Feasibility and Efficacy of Bone Marrow PRP Injection in Refractory Fissure Tendinopathies of the Lateral Epicondylar Tendons

Обзор

Lateral epicondylitis with tendon tear resistant to conservative treatment remains a common clinical condition with limited therapeutic options before surgery is considered. Platelet-rich plasma (PRP) injections are used in tendinopathies because of their potential regenerative properties. More recently, platelet-rich plasma derived from bone marrow aspirate (bone marrow-derived PRP) has emerged as an alternative source of platelets and bioactive factors. However, the clinical implications of its different biological composition compared with peripheral blood-derived PRP remain poorly understood. This monocentric randomized pilot trial aims to assess the feasibility of the intervention and to estimate the effect of bone marrow-derived PRP compared with peripheral blood-derived PRP in patients with resistant partial-thickness lateral epicondylar tendinopathy. Participants will be randomly assigned in a 1:1 ratio to receive either bone marrow-derived PRP or peripheral blood-derived PRP injection. Clinical outcomes, pain, functional scores, imaging findings, safety, and feasibility parameters will be assessed over a 12-month follow-up period. The study is not powered to demonstrate superiority between treatments but is intended to generate preliminary effect estimates and feasibility data for the design of a future confirmatory trial.

Вмешательства

• Процедура Bone Marrow-Derived PRP
  Participants receive a platelet-rich plasma (PRP) injection prepared from bone marrow aspirate obtained from the posterior iliac crest. After processing, the PRP is injected under ultrasound guidance into the affected lateral elbow tendon.
• Процедура Peripheral Blood-Derived PRP
  Participants receive a platelet-rich plasma (PRP) injection prepared from peripheral venous blood. After processing, the PRP is injected under ultrasound guidance into the affected lateral elbow tendon.

Первичные конечные точки

• Change in QuickDASH score from baseline to 3 months [Срок оценки: Baseline and 3 months after injection]

Вторичные конечные точки (12)

• Change in QuickDASH score at 6 and 12 months [Срок оценки: Baseline, 6 months, and 12 months after injection]
• Change in PRTEE score [Срок оценки: Baseline, 3 months, 6 months, and 12 months after injection]
• Change in MEPS score [Срок оценки: Baseline, 3 months, 6 months, and 12 months after injection]
• Proportion of patients achieving a clinically meaningful improvement [Срок оценки: 3 months, 6 months, and 12 months after injection]
• Change in common extensor tendon tear size measured by ultrasound [Срок оценки: Baseline, 3 months, 6 months, and 12 months after injection]
• Rate of surgical treatment during follow-up [Срок оценки: Up to 12 months after injection]
• Time to surgery [Срок оценки: Up to 12 months after injection]
• Time between study inclusion and surgical intervention for lateral elbow tendinopathy. [Срок оценки: From injection to 12 months]
• Participant recruitment rate [Срок оценки: Throughout study completion (up to 12 months)]
• Presence of tendon hypervascularization on ultrasound [Срок оценки: Baseline, 3 months, 6 months, and 12 months after injection]
• Presence of local effusion on ultrasound [Срок оценки: Baseline, 3 months, 6 months, and 12 months after injection]
• Participant retention rate [Срок оценки: Up to 12 months after injection]

Критерии участия

Критерии включения

• Diagnosis of chronic lateral epicondylitis with partial-thickness tendon tear of the common extensor tendon confirmed by ultrasound.
• Symptoms persisting despite appropriate conservative treatment for at least 3 months.
• Indication for platelet-rich plasma (PRP) injection established by the treating physician.
• Ability to understand the study procedures and comply with follow-up requirements.
• Written informed consent obtained prior to participation.
• Affiliation to a health insurance system (as required by French regulations).

Критерии исключения

• Full-thickness tear of the common extensor tendon.
• Previous surgery of the affected elbow.
• PRP injection in the affected elbow within the previous 6 months.
• Corticosteroid injection in the affected elbow within the previous 3 months.
• Current treatment with medications incompatible with PRP preparation according to study procedures.
• Active infection at the injection site or systemic infection.
• Known hematologic disorder affecting platelet function or coagulation.
• Current anticoagulant therapy that cannot be interrupted according to study requirements.
• Pregnancy or breastfeeding.
• Participation in another interventional clinical trial that could interfere with study outcomes.
• Any medical, psychiatric, or social condition that, in the investigator's opinion, could compromise participant safety or compliance with study procedures.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07717203 · 2025-44-SBM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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