Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1.1
Study information
Scientific title
Autologous Bone Marrow Implantation University of Southampton (ABICUS) versus Microfracture in the knee
Acronym
ABICUS
Study hypothesis
ABICUS has a better clinical outcome than microfracture in the knee.
Ethics approval
Not available at the time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Musculoskeletal surgery
Intervention
1. Group 1: microfracture
2. Group 2: ABICUS (Autologous Bone Marrow Implantation University of Southampton) procedure
Intervention type
Procedure/Surgery
Phase
Drug names
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 trial start date
01/07/2013
Overall trial end date
01/07/2015
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant 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
Recruitment start date
01/07/2013
Recruitment end date
01/07/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
Funders
Funder type
Industry
Funder name
Neurotechnics Limited (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list