Conformis total knee replacement faqs feb 2015

ConforMIS Total Knee Replacement (iTotal) FAQs What are the main advantages?

It gives a knee that feels like your own and restores quality of life.

This has been reported at national meetings in scientific studies and has been my experience.

Comments from my patients include: "It feels like my young knee" "It feels like my own, always has" (since the operation) “I forget about it” It is also rated highly for the feeling of stability.

A study presented at the 2014 British Association for Knee Surgery reported that 61% of patients as early as 7 months post-op said it felt like it was their own knee all of the time, the remaining 39% said it felt like their own knee some of the time.

Is it available on the NHS? No, unfortunately not although this may change in the future. For patients in Germany the German public health system fund it, presumably because they see the benefits, hopefully the same thinking will follow in the UK. How much more expensive is it than an off the shelf total knee replacement? £3000, but this also includes custom 3D printed “nylon” positioning guides (see video!) which, on their own, for an off the shelf knee are approximately £500. Furthermore the length of stay is 1 day less so the real cost is £2000 more.

Financial details In reality NHS patients are unable to pay a "top-up" because of the NHS principle of being free at the point of use.

Insured patients are covered for the cost of knee replacement surgery worked out on the basis of an off-the-shelf knee, therefore the Hospital will ask you to pay a £3000 top up for a custom knee, so this might not be for everyone.

Self-paying patients would pay an "all inclusive package price" of £ 11,360.00 for the best polyethylene plus £725 for a CT scan and £150 for a consultation.

An off the shelf knee replacement (best in class for survivorship at 10 years national joint registry) "all inclusive package price" is £ 8160 and £150 for an initial consultation.

How long does it take? 5.5 weeks from start to surgery.

A consultation is available within 1 week,

CT scan on the day of consultation if on a Thursday or Friday - don't ask why!

Scans are electronically uploaded to Bedford, Massachusetts, USA. New custom knee and positioning guides arrive at Goring Hall Sterile 5.5 weeks later.

What’s special about Goring Hall Hospital?

The key strengths are teamwork and people, attention to detail, single rooms, clean fresh air in its sea-side location, combined with an extensive experience and focus on a retirement population.

Energy for continual innovation and an award winning enhanced recovery program.

Excellent state-of-the-art anesthesia, and world leading surgical strengths.

In short the product of drive, focus, location, people and compassion.

All-inclusive package A truly transparent package with no hidden costs.

The only extra costs would be landline calls from your room, and wine ordered or a meal order for a visiting guest.

Physicool bandaging fluid that is optional (£16.65 a bottle - usually 3 for £50 works well) – the bandage itself is supplied.

Specifically the package includes: Pre-assessment Surgeon and Anesthetic fees Prosthesis fees All nursing / physic / theatre costs / hospital costs/ all medicines including post discharge for 2 weeks 6 sessions of physio post discharge (local to you, guided by us) Any walking aids or "gadgets" Unlimited follow up as required with Mr. Lewis 1 month of insurance such that for any unexpected problems relating to care, you would be covered for further care at Goring Hall.

Blood transfusion Mr. Lewis works at avoidance; audit data is a 0% transfusion rate for knee surgery.

Risks Medical case law requires a reasonable time to weigh information and all the risks to be understood to avoid the situation "I wouldn't have had it if I had known”.

This can lead to a long list of risks, which is not because the treatment isn't any good; it is because of current case law.

Risks can be thought of as Medical Risks and Knee Risks.

Medical Risks These include death, stroke, heart problems, chest infection, bladder or

"waterworks problems", nerve injury from the anaesthetic.

A short-term (8 hours) urine catheter is common in male patients.

The slimmer and fitter one is the lower the medical risks.

The Hospital and anaesthetic team are used to looking after patients on warfarin, high blood pressure and many other medical concerns. Risk prevention, detailed pre-assessment, consultant only anaesthesia and surgery and fitness optimisation are key components of care.

Knee Risks Infection (0.25%), Thrombosis - now fairly rare due to prevention strategy including walking the same day. Wound problems - again rare. Stiffness. The need for bending under anaesthesia as a second procedure (1%), fracture rare, component failure - rare, inability to kneel - 10%, the need for further surgery. Soft tissue discomfort - sometimes if the knee hasn't been straight for a while, when it is straightened the hamstrings can then be stretched a little and this can cause pain - often treated with an injection of cortisone.

Long term wear or failure - this risk should be emphasised because as a relatively new product (2007) the long term results are not known however the wear simulator studies are impressive with wear rates 40 x less than standard off the shelf implant’s polyethylene (personal communication with the chief engineer at the American Academy meeting 2014).

All implants are entered into the National Joint Registry for monitoring, and this entry process in itself is also audited.

However there have been situations in the past where there were simulator studies have turned out not to detect a design problem with a given implant Ultimately there will always be this risk in a new or recent product. One has a choice between old technology and old design principles but with long-term data or a new or recent product with up-to-date design but limited long-term data.

The PFC cruciate retaining knee, which is best in-class for survivorship at 10 years (NJR data) gives a good quality off-the-shelf knee replacement and is the UK’s most widely used knee replacement as chosen by surgeons.

In summary surgery is not risk free, however the team works strenuously to minimise risk at every level.

The decision to proceed is always a joint one between the patient and surgeon after considering the alternatives.

Expertise Mr. Lewis has given lectures on ConforMIS design aspects, surgical technique and clinical outcomes in:  USA  India  London

He has also spoken at a 2 day UK user group meeting.

Mr. Lewis has a Masters degree in Orthopaedic Engineering and with this background and curiosity has spent many hours with the senior design engineer at ConforMIS understanding the intricacies of the product, and carrying out due diligence.

He is the leading surgeon in the UK in terms of custom ConforMIS experience when combined with being infection free.

Results: Patient feedback I have been fortunate to have had patients chose to come from afar including Dubai, and as far North in the UK as Middlesborough for custom knee surgery as well as Luxemburg, Ireland, and Holland for other surgeries.

Unsolicited Conformis feed back is: Mr Lewis, I have just enjoyed my first ski trip following my custom knee resurfacing seven months ago. I am delighted to report that the knee performed flawlessly with no pain or swelling whatsoever.

Thank you once again for such an excellent result, I will be glad to refer patients to you for this procedure if required.

Kind Regards, Dr Douglas Ferguson Dubai.

I have been involved in sport all my life and physical fitness has been one of my passions. In recent years I have had to give up many of the activities that gave me so much pleasure due to pain in my knees.

I was advised that I need a knee replacement a few years ago, but was unwilling to undergo the surgery that was commonly available. I have been searching the internet looking for something different. Early this year I came across The Conformis system of custom made knee surgery.

I discovered that one of the few surgeons experienced in this method was Mr. James Lewis, based in Worthing, Sussex. I took the plunge and had the surgery performed some three months ago.

I have been extremely happy with the results and even at this early stage I am able to resume activities I have not attempted for the past 10 years, like tough Mountain biking, jogging, tennis and weight training.

I cannot speak highly enough of James Lewis and his team at the Sussex Orthopaedic Clinic and I consider Conformis to be the Rolls Royce of knee replacements.

David Pike.

Hello James I recently returned from a week at Kicking Horse Mountain Resort, BC, rated by Powder magazine as one of the five most challenging ski areas in North America. I

am pleased to say the knee responded brilliantly; no pain, discomfort or swelling. I did catch the inside edge of my right ski a couple of times on day one. I put this down to the fact that pre op I was slightly bow legged, but after the operation I was back in true alignment. Once I had made a small mental recailbration to my technique, I was able to once again really enjoy the steep and deep, with confidence.

Thank you for performing my iDuo knee surgical procedure with such expertise.

Research Article on Satisfaction.

A paper published at the German Knee Society meeting in 2014 reported patient satisfaction of 95% (ConforMIS) versus 75% for a conventional offthe–shelf system.

Further studies report increased range of motion compared to some standard knees (Triathalon).

Videos Shown here Infection rate: 0% Thrombosis rate: 0% Written 20 /02/2015 by James Lewis