The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616000458437
Ethics application status
Approved
Date submitted
31/03/2016
Date registered
7/04/2016
Date last updated
5/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
An Open-Label, Randomised Study of Ortho-ATI (Trademark) Versus Surgery for Treatment of Severe, Chronic, Resistant Lateral Epicondylitis
Scientific title
An Open-Label, Randomised Study of Ortho-ATI (Trademark) Versus Surgery for Treatment of Severe, Chronic, Resistant Lateral Epicondylitis
Secondary ID [1] 288895 0
ATI-005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe, chronic, resistant lateral epicondylitis 298230 0
Condition category
Condition code
Musculoskeletal 298365 298365 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.

Intervention code [1] 294353 0
Treatment: Other
Comparator / control treatment
Lateral Epicondylitis Surgery
Under general anaesthetic the patient is placed supine on the operating table. A tourniquet is placed on the operative arm. The arm is prepped and draped in a sterile manner. Intravenous antibiotic prophylaxis is given. An Esmarch bandage is applied, then the tourniquet inflated to 250mmHg. A curvilinear incision is made over the lateral aspect of the elbow overlying and distal to the lateral epicondyle. The lateral epicondyle is approached and the extensor carpi radialis longus (ECRL) tendon split giving exposure to the underlying extensor. The degenerative extensor carpi radialis brevis (ECRB) is evident by the appearance of the tissue. The degenerative ECRB is excised removing all degenerative appearing tissue down to the lateral epicondyle. The lateral epicondyle is abraded and multiple drill holes using 1.2mm K-wire are created to encourage bone bleeding for tendon reattachment. The wound is then thoroughly irrigated. The common extensor tendon is repaired to the lateral epicondyle using a 2.9mm suture anchor and two interlocking sutures. The ECRL split and incision are then closed using resorbable sutures. Post-operatively, the patient will be placed in a volar wrist splint for 6 weeks. A sling is used as required for comfort for 2 weeks. The patient will be instructed not to use the elbow to lift anything greater than a coffee cup for six weeks. The procedure is performed by an orthopaedic surgeon and takes approximately 1-2 hours.
Control group
Active

Outcomes
Primary outcome [1] 297837 0
Efficacy; QuickDASH score
Timepoint [1] 297837 0
12 months post-treatment
Secondary outcome [1] 322378 0
Secondary Efficacy Endpoint:
Visual Analogue Pain score
Timepoint [1] 322378 0
1, 3, 6 and 12 months post-treatment
Secondary outcome [2] 322600 0
Secondary Efficacy Endpoint:
Grip strength measured via dynamometer
Timepoint [2] 322600 0
1, 3, 6 and 12 months post-treatment
Secondary outcome [3] 322601 0
AQoL-6D score
Timepoint [3] 322601 0
1, 3, 6 and 12 months post-treatment
Secondary outcome [4] 322602 0
MRI tendinopathy score
Timepoint [4] 322602 0
Baseline and 12 months post-treatment

Eligibility
Key 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
Minimum age
30 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5536 0
The Avenue Private Hospital - Windsor
Recruitment hospital [2] 7774 0
Epworth Richmond - Richmond
Recruitment postcode(s) [1] 15707 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 293248 0
Commercial sector/Industry
Name [1] 293248 0
Orthocell
Address [1] 293248 0
Orthocell Ltd
Building 191, Murdoch University
South Street, Murdoch WA 6150
Country [1] 293248 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Orthocell Ltd.
Address
Orthocell Ltd
Building 191, Murdoch University
South Street, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 292050 0
None
Name [1] 292050 0
NA
Address [1] 292050 0
NA
Country [1] 292050 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294726 0
The Avenue Hospital Human Research Ethics Committee
Ethics committee address [1] 294726 0
Ground Floor, Linay Pavilion,
The Avenue Hospital
40 The Avenue
WINDSOR VIC 3181
Ethics committee country [1] 294726 0
Australia
Date submitted for ethics approval [1] 294726 0
29/03/2016
Approval date [1] 294726 0
01/05/2016
Ethics approval number [1] 294726 0

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64838 0
A/Prof Eugene Ek
Address 64838 0
Melbourne Orthopaedic Group
33 The Avenue
Windsor VIC 3181
Country 64838 0
Australia
Phone 64838 0
+61 (3) 9573 9678
Fax 64838 0
Email 64838 0
admin@mog.com.au
Contact person for public queries
Name 64839 0
A/Prof Eugene Ek
Address 64839 0
Melbourne Orthopaedic Group
33 The Avenue
Windsor VIC 3181
Country 64839 0
Australia
Phone 64839 0
+61 (3) 9573 9678
Fax 64839 0
Email 64839 0
admin@mog.com.au
Contact person for scientific queries
Name 64840 0
Dr Clair Lee
Address 64840 0
Building 191 Murdoch University
South Street, Murdoch WA 6150
Country 64840 0
Australia
Phone 64840 0
+ 61 8 9360 2888
Fax 64840 0
Email 64840 0
clair@orthocell.com.au

No information has been provided regarding IPD availability
Summary results
No Results