KARTILAGE

Medical device CE 0499, class III, indicated, by intra-articular injection, for the treatment of pain associated with degenerative osteoarthritis of the joints such as knee and hip osteoarthritis, especially following failure or intolerance to treatment with anti-inflammatories (AINS, AIS) , and in cases of pain or limitation of joint mobility, both of traumatic and degenerative origin. The generic treatment protocol provides for an injection, once a week, for a period of 3 weeks.
Kartilage is a viscoelastic gel of hyaluronic acid (polysaccharide naturally present in the body) highly purified, with high molecular weight, containing an antioxidant (mannitol).
It is obtained by bacterial fermentation, thus avoiding any risk of viral infection.
Kartilage is distinguished by its characteristics of viscoelasticity and its lubricating properties, it is sterile, non-pyrogenic, with physiological pH and osmolarity, packaged in a 2 ml pre-filled glass syringe, sterilized in an autoclave. Kartilage is disposable.
The 2ml syringes are intended for joints such as the ankle, shoulder, knee, hip.

Mechanism of action
Hyaluronic acid is a natural component of the synovial fluid of the joints and determines its lubricating and shock-absorbing properties. The intra-articular injection of Kartilage has the purpose of improving joint function and therefore alleviating the pain caused by arthrosis of the joints; it improves joint mobility and flexibility and normalizes the altered synovial fluid, its effect is delayed: the decrease in pain reaches its maximum 2-3 months after the first injection.

Contraindications
Known sensitivity to one of the components of Kartilage (especially hyaluronic acid and/or mannitol).
Pre-existing skin infections at the intended injection site.
Immune system disorders (acute articular rheumatism, rheumatoid polyarthritis).
Osteoarthritis inflammatory attack.
Septic arthritis.
Hemostasis disturbances, lymphatic or venous flow.

Precautions for use
Only professional doctors with knowledge of intra-articular injection techniques are authorized to inject Kartilage.
The aseptic procedures in use for intra-articular injections must be strictly observed.
Kartilage must be injected exclusively intra-articularly.
Do not inject intravascularly, extra-articularly or into tissues.
It is recommended to use needles with CE marking from 18 to 22G.
If pain increases during the injection, stop the operation and remove the needle.
The product is disposable. Do not reuse. Do not resterilize. Use for a single patient to avoid any risk of contamination.
Inject immediately after opening; after injection, discard according to the regulations for the treatment of special waste.
Do not use if blister or sterile barrier is opened or damaged.
Kartilage has not been tested in pregnant or breastfeeding women or in children.

Posology - method of administration
The sterile needle must be fixed to the Kartilage syringe by a specialist doctor, strictly respecting the aseptic procedures.
The choice of the caliber of the needle, sterile and disposable, is up to the specialist doctor.
Make sure the needle is firmly attached to the syringe before injecting.
The quantity of Kartilage to be injected into the involved intra-articular space depends on the specific site, on the patient's anatomy, and must be established by the specialist doctor in charge of the operation.
Aspirate any joint effusion first