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

Document Type : RESEARCH PAPER

Authors

1 Department of Orthopedic Surgery, Amphia Hospital, Breda, the Netherlands

2 Department of Anatomy, University Medical Center Utrecht, the Netherlands

3 3 Department of Orthopedic Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands 4 Department of Human Movement Sciences, Vrije Universiteit Amsterdam, the Netherlands

Abstract

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. 
Level of evidence: IV

Keywords

References

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The Archives of Bone and Joint Surgery
Volume 10, Issue 5
May 2022
Pages 413-419

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History

  • Receive Date: 28 May 2020
  • Revise Date: 29 August 2021
  • Accept Date: 06 October 2021
  • First Publish Date: 25 October 2021

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