Articular cartilage treatment with CartiFill™
Patient Information Leaflet
Version 1.1, 11/2013
CartiFill™ is imported by RMS Innovations UK Ltd (Hertfordshire, UK) and
manufactured by Sewon Cellontech (Seoul, South Korea)
If your surgeon has found this CartiFill is applied following a
treatment to be appropriate for your Microfracture procedure, whereby your
condition, you will receive a copy of bone marrow cells, including your own
this Patient Information Leaflet stem cells, are released into the
along with an Informed Consent wound site. CartiFill acts as a
Form. Please ensure that you are structural scaffold for cells, fixing them
satisfied with your level of to a 3-dimensional network where they
knowledge for this treatment before can grow. Collagen is used for this
consenting. purpose as its presence encourages
the growth and development of the
cartilage.
What is CartiFill? The released cells multiply in numbers
and form their own natural network
CartiFill is a highly purified porcine- over time, forming healthy cartilage,
derived collagen that has been after which the CartiFill is safely
modified to virtually eliminate the risk broken down and removed by the
of rejection from your body. The body.
collagen is supplemented with
nutrients to help your cartilage tissue
grow. CartiFill will be prepared with Your Treatment
special biological ‘glue’ which mimics
the body’s natural healing conditions The surgery can be summarised by 3
and allows the mixture to set in the key stages:
wound area.
1. Debridement or ablation.
This removes undesirable loose
The Logic and fibrous tissue to prepare the
wound area for CartiFill. This also
Your body struggles to repair damaged helps to decrease pain from the
cartilage due to the lack of blood rubbing of tissues.
supply. This can result in cartilage 2. Microfracture or Microdrilling.
which progressively degenerates. Small holes are made at the
wound site to allow bone marrow
cells, including stem cells, to be Rehabilitation and Follow-up Visits
released into the site to help
repair the area. Your assigned physiotherapist will plan
3. Application of CartiFill. an appropriate rehabilitation
CartiFill will be prepared in programme for you following your
theatre prior to its use. CartiFill is surgery.
applied over the wound area and
it fixes to the surrounding tissue.
Who qualifies for this treatment?
Your surgeon may perform the
treatment through key-hole surgery, This treatment will typically be given to
leaving two very small marks where patients with isolated regions of
the medical instruments were inserted. damaged cartilage in joints.
In this case the knee will not be
surgically opened and the patient may This treatment may be inappropriate
have the opportunity to return home for people who have a family history of
the same day. The alternative is a autoimmune disease, have ever
‘mini-open’ procedure, whereby a suffered an anaphylactic shock, have
small opening on the knee is made to ever experienced hypersensitivity to an
expose the area for treatment. implant, or have a history of allergy to
porcine or bovine protein. Your
Both treatment methods have their surgeon will advise you of your best
own benefits and risks. Please course of treatment.
consult your surgeon for their
advice on which is the most
appropriate treatment for you. The risks
CartiFill is a CE-marked medical
device and meets all of the
requirements set out by the relevant
European legislation (EC MDD
93/42/EEC; amended by 2007/47/EC).
The surgery risks should be explained
to you in more detail by your surgeon.
These include infection, post-operative
pain, bleeding, injury to nerves,
numbness, joint stiffness, and swelling
of the joint. Your medical history may
also result in additional risks. Please awareness to the potential risks
consult your surgeon for more related to this CartiFill procedure. We
information. encourage the reporting of any side
effects you encounter. Any that are
The application of CartiFill has some made known to us will be shared with
associated possible side effects. the regulatory authorities to be
These include fever, nightsweats, assessed. This will be done under the
weight loss, loss of strength, pricking applicable EU privacy and data
pain, numbness, visual disorders, flu- protection legislation by the criteria set
like symptoms, headache and, though in accordance with EU law. Information
rare, anaphylactic shock. from your medical records may also be
included under the same terms of
Allergic reaction may occur if you confidentiality and privacy.
suffer from a porcine allergy and
should notify your surgeon. The ‘fibrin
glue’ used by the hospital will carry its Key Messages
own risks. Please consult your
surgeon about these. A network of collagen fibres secure
bone marrow cells to the damaged
The healing process will vary from area.
patient to patient. Some may have Your own cartilage is encouraged
cartilage under-growth, while others to grow and repair the damage.
may have over-growth; some patients As with any medical procedure,
may have a higher quality of tissue there are associated risks.
than others; and some patients may
heal faster than others [note: smokers
tend to heal slower]. Please contact your surgeon with
any questions you have. Should
There may be unforeseen risks. If they need any further information
you notice any new or unusual from RMS, they will contact them
symptoms following the surgery, directly.
please notify your surgeon for
assessment.
Confidentiality and Privacy
In this Patient Information Leaflet,
RMS has endeavoured to raise your
