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The Tempe PRP Ledger
Regulatory words, clinical results and local decisions

The Tempe PRP Ledger

Straight answers about platelet-rich plasma (PRP), a shot prepared from your blood

These answers cover what the blood-based shot involves, what it may cost, and when a sore joint needs help. They're short because you need the point, not a lecture. No answer can tell whether the treatment suits you without an exam. If I were deciding, I'd take these questions to the visit and listen for plain replies.

Sometimes the honest answer is that nobody knows yet.

Is PRP FDA approved?

No. PRP means platelet-rich plasma, a shot prepared from your blood. A machine separates the blood and keeps more platelets, the tiny cells that help a cut stop bleeding. Some blood-separating machines are cleared for that stated job. The clearance doesn't approve PRP as joint or tendon care, and it can't promise that your soreness will ease.

Is PRP covered by insurance?

Usually not for joint or tendon care. Medicare's national policy doesn't cover that use. The exception is certain wounds that won't heal, and only when the care is part of covered research. That exception doesn't pay for ordinary joint or tendon care. Other insurance plans have their own rules. Check your plan and get the full cash price in writing.

Does PRP work?

Some people report relief, but the studies are mixed. Some knee studies found more relief with PRP than with other care. A large knee study found no more help than saline, sterile salt water used for comparison. Ankle and Achilles studies found no clear added help. The studies can't tell how your own joint will respond. Ask whether they covered your sore body part.

What can I expect after PRP?

The treated area may ache and swell for a while. Ask how much is expected and when it ought to fade. Find out which change means you need to call. You'll also need clear limits for walking, driving, exercise, and work. Don't leave without written instructions you can follow at home.

When does a sore joint need urgent care?

Get urgent help when a joint feels hot and badly swollen, especially with fever or sudden illness. Fast-growing redness, drainage, or severe pain after a procedure also calls for quick care. So does a major injury, a joint you can't use, or new weakness. Calf pain with swelling can't be brushed off either.

What happens at a QC Kinetix visit?

Clinic staff can ask about your soreness, move the joint, and review past care and medicines. QC Kinetix offers regenerative treatments; its medical providers, the staff who examine you and give care, draw and separate your blood before putting the concentrated clotting cells near the sore area. Ask what they learned from the exam, what soreness may follow, how long recovery may take, and what you'll pay. The answer may be that this care isn't right for you.

Sources

  1. 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.

  2. FDA states verbatim of stem cell, stromal vascular fraction, umbilical cord blood, Wharton's jelly, amniotic fluid and exosome products: 'None of these products have been approved for the treatment of any orthopedic condition, such as osteoarthritis, tendonitis, disc disease, tennis elbow, back pain, hip pain, knee pain, neck pain, or shoulder pain.' The only FDA-approved stem cell products in the United States are blood-forming cells from umbilical cord blood, approved only for disorders of blood production, and there are no FDA-approved exosome products. PRP is a different product from all of these and the categories must not be blurred in either direction.

    U.S. Food and Drug Administration — Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes. FDA (Center for Biologics Evaluation and Research), 2020.

  3. 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.

  4. In January 2025 the FTC and the Georgia Attorney General obtained federal court orders permanently BANNING the co-founders of the Stem Cell Institute of America and related companies from marketing stem cell therapy, plus $5,155,146 in civil penalties and consumer refunds. The court found on summary judgment that the defendants published false and misleading advertisements about the efficacy and approval of stem cell injections for conditions including osteoarthritis; the affiliated clinic had charged up to $5,000 per injection, almost exclusively to elderly and disabled consumers.

    Federal Trade Commission — Stem Cell Institute Co-Founders and Companies Banned from Marketing Stem Cell Treatments and Ordered to Pay More Than $5.1 Million for Refunds and Civil Penalties. FTC Press Release, 2025.

  5. 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.

  6. 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.

  7. 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.

  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.

  9. A meta-analysis of 18 Level I randomized trials (811 patients receiving PRP, 797 receiving hyaluronic acid, mean follow-up 11.1 months) found mean improvement in total WOMAC scores was significantly higher with PRP (44.7%) than with hyaluronic acid (12.6%) (P<.01), and 6 of 11 VAS-reporting studies found significantly less pain with PRP at latest follow-up.

    Belk JW, Kraeutler MJ, Houck DA, et al. — Platelet-Rich Plasma Versus Hyaluronic Acid for Knee Osteoarthritis: A Systematic Review and Meta-analysis of Randomized Controlled Trials. American Journal of Sports Medicine, 2021. DOI: 10.1177/0363546520909397.

  10. A meta-analysis of 73 articles covering 5,895 patients quantified the PLACEBO response to intra-articular injection in knee osteoarthritis: statistically and clinically significant improvements in pain, function and quality of life at 1, 3 and 6 months, with responder rates above 50% at each of those points, declining by 12 months. The placebo response was stronger in trials with more female participants and in more recently published trials. This is why an uncontrolled 'our patients improved' figure carries almost no information.

    Previtali D, Boffa A, Di Laura Frattura G, et al. — Placebo response to intra-articular injections in knee osteoarthritis: magnitude, evolution over time, and influencing factors. A systematic review and meta-analysis with meta-regression. EFORT Open Reviews, 2025. DOI: 10.1530/EOR-2025-0022.

Bring your joint questions to the visit

Have your medicines written down, along with when the soreness started. Say which motion hurts and what care you've tried. Ask what the clinic learned during the exam, which choices may suit you, how recovery works, and what you'll pay.

For most of Tempe, the Chandler location at 1100 S. Dobson Rd., Suite 210 is the direct route. From north Tempe, Scottsdale might take less time. Call (602) 837-PAIN.

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