Purpose
Viscoelastic prosthetics of synovial fluid in patients with degenerative-dystrophic and post-traumatic joint lesions, as well as in individuals with increased loads on damaged joints. Indications for use - osteoarthritis / osteoarthrosis (OA), post-traumatic and other degenerative changes in large joints; - restoration of synovial fluid properties in orthopedic joint surgery, as well as in individuals with increased loads on damaged joints.
Method of application
Injections are performed by medical professionals under aseptic conditions. Before inserting the implant, the contents of the syringe should be visually assessed for transparency and homogeneity. Turbidity, crystallization, the appearance of color and / or foreign inclusions may indicate a violation of the rules for transportation and storage of the product. If the above signs appear, the introduction of the agent for replacing synovial fluid is prohibited. The implant is inserted intra-articularly under aseptic conditions of procedural and manipulation rooms. Before performing the injection, remove the covering membrane and remove the filled syringe with the implant from the blister. Manually attach the finger adapter to the stop of the syringe barrel. Holding the Luer tip, carefully unscrew the cap of the syringe tip (as shown below). Avoid excessive loads on the syringe when fixing the needle to prevent deformation of the Luer-Lock mechanism. While continuing to firmly hold the Luer tip, screw a sterile needle of the recommended size 21G or 23G (not included) to the syringe latch until it is secured. The length of the needle is selected by the doctor in accordance with the patient's constitution and the thickness of the subcutaneous tissue at the puncture site. Before injection, release air bubbles from the syringe, if any. Inject slowly. The patient should avoid any physical activity or weight-bearing loads for 48 hours after the intra-articular injection. 3 syringes are recommended for the course of treatment. For the treatment of osteoarthritis / osteoarthrosis (OA) of joints in adults, 1 injection per week is administered. The number and frequency of injections may vary depending on the severity of symptoms.
Expected effectiveness and principle of operation
The hyaluronic acid molecule has a helical long-chain structure that allows it to retain or absorb water molecules. Intra-articular enrichment of synovial fluid with sodium hyaluronate injections helps to improve or restore the viscoelastic properties of natural synovial fluid. Sodium hyaluronate is responsible for the viscoelastic properties of synovial fluid, thus viscoelastic prosthetics allows to compensate for the deficiency of hyaluronic acid in the synovial fluid or a decrease in its viscosity, soften external loads on the joint, provides lubrication, restoration of elasticity and viscosity, cushioning, moisturizing and enveloping the articular surfaces, covering the cartilage and synovial receptors with a lubricating protective layer. This helps to increase the range of motion and provides mechanical protection of the tissues of the joint cavity, which in turn can improve the course of osteoarthrosis / osteoarthritis and other degenerative-dystrophic and post-traumatic joint pathologies. The expected duration of the effect is 6 months after the course of treatment.
Contraindications
• Do not use in patients with hypersensitivity to sodium hyaluronate.
• Intra-articular injections are prohibited in cases of past or current infectious or skin diseases in the area of the site where the injection is supposed to be performed.
Precautions
Due to the fact that septic arthritis is a serious side effect, all standard precautions for surgical interventions must be observed. When obtaining aspiration fluid before performing viscoelastic prosthetics, appropriate studies should be carried out to exclude bacterial etiology of arthritis. The product is intended for intra-articular administration. Intravascular or interstitial administration of the product must be avoided. The product should be used before the expiration date stated on the package. Use with caution in patients with allergies, as well as in patients with liver disease. In the first days after the injection, oral administration of analgesics or anti-inflammatory drugs may be recommended. The use of the product together with quaternary ammonium compounds is prohibited. For single use only. Repeated sterilization and use of the product is prohibited due to the risk of infection, cross-infection and / or product defect. Do not use a syringe from an open and / or damaged sterile package. Do not use a syringe with an open or damaged sterile syringe cap. If sterility is compromised or there is a suspicion of a violation of sterility of the implant, the product must be disposed of.
Elderly patients
Use with caution due to the general decrease in the functional activity of organs and body systems.
Pregnancy and lactation
Use if the benefit of treatment outweighs the risk of developing adverse events. Breastfeeding should be discontinued during treatment.
Children
The safety of the product in children has not been sufficiently studied, so use with caution.