NOLTREX™ — IS A MEDICAL DEVICE FOR THE TREATMENT OF JOINT ARTHRITIS AND ARTHROSIS
NOLTREX™ is a synthetic implant based on three-dimensional polyacrylamide cross-linked polymer with silver ions added. It helps to alleviate the symptoms of arthrosis, osteoarthritis arthritis, osteoarthritis, such as mild or severe pain, joint stiffness.
NOLTREX™ MOLECULAR WEIGHT > 10 000 000 DALTON.
4,0 ± 1,5
0,07 ± 0,005
0,0001 - 0,0025
0,0028 ± 0,0001
A disposable syringe of NOLTREX™ contains 2.5 ml of gel to be administered into the joint cavity.
Unlike other products commonly used in intra-articular injections, NOLTREX™ does not contain hyaluronic acid or other substances susceptible to degradation under the influence of enzymes contained in the human body, which ensures its long presence in the injection site.
NOLTREX™ is a biocompatible material, that has neither immunogenic, nor antigenic properties, it does not cause allergic reaction due to its synthetic nature.
MECHANISM OF ACTION
PROTECTION OF CARTILAGE
Intra-articularly injected NOLTREX™ covers the entire joint surfaces and the synovial lining with a uniform layer of lubricating gel. The hydrogel layer creates a shock-absorbing effect, cushions the mechanical load on the joint, which helps to preserve the integrity of cartilage/stop further destruction of the cartilage.
PHYSICAL SEPARATION OF FRICTIONING SURFACES
Due to synovial viscosupplementation the joint space widens, i.e. the contacting and frictioning surfaces of the affected joint are physically separated. Thus, due to the reduced friction a mechanical protection of articular cartilages is achieved; the irritant constantly present in the joint, typically leading to pain and inflammation, is eliminated.
SYNOVIAL VISCOSUPPLEMENTATION OF JOINTS
When injected in the joint affected by osteoarthritis, NOLTREX™ substitutes for compromised synovial fluid. This does not lead to the formation of any new chemical molecules, does not alter the biologic interaction of the synovial fluid or mediate a bodily response. Reduction of pain and inflammation are secondary effects resulting from improved joint lubrication.
Given the complexity and the irreversibility of the processes occurring in the joints of patients with osteoarthritis, the physician should make a choice of treatment which is not only safe, but also effective. This is necessary to achieve maximum stabilization of the pathological process and prevent secondary changes in the joint. The preservation of the joint functions and the maximum reduction of the impact of the disease on the patient’s life quality depend on the effectiveness of the treatment.
NATURAL OR SYNTHETIC?
There is a misconception that the use of hyaluronic acid-based products is preferable as opposed to fully synthetic preparations. Claims are often made that the preparations based on hyaluronic acid are similar in composition to the human synovial fluid. However, the trouble is that the resemblance is not absolute, which is exactly what reduces their effectiveness in terms of quality. The preparations manufactured from animal raw materials are easily detected by immune cells of the body (phagocytes), destroyed and removed from the body. Besides, the use of animal raw materials often provokes allergic reactions and inflammations in the joint.1-4 Besides, the high speed of resorption accounts for a very short recommended interval between repeated injections.
The injections of NOLTREX™ should be repeated not more often than every nine months - two years.5 This is accounted for by the macromolecules of the cross-linked polymer, which are virtually invisible for phags and eliminated from the body very slowly, enabling to maximize the length of therapeutic effect. Due to synthetic origin of the preparation allergic reactions to it are rare. For long history of its therapeutic use no allergic reactions have been reported.
Thus, there is an obvious answer to the question of choice of the treatment of osteoarthritis. At the moment NOLTREX™ is the absolute leader among the medical devices for the treatment of arthritis in terms of effectiveness and safety.
Inert macromolecules of NOLTREX™ do not react with body tissues. Over the years, the researches of polyacrylamides, a group of substances on which NOLTREX™ material is based, have shown that they are highly biocompatible with human tissues, exceptionally hypoallergenic and do not have any adverse impact on the vital functions of the patient’s body.6-10
Possible side-effects and complications are related to its administration (intra-articular injection) and include: pain or swelling at the site of injection, infections (septic arthritis, osteomyelitis, sepsis, etc.), neuropathies, embolia cutis medicamentosa, aseptic acute arthritis, joint effusion, bursting sensation, burning sensation, arthralgia, granuloma.
Some of these complications of intra-articular injections in general can be avoided thorough asepsis and careful administration technique. Some of the complications reported in the studies and in the post-marketing surveillance are explained by non-compliance with the precautions and contraindications (e.g. injection into a joint with synovitis). Periprocedural or temporary postproce-dural (not exceeding 72 hours) pain or burning sensation was the most common reported complication.
The most common complication (burning sensation, pain) can be managed well with non-steroidal anti-inflammatory analgesics. As Hondrexsyn does not contain any material of animal origins, the chance of allergic reactions is very low, although not impossible: no allergic reactions or rejections were reported neither in the clinical studies nor during the post-marketing surveillance, although there was one reported anaphylactoid reaction to a different, but similar polyacrylamide hydrogel found in scientific literature.
- Goldberg V.M., Coutts R.D.. Pseudoseptic reactions to hylan viscosupplementation: diagnosis and treatment. Clin Orthop Relat Res. 2004; (419):130-7.
- Pullman-Mooar S. et al.. Are there distinctive inflammatory flares after hylan g-f 20 intraarticular injections? J Rheumatol. 2002; 29(12):2611-4.
- Leopold S.S. et al.. Increased frequency of acute local reaction to intra-articular Hylan GF-20 (synvisc) in patients receiving more than one course of treatment. J Bone Joint Surg Am. 2002; 84-A(9):1619-23.
- Chen A.L. et al.. Granulomatous inflammation after Hylan GF-20 viscosupplementation of the knee : a report of six cases. J Bone Joint Surg Am. 2002; 84-A(7):1142-7.
- Загородний Н.В., Зар В.В.. Эффективность и безопасность лечения остеоартроза коленного сустава Нолтрексом — полимером с перекрёстными связями. // Эффективная фармакотерапия. 2011, № 1, с. 58-65.
- Перова Н.М.. Изучение биологического эффекта материала-биополимера водосодержащего с ионами серебра «Аргиформ». Протокол серии доклинических исследований: Всероссийский научно-исследовательский и испытательный институт медицинской техники МЗ РФ. Москва, 2003.
- Christensen L.H. et al.. Long-term effects of polyacrylamide hydrogel on human breast tissue. Plast Reconstr Surg. 2003; 111(6):1883-90.
- Zarini E. et al.. Biocompatibility and tissue interactions of a new filler material for medical use. Plast Reconstr Surg. 2004; 114(4):934-42.
- Breiting V. et al.. A study on patients treated with polyacrylamide hydrogel injection for facial corrections. Aesthetic Plast Surg. 2004 Jan-Feb; 28(1):45-53. Epub 2004 May 3.
- Wolters M., Lampe H.. Prospective multicenter study for evaluation of safety, efficacy, and esthetic results of cross-linked polyacrylamide hydrogel in 81 patients. Dermatol Surg. 2009; 35 Suppl 1:338-43.