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Trial registered on ANZCTR


Registration number
ACTRN12612000383864
Ethics application status
Not yet submitted
Date submitted
2/04/2012
Date registered
4/04/2012
Date last updated
4/04/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective pilot study investigating the effect of Autologous Tenocyte Implantation on gluteal tendinopathy
Scientific title
Patients with gluteal tendinopathy who undergo autologous tenocyte implantation will have improved clinical and radiological outcomes at 3,6,12 and 24 months post injection
Secondary ID [1] 280269 0
Nil
Universal Trial Number (UTN)
U1111-1129-6878
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gluteal Tendinopathy 286216 0
Condition category
Condition code
Musculoskeletal 286432 286432 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Autologous tenocyte implantation is a two stage process:

The ATI Tendon Biopsy

The tendon biopsy is performed by a consultant radiologist. Under local anaesthetic and with suitable aseptic precautions a small piece of patella tendon will be harvested with a trucut needle. The biopsy is very small and will not cause significant problems to the integrity of the patella tendon. The biopsy will be placed in carrier medium and transported to the Orthocell facility. Orthocell has licencensed authorisation for the manufacture, storage and release for supple of Autologous Tenocytes by the Australian Therapeutic Goods Administration within the Department of Health and Aging.
The tenocytes are cultured for 5-6 weeks. A vial of cultured tenocytes contains 2 million cultured cells.

Autologous Tenocyte Implantation

The second stage of treatment is implantation. This will also be performed at Perth Radiological Clinic by a Consultant radiologist. An ultrasound probe will be used to locate the diseased area of gluteal tendons. A needle will then be placed under ultrasound control into the tendon, and the tenocytes injected. This is an outpatient procedure and therefore the patient will go home the same day.

Both procedures are performed just once and there are no current plans for repeat treatments
Intervention code [1] 284619 0
Treatment: Other
Comparator / control treatment
This is a pilot study, therefore there is no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286875 0
Visual analogue pain scores
Timepoint [1] 286875 0
3,6, 12 and 24 months
Primary outcome [2] 286876 0
Oxford Hip scores
The Oxford hip score is a validated self reported questionnaire that measures symptoms arising from the hip joint. It consists of 12 questions that are have responses scored from 1 to 5. For example: How would you describe the pain you usually have from your hip?
Timepoint [2] 286876 0
3, 6, 12 and 24 months
Primary outcome [3] 286877 0
SF-36
The improvement in physical health and mental health as measured by the SF-36 health survey.
Timepoint [3] 286877 0
3,6, 12 and 24 months
Secondary outcome [1] 296884 0
MRI scan
The changes in appearance of the gluteal tendons on MRI scan following tenocyte injection. The scans will be reported by an independent radiologist.
Timepoint [1] 296884 0
6 months

Eligibility
Key inclusion criteria
Gluteal tendinopathy, with or without partial tears.
Failure of normal conservative treatments
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Previous surgery
Full thickness gluteal tendon tears
Hip osteoarthritis
Active infection

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285032 0
Commercial sector/Industry
Name [1] 285032 0
Orthocell
Country [1] 285032 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Orthocell
Address
Building 191 Murdoch University
South St
Murdoch
Perth
WA 6150
Country
Australia
Secondary sponsor category [1] 283896 0
None
Name [1] 283896 0
Address [1] 283896 0
Country [1] 283896 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287038 0
Ethics committee address [1] 287038 0
Ethics committee country [1] 287038 0
Date submitted for ethics approval [1] 287038 0
16/04/2012
Approval date [1] 287038 0
Ethics approval number [1] 287038 0

Summary
Brief summary
Tendons and Tendinopathy
Tendons are the tough fibrous bands of tissue that connect our muscles to bony prominences on the human skeleton. They are extremely strong and allow muscles to work to allow movement and stability of the human body. Tendinopathy is degeneration of healthy tendons and is sometimes called tendonitis or tendinosis. It is usually caused by microtears within the tendon and a decrease in tendon repair cells.

GTPS and Gluteal tendinopathy
Greater trochanteric pain syndrome (GTPS) is a common condition that typically affects females in the 40-60 year age bracket. Patients complain of pain felt over the outer aspect of the hip. The condition was previously labelled trochanteric bursitis however modern imaging techniques and better understanding has revealed that a common cause of GTPS is tendinopathy or tears of the gluteal tendons around the hip. The reported incidence is 1.8 patients per 1000 per year.

Current treatments
Currently, initial treatments centre around non-steroidal anti-inflamatory drugs, physical therapy and weight loss. The next stage of treatment is often corticosteroid injections into the gluteal bursa. These may be targeted under xray control, or blind. Steroid injections often give short term relief of symptoms, for 6 to 12 weeks but relapse of symptoms is common. At present, common treatment methods have proven relatively ineffective.

Tendinopathy
Tendinopathy is also common in other areas of the body such as the achilles tendon, patella tendon, rotator cuff and tendons around the elbow that give rise to tennis elbow. Studies have shown that the process in these diseased tendons is similar. There are micro-tears in and around the tendon that lead to a decrease in tendon repair cells. Given that examination of tendinopathic tendons has revealed cell death there has been recent interest in developing cell technology to potentially aid repair and regeneration. The precursors to tendon cells can be harvested from normal tendons and grown in a laboratory. They can then be injected into diseased tendons. Preliminary animal studies have shown that this treatment can improve tendon remodelling, collagen content and tensile strength. Clinical pilot trials in human tendons for lateral epicondylitis (tennis elbow) have demonstrated safety and efficacy of the techninque, as well improved clinical and radiological outcomes. At present, there is a clinical trial being conducted into the injection of autologous tenocytes for achilles tendinopathy. (http://clinicaltrials.gov/ct2/show/NCT01343836)

ATI therapy

Autologous tenocyte implantation (ATI) is a new tissue engineering technique that involves an initial biopsy of healthy tendon cells. This is usually taken from the patella tendon. A very small piece of tendon is taken with a needle and then the cells within are cultured and grown over a period of 5-6 weeks in the Orthocell laboratory. The cells are then injected back into the injured tendon under ultrasound guidance. This delivers around 2 million tenocyte cells directly to the area of degenerate tendon.

Given the promising work in animal studies and clinical studies in human tendons, we propose a pilot study to investigate the use of ATI in gluteal tendinopathy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34015 0
Address 34015 0
Country 34015 0
Phone 34015 0
Fax 34015 0
Email 34015 0
Contact person for public queries
Name 17262 0
Thomas Bucher
Address 17262 0
Perth Orthopaedic and Sports Medicine Centre
31 Outram St
West Perth
WA 6005
Country 17262 0
Australia
Phone 17262 0
+61892124200
Fax 17262 0
Email 17262 0
[email protected]
Contact person for scientific queries
Name 8190 0
Thomas Bucher
Address 8190 0
Perth Orthopaedic and Sports Medicine Centre
31 Outram St
West Perth
WA 6005
Country 8190 0
Australia
Phone 8190 0
+61892124200
Fax 8190 0
Email 8190 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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