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NCT07717203
Feasibility and Efficacy of Bone Marrow PRP Injection in Refractory Fissure Tendinopathies of the Lateral Epicondylar Tendons
Conditions: Epicondylitis, Lateral
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 24
Sponsor: Clinique du Sport, Bordeaux Mérignac
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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.
Source: ClinicalTrials.gov (NCT07717203). StuddyBuddy aggregates publicly available trial information.