A new knee stabilization plate that could improve the quality of life for many patients has been given the green light by the MHRA (Medicines and Healthcare products Regulatory Agency) for trial in the UK.
TOKA stands for Tailored Osteotomy Knee Alignment and is the name of a new tailored treatment for people with osteoarthritis of the knee. The UK’s MHRA has just given the go-ahead for trials in the country. Thousands of patients could have a much better quality of life as a result. ‘Knee osteoarthritis is a major health, social and economic problem and it doesn’t get the attention it deserves,’ says Professor Richie Gill of the Centre for Therapeutic Innovation. A quarter of women over 45 suffer from it, and about 15% of men, so it’s a big problem that many patients live with.”
Custom 3D plates and screws
This is the world’s first 3D-printed tibial osteotomy device. A tibial osteotomy is a procedure to correct lower limb deformities by aligning the tibia or, less commonly, the femur. This treatment is suitable for patients with osteoarthritis of the knee but who do not meet the criteria for arthroplasty, which is surgery to replace all or part of the affected joint, in this case, the knee. “Knee replacement is only useful for end-stage osteoarthritis, so you may be in pain and living with disability for a long time, even decades before it is possible,” Professor Richie Gill continued.
“We hope the new TOKA treatment we’ve developed will change that.” The goal of tibial flap osteotomy, therefore, is to reduce stress on the joint region of the affected knee by making the procedure easier. After surgery, however, patients have a stabilizing plate to support the tibia while it heals. Typically, the plates used are standardized and therefore not necessarily well fitted to the patient. The plates offered by TOKA are custom-made from titanium and 3D printed. This means they fit the person’s bones exactly, reducing irritation to the surrounding skin and pain. In addition, the screws used to hold the plate in place are also 3D-printed so they can be optimally placed on the bone.
Reduction of osteoarthritis symptoms
TOKA plates have already undergone virtual safety testing in an online study with data from 28 patients. The clinical trial highlighted the pressures applied to the plates and showed they are as safe as standard treatments. Patients who will now test them in the UK will undergo a 3D CT scan of their knee. This is an imaging test that creates detailed three-dimensional images of the organs. As a result, a custom surgical guide and plate are also 3D printed, both of which are customized to the person’s tibia. The surgical guide simplifies the surgery and is expected to improve surgical accuracy. “The custom 3D printing of the plate and scanning before surgery means surgeons know exactly what they will see before surgery and where the implant will go,” says Professor Richie Gill. Importantly, this type of treatment relieves the symptoms of knee osteoarthritis while preserving the natural joint.” Trials will begin in the UK as soon as clinical centers reopen for elective surgery.
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