Multiple Perforations of the ECRB Tendon Using an Innovative Standardized, Reproducible Technique; A Cadaveric Study on Accuracy and Prospective Clinical Safety Assessment Pilot Study. No Adverse Effects in the First 122 Patients with Lateral Epicondylitis

Background: In LE (Lateral Epicondylitis) otherwise known as Tennis Elbow, the Extensor Carpi Radialis Brevis (ECRB) tendon is most commonly involved. In the majority of studies, injections are performed with a lack of standardization. The Instant Tennis Elbow Cure (ITEC) device has been developed to perform reproducible and standardized perforations by multiple needles. The goal of this pilot study was to estimate the accuracy of this ITEC device by means of a cadaveric study and to assess the clinical safety of this procedure. Methods: Ten cadaveric arms were injected using the ITEC device. The location and depth of the ECRB tendon was measured by ultrasound imaging. The accuracy of the infiltration was assessed by locating the injected dye through dissection and arthrotomy of the cadaveric elbow. A prospective clinical pilot study was conducted to assess the safety of the ITEC device in treating patients with chronic LE. An optional infiltration with an injection fluid was carried out Primary outcome measures were side effects and complications of the ITEC device occurring within a follow up period of 8 weeks after treatment. Results: In all cadaveric elbows the injection fluid ( in this case an injection fluid) was located at the ECRB tendon. In one cadaver, a minimal amount of dye was found intra-articular and in 3 cadavers a small quantity was located in the surrounding tissue of the ECRB tendon. 122 patients with LE were treated with the ITEC device. No adverse effects or complications were reported at 8-week follow up. Conclusion: Treatment of LE using the ITEC device appears accurate and safe. It may improve future research since it is reproducible and it can be performed in a standardized way.