Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof James Richardson
+44 (0)1691 404386
james.richardson@nhs.net


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

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Be Part of Research - Trial Details - Autologous chondrocyte transplantation/implantation versus existing treatments

Autologous chondrocyte transplantation/implantation versus existing treatments

Not Recruiting

Open to: All Genders

Age: Not Specified

Medical Conditions

Orthopaedics


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Defects in the cartilage covering the bones of the knee (chondral defects) do not heal by themselves. A technique to treat cartilage defects called autologous chondrocyte implantation (ACI) was developed in Sweden and has been used on many patients in the UK and US. The ACI treatment involves two operations. At the first operation a small sample of healthy cartilage is taken from the knee to a laboratory for the cells to be grown for 3-5 weeks, and at the second operation the cells are injected into the knee defect. This treatment appears to have been successful in treating many patients but has not yet been tested in a formal study. The aim of this study is to compare ACI with conventional treatments for patients who have had a failed primary treatment for chondral defects in the knee.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

22 Dec 2004 09 Nov 2012

Participants receive a full knee assessment and complete questionnaires about their knee function and how it affects their quality of life. Participants are randomly allocated into one of two groups. One group has the ACI treatment and the other group receive the most appropriate alternative treatment agreed with their surgeon. Both groups receive the standard physiotherapy and rehabilitation programme that is best for the treatment they received, and attend a follow-up appointment 2 or 3 months after surgery and again at 6 months and at 1 year after surgery. On each occasion participants complete questionnaires and their knee function is assessed. Because we want to compare the long-term outcome of the treatments participants are asked to return to the clinic 3, 5 and 10 years later. We also contact participants by post, phone or e-mail on one occasion each year for 10 years so we can check on their progress.


Patients who are still getting symptoms from the defect in their knee cartilage despite having surgical treatment for it in the past.

You can take part if:


Current inclusion criteria as of 09/11/2012:
1. Symptomatic chondral defect(s) on the medical or lateral femoral condyle, trochlea or patella suitable for either ACT or one of the existing conventional treatments (debridement, abrasion, drilling, microfracture, mosaicplasty)
2. Surgical treatment for the same defect carried out at least 12 months previously, that has not relieved symptoms
3. Not more than two defects, not kissing and total area not greater than 12cm2
4. Likely to comply with appropriate phy


You may not be able to take part if:


1. Concurrent meniscectomy/osteotomy or untreated malalignment of patella2. Generalised osteoarthritis, inflammatory condition or history of mesenchymal tumors3. Patient in different clinical trial involving the knee, currently or in last 6 months


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • The Robert Jones and Agnes Hunt Orthopaedic and District Hospital, NHS Trust
    Oswestry
    SY10 7AG

We hope that whichever treatment participants have will help them. However, this cannot be guaranteed. The information we get from this study may help us to recommend the best course of action for patients in the future. For participants treated with ACI, in addition to the normal risks of knee surgery there is a small risk that they may experience an allergic reaction to a substance used in the cell transplantation. However, this reaction is very rare.

Prof James Richardson
+44 (0)1691 404386
james.richardson@nhs.net



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by Keele University (UK) and funded by Medical Research Council (UK).




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Read full details for Trial ID: ISRCTN48911177

Or CPMS 2432

Last updated 16 March 2016

This page is to help you find out about a research study and if you may be able to take part

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