Homologous PRP vs Placebo in Knee Osteoarthritis in Over 65 Years Old Patients

Официальное название

Homologous PRP Versus Placebo in the Infiltrative Treatment of Knee Osteoarthritis in Over 65 Years Old Patients.

Обзор

The aim of the study is to compare the 6 months clinical outcome of the treatment with a single injection of Homologous PRP versus single injection of placebo (saline solution) in the infiltrative treatment of knee osteoarthritis in over 65 years old patients. The evaluation will be performed through clinical, subjective and objective assessments.

Подробное описание

204 patients affected by knee osteoarthritis will be included in a double-blinded RCT with possibility ,after 6 months, to cross-over from control arm ( saline solution ) to the treatment arm (Homologous PRP). Patients will be followed-up with clinical evaluation at 1,3 and 6 months. During the follow-up visits ,will be evaluated the inflammatory status of the knee by thermographic assessment. Patients in the treatment arm (Homologous PRP) will be followed for an additional 6 months (up to 12 months of follow-up). After 6 months, patients in the control arm have the possibility to cross-over into the treatment arm, in which case they will be followed for an additional 12 months.

Вмешательства

• Процедура Homologous PRP injections
  Patients will be treated with a single injection of Homologous PRP (5 ml) in the knee joint affected by osteoarthritis.
• Процедура Placebo injection (saline solution)
  Patients will be treated with a single injections of saline solution (5 ml) in the knee joint affected by osteoarthritis

Первичные конечные точки

• KOOS-Pain Score [Срок оценки: 6 months FU]

Вторичные конечные точки (9)

• KOOS Score [Срок оценки: baseline, 1 month, 3 months, 6 and 12 months follow-up]
• IKDC-Subjective Score [Срок оценки: baseline, 1 month, 3 months, 6 and 12 months follow-up]
• Visual Analogue Scale (VAS) [Срок оценки: baseline, 1 month, 3 months, 6 and 12 months follow-up]
• EQ-VAS [Срок оценки: baseline, 1 month, 3 months, 6 and 12 months follow-up]
• EQ-5D (EuroQoL) Current Health Assessment [Срок оценки: baseline, 1 month, 3 months, 6 and 12 months follow-up]
• Tegner Activity Level Scale [Срок оценки: baseline, 1 month, 3 months, 6 and 12 months follow-up]
• Objective parameters- Range of Motion [Срок оценки: baseline, 1 month, 3 months, 6 and 12 months follow-up]
• Patient Acceptable Symptom State (PASS) [Срок оценки: baseline, 1 month, 3 months, 6 and 12 months follow-up]
• Objective parameters - Circumferences [Срок оценки: baseline, 1 month, 3 months, 6 and 12 months follow-up]

Критерии участия

Критерии включения

• Unilateral involvement;
• Signs and symptoms of degenerative pathology of the knee cartilage;
• Radiographic or MRI signs of degenerative pathology of the knee cartilage (Kellgren-Lawrence 1-4 grades);
• Ability and consent of patients to actively participate in clinical follow-up;
• Signature of informed consent

Критерии исключения

• Patients undergoing knee surgery within the previous 12 months;
• Patients with malignant neoplasms;
• Patients with rheumatic diseases;
• Patients with diabetes;
• Patients with hematologic diseases (coagulopathies);
• Patients with metabolic disorders of the thyroid gland;
• Patients abusing alcoholic beverages, drugs or medications
• Body Mass Index > 35

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Istituto Ortopedico Rizzoli — Bologna

Публикации

• Di Martino A, Di Matteo B, Papio T, Tentoni F, Selleri F, Cenacchi A, Kon E, Filardo G. Platelet-Rich Plasma Versus Hyaluronic Acid Injections for the Treatment of Knee Osteoarthritis: Results at 5 Years of a Double-Blind, Randomized Controlled Trial. Am J Sports Med. 2019 Feb;47(2):347-354. doi: 10.1177/0363546518814532. Epub 2018 Dec 13. PMID 30545242
• Filardo G, Kon E, Pereira Ruiz MT, Vaccaro F, Guitaldi R, Di Martino A, Cenacchi A, Fornasari PM, Marcacci M. Platelet-rich plasma intra-articular injections for cartilage degeneration and osteoarthritis: single- versus double-spinning approach. Knee Surg Sports Traumatol Arthrosc. 2012 Oct;20(10):2082-91. doi: 10.1007/s00167-011-1837-x. Epub 2011 Dec 28. PMID 22203046
• Braun HJ, Kim HJ, Chu CR, Dragoo JL. The effect of platelet-rich plasma formulations and blood products on human synoviocytes: implications for intra-articular injury and therapy. Am J Sports Med. 2014 May;42(5):1204-10. doi: 10.1177/0363546514525593. Epub 2014 Mar 14. PMID 24634448
• Cavallo C, Filardo G, Mariani E, Kon E, Marcacci M, Pereira Ruiz MT, Facchini A, Grigolo B. Comparison of platelet-rich plasma formulations for cartilage healing: an in vitro study. J Bone Joint Surg Am. 2014 Mar 5;96(5):423-9. doi: 10.2106/JBJS.M.00726. PMID 24599205
• Everts PA, Knape JT, Weibrich G, Schonberger JP, Hoffmann J, Overdevest EP, Box HA, van Zundert A. Platelet-rich plasma and platelet gel: a review. J Extra Corpor Technol. 2006 Jun;38(2):174-87. PMID 16921694

Идентификаторы

NCT: NCT04901273 · PRP-o65

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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