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

NCT07717203 | Not Yet Recruiting DMC

• 1 other identifier: 2025-44-SBM
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Epicondylitis, Lateral

Keywords

bone marrow concentrate; Platelet rich plasma; fissure; tendon

Outcome Measures

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.

  Baseline and 3 months after injection

Secondary Outcomes (14)

• Change in QuickDASH score at 6 and 12 months

  Baseline, 6 months, and 12 months after injection

• Change in PRTEE score

  Baseline, 3 months, 6 months, and 12 months after injection

• Change in MEPS score

  Baseline, 3 months, 6 months, and 12 months after injection

• Proportion of patients achieving a clinically meaningful improvement

  3 months, 6 months, and 12 months after injection

• Change in common extensor tendon tear size measured by ultrasound

  Baseline, 3 months, 6 months, and 12 months after injection

Study Arms (2)

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.

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.

Procedure: Peripheral Blood-Derived PRP

Interventions

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.

Bone marrow-derived PRP

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.

Peripheral blood-derived PRP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinique du Sport, Bordeaux Mérignac: lead

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Central Study Contacts

Marion Mandon, PhD

CONTACT

+336 78 27 76 72; drc@vivalto-sante.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 21, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share