Viscosupplimentation: Does It Work? What Do We Do When No...
Transcript of Viscosupplimentation: Does It Work? What Do We Do When No...
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!