An Open-Label, Randomised Study of Ortho-ATI (Trademark) Versus Surgery for Treatment of Severe, Chronic, Resistant Lateral Epicondylitis

INTERVENTION: Ortho‐ATI (Trademark) is a Class 3 Biological autologous tenocyte implantation (ATI) product manufactured in Australia by Orthocell since 2008. Ortho‐ATI (Trademark) is intended for homologous and autologous use only. The product comprises autologous tendon cells taken from healthy patellar tendons of patients. These autologous cells are proliferated using an in vitro cell culture technique and reconstituted with patient’s own serum for local injection. Patellar Tendon Biopsy Autologous tenocytes will be harvested from participants via patellar tendon biopsy under local anaesthetic by an orthopaedic surgeon. A 3 x 1mm strip of tendon will be harvested from the superficial surface of the patellar tendon using a 14 gauge biopsy needle. Participants will be advised to avoid over use or excessive repetitive motions for 1‐2 days Tenocyte Injection Approximately 4 weeks post‐biopsy, the orthopaedic surgeon is provided with 2 vials containing 1ml each of autologous human tenocytes (2‐5 x 106 cells/ml) suspended in 10% autologous human serum. Under ultrasound guidance, using an 18‐gauge needle, the surgeon will inject the suspension as described above into the tendinopathy site at the extensor carpi radialis brevis (ECRB) tendon. The final volume injected will be determined by the surgeon during the procedure according to the capacity of the anatomical site. Participants will be advised to rest for two days and restrict activity to light household/office duties for four weeks. CONDITION: Severe, chronic, resistant lateral epicondylitis PRIMARY OUTCOME: Efficacy; QuickDASH score SECONDARY OUTCOME: AQoL‐6D score MRI tendinopathy score Secondary Efficacy Endpoint: ; Grip strength measured via dynamometer Secondary Efficacy Endpoint: ; Visual Analogue Pain score ; INCLUSION CRITERIA: Male or female aged 30‐70 years of age Diagnosis of lateral epicondylitis: Pain over the outside of the elbow AND Pain when lifting objects AND Pain radiating down the forearm AND Positive Mills test AND Ultrasound or MRI‐confirmed tendinosis History of lateral epicondylitis > 6 months Previously received injectable therapy but did not respond Gives written consent to participate in the study