The SISMIC Study
Research type
Research Study
Full title
A Randomised Controlled Trial of Scaffold InSertion and MIcrofracture Compared to Microfracture Alone for the Treatment of Chondral or Osteochondral Defects of the Knee: The SISMIC Study
IRAS ID
270719
Contact name
Michael Whitehouse
Contact email
Sponsor organisation
North Bristol NHS Trust
ISRCTN Number
ISRCTN90992837
Duration of Study in the UK
5 years, 1 months, 31 days
Research summary
Knee injuries are common and can lead to pain and disability. Injuries to the smooth cartilage that lines the ends of the bone in joints can cause ongoing problems as the cartilage does not have a blood supply and rarely heals once injured. 10,000 people a year in the UK have a severe articular cartilage injury that warrants surgical treatment. One way to treat this is to try to repair or restore the cartilage in the damaged area. Cartilage does not grow back on its own, so an operation known as “microfracture” can be performed to encourage the cartilage to grow. A surgical tool is used to make perforations in the bone in the damaged area which allows blood and bone marrow to seep out of the holes, encouraging healing. A “scaffold”, which is usually made of the same material that makes up most of the cartilage (collagen), can be added, termed Autologous Matrix-Induced Chondrogenesis (AMIC). The scaffold is secured in place and acts as a template for new cartilage to form on. It is not clear if using a scaffold improves the outcome for patients. Using scaffold makes the operation more complex (approximately 20 minutes longer) and the cost of the scaffold is approximately £900, so it is important to establish if adding a scaffold results in a better outcome for patients and is cost-effective for the NHS. The study will find out whether adding the scaffold is worthwhile or not for patients with knee articular cartilage injuries.
We aim to recruit 176 patients, who will be randomised into two equal sized groups. One group of patients will have microfracture alone and the other will have microfracture plus scaffold (AMIC). Both groups will be followed for 2 years to collection information about quality of life, symptoms and pain in the knee, complications of surgery, need for further surgery and costs to the NHS and patients.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
21/WM/0110
Date of REC Opinion
16 Jun 2021
REC opinion
Further Information Favourable Opinion