Autologous chondrocyte transplantation/implantation versus existing treatments
| ISRCTN | ISRCTN48911177 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48911177 |
| Secondary identifying numbers | G0200055 |
- Submission date
- 18/05/2001
- Registration date
- 18/05/2001
- Last edited
- 16/03/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
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.
Who can participate?
Patients who are still getting symptoms from the defect in their knee cartilage despite having surgical treatment for it in the past.
What does the study involve?
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.
What are the possible benefits and risks of participating?
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.
Where is the study run from?
The Robert Jones and Agnes Hunt Orthopaedic and District Hospital, NHS Trust (UK)
When is the study starting and how long is it expected to run for?
December 2004 to December 2021
Who is funding the study?
Medical Research Council (UK)
Who is the main contact?
Prof James Richardson
james.richardson@nhs.net
Contact information
Scientific
Institute of Orthopaedics
The Robert Jones and Agnes Hunt Orthopaedic and District Hospital, NHS Trust
Oswestry
SY10 7AG
United Kingdom
| Phone | +44 (0)1691 404386 |
|---|---|
| james.richardson@nhs.net |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information leaflet in http://www.active-trial.org.uk/ACTIVESite/PILv3.1.doc |
| Scientific title | Autologous Chondrocyte Transplantation/Implantation Versus Existing treatments: a randomised controlled trial |
| Study acronym | ACTIVE |
| Study objectives | To compare autologous chondrocyte implantation with 'conventional' treatments for patients who have had a failed primary treatment for chondral defect(s) in the knee. |
| Ethics approval(s) | NRES Committee West Midlands, July 2004, ref:04/Q2604/10 |
| Health condition(s) or problem(s) studied | Orthopaedics |
| Intervention | Arm 1: Autologous chondrocyte implantation (ACI) Arm 2: One 'conventional' treatment chosen by surgeon/ patient from following list: Debridement; Abrasion; Drilling; Microfracture; Mosaicplasty. Arm 1 (ACI) is further randomised to receive a patch made from either: a) Periosteum or b) Collagen membrane |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Time to cessation of benefit: as defined when 2/3 assessment criteria show no improvement compared to preoperative assessment levels at least 12 months after surgery: 1. Independently assessed Lysholm Knee score 2. Patient self-assessed Lysholm Knee questionnaire 3. Independent assessor's judgement based on impact on quality of life, physical examination and functional observation |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 22/12/2004 |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 400 |
| Key inclusion criteria | 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 physiotherapy Previous inclusion criteria until 09/11/2012: 1. Symptomatic chondral defect(s) on the medical or lateral femoral condyle or trochlea 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 physiotherapy |
| Key exclusion criteria | 1. Concurrent meniscectomy/osteotomy or untreated malalignment of patella 2. Generalised osteoarthritis, inflammatory condition or history of mesenchymal tumors 3. Patient in different clinical trial involving the knee, currently or in last 6 months |
| Date of first enrolment | 22/12/2004 |
| Date of final enrolment | 09/11/2012 |
Locations
Countries of recruitment
- England
- Norway
- United Kingdom
Study participating centre
SY10 7AG
United Kingdom
Sponsor information
University/education
-
Keele
ST5 5BG
England
United Kingdom
| Website | http://www.keele.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/00340yn33 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
On 09/11/2012 the following changes were made to the trial record:
1. The overall trial end date was changed from 08/03/2016 to 31/12/2021.
2. The target number of participants was updated from 660 to 400.
