Condition category
Musculoskeletal Diseases
Date applied
18/05/2001
Date assigned
18/05/2001
Last edited
16/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

http://www.active-trial.org.uk/

Contact information

Type

Scientific

Primary contact

Prof James Richardson

ORCID ID

Contact details

Institute of Orthopaedics
The Robert Jones and Agnes Hunt Orthopaedic and District Hospital
NHS Trust
Oswestry
SY10 7AG
United Kingdom
+44 (0)1691 404386
james.richardson@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0200055

Study information

Scientific title

Autologous Chondrocyte Transplantation/Implantation Versus Existing treatments: a randomised controlled trial

Acronym

ACTIVE

Study hypothesis

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

NRES Committee West Midlands, July 2004, ref:04/Q2604/10

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information leaflet in http://www.active-trial.org.uk/ACTIVESite/PILv3.1.doc

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

22/12/2004

Overall trial end date

31/12/2021

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

400

Participant 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

Recruitment start date

22/12/2004

Recruitment end date

09/11/2012

Locations

Countries of recruitment

Norway, United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Keele University (UK)

Sponsor details

-
Keele
ST5 5BG
United Kingdom

Sponsor type

University/education

Website

http://www.keele.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

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.