Autologous Chondrocyte Transplantation / Implantation Versus Existing treatments
PARTICIPANTS Chondral defects Why ACTIVE? Which Hospitals? Your Participation
ACTIVE surgeons are listed here along with their local team members
All ACTIVE surgeons must have previous experience of performing the techniques used in the trial before starting recruitment. If you are a surgeon wanting to participate you can gain the necessary experience with ACI by visiting the RJAH Orthopaedic Hospital and assisting Professor James Richardson. To arrange a visit please contact the Trial Manager. Workshops are also run so that you can practice using the Chondro-Gide collagen membrane. The picture below was taken during a workshop where surgeons are practicing on cow stifle joints. Apparently suturing the membrane to live human cartilage is much easier!
Although ACI appears to be a promising technique, at the moment there is insufficient evidence to support the use of ACI in preference to other techniques. As an ACTIVE surgeon you must have an open mind about which is the best treatment for chondral defects. You can only enter patients into the trial if you are undecided about whether ACI or your non-ACI alternative is the best treatment. You should discuss with the patient an alternative treatment which must be one of the following: microfracture; mosaicplasty; debridement; drilling; or abrasion.
We particularly need to compare the long-term effectiveness of ACI versus non-ACI surgical procedures which is why it is important that our ACTIVE patients continue to be followed up for 10 years.
The most important messages to get across to patients are:
1. "You could benefit from more than one type of treatment including ACI but it is not clear which is the best treatment for you."
Describe ACI, the blood tests needed and the rehab involved.
2. "By participating in ACTIVE you will be helping to find out which is the best treatment."
3. "The trial is randomised so you and I won't be able to choose your treatment . You will have approximately a 50:50 chance of getting ACI or the alternative". Describe your alternative. The alternative treatment must be stated on the Patient Entry Form before randomisation.
4. "Before agreeing to participate you must take home the patient information leaflet and read it carefully."
5. "You must be prepared to have either one of the treatments."
6. "You will still receive normal routine treatment as required in the future while participating in ACTIVE."
7. "You will be expected to complete questionnaires at least annually and come to the hospital several times for assessment as described in the patient information leaflet."
8. "We appreciate your co-operation which is vital to the success of the trial. We could not do this important work without you."
After surgery on trial patients please remember to complete the Treatment Record Form and forward a copy to your local co-ordinator.
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ACTIVE is being carried out by the Robert Jones & Agnes Hunt Orthopaedic & District Hospital NHS Trust in collaboration with the University of Birmingham Clinical Trials Unit and Health Economics Facility. The trial is funded by the Medical Research Council and administrated by Keele University.