Case Study

A clinical trial of an arthroscopic brush that may enhance cartilage repair is underway in Leeds, to provide the evidence needed for full commercialisation of the device.

The brush device was developed by Dr Thomas Baboolal from the University of Leeds, with proof of concept funding from the IKC. The trial is looking at its use during keyhole microfracture knee surgery, where tiny holes are drilled into the bone near the cartilage injury to release bone marrow stem cells into the damaged area.

The device provides additional healing capability by mobilising stem cells from the synovium – which has a higher concentration of stem cells than bone marrow – allowing them access to the injury site.

The trial at Chapel Allerton Hospital in Leeds, supported by the NIHR Leeds Biomedical Research Centre, is recruiting patients with a full thickness cartilage defect, an injury severe enough to impact on joint movement.

This is to ensure that any clinical benefit from the device will be clearly seen, although as the full extent of cartilage damage is often only diagnosed during surgery, it can make recruitment to the trial more difficult.

Dr Baboolal said: “This type of cartilage injury is clearly defined in previous research, which gives us other studies to compare our trial against. This means that we can get more robust results to support a clinical case for use of the device, so it can be taken forward for manufacture and marketing.”

Nearly half of the trial cohort has been recruited to date, of which two met the criteria during surgery. The trial is set to run for a further six months, with an extension likely to ensure full recruitment.

A licensing agreement has already been signed with Leeds-based medical device company, Xiros, who aim to apply for the device to be CE marked once the clinical evidence is completed.

The researchers are also considering the device’s potential for use with other surgical devices, including scaffold implants, or with other procedures such as the new technique of joint distraction, where the knee joint is held apart to enable recovery from more severe cartilage damage.