An Open-Label, Randomised Study of Ortho-ATI (Trademark) Versus Surgery for Treatment of Severe, Chronic, Resistant Lateral Epicondylitis
Orthocell Ltd.
50 participants
Jul 14, 2016
Interventional
Conditions
Summary
Lateral epicondylitis (LE) or "tennis elbow" is the most commonly diagnosed condition of the elbow and occurs mostly in patients whose activities require strong gripping or repetitive movements. 1 in 10 patients with LE who receive standard therapies like coricosteriod injections do not obtain relief from symptoms. In Australia, such patients with severe, chronic non responsive LE for over 6 months are referred for surgical treatment. OrthoATI (Trademark) is a class 3 biological autologous tenocyte implantation (ATI) product manufactured in Australia by Orthocell Ltd, that could potentially prevent or delay the need for surgery in LE patients who don't respond to standard therapies. OrthoATI (Trademark) is indicated for patients with symptoms of degenerative tendon injury who have failed conservative treatment methods. The current research project is a 1 year, single dose, single-centre, randomised, open label, parallel group, comparator controlled, non-inferiority study to assess the efficacy, safety and tolerability of OrthoATI (Trademark) in patients with severe, chronic, treatment resistant lateral epicondylitis compared to surgery.
Eligibility
Inclusion Criteria10
- 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
Exclusion Criteria10
- Participant diagnosed with posterior inter-osseous nerve compression in the affected arm
- Unrelated injury in the ipsilateral upper limb, including nerve compression and arthritis
- Known hypersensitivity to the comparator product or its components or known relevant medication allergy
- Corticosteroid or other treatment injection into relevant joint within previous 3 months
- Prior surgical intervention for lateral epicondylitis
- Known history of inflammatory musculoskeletal disorder (eg., rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythromatosis etc)
- Female participant who is pregnant or lactating
- Known substance abuse
- Participation in another study with an investigational product within 2 months of the planned first study visit
- Clinically significant disease or other medical condition that would, in the opinion of the Investigator, compromise the safety of the participant or quality of data collected
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Interventions
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.
Locations(3)
View Full Details on ANZCTR
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ACTRN12616000458437