Feasibility and Efficacy of Bone Marrow PRP Injection in Refractory Fissure Tendinopathies of the Lateral Epicondylar Tendons
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 主要终点
- Change in QuickDASH score from baseline to 3 months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors are blinded to treatment allocation. Clinical follow-up assessments are performed by an orthopedic surgeon who does not have access to the randomization sequence or treatment assignment. Ultrasound follow-up evaluations are performed by a radiologist who did not perform the intervention. Participants are instructed not to disclose their treatment allocation during follow-up visits. Any accidental unblinding will be documented.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Change in QuickDASH score from baseline to 3 months
时间窗: Baseline and 3 months after injection
The primary outcome is the change in the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score between baseline and 3 months. The QuickDASH is a patient-reported questionnaire assessing upper-limb disability and symptoms. Scores range from 0 to 100, with higher scores indicating greater disability.
次要结局
- Change in QuickDASH score at 6 and 12 months(Baseline, 6 months, and 12 months after injection)
- Change in PRTEE score(Baseline, 3 months, 6 months, and 12 months after injection)
- Change in MEPS score(Baseline, 3 months, 6 months, and 12 months after injection)
- Proportion of patients achieving a clinically meaningful improvement(3 months, 6 months, and 12 months after injection)
- Change in common extensor tendon tear size measured by ultrasound(Baseline, 3 months, 6 months, and 12 months after injection)
- Rate of surgical treatment during follow-up(Up to 12 months after injection)
- Time to surgery(Up to 12 months after injection)
- Time between study inclusion and surgical intervention for lateral elbow tendinopathy.(From injection to 12 months)
- Participant recruitment rate(Throughout study completion (up to 12 months))
- Presence of tendon hypervascularization on ultrasound(Baseline, 3 months, 6 months, and 12 months after injection)
- Presence of local effusion on ultrasound(Baseline, 3 months, 6 months, and 12 months after injection)
- Participant retention rate(Up to 12 months after injection)
- Treatment adherence(From intervention to study completion (12 months))
- Completeness of study data collection(Up to 12 months after injection)