD, Andrea Pecora,* MD,Giuseppe De

Biasi,|| and Michele Ciuffreda||Investigation performed at the Paolo Colombo

Hospital of Velletri, Rome, Italy

Purpose: To compare the clinical response of hyaluronic acid (HA) and

platelet-rich plasma (PRP) treatment in 2 groups of patients affected by

gonarthrosis.

Study Design: Randomized controlled trial; Level of evidence, 1.

Methods: A total of 120 patients affected by clinically and radiographically

documented gonarthrosis were included in this study.

The gonarthrosis was graded using the Kellgren-Lawrence radiographic

classification scale. The 120 patients were randomized into 2 study

groups in a 1:1 ratio: 60 patients received 4 intra-articular injections of

PRP (specifically, autologous conditioned plasma [ACP], 5.5 mL), and 60

patients received 4 intra-articular injections of HA (20 mg/2 mL). An

unblinded physician performed

infiltration once a week for 4 weeks into the knee affected by clinically

relevant gonarthrosis (in both groups). All patients were evaluated with

the Western Ontario and McMaster (WOMAC) score before the infiltration

and at 4, 12, and 24 weeks after the first injection.

.

Results: Treatment with a local injection of ACP had a significant effect shortly after the final infiltration and a

continuously

improving sustained effect up to 24 weeks (WOMAC score, 65.1 and 36.5 in the HA and ACP groups, respectively; P

\.001), where the clinical outcomes were better compared with the results with HA. In the HA group, the

worst results were obtained for grade III gonarthrosis,

whereas the clinical results obtained in the ACP group did

not show any statistically significant difference in terms of

the grade of gonarthrosis. The mean WOMAC scores for grade III gonarthrosis were 74.85 in the HA group and

41.20 in the ACP group (P\.001).

Conclusion: Treatment with ACP showed a

significantly better clinical outcome than did

treatment with HA, with sustained lower

WOMAC scores. Treatment with HA did not seem

to be effective in the patients with grade III

gonarthrosis.

Platelet-Rich Plasma Intra-Articular

Injection Versus Hyaluronic

Acid Viscosupplementation as

Treatments for Cartilage

Pathology: From Early Degeneration to

Osteoarthritis

Level of Evidence: Level II, prospective comparative study.

Elizaveta Kon, M.D., Bert Mandelbaum, M.D., Roberto Buda, M.D.,

Giuseppe Filardo, M.D., Marco Delcogliano, M.D., Antonio Timoncini, M.D.,

Pier Maria Fornasari, M.D., Sandro Giannini, M.D., and Maurilio Marcacci,

M.D.

Purpose: The aim of our study is to compare the efficacy of

platelet-rich plasma (PRP) and viscosupplementation

(hyaluronic acid [HA]) intra-articular injections for the treatment

of knee cartilage degenerative lesions and osteoarthritis (OA).

Methods: The study involved 150 patients affected by cartilage

degenerative lesions and early and severe OA. Fifty

symptomatic patients were treated with 3 autologous PRP intra-

articular injections and were evaluated prospectively at

enrollment and at 2- and 6-month follow-up. The results

obtained were compared with 2 homogeneous groups of

patients treated with HA injections. One group was treated with

injections of high– molecular weight HA; the other group was

treated with low–molecular weight (LW) HA. International Knee

Documentation Committee and EQ VAS scores were used for

clinical evaluation; adverse events and patient satisfaction were

also recorded.

Results: At 2 months’ follow-up, the PRP and LW HA groups showed a similar improvement, with higher results compared with

the high– molecular weight HA group (P .005). At 6 months’ follow-up, better results were observed in the PRP group (P .005).

PRP and LW HA treatments offered similar results in patients aged over 50 years and in the treatment of advanced OA. PRP

showed a better performance compared with HA in younger patients affected by cartilage lesions or early OA.

Conclusions: Autologous PRP

injections showed more and longer

efficacy than HA injections in reducing

pain and symptoms and recovering

articular function. Better results were

achieved in younger and more active

patients with a low degree of cartilage

degeneration, whereas a worse outcome was obtained in more degenerated joints and in

older patients, in whom results similar to those of viscosupplementation have been observed.

Level of Evidence: Level II, prospective comparative study.

PRP Benefits • Self Derived Blood Product

• Abundant product

• Inexpensive

– 10 to 60 cc’s of blood

• Proprietary Kit ($200)

• Injection – 20610 ($50)

• The Real Question is which PRP is

BEST!

PRP Controversy

• Which PRP

–Platelets only

–Buffy coat (wbc’s)

• How much?

• Alone or in conjunction with?

• Not covered by insurers

Questions?

Vote!

Thanks!