Common PRP questions have direct answers

Sources

1. Medicare's national coverage policy covers autologous platelet-rich plasma ONLY for patients with chronic non-healing diabetic, pressure and/or venous wounds, and only within an approved coverage-with-evidence-development clinical study. There is no Medicare national coverage for PRP in osteoarthritis or tendinopathy, which is why these injections are billed to the patient as cash-pay.

   Centers for Medicare & Medicaid Services — Autologous Platelet-rich Plasma (Coverage with Evidence Development). CMS.gov, 2024.

2. The devices used to spin PRP at the point of care are cleared by FDA as clinical centrifuges, product code JQC, a Class I device under 21 CFR 862.2050 - for example the Biomet GPS Platelet Separation Kit (K030555, cleared 2003) and the Harvest SmartPrep2 / SmartPrep Platelet Concentration System (K103340, cleared 2010). That clearance covers the equipment that separates blood. It is not an FDA approval of platelet-rich plasma as a treatment for osteoarthritis, tendinopathy or any other orthopedic condition, and copy must never blur the two.

   U.S. Food and Drug Administration (Center for Devices and Radiological Health) — 510(k) Premarket Notification database and Product Classification: JQC, Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use, 21 CFR 862.2050. FDA accessdata (CDRH device databases), 2003.

3. A systematic review of 105 clinical PRP studies in orthopaedics published 2006-2016 found that only 11 (10%) described the preparation protocol clearly enough for another investigator to repeat it, and only 17 (16%) reported any quantitative metric of the final PRP composition. The authors concluded that the current reporting of PRP preparation and composition does not allow the PRP products actually delivered to patients to be compared between studies.

   Chahla J, Cinque ME, Piuzzi NS, et al. — A Call for Standardization in Platelet-Rich Plasma Preparation Protocols and Composition Reporting: A Systematic Review of the Clinical Orthopaedic Literature. Journal of Bone and Joint Surgery (American), 2017. DOI: 10.2106/JBJS.16.01374.

4. The DEPA classification was built because platelet and leukocyte counts alone do not describe an injection. Applied retrospectively to 20 published PRP preparations, the dose of injected platelets ranged from 0.21 billion to 5.43 billion - a 25-fold spread. No device recovered more than 90% of the platelets in the blood drawn, and most preparations were contaminated with red blood cells: only three of the devices reached a purity score corresponding to more than 90% platelets relative to red cells and leukocytes.

   Magalon J, Chateau AL, Bertrand B, et al. — DEPA classification: a proposal for standardising PRP use and a retrospective application of available devices. BMJ Open Sport & Exercise Medicine, 2016. DOI: 10.1136/bmjsem-2015-000060.

5. The ESSKA-ICRS consensus applied the RAND/UCLA appropriateness method to 216 clinical scenarios for intra-articular PRP in knee OA. Only 84 scenarios (38.9%) were rated appropriate, 9 (4.2%) inappropriate and 123 (56.9%) uncertain. PRP was judged appropriate in patients aged 80 or under with KL grade 0-III osteoarthritis AFTER failed conservative non-injective or injective treatment; it was NOT considered appropriate as a first treatment, nor in KL grade IV (bone-on-bone) osteoarthritis, where 91.7% and 87.5% of scenarios respectively were uncertain.

   Kon E, de Girolamo L, Laver L, et al. — Platelet-rich plasma injections for the management of knee osteoarthritis: The ESSKA-ICRS consensus. Recommendations using the RAND/UCLA appropriateness method for different clinical scenarios. Knee Surgery, Sports Traumatology, Arthroscopy, 2024. DOI: 10.1002/ksa.12320.

6. A Bayesian network meta-analysis of nine studies (six RCTs, 1055 patients) found leukocyte-POOR PRP produced significantly better WOMAC scores than hyaluronic acid (mean difference -21.14; 95% CI -39.63 to -2.65) and than placebo (-17.84; 95% CI -34.95 to -0.73), while leukocyte-RICH PRP showed no such significant difference versus placebo. PRP of either type caused more local adverse reactions than hyaluronic acid (OR 5.63; 95% CI 1.38-22.90), almost always local swelling and pain, with no difference in safety between the two PRP types.

   Riboh JC, Saltzman BM, Yanke AB, et al. — Effect of Leukocyte Concentration on the Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis. American Journal of Sports Medicine, 2016. DOI: 10.1177/0363546515580787.

7. A prospective fixed-sequence controlled laboratory study in healthy men found that daily low-dose aspirin significantly reduced release of VEGF, PDGF-AB and TGF-beta1 from freshly isolated leukocyte-rich PRP when activated with arachidonic acid. This is the mechanistic basis for the routine instruction to review antiplatelet and NSAID use before a PRP draw - and the authors noted clinical studies are still needed to establish how much this matters in vivo.

   Jayaram P, Yeh P, Patel SJ, et al. — Effects of Aspirin on Growth Factor Release From Freshly Isolated Leukocyte-Rich Platelet-Rich Plasma in Healthy Men: A Prospective Fixed-Sequence Controlled Laboratory Study. American Journal of Sports Medicine, 2019. DOI: 10.1177/0363546519827294.

8. In the RESTORE trial - the largest placebo-controlled PRP trial in knee osteoarthritis - 288 adults aged 50+ with symptomatic Kellgren-Lawrence grade 2-3 medial knee OA received three weekly intra-articular injections of leukocyte-poor PRP from a commercial system or saline placebo. At 12 months the mean change in knee pain was -2.1 points with PRP versus -1.8 with saline (difference -0.4; 95% CI -0.9 to 0.2; P=.17) against a minimum clinically important difference of 1.8, and the change in medial tibial cartilage volume was -1.4% versus -1.2% (difference -0.2%; 95% CI -1.9% to 1.5%; P=.81). Twenty-nine of 31 prespecified secondary outcomes showed no significant between-group difference. The authors concluded the findings do not support use of PRP for knee OA.

   Bennell KL, Paterson KL, Metcalf BR, et al. — Effect of Intra-articular Platelet-Rich Plasma vs Placebo Injection on Pain and Medial Tibial Cartilage Volume in Patients With Knee Osteoarthritis: The RESTORE Randomized Clinical Trial. JAMA, 2021. DOI: 10.1001/jama.2021.19415.