A new style of hip implant that enables women to have a type of hip surgery previously only suitable for men has been awarded a CE mark.
A new style of hip implant that enables women to have a type of hip surgery previously only suitable for men, and can lead to better outcomes for younger and more active patients, has been awarded a CE mark.
Hip resurfacing is surgery to repair damage inside the hip joint. It is typically carried out on younger patients rather than total hip replacement and involves the surgeon removing the diseased cartilage of the hip joint and resurfacing the joint. This approach is less invasive than total hip replacement and leaves the patient with greater mobility after surgery.
However, until now, women have been unable to have hip resurfacing surgery. This is because it used metal implants that were not optimised for women's hip shapes and which released particles that caused tissue reactions, leading to high failure rates.
The treatment is also not available for men who have smaller femoral heads. The femoral head is the highest part of the thigh bone and where this measures less than 50 millimetres across hip resurfacing has not been offered, due to increased risk of complications.
Improving the picture for women
The new H1 implant was designed to address these issues by using ceramic rather than metal to coat the two faces of the hip joint. Ceramic is a more wear-resistant material and does not interfere with tissues in the body. It can also be shaped to fit the natural contours of the joint. This means that it is suitable for women as well as men.
The implant was developed by researchers in Imperial College London's spinout Embody Orthopaedic.
Every year around 100,000 people undergo primary hip replacements in the UK, with 59 per cent of patients being women.
Professor Justin Cobb, Chair in Orthopaedic Surgery in the Department of Surgery and Cancer at Imperial College London, Head of Elective Surgery at Imperial College Healthcare NHS Trust and Co-Founder of Embody Orthopaedic, said:
"It is great to see the H1 device being granted the CE Mark and it's a recognition of its quality and impact.
"We are really pleased that our new implant enables women and smaller men to benefit from hip resurfacing. Resurfacing has always been an effective option for active and younger patients who don't need a total hip replacement, but for 10 years its use has been restricted to large men.
"Alongside improving the picture for women, the new implant also reduces the risk of side effects. Current resurfacing devices are metal-on-metal and particles can be released into the body that can cause unpleasant side effects and in some cases patients require further surgery."
Return to physical activities
Professor Cobb, who is also part of the Biomedical Engineering Theme team at the National Institute of Health and Care Research Imperial Biomedical Research Centre (BRC), added:
"By keeping the flexibility and strength of living bone in the hip, H1 enables patients to return to fitness, helping to sustain health and wellbeing – a priority for the government today."
Clinical trials of the new implant in over 100 patients at Charing Cross Hospital, part of Imperial College Healthcare NHS Trust, the researchers found that patients could return to physical activities such as swimming and cycling within six weeks – like all modern hip replacements - of their operation.
First in the world
"Alongside improving the picture for women, the new implant also reduces the risk of side effects." Professor Justin Cobb Chair in Orthopaedic Surgery in the Department of Surgery and Cancer at Imperial College London, Head of Elective Surgery at Imperial College Healthcare NHS Trust and Co-Founder of Embody Orthopaedic
The H1 implant can now be sold to clinics throughout Europe and in other countries that recognise the CE mark, such as the United Kingdom.
It is the first hip resurfacing device to receive the CE mark under the European Union's new Medical Device Regulation (MDR) guidelines and is the first non-metal resurfacing implant to receive regulatory approval anywhere in the world.
Dr Susannah Clarke, Co-Founder and CEO of Embody Orthopaedic, said:
"The CE mark represents a significant step of making the device more widely available to patients.
"The development of the H1 implant shows what can be achieved when engineers, scientists, clinicians and industry work together on a shared goal. It's a wonderful and concrete example of bench to bedside translational research coming from the Sir Michael Uren Hub.
"In the MSK lab at Imperial we have been looking at patients five years after surgery – their performance is even better than it was at one-year post-op. By simply resurfacing their hips instead of replacing them, patients appear to be returning to higher levels of activity which are good for their general health and well-being."
Between September 2017 and March 2022, 250 hip resurfacings were undertaken using the H1 device in both men and women at Charing Cross Hospital. With over 100 patients now more than five years post-surgery, H1 appears to function like other well designed hip resurfacing devices.
The device is now being prepared for a European market launch. Zimmer Biomet, a leading global medical technology company, holds an exclusive development and licensing agreement with Embody Orthopedic for the device.
