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

Study Overview

• Status: Not yet recruiting
• Conditions: Epicondylitis, Lateral
• Intervention / Treatment: Procedure: Bone Marrow-Derived PRP; Procedure: Peripheral Blood-Derived PRP

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marion Mandon, PhD; Phone Number: +336 78 27 76 72; Email: drc@vivalto-sante.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 3 months after injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 6 months, and 12 months after injection
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.	Baseline, 3 months, 6 months, and 12 months after injection
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.	Baseline, 3 months, 6 months, and 12 months after injection
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).	3 months, 6 months, and 12 months after injection
Change in common extensor tendon tear size measured by ultrasound	Change in the size of the common extensor tendon tear measured by ultrasound in longitudinal and transverse planes. Tear size is recorded in millimeters (mm).	Baseline, 3 months, 6 months, and 12 months after injection
Rate of surgical treatment during follow-up	Proportion of participants requiring surgical treatment for lateral elbow tendinopathy during the 12-month follow-up period.	Up to 12 months after injection
Time to surgery	Time between study inclusion and surgical intervention for lateral elbow tendinopathy.	Up to 12 months after injection
Time between study inclusion and surgical intervention for lateral elbow tendinopathy.		From injection to 12 months
Participant recruitment rate	Number of participants enrolled divided by the number of eligible participants screened during the recruitment period.	Throughout study completion (up to 12 months)
Presence of tendon hypervascularization on ultrasound	Presence or absence of hypervascularization at the common extensor tendon insertion assessed by Doppler ultrasound.	Baseline, 3 months, 6 months, and 12 months after injection
Presence of local effusion on ultrasound	Presence or absence of local effusion at the common extensor tendon insertion assessed by ultrasound.	Baseline, 3 months, 6 months, and 12 months after injection
Participant retention rate	Proportion of randomized participants who complete the 12-month follow-up.	Up to 12 months after injection
Treatment adherence	Proportion of participants who receive the allocated intervention and complete study procedures according to the protocol.	From intervention to study completion (12 months)
Completeness of study data collection	Proportion of expected study data collected during follow-up visits.	Up to 12 months after injection

Collaborators and Investigators

• Sponsor: Clinique du Sport, Bordeaux Mérignac

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 21, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: tendon; Platelet rich plasma; bone marrow concentrate; fissure
• Additional Relevant MeSH Terms: Elbow Tendinopathy; Elbow Injuries; Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Tendon Injuries; Arm Injuries; Tendinopathy; Tennis Elbow
• Other Study ID Numbers: 2025-44-SBM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No