Bone Marrow Aspirate Versus Platelet-Rich Fibrin for the Treatment of Chronic Plantar Fasciitis

Официальное название

Bone Marrow Aspirate Versus Platelet-Rich Fibrin for the Treatment of Plantar Fasciitis - A Double-Blind Randomized Clinical Trial

Обзор

This randomized, double-blind clinical trial aims to compare the clinical and imaging effects of autologous bone marrow aspirate versus platelet-rich fibrin injections in patients with chronic plantar fasciitis. The procedures are performed under ultrasound guidance to ensure precision and safety. The study evaluates pain reduction, foot function, and ultrasonographic changes in the plantar fascia at follow-up intervals.

Подробное описание

Chronic plantar fasciitis is a common cause of heel pain that may persist despite standard conservative measures such as physical therapy, stretching, orthoses, and corticosteroid injections. Regenerative medicine techniques, including autologous platelet concentrates and bone marrow-derived products, have emerged as potential alternatives to promote tissue healing and long-term symptom improvement.

This randomized controlled trial investigates and compares two minimally invasive orthobiologic interventions:

Bone Marrow Aspirate (BMA) - obtained from the posterior iliac crest under local anesthesia and injected into the most symptomatic region of the plantar fascia under ultrasound guidance.

Platelet-Rich Fibrin (PRF) - prepared from autologous venous blood by centrifugation without anticoagulants, forming a fibrin matrix injected into the plantar fascia under ultrasound guidance.

All procedures are performed under sterile conditions and tibial nerve regional anesthesia.

Pain and safety will be monitored using the Visual Analog Scale (VAS) and by recording adverse events at the following time points: baseline (0), 30 minutes, 1, 6, 12, and 24 months after the procedure.

Functional outcomes will be collected with Modified AOFAS Score at baseline, 1, 6, 12, and 24 months. Ultrasonography will measure plantar fascia thickness immediately before the intervention and at 12 months.

This research contributes to the growing evidence supporting orthobiologic therapies as viable, minimally invasive options for chronic plantar fasciitis management.

Вмешательства

• Биопрепарат Bone Marrow Aspirate Injection
  Ultrasound-guided injection of autologous bone marrow aspirate obtained from the posterosuperior iliac crest under local anesthesia. Approximately 8mL of aspirate is injected into/around the plantar fascia.
• Биопрепарат Platelet-Rich Fibrin Injection
  Ultrasound-guided injection of autologous platelet-rich fibrin (PRF) prepared from 60 mL of venous blood centrifuged to form a fibrin clot. Approximately 8mL of PRF is injected into/around the plantar fascia.

Первичные конечные точки

• Change in pain intensity (VAS) and occurrence of adverse events [Срок оценки: baseline (0), 30 minutes, 1, 6, 12, and 24 months]

Вторичные конечные точки (2)

• Change in Modified AOFAS Score [Срок оценки: baseline, 1, 6, 12, 24 months]
• Change in Plantar Fascia Thickness by Ultrasound [Срок оценки: Pre-procedure (baseline) and 12 months]

Критерии участия

Критерии включения

• Adults aged 18 to 75 years.
• Clinical diagnosis of chronic plantar fasciitis for more than 6 months, confirmed by ultrasonography (increased plantar fascia thickness and hypoechogenicity).
• Persistent heel pain refractory to conventional conservative treatment (stretching, orthotics, physical therapy, or corticosteroid injections).
• Visual Analog Scale (VAS) pain score ≥ 4 at baseline.
• Ability and willingness to comply with study procedures and follow-up assessments.
• Signed informed consent.

Критерии исключения

• Previous foot or ankle surgery on the affected limb.
• Acute trauma, infection, or ulceration in the region of the plantar fascia.
• Systemic inflammatory diseases (e.g., rheumatoid arthritis, lupus, psoriatic arthritis).
• Metabolic or endocrine disorders interfering with healing (e.g., diabetes mellitus with poor glycemic control, thyroid disorders).
• Current use of systemic corticosteroids, immunosuppressants, or anticoagulants.
• Active neoplasia or hematologic disorders.
• Pregnancy or breastfeeding.
• Peripheral vascular disease or neuropathy affecting the lower limbs.
• Contraindications to local anesthesia or venipuncture.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Federal University of São Paulo - Hospital São Paulo — São Paulo

Идентификаторы

NCT: NCT07242729 · CAAE 90411925.0.0000.5505

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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