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NCT Number: NCT07717203

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

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.

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Key information

Conditions

Epicondylitis, Lateral Arm Injuries Elbow Injuries Elbow Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Injuries Tennis Elbow Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bone Marrow-Derived PRP

Procedure

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

Procedure

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 outcomes

  1. Change in QuickDASH score from baseline to 3 months

    Time frame: Baseline and 3 months after injection

    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.

Secondary outcomes

  1. Change in QuickDASH score at 6 and 12 months

    Time frame: Baseline, 6 months, and 12 months after injection

    Change in QuickDASH score over time. Scores range from 0 to 100, with higher scores indicating greater disability.

  2. Change in PRTEE score

    Time frame: Baseline, 3 months, 6 months, and 12 months after injection

    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.

  3. Change in MEPS score

    Time frame: Baseline, 3 months, 6 months, and 12 months after injection

    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.

  4. Proportion of patients achieving a clinically meaningful improvement

    Time frame: 3 months, 6 months, and 12 months after injection

    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).

  5. Change in common extensor tendon tear size measured by ultrasound

    Time frame: Baseline, 3 months, 6 months, and 12 months after injection

    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).

  6. Rate of surgical treatment during follow-up

    Time frame: Up to 12 months after injection

    Proportion of participants requiring surgical treatment for lateral elbow tendinopathy during the 12-month follow-up period.

  7. Time to surgery

    Time frame: Up to 12 months after injection

    Time between study inclusion and surgical intervention for lateral elbow tendinopathy.

  8. Time between study inclusion and surgical intervention for lateral elbow tendinopathy.

    Time frame: From injection to 12 months

  9. Participant recruitment rate

    Time frame: Throughout study completion (up to 12 months)

    Number of participants enrolled divided by the number of eligible participants screened during the recruitment period.

  10. Presence of tendon hypervascularization on ultrasound

    Time frame: Baseline, 3 months, 6 months, and 12 months after injection

    Presence or absence of hypervascularization at the common extensor tendon insertion assessed by Doppler ultrasound.

  11. Presence of local effusion on ultrasound

    Time frame: Baseline, 3 months, 6 months, and 12 months after injection

    Presence or absence of local effusion at the common extensor tendon insertion assessed by ultrasound.

  12. Participant retention rate

    Time frame: Up to 12 months after injection

    Proportion of randomized participants who complete the 12-month follow-up.

  13. Treatment adherence

    Time frame: From intervention to study completion (12 months)

    Proportion of participants who receive the allocated intervention and complete study procedures according to the protocol.

  14. Completeness of study data collection

    Time frame: Up to 12 months after injection

    Proportion of expected study data collected during follow-up visits.

Study contacts

Contact information is provided by the study sponsor or research team.

Marion Mandon, PhD

CONTACT

[email protected]

+336 78 27 76 72

Sponsors and collaborators

Lead sponsor

Clinique du Sport, Bordeaux Mérignac

Other

Registry information

Acronym: EPI-PRP

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 21, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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