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Clinical trial of the BioPoly implant

Mr Dinesh Nathwani, Orthopaedic Surgeon at The London Clinic, is a strong advocate of using new technology in partial and total knee replacement surgery. He recently installed the BrainLab® surgical navigation system here and is also involved in a clinical trial that The Clinic is running to test Biopoly™, a new type of knee implant.

Mr Nathwani received his clinical and surgical training in Sheffield and Liverpool before moving to Imperial College as Consultant Surgeon in Orthopaedics in 2004. He is an experienced knee replacement and trauma surgeon and, in 2005, spent time at the University of Perth in Australia training in computer-assisted surgery. He followed this with a post in Sydney, where he specialised in partial knee joint replacement and reconstruction of the knee ligaments and meniscus reconstruction surgery.

His special interest is in using computer navigation to improve outcomes in partial knee and total replacement and in researching new and better prosthetics such as the Biopoly™ implant.

Mr Nathwani’s philosophy when it comes to partial knee replacement is to take away the smallest amount of bone possible without leaving any arthritic or damaged bone.

“Only 8 % of the UK’s orthopaedic surgeons are currently doing partial knee replacements, which means a large number of patients are losing a lot of healthy tissue as well as diseased bone. The functional results of a partial knee replacement are better and we are getting very good results using the BrainLab® navigation system that we now have at The London Clinic.

I am still keen to advance techniques further, and so I am also involved in a clinical trial at The Clinic, the first one in orthopaedics.”

The trial is investigating the outcome of using the Biopoly™ RS implant in 35 patients in a Phase II trial. Patients will be assessed over 5 years to see how the implant performs and the level of function they develop and how much residual pain they have after surgery.

“Biopoly™ is a smaller implant than we currently use in partial knee replacement; it is actually a small cartilage resurfacing implant that is only 10-25 mm in diameter. The idea is to identify wear in the knee and then put this in place to protect the underlying tissue.”

The London Clinic: one of several UK trial centres

This first trial includes 35 patients in the UK, some of whom will be private patients from The Clinic, with the rest coming from other centres in the UK. This will be the first time that the Biopoly™ implant has been tested in people and researchers are hopeful that it will work well. It’s an innovative design and construction and results from laboratory studies certainly provide reason for optimism.

“We still need to investigate thoroughly by carrying out a proper clinical trial with inclusion criteria, careful collection of data and thorough analysis.”

The implant is made from an ultra-high molecular weight polyethylene, the same type that is used in current knee replacements, but this is bonded with hyaluronic acid, a lubricant produced naturally in human joints. 

“The rationale behind the design of the Biopoly™ implant is what happens in the joint during early arthritis. Studies have shown that patients have low levels of hyaluronic acid inside their knee joint and their condition can be improved by having hyaluronic acid injections directly into cavities within the joint.

The Biopoly™ implant therefore combines polyethylene with an additional layer of lubrication from a natural protein. Tests in the laboratory show that this results in a more favourable coefficient of friction, so further wearing is less likely. These studies have also shown that the plastic does not damage the bone onto which it is attached. The implant can be used on just half of the knee joint rather than on both sides, so small areas of damage can be treated effectively.”

Mr Nathwani is encouraged by the way that the Clinical Research Centre at The London Clinic is developing and hopes to be involved in more orthopaedic trials in the future.

Preventing knee damage at every opportunity

Mr Nathwani is keen to encourage other techniques that repair damaged tissues in the knee at an earlier stage, so that more extensive operations can be avoided, or at least postponed.

“This involves repairing and preserving the cartilage as well as the bone. I also perform meniscal repairs to try and preserve the meniscus cartilage when it’s torn. We now have access to a meniscus scaffold that we can insert that allows the natural cartilage to regenerate. We are moving away from removing damaged tissues to repairing and regenerating them.

This matches closely with the concept involved in developing the Biopoly™ implant. Our ultimate goal should be to devise a set of procedures that can help patients at different stages in life. If you have someone aged 20 who has been active in sports and who has an anterior cruciate ligament injury and a tear in the meniscus, we need to try and repair the meniscus and reconstruct the anterior cruciate before the damage gets any worse. This will prevent them developing further cartilage and bone damage that could lead to a knee replacement.

If they do develop more cartilage damage in their 40s, the Biopoly™ implant could be attempted to prevent or reduce the chances of them having a partial knee replacement. Even when the joint starts to degenerate in old age, we can still go in with a partial knee replacement at an early stage to avoid the need for a total joint replacement. Preserving the natural tissue for as long as possible is the key to preserving function.”

Knee replacement treatments

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