| ISRCTN | ISRCTN67230654 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67230654 |
| Secondary identifying numbers | 1.1 |
- Submission date
- 04/05/2013
- Registration date
- 06/06/2013
- Last edited
- 01/09/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Damage to joint surface in the knee is commonly caused by sports injuries and falls. It does not restore itself when injured and ultimately the patient may develop arthritis in the knee joint. Many techniques have been developed to repair the damaged surface and the most commonly performed technique (gold standard) is micro fracture. In this procedure, drill holes are made in the damaged cartilage via a keyhole surgery (arthroscopy) to promote bleeding and scar tissue in place of the damaged surface. This technique has variable results and does not lead to the formation of new joint surface. Much research has been done on the ability of stems cells (patients own biological cells) to change into new joint surface cells. This study aims to find out the effectiveness of a new surgical procedure (ABICUS - Autologous Bone marrow Implantation of Cells University of Southampton), involving the use of patients own stem cells to restore joint surface in the knee and compare the results of this surgery with an existing, well established technique.
Who can participate?
Patients aged 18 to 65 with a proven joint defect in the knee
What does the study involve?
Patients are randomly allocated to one of two groups. Group 1 receive the conventional treatment (microfracture) and group 2 receive ABICUS. In group 2 patients, following anaesthesia, a sample of cells from inside the bone (bone marrow sample) is taken from the hip using a fine needle. A keyhole surgery of the knee is then performed and a mixture of the cells from the sample is collected and fibrin glue (an adhesive) is placed over the damaged area and allowed to set. Outcome scores using questionnaires and MRI scans of the knee are compared in the two groups.
What are the possible benefits and risks of participating?
There will be no risks different to those involved in the conventional treatment.
Where is the study run from?
University Hospital Southampton NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
July 2013 to July 2015
Who is funding the study?
Neurotechnics Ltd (UK)
Who is the main contact?
Mr Gorav Datta
gdatta@doctors.org.uk
Contact information
Scientific
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
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 | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Autologous Bone Marrow Implantation University of Southampton (ABICUS) versus Microfracture in the knee |
| Study acronym | ABICUS |
| Study objectives | ABICUS has a better clinical outcome than microfracture in the knee. |
| Ethics approval(s) | Not available at the time of registration |
| Health condition(s) or problem(s) studied | Musculoskeletal surgery |
| Intervention | 1. Group 1: microfracture 2. Group 2: ABICUS (Autologous Bone Marrow Implantation University of Southampton) procedure |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Clinical function, measured by the mean Lysholm, Knee injury and Osteoarthritis Outcome Score (KOOS) and International Knee Documentation Committee (IKDC) scoring scales at 6 weeks, 3 months, 6 months, 1 and 2 years post-operatively |
| Secondary outcome measures | Cartilage growth, assessed by MRI [Magnetic resonance Observation of CArtilage Repair Tissue (MOCART) score] at 1 and 2 years post-operatively |
| Overall study start date | 01/07/2013 |
| Completion date | 01/07/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Participant is willing and able to give informed consent for participation in the study 2. Male or female, aged 18 years to 65 years 3. Diagnosed with articular cartilage defect in the knee as assessed on MRI scan 4. No other significant medical comorbidities (medical diseases) 5. Able and willing to comply with all study requirements |
| Key exclusion criteria | 1. Generalised and/or inflammatory arthritis 2. Active joint inflammation 3. Obvious deformity in the knee 4. Age below 18 and over 65 years 5. Significant medical comorbidities |
| Date of first enrolment | 01/07/2013 |
| Date of final enrolment | 01/07/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SO16 6YD
United Kingdom
Sponsor information
Industry
c/o Gary Swattridge
Cephalon House
Unit 8 Manor Park
Banbury
Banbury
OX16 3TB
United Kingdom
"ROR" |
https://ror.org/03hmb2468 |
|---|
Funders
Funder type
Industry
No information available
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
01/09/2020: No publications found. Added trial website.
09/08/2017: No publications found, verifying study status with principal investigator.
