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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinique du Sport, Bordeaux Mérignac

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Bone Marrow-Derived PRP
  • Peripheral Blood-Derived PRP

Treatment groups

24 Participants
are divided into 2 treatment groups

Locations

This trial has no locations