Condition category
Musculoskeletal Diseases
Date applied
04/05/2013
Date assigned
06/06/2013
Last edited
06/06/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 (patient’s 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 patient’s 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?
Any patient with a proven joint defect in the knee can participate in this study.

What does the study involve?
Patients will be randomly allocated to one of two groups. Group 1 will receive the conventional treatment (micro fracture) and group 2 will receive ABICUS. In group 2 patients, following anaesthesia (loss of sensation), a sample of cells from inside the bone (bone marrow sample) will be taken from the hip, using a fine needle. A key-hole surgery of the knee will then be performed and a mixture of the cells from the sample collected and fibrin glue (an adhesive) will be placed over the damaged area and allowed to set. Outcome scores using knee questionnaires, and MRI scanning of the knee will be 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 FoundationTrust

When is the study starting and how long is it expected to run for?
The study will begin in July 2013 and is expected to run for two years.

Who is funding the study?
Neurotechnics Ltd (UK)

Who is the main contact?
Mr Gorav Datta
gdatta@doctors.org.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mr Gorav Datta

ORCID ID

Contact details

Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

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 below to request a patient information sheet

Condition

Musculoskeletal surgery

Intervention

1. Group 1: micro fracture
2. Group 2: ABICUS (Autologous Bone Marrow Implantation University of Southampton) procedure

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The primary outcome measure is clinical function.
These outcomes will be 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

The secondary outcome measures are cartilage growth as assessed on MRI scanning of the knee. Cartilage growth will be measured by MRI studies [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

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

Sponsor information

Organisation

Neurotechnics Limited (UK)

Sponsor details

c/o Gary Swattridge
Cephalon House
Unit 8 Manor Park
Banbury
Banbury
OX16 3TB
United Kingdom

Sponsor type

Industry

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes