CHondroGrid®

Description:

Lyophilized low molecular weight Collagen Hydrolysate for intra and peri- articular injection and in musculo-tendinous-ligamentous structures.

Composition:

Bovine low molecular weight Collagen Hydrolysate

Indications/Intended use:

CHondroGrid® is indicated for the treatment of pain symptoms and loss of functionality of the major joints (knee, shoulder, hip, wrist and ankle) and of musculotendinous and ligamentous structures, caused by degenerative diseases or traumatic events or overload. The most common indications for use of CHondroGrid ® are the symptoms management and functional treatment of: osteoarthritis, acute or chronic arthrosynovitis secondary to osteoarthritis or rheumatoid arthritis, traumas or injuries, overload and overwork to the joints. CHondroGrid ® is also indicated in cases of meniscopathy and as preparative and maintenance therapy before and following meniscectomy surgery, ligament reconstruction or cleaning and/or reconstruction of the articular cartilage. Application for these indications is performed through intra- articular injection. In case of traumas and/or peri-articular lesions to musculotendinous and ligamentous structures the application is performed through peri-articular injection and/or infiltration of the involved structures.

Mechanism of Action:

Intra-articular injection: low molecular weight Collagen Hydrolysate spreads onto articular surface reinforcing the cartilage matrix, which is made of a dense network of collagen fibers, deteriorated by the in-progress pathologic processes. CHondroGrid® therefore acts as a direct mechanical reinforcement of weakened and/or damaged collagen matrix, improving mobility and helping to reduce painful symptoms affecting the joint.

Peri-articular injection and in musculo-tendinous-ligamentous structures: low molecular weight Collagen Hydrolysate acts as a direct reinforcement of damaged collagen scaffold of the peri-articular structures, such as tendons and or ligaments, contributing to pain reduction and a faster functional recovery.

Therapy Protocol:

• Intra-articular injection

The treatment is based on three injections: two performed at 15 days apart and the third at one month after the last injection.

• Peri-articular injection

The treatment includes two injections 30 days apart from each other.

• Infiltration in musculotendinous and ligamentous structures

Two injections with an interval of about 10 days each other.

Materials required for the use of the device (not included in the

packaging)

One vial of sterile apyrogenic water for injection (2 ml or more)

One sterile syringe (5 ml or more)

Two sterile needles

Instructions for Use:

Attention: in case of effusion, proceed to drain it before injecting CHondroGrid.

1. Open the vial of sterile water for injection.
2. Draw 2 ml of sterile water for injection into the 5 ml syringe.
3. Open the blister, remove the vial and inject the sterile water through the rubber cap.
4. Stir until complete solubilization.
5. Draw the resulting solution into the syringe.
6. Replace the used needle with the second sterile one.
7. Inject the product under proper aseptic conditions.

Intra-articular injection

Inject the solution into the articular space, if necessary under instrumental guidance, such as echography, especially when treating hip and shoulder.

Peri-articular infiltration of musculotendinous and ligamentous structures

Locate the point or points of maximum tenderness and if necessary mark them with a dermographic-marker pen. The injection can be performed under instrumental guidance to locate the site of injury.

Warnings and Precautions:

CHondroGrid® should be used only by qualified medical personnel, following strict aseptic procedures. Use of CHondroGrid® in direct association with medicines has not been tested.

Use of CHondroGrid® in combination with injectable compounds, apart from sterile apyrogenic water, has not been tested. It is however indicated in patients previously treated with injections of hyaluronic acid or autologous PRP. If further supportive therapy to the cartilage is required, the use of CHondroGrid ® may be associated with the oral intake of low molecular weight Collagen Hydrolysate food supplements. Do not load excessively the treated joint in the hours immediately following the infiltration.

Do not use CHondroGrid® if the package is opened or damaged. Do not inject CHondroGrid ® intravascularly. Do not use after the expiration date. The expiration date refers to the product unopened and stored properly. Keep out of the reach of children.

Contraindications and Side Effects:

Patients with known hypersensitivity to collagen. Articular or peri-articular infection, hemarthrosis, erythema and/or psoriatic spots in the area to infiltrate. The intra- and peri-articular injection may occasionally cause transient pain, slight swelling, redness and superficial skin reaction due to the mechanical action of the needle. These reactions are usually short-lived and resolve spontaneously within few days with rest and application of ice.

Sterilization and Storage:

The device is sterilized by beta irradiation at 25 kGy. Store out of direct sunlight in a cool, dry place, at a maximum temperature of 25°C + 2°C. The device can be stored/transported at temperatures up to 40°C for short periods (less than 6 continuative months). In correct storage conditions the integrity of the package and therefore the sterility of the product are guaranteed for 3 years from the date of production (see expiration date on the external label).