Epicondylitis, LateralEPI-PRPNCT07717203
Feasibility and Efficacy of Bone Marrow PRP Injection in Refractory Fissure Tendinopathies of the Lateral Epicondylar Tendons
A study testing Bone Marrow-Derived PRP and Peripheral Blood-Derived PRP in people with Epicondylitis, Lateral, run by Clinique du Sport, Bordeaux Mérignac.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epicondylitis, Lateral
- What is being tested?
- Bone Marrow-Derived PRP and Peripheral Blood-Derived PRP
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
- Conditions
- Epicondylitis, Lateral
- Being tested
- Bone Marrow-Derived PRP, Peripheral Blood-Derived PRP
- Keywords
- bone marrow concentrate, Platelet rich plasma, fissure, tendon
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow-Derived PRPProcedure or surgery
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 PRPProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Bone marrow-derived PRP | Experimental | 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. Receives: Procedure: Bone Marrow-Derived PRP |
| Peripheral blood-derived PRP | Active comparator | 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. Receives: Procedure: Peripheral Blood-Derived PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 3 months after injection
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Up to 12 months after injection
Time to surgery
Time between study inclusion and surgical intervention for lateral elbow tendinopathy.
Measured: Up to 12 months after injection
Time between study inclusion and surgical intervention for lateral elbow tendinopathy.
Measured: From injection to 12 months
Participant recruitment rate
Number of participants enrolled divided by the number of eligible participants screened during the recruitment period.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months, 6 months, and 12 months after injection
Participant retention rate
Proportion of randomized participants who complete the 12-month follow-up.
Measured: Up to 12 months after injection
Treatment adherence
Proportion of participants who receive the allocated intervention and complete study procedures according to the protocol.
Measured: From intervention to study completion (12 months)
Completeness of study data collection
Proportion of expected study data collected during follow-up visits.
Measured: Up to 12 months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epicondylitis, LateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique du Sport, Bordeaux Mérignac
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717203
- Sponsor's protocol ID
- 2025-44-SBM
- Acronym
- EPI-PRP
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy of Bone Marrow PRP Injection in Refractory Fissure Tendinopathies of the Lateral Epicondylar Tendons
- ClinicalTrials.gov ID
- NCT07717203
- Acronym / sponsor ID
- EPI-PRP / 2025-44-SBM
- Conditions
- Epicondylitis, Lateral
- Keywords
- bone marrow concentrate, Platelet rich plasma, fissure, tendon
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Clinique du Sport, Bordeaux MérignacUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bone marrow-derived PRP | Experimental | Procedure: Bone Marrow-Derived PRPParticipants 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 | Active comparator | Procedure: Peripheral Blood-Derived PRPParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone Marrow-Derived PRPParticipants 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 or surgery | Bone marrow-derived PRP |
| Peripheral Blood-Derived PRPParticipants 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 or surgery | Peripheral blood-derived PRP |
Primary outcome
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.
14 secondary outcomes
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
Treatment adherence
Time frame: From intervention to study completion (12 months)
Completeness of study data collection
Time frame: Up to 12 months after injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Bone Marrow-Derived PRP and Peripheral Blood-Derived PRP in people with Epicondylitis, Lateral, run by Clinique du Sport, Bordeaux Mérignac.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marion Mandon, PhD (+336 78 27 76 72, drc@vivalto-sante.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in QuickDASH score from baseline to 3 months (time frame: Baseline and 3 months after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.