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

Overview

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.

Interventions

• 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.
• 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.

Primary outcome measures

• Change in QuickDASH score from baseline to 3 months [Time frame: Baseline and 3 months after injection]

Secondary outcome measures (12)

• Change in QuickDASH score at 6 and 12 months [Time frame: Baseline, 6 months, and 12 months after injection]
• Change in PRTEE score [Time frame: Baseline, 3 months, 6 months, and 12 months after injection]
• Change in MEPS score [Time frame: Baseline, 3 months, 6 months, and 12 months after injection]
• Proportion of patients achieving a clinically meaningful improvement [Time frame: 3 months, 6 months, and 12 months after injection]
• Change in common extensor tendon tear size measured by ultrasound [Time frame: Baseline, 3 months, 6 months, and 12 months after injection]
• Rate of surgical treatment during follow-up [Time frame: Up to 12 months after injection]
• Time to surgery [Time frame: Up to 12 months after injection]
• Time between study inclusion and surgical intervention for lateral elbow tendinopathy. [Time frame: From injection to 12 months]
• Participant recruitment rate [Time frame: Throughout study completion (up to 12 months)]
• Presence of tendon hypervascularization on ultrasound [Time frame: Baseline, 3 months, 6 months, and 12 months after injection]
• Presence of local effusion on ultrasound [Time frame: Baseline, 3 months, 6 months, and 12 months after injection]
• Participant retention rate [Time frame: Up to 12 months after injection]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07717203 · 2025-44-SBM

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗