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.
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.
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.
Parallel
Bone Marrow-Derived PRP
Procedure/SurgeryParticipants 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.
Peripheral Blood-Derived PRP
Procedure/SurgeryParticipants 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.
Change in QuickDASH score from baseline to 3 months
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.
Change in QuickDASH score at 6 and 12 months
Change in QuickDASH score over time. Scores range from 0 to 100, with higher scores indicating greater disability.
Change in PRTEE score
Change in the Patient-Rated Tennis Elbow Evaluation (PRTEE) score. The PRTEE assesses pain and functional limitations related to lateral elbow tendinopathy. Scores range from 0 to 100, with higher scores indicating worse symptoms and disability.
Change in MEPS score
Change in the Mayo Elbow Performance Score (MEPS). The MEPS evaluates pain, range of motion, stability, and function of the elbow. Scores range from 0 to 100, with higher scores indicating better elbow function.
Proportion of patients achieving a clinically meaningful improvement
Proportion of participants achieving the minimal clinically important difference (MCID), defined as an improvement of at least 16 points in the QuickDASH score (Scores range from 0 to 100, with higher scores indicating greater disability).
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