| Registry | NCT07717203, acronym EPI-PRP |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 24 (Estimated) |
| Sponsor | Clinique du Sport, Bordeaux Mérignac (Other) |
| Conditions | Epicondylitis, Lateral |
| Interventions | Bone Marrow-Derived PRP, Peripheral Blood-Derived PRP (Procedure) |
| Dates | start 2026-09-01 (estimated), primary completion 2029-01-01 (estimated), completion 2029-03-01 (estimated), first posted 2026-07-21, last updated 2026-07-21 |
Related Papers Related Patents Related Grants Related Experts
All trials for Epicondylitis, Lateral All trials of Bone Marrow-Derived PRP All trials of Peripheral Blood-Derived PRP
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Bone marrow-derived PRP | Experimental | Procedure: 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. |
| Peripheral blood-derived PRP | Active comparator | Procedure: 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. |
Sex: All, ages: 18 Years to any
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.