• By Dr. Shamsaldin Qais Sulayman Al-Said
• First published: 12th November 2015 | Paper used by: Cambridge University and North Arizona University. 

The surgical technique set to revolutionise knee surgery

A very exciting technology equally steeped in a medical and technological revolution has changed the way we are about to think of degenerative joint problems. The move is an innovative shift from invasive treatments to early stage preventative measures.

Currently sports injuries or natural degeneration of joint cartilage is treated with a less than epically successful systems of biological interventions and painkillers, until eventually after many painful years of slowly loosing mobility a total joint replacement is often required.

Such was the case with 36 years old patient B, whom after 5 procedures of arthroscopic clean up under general aesthetic. Surgeons told the patient that they could not carry out any further procedures as this would take too much cartilage away. Meaning that this young woman has perhaps an agonising 20 year wait suffering progressive degeneration and loss of mobility until she will finally be ready for a full knee prosthesis.

See how this new technology turned her fortunes around:

Knee replacements are a traumatic operation, highly invasive and involve sawing away significant portions of bone. The recovery process is slow, and often not total, with regards to full living functionality such as jogging or cycling. From the hospital’s point of view they are lengthy procedures, costing £5’000 – £10’000 (In the UK, NHS and private  sectors respectively), in addition to this cost however is a large inventory of implants and tools required for the procedure which the hospitals much stock. In terms of facility and theatre management total knee prosthesis is a technique which requires substantial capital investment.

The preventative measures currently available are typically limited to: Painkillers, Mosaicplasty, Microfracturing and ACI.

Mosaicplasty is a technique where small dowels of healthy cartilage from the non-weight bearing areas of a joint, such as the side of the knee, are removed and used to replace the damaged cartilage.
This technique although very invasive, can be successful in most people. However, it is only suitable for treating relatively small areas of cartilage damage. This is because removing too much healthy cartilage could damage the section of the body where the cartilage was taken from. Studies carried out in 2008 found that if caught in time, for those suitable, which is a limited number of patients, the operation had an 85% success rate, with a 10 week recovery period to gain weight baring and normal every day activity functionality again, and 12 months to regain near full mobility. The risk of further degeneration years on however is not entirely removed as the healthy cartilage is grafted over the affected area, leaving the original causation quite literally as an ongoing underlying medical risk.

Microfracture surgery is a key hole surgery usually done under spinal anesthesia. The process involves multiple small holes being drilled into the bone in close proximity to the damaged cartilage. The theory behind this surgery is that the freshly damaged bone releases naturally produced cells to repair damage, not only to the small holes, but also to the damaged cartilage. The initial recovery period is typically around 6 months, most well suited to patients under 40 years of age and with no weight issues. The new cartilage that forms is not as strong as the original cartilage, thus breaks down and degenerates at a much faster rate than before, meaning this surgery will, in a lot of cases, need to be repeated. Microfracturing is often described as a method of slowing degeneration rather than a way of stopping it. The surgery also carries a risk of increased stiffness in the joint.

Autologous chondrocyte implantation (ACI) uses a two-stage technique. During the first stage, the surgeon takes a small sample of cartilage cells from the edge of your knee during an arthroscopy.
The cells are sent to a laboratory and placed in an incubator, where they are given nutrients to encourage them to divide and produce new cells.
After a few weeks, the number of cartilage cells will have increased from 2 to 20 million. The new cartilage cells are used to replace the damaged cartilage.
The second stage involves placing these cells on a collagen patch, which is then sutured or glued on to the damaged area, usually through a small incision.
After studying ACI, the National Institute for Health and Care Excellence (NICE) decided there is not enough evidence about the procedure’s long-term effects or safety. The procedure is therefore currently only offered by a very limited number of hospitals. However, a number of private clinics may offer ACI. The cost of treatment can be expensive and depends on the complexity of the operation. The procedure can incur costs in the region of £25’000. ACI currently averages a 50% success rate.

Should the above fail, or relapse, patients are then left with a lengthy wait for mass degeneration until the joint’s condition is deemed severe enough for an invasive total knee prosthesis.

So what’s new? 

The Episealer from Episurf (other brands are available, patent restrictions applicable) is a less invasive open operative implant that acts as an early preventative measure. The totally inert chromium-cobalt, titanium alloy, which is coated in hydroxyapatite, encourages bone growth onto the implant itself ensuring a naturally strong and long lasting bond.

Using complex and unique sequences for MRI scans involving a knee coil, detailed images are uploaded to a cloud based platform where the images are mapped out into highly detailed 3D images with damage markers, giving precise and detailed pre-operative reports, a process involving some 80 patents.

The implants which run throughout the size ranges of British coins are then bespoke to the individual patient along with a guide and just seven tools, many of which are printed using a 3D printer.

The theory is that be removing the degenerating region along with a small amount of the sub conjugal bone, the degeneration will not spread, in a similar way one might remove dead wood to halt, or at least dramatically slow the progression.

“It’s the power of the technology that benefits of the surgeons and patients”

Innovation such as this is very easily glossed over leaving an impression that impresses but does not last. It is just as important for patents to understand the technology in order to request the procedure as it is for the consultants and surgeons to recommend it. CEO of Episurf, Rosemary Cunningham Thomas runs through the patient’s perspective  for us during a discussion in central London.

To be crude and cut straight to the point, many potential patients and medical personnel alike will be worrying about the costs at this point, bespoke is not a word that comes freely, nor are the words, CE certified, patented revolutionary technology. Well, you may be in for a surprise. Yes, the bespoke nature means that the guides can not be recycled or reused, and yes the production costs are considerable, but with a modest €2’500 guide price for the implants the procedure is much more affordable that many anticipated.

Firstly there is a saving in hospital inventory, with only 7 surgical tools required, which are provided along with the implant and guide as a complete package just in time for the procedure, thus cutting out the requirement for long term prosthesis stock and an array of tools. Music to the ears of theatre managers in terms of inventory management.

The procedure is medically speaking a very simple one, taking on average 20 to 45 minutes to operate, dependent on the surgeon, the implant comes with a guide, and no surgeon re-training is required. Episurf assist the surgeon in the first operation to ensure the correct procedures are used. (Other brands techniques may vary slightly due to patent restrictions, it is essential that the surgeon is 100% certain of the appropriate techniques for the chosen brand).

Most long lasting however is the socio-economic saving. Governments around Europe and indeed the world, are always highlighting the socio-economic costs of long term health care, lost work and welfare payments resulting from issues such as obesity.

Perhaps the recent case study of a young 30 year old carpenter will better explain: With serious damage including fractures and 4cm squared cartilage lesions, the carpenter had been off work for 8 months, claiming welfare and in substantial pain and immobility. Within 6 weeks of an Episealer implant, the patient was back to working on his knees, with in 12 months the patient had regained full sporting functionality with the exception of hard sprinting, taking up jogging and cycling. Compared to the aforementioned 36 year old patient whom after multiple operations, was told “sorry, there is nothing more we can do”, who would have most probably lost mobility and work resulting in a reliance on pain medication and welfare for support, there is a huge socio-economic benefit in this style of preventative treatment.

All technology has limitations.. Or maybe not?

All technology has limitations, so what confines Episurf’s intelligent Episealer implants?

The implants are restricted in terms of primary suitability being for grades 3 and 4 cartilage lesions, this equates to damage areas approximately 2cm in diameter. Currently patients with this level of damage are left to suffer until the degenerative progress is such that major operable options can be implemented, this equates to some 500’000 EU and over 600’000 US patients every year. 1.1 million people in the EU and US alone, per year, are eligible for preventative intervention such as the Episealer.

The implants are not susceptible to extremes in temperatures.
There is no weight limit for the patients.
As the implant is preventative it is suitable for all adult age groups, currently being used mainly in the 35-65 years age bracket.
Recovery time is typically 4 to 12 weeks, dependent on age and secondary health.
The accuracy of the 3D modelling has been extensively compared to live, mid operative photography, the results confirming a 100% accuracy on size, severity and location of lesion.
The procedure is equally suited to sports induced and naturally occurring degenerative injuries.

Any patient who is seen to be unsuitable via the non invasive pre-screening and modelling stages, will have such an accurate 3D model of their injuries, that an alternative treatment course can be planned out with out the need for invasive investigation.

The hospitals will not print out the 3D printed components, as Episurf’s CE approved and highly regulated internal quality control system could not otherwise be ensured, as such all components come in one, neat little package, bespoke and without the costly need for the medical unit to invest in 3D printing capabilities.

One problem that some European countries have is social medical care’s triage priority listing, this means that the wait for the specific MRI sequencing could be heavily delayed. Episurf have the ability to fast track patients on to private MRI machines should the state waiting list be unreasonable.

There does not appear to be many hurdles that have not been over come in the pre screening, production, design or operative sides, but what about after care?

Remember Episurf is just as much a technology giant as they are medical innovators. Cloud based remote access applications such as smart phone apps can advise and instruct patients on their daily recovery exercises and regimes from their own homes, without the need for time consuming, inconvenient and costly face to face heath centre visits. This does not mean that the patient will not see a doctor again. Whilst a medical practitioner will remain involved, Episurf as a company offer the reassurance that they will be involved every step of the way from the pre screening, guiding of the surgery to the after care. Remote aftercare can severely unclog a practice’s waiting lists, however does carry the risk of patients not following the procedure correctly or at all.

“Being half an implant and half an IT tech company, it makes sense to build aps the patients can use during post op rehab”

 Who is Episurf?

Episurf is a Swedish medical device company, using sophisticated IT platforms. The company actually started as an internal research and development program with in the Swedish advanced materials company Diamorph back in 2008. Through out 2009 and 2010 both the implant and the technology behind the mapping system gathered traction becoming subsidiaries, floating on Sweden’s domestic smaller markets to raise R&D capital. In 2011 the two corporate elements came together to be floated on the Swedish NASDAQ at a very early stage, a phenomena not uncommon among tech companies in Sweden. By 2012 clinical trials had started with CE approval, followed by NASDAQ Main Market listing in 2014. Commercial activity in Germany and the UK under GMBH and Ltd subsidiaries respectively started in 2015 when CEO Rosemary Cunningham Thomas was appointed, bringing a strong ambition and future channels for further development to the company. Episurf anticipates gaining measurable market penetration as a preventative treatment for early cartilage damage by the end of 2017.

From left to right: Ladan Amiri – head of Regulatory and QA | Jeanette Spanberg – Chief Operations Officer | Lena Lonee – Chief Financial Officer | Rosemary Cunningham Thomas – Chief Executive Officer

Room for growth

When pressed about future developments for Episurf, Thomas explains that for osteoarthritis, the mapping technology in conjunction with bio markers, has the potential to track progression in great detail without any need for invasive techniques. There is also the very real possibility of the devices being developed for use in other joins such as wrists, shoulders and ankles, with surgeons already expressing great interest in ankle and hip implants specifically, Episurf’s advisory board began in late 2015 assessing how to apply the company’s technology to other joints.

What is the process and how does a patient receive this treatment?

• Pre screen mapping. The unique MRI sequencing and 3D mapping process to determined the extent and type of damage.
• Setting a surgery date, dependent on theatre schedule and surgeon response time this is typically 4 to 6 weeks.
• Production of the guide and implant.
• The operation along with assistance should this be the first time the surgeon has used the implants.
• The stay in hospital is typically over night, although patients report that there is no joint pain when waking up form surgery.
• App based rehabilitation, regaining weight baring capabilities and even light exercise abilities in around 4 to 12 weeks depending on age, life style etc.
• Full recovery with ability to play sports after 12 months.

Obtaining this procedure, or at least having your joint mapped for compatibility is rather simple, more and more surgeons across Europe are taking up this technique. Such as Dr. Fahad Attar, from Manchester, UK, whom offers this preventative measure on his website. Read more…

Across Germany, the Scandinavian nations and the UK, the implants are showing impressive clinical results. The CE mark approval does also mean that the treatment is available across Europe.
Simply make the suggestion to your practitioner.

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