Platelet Rich Plasma for Musculoskeletal Conditions

Обзор

The primary purpose of this study is to follow patients with various musculoskeletal (MSK) conditions over a one-year follow-up period after receiving a platelet rich plasma (PRP) injection, assessing changes in their pain levels, functional abilities, and overall patient satisfaction. This will develop a robust registry of patients treated with PRP for a range of MSK conditions. These conditions include, but are not limited to, osteoarthritis (OA) of the knee, hip, glenohumeral joint, elbow, ankle, and sacroiliac joint, as well as rotator cuff tendinopathy, lateral and medial epicondylitis, plantar fasciitis, patellar tendinopathy, Achilles tendinopathy, and proximal hamstring tendinopathy.

Подробное описание

Platelet-Rich Plasma (PRP) is an injectable preparation of a patient's blood that can be used for numerous conditions and has received significant attention over the past several years for its potential application for the treatment of pain and functional impairment due to osteoarthritis (OA) and other musculoskeletal conditions. Research on PRP has expanded dramatically over the last several decades, elevating its status from snake oil to a proven injection option superior to corticosteroids. It has demonstrated superior efficacy to standard-of-care corticosteroids in numerous musculoskeletal conditions. Systematic reviews of randomized-controlled trials have demonstrated equivalent-to-superior treatment outcomes associated with the use of intra-articular PRP compared to placebo, hyaluronic acid, and corticosteroid for the most commonly-studied condition, knee OA. Most importantly, just as corticosteroids have been used in numerous musculoskeletal conditions (OA, tendinopathy, bursitis, etc.), PRP has the same potential, but with vastly reduced risk; corticosteroids have many known dangers. To summarize, PRP has demonstrated level 1 evidence of superiority to corticosteroids in pain and function in numerous musculoskeletal conditions, with considerably less risk.

This study will evaluate pain, function, and overall patient satisfaction outcomes for the use of PRP for the treatment of a diverse MSK conditions, including, but not limited to, OA of the knee, hip, glenohumeral joint, elbow, ankle, and sacroiliac joint, as well as rotator cuff tendinopathy, lateral and medial epicondylitis, plantar fasciitis, patellar tendinopathy, Achilles tendinopathy, and proximal hamstring tendinopathy.

Вмешательства

• Биопрепарат Platelet Rich Plasma Injection
  Participants who are eligible and provide consent to participate will undergo a Platelet-Rich Plasma (PRP) injection. Their blood will be analyzed using a cell counter, and they will be asked to complete follow-up surveys at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months.
• Устройство Platelet Rich Plasma Preparation
  The patient's blood is collected into syringes. That blood is spun in a centrifuge at high speeds, which separates their blood into layers (red blood cells, white blood cells, and plasma). The plasma portion, which contains the platelets, is transferred to a different syringe for later injection. In some cases, the plasma is spun in the centrifuge again (a "double spin" technique) to further concentrate the platelets in the plasma. The patient's blood is not exposed to air, and it is transferred

Первичные конечные точки

• Visual analog score (pain) [Срок оценки: 6 months]

Вторичные конечные точки (7)

• Visual Analog Score (pain) [Срок оценки: 1, 3, and 12 months]
• Global satisfaction [Срок оценки: 1, 3, 6, 12 months]
• Western Ontario and McMaster Universities Arthritis Index (knee) [Срок оценки: 1, 3, 6, 12 months]
• Disorders of the Arm, Shoulder, and Hand (QuickDASH) [Срок оценки: 1, 3, 6, 12 months]
• International Hip Outcome Tool 12 (IHOT12) [Срок оценки: 1, 3, 6, 12 months]
• Foot and Ankle Outcome Score (FAOS) [Срок оценки: 1, 3, 6, 12 months]
• EQ-5D [Срок оценки: 1, 3, 6, 12 months]

Критерии участия

Критерии включения

• 18+ years old
• Musculoskeletal pathology that may benefit from a PRP injection
• Failed other conservative treatments

Критерии исключения

• No active malignancy
• No active infection in the area of injection
• No platelet disorder
• No active systemic infections
• No patients currently undergoing dialysis

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Utah Orthoaedic Center — Salt Lake City

Публикации

• Cushman DM, Johnson LA, Burnham T, Nelson R, Egbert J, Burnham R. An evaluation of a low-cost platelet-rich plasma for osteoarthritis of the knee: A pilot study. J Exp Orthop. 2025 Sep 5;12(3):e70420. doi: 10.1002/jeo2.70420. eCollection 2025 Jul. PMID 40919485
• Baria MR, Vasileff WK, Borchers J, DiBartola A, Flanigan DC, Plunkett E, Magnussen RA. Treating Knee Osteoarthritis With Platelet-Rich Plasma and Hyaluronic Acid Combination Therapy: A Systematic Review. Am J Sports Med. 2022 Jan;50(1):273-281. doi: 10.1177/0363546521998010. Epub 2021 Apr 8. PMID 33831332
• Elksnins-Finogejevs A, Vidal L, Peredistijs A. Intra-articular platelet-rich plasma vs corticosteroids in the treatment of moderate knee osteoarthritis: a single-center prospective randomized controlled study with a 1-year follow up. J Orthop Surg Res. 2020 Jul 10;15(1):257. doi: 10.1186/s13018-020-01753-z. PMID 32650801
• Forogh B, Mianehsaz E, Shoaee S, Ahadi T, Raissi GR, Sajadi S. Effect of single injection of platelet-rich plasma in comparison with corticosteroid on knee osteoarthritis: a double-blind randomized clinical trial. J Sports Med Phys Fitness. 2016 Jul-Aug;56(7-8):901-8. Epub 2015 Jul 14. PMID 26173792
• Joshi Jubert N, Rodriguez L, Reverte-Vinaixa MM, Navarro A. Platelet-Rich Plasma Injections for Advanced Knee Osteoarthritis: A Prospective, Randomized, Double-Blinded Clinical Trial. Orthop J Sports Med. 2017 Feb 13;5(2):2325967116689386. doi: 10.1177/2325967116689386. eCollection 2017 Feb. PMID 28255569
• Tan J, Chen H, Zhao L, Huang W. Platelet-Rich Plasma Versus Hyaluronic Acid in the Treatment of Knee Osteoarthritis: A Meta-analysis of 26 Randomized Controlled Trials. Arthroscopy. 2021 Jan;37(1):309-325. doi: 10.1016/j.arthro.2020.07.011. Epub 2020 Jul 15. PMID 32679294
• Habib GS. Systemic effects of intra-articular corticosteroids. Clin Rheumatol. 2009 Jul;28(7):749-56. doi: 10.1007/s10067-009-1135-x. Epub 2009 Feb 28. PMID 19252817
• Dai WL, Zhou AG, Zhang H, Zhang J. Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Meta-analysis of Randomized Controlled Trials. Arthroscopy. 2017 Mar;33(3):659-670.e1. doi: 10.1016/j.arthro.2016.09.024. Epub 2016 Dec 22. PMID 28012636

Идентификаторы

NCT: NCT07231471 · 00191115

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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