Epicondylitis, Lateral
Conditions
Keywords
bone marrow concentrate, Platelet rich plasma, fissure, tendon
Brief 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.
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.
Sponsors
Clinique du Sport, Bordeaux Mérignac
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors are blinded to treatment allocation. Clinical follow-up assessments are performed by an orthopedic surgeon who does not have access to the randomization sequence or treatment assignment. Ultrasound follow-up evaluations are performed by a radiologist who did not perform the intervention. Participants are instructed not to disclose their treatment allocation during follow-up visits. Any accidental unblinding will be documented.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in QuickDASH score from baseline to 3 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in QuickDASH score at 6 and 12 months | 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. |
| Change in PRTEE score | 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. |
| Change in MEPS score | 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. |
| Proportion of patients achieving a clinically meaningful improvement | 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). |
| Change in common extensor tendon tear size measured by ultrasound | 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). |
| Rate of surgical treatment during follow-up | Up to 12 months after injection | Proportion of participants requiring surgical treatment for lateral elbow tendinopathy during the 12-month follow-up period. |
| Time to surgery | Up to 12 months after injection | Time between study inclusion and surgical intervention for lateral elbow tendinopathy. |
| Time between study inclusion and surgical intervention for lateral elbow tendinopathy. | From injection to 12 months | — |
| Participant recruitment rate | Throughout study completion (up to 12 months) | Number of participants enrolled divided by the number of eligible participants screened during the recruitment period. |
| Presence of tendon hypervascularization on ultrasound | 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. |
| Presence of local effusion on ultrasound | 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. |
| Participant retention rate | Up to 12 months after injection | Proportion of randomized participants who complete the 12-month follow-up. |
| Treatment adherence | From intervention to study completion (12 months) | Proportion of participants who receive the allocated intervention and complete study procedures according to the protocol. |
| Completeness of study data collection | Up to 12 months after injection | Proportion of expected study data collected during follow-up visits. |
Contacts
CONTACTMarion Mandon, PhD
Outcome results
None listed