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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]

Nil

Universal Trial Number (UTN)

U1111-1129-6878

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Gluteal Tendinopathy

Condition category

Condition code

Musculoskeletal

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]

Treatment: Other

Comparator / control treatment

This is a pilot study, therefore there is no control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Visual analogue pain scores

Timepoint [1]

3,6, 12 and 24 months

Primary outcome [2]

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]

3, 6, 12 and 24 months

Primary outcome [3]

SF-36
The improvement in physical health and mental health as measured by the SF-36 health survey.

Timepoint [3]

3,6, 12 and 24 months

Secondary outcome [1]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Orthocell

Address [1]

Building 191 Murdoch University
South St
Murdoch
Perth
WA 6150

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

16/04/2012

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Thomas Bucher

Address

Perth Orthopaedic and Sports Medicine Centre
31 Outram St
West Perth
WA 6005

Country

Australia

Phone

+61892124200

Fax

tombucher@doctors.net.uk

Contact person for scientific queries

Name

Thomas Bucher

Address

Perth Orthopaedic and Sports Medicine Centre
31 Outram St
West Perth
WA 6005

Country

Australia

Phone

+61892124200

Fax

tombucher@doctors.net.uk

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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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