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Funded by the MRC. AUTOLOGOUS CHONDROCYTE TRANSPLANTATION/IMPLANTATION VERSUS EXISTING TREATMENTS ISCRCTN 48911177. NEWSLETTER April 2008 Issue 14. Protocol amendments Good news! After a lengthy process the MRC and ethics have approved the

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Funded by the MRC



NEWSLETTER April 2008 Issue 14

Protocol amendments

Good news! After a lengthy process the

MRC and ethics have approved the

following changes to the protocol:


An extension to the recruitment period

of up to the end of 2009 to recruit at

least 480 patients.

Patella lesions

Patella lesions can now be treated in

the trial.


Osteochondral defects can now be

treated in the trial. Any OCDs

involving more than 3 mm of bone loss

must be grafted but the type and

timing of bone graft is down to

surgeons’ choice since there is a lack of

evidence to support any one particular


Matrix-ACI option

As you know MACI is already a cell

grafting option in the trial. A further

matrix version of ACI called Chondron

in which the cells are suspended in a gel

at the time of surgery is now an option as

a subrandomisation against MACI.

Surgeons choosing this option must still

select a standard treatment as part of

the main randomisation.

Number of patients randomised Total: 208

Recruitment / new centres

Thanks to everyone who has contributed to

getting us past the 200 mark for

recruitment. Just another 280 to go!

Fortunately we anticipate a large increase in

the rate of recruitment now that Stanmore

is ready to start.

Fairfield General Hospital in Bury is our

latest centre to begin recruitment and

further centres are being set up.

ACTIVE Workshop

A workshop for new surgeons is being

planned to take place at Oswestry on either

the 3rd or 10th June (or both days depending

on numbers). If you are new to the trial or

know of colleagues who would like to attend

please contact Heather. New co-ordinators

and assessors are also welcome. The

workshop involves talks on surgical

techniques and the ACTIVE protocol;

observing a 2nd stage ACI in theatre with

Prof Richardson; and a hands-on

practice of cell-grafting techniques using

cow stifle joints.

New forms

Each co-ordinator will be sent a pack of the latest version (v 3.1) of the Patient Information Leaflet. A further version (3.2) is to be used by Stanmore and any other centres who decide to use Chondron. New Patient Entry Forms and Treatment Records will be sent out shortly to include the above protocol changes. Please continue using your existing forms until the new ones arrive. If you are entering patients with an OCD or patella lesion please notify Heather first.


  • Health economics

  • An important aspect of ACTIVE is to evaluate the cost effectiveness of ACI versus

  • standard treatments. We are fortunate that recently Prof. Marilyn James and

  • Liz Stokes from Liverpool John Moores University have taken on the role of Health

  • Economists for the trial. As a result we have introduced some changes to the collection

  • of resource usage:

  • New Resource Usage forms have been sent out to every centre. These are to be completed by patients at 2/3, 6 & 12 months, then annually. It is no longer collected at pre-op. We will notify you when the database is ready to accept these new forms. In the meantime please send copies of completed forms to the trial office as a backup.

  • Co-ordinators will be sent a new form and asked to complete further details about hospital resource usage using hospital notes (e.g. length of stay in hospital; additional procedures). This new form is currently being piloted at Oswestry but will be finalised and sent out soon.

UK-ICRS Meeting

A UK-ICRS conference is planned for the Autumn, to take place at Stanmore, led by Prof. Dave Marsh and Prof. George Bentley – date to be confirmed.

The latest version of the protocol can be downloaded from the website under “study documents” along with a summary of all the protocol amendments. A hard copy will be sent to every centre in due course.

Best wishes,

Heather Smith

ACTIVE Trial Manager

[email protected]

Tel: 01691 404142

Happy at work in St. Olavs Hospital, Trondheim – from left to right: Bente Johansen (co-ordinator) Ingrid Solhjem (assessor) and Berit Wenaas (admin assistant) looking very organised with their ACTIVE files