ClinicalTrials.gg
Not yet recruitingNCT07717203EPI-PRPUpdated Jul 21, 2026

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

An interventional study of Bone Marrow-Derived PRP and Peripheral Blood-Derived PRP in Epicondylitis, Lateral, sponsored by Clinique du Sport, Bordeaux Mérignac. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by Clinique du Sport, Bordeaux Mérignac · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Epicondylitis, Lateral

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Keywords

  • bone marrow concentrate
  • Platelet rich plasma
  • fissure
  • tendon
03

In context

Tennis Elbow

296 studies on the registry are indexed under Tennis Elbow; 64 are open to participants now.

This study's planned enrollment of 24 is below the median of 50 across 262 interventional studies indexed under Tennis Elbow.

Browse Tennis Elbow studies →

Lead sponsor

Clinique du Sport, Bordeaux Mérignac is the lead sponsor of 11 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 -rich plasma (PRP) injection established by the treating physician.
  • Ability to understand the study procedures and comply with follow-up requirements.
  • Written obtained prior to participation.
  • Affiliation to a health insurance system (as required by French regulations).

Exclusion criteria

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.
  • 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 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
24 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • ProcedureBone 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.

  • ProcedurePeripheral 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and 3 months after injection

Secondary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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).

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

  5. 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).

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

  6. Rate of surgical treatment during follow-up

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

    Time frame: Up to 12 months after injection

  7. Time to surgery

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

    Time frame: Up to 12 months after injection

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

    Time frame: From injection to 12 months

  9. Participant recruitment rate

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

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

  10. Presence of tendon hypervascularization on ultrasound

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

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

  11. Presence of local effusion on ultrasound

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

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

  12. Participant retention rate

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

    Time frame: Up to 12 months after injection

  13. Treatment adherence

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

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

  14. Completeness of study data collection

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

    Time frame: Up to 12 months after injection

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07717203
Lead sponsor
Clinique du Sport, Bordeaux Mérignac
Responsible party
Sponsor
First posted
Jul 21, 2026
Start date
Sep 2026 (estimated)
Primary completion
Jan 2029 (estimated)
Completion
Mar 2029 (estimated)
Last update
Jul 21, 2026

Study contacts

Marion Mandon, PhD
Contact
drc@vivalto-sante.com
+336 78 27 76 72

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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