CINGAL is the first and only CE mark approved hyaluronic acid (HA) and corticosteroid combination product.
First in its class, CINGAL is a unique product that combines an HA viscosupplement to provide long-term pain relief with a well-established corticosteroid to treat inflammation and provide rapid pain reduction.
Hyaluronic acid (HA) is vital for maintaining the function and elasticity of the synovial fluid in human joints. Osteoarthritis (OA) causes the natural HA to break down leaving lower concentrations of HA in synovial fluid.
CINGAL is designed to supplement the reduced amount of natural HA in synovial fluid in osteoarthritic joints. The formulation of CINGAL allows for long-term relief of the symptoms of OA through lubrication and mechanical support from the viscosupplement component, enhanced by short-term pain relief provided by triamcinolone hexacetonide (TH) corticosteroid.
CINGAL demonstrated a very good safety profile in its clinical study as a combination HA plus corticosteroid product in the treatment of knee pain due to osteoarthritis.
In addition, both HA viscosupplements and corticosteroids are individually well established with proven track records supporting their safety and performance in the treatment of the pain of osteoarthritis.1,2
HA viscosupplements have been proven to be a safe, targeted therapy for osteoarthritis with minimal side effects. HA injections have been used for more than 25 years3 to reduce pain associated with osteoarthritis (OA), improve viscoelastic properties of the synovial fluid and protect the surface of articular cartilage.
Corticosteroid injections have been used for over 45 years4 in the treatment of the symptoms of osteoarthritis for their potent anti-inflammatory effects, to reduce pain quickly and allow earlier motion.
CINGAL is injected directly into the joint space where it supplements the HA in the synovial fluid. It is a simple procedure that may be done in a clinician’s office.
In a CINGAL clinical study, a low number of patients experienced minor side effects. All were common side effects seen with viscosupplement injections, including injection site pain, joint pain, rash, redness or swelling, and all were resolved naturally without treatment.5
For additional details and information about the product, please refer to the Instructions for Use that are included in the product’s packaging.
Every patient’s experience is slightly different. For some, pain relief happens almost immediately, while it may take a few days for others. In a clinical study, CINGAL patients experienced statistically significant reduction in knee pain in the first week.5
In a CINGAL clinical study, significant knee pain relief was sustained through 6 months. Although there were no time points measured after 26 weeks, clinical results show that the effects of CINGAL lasted and appeared to get stronger at 6 months, allowing patients to continue to experience maximum pain relief.5
Yes. The safety of receiving a repeat injection of CINGAL was confirmed in a follow up clinical study.6 In this study, patients received a second injection six months after their initial injection of CINGAL. Repeated treatments can be performed as directed by a clinician.
CINGAL is CE mark approved as a viscoelastic supplement or a replacement for synovial fluid in all synovial joints. In Canada, CINGAL is approved for use in the knee.
Patients who have mild to moderate osteoarthritis (OA) and whose conservative treatments such as lifestyle changes or pain medications no longer effectively manage their pain due to osteoarthritis may benefit from a CINGAL injection.
CINGAL is designed for patients who demand quick results, desire to remain active, prefer a single visit treatment, or are looking to delay reconstructive surgery.
CINGAL is a transparent gel that contains natural, non-animal sourced hyaluronic acid (HA), combined with a corticosteroid.
CINGAL is provided as a single injection of 4.0 mL supplied in a 5.0 mL syringe. The clinician may recommend a different dose based on the affected joint.
Viscosupplementation is a procedure where hyaluronic acid (HA) is injected into the synovial fluid surrounding the joint for the treatment of the pain associated with osteoarthritis.
In osteoarthritic joints, the natural HA found in the synovial fluid, the thick liquid that helps lubricate and cushion the joint, begins to break down. As a result, the synovial fluid becomes thinner and less effective at cushioning, lubricating and protecting the joint, causing pain, swelling and loss of motion.
Hyaluronic acid viscosupplements are designed to replace some of the natural HA that has been lost due to osteoarthritis, providing pain relief, joint lubrication and increased mobility.
Corticosteroids are naturally occurring hormones that mimic the anti-inflammatory effects of the hormone cortisol in the body, and are used to reduce inflammation in the treatment of a range of orthopedic problems including osteoarthritis.
Corticosteroids should not be confused with anabolic steroids which are known for their use (or abuse) by athletes who take them for their muscle and strength building properties.7
CINGAL’s CE mark approval is for a medical device given that the major component of the product is hyaluronic acid (HA). The steroid is considered an ancillary drug component that does not impair the mechanism of action or structure of the HA.8
1. Bellamy N, Campbell J, Robinson V, et al. Intraarticular corticosteroid for treatment of osteoarthritis of the knee. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD005328.
2. Ozturk C, Atamaz F, Hepguler S, et al. The safety and efficacy of Intra-articular hyaluronan with/without corticosteroid in knee osteoarthritis: 1-year, single-blind, randomized study. Rheumatol Int. 2006 Feb;26(4):314-9.
3. Ault A. From the Head of a Rooster To a Smiling Face Near You. New York Times, 2003 Dec.
4. Zoorob R., Cender D. A Different Look at Corticosteroids. Am Fam Physician. 1998 Aug 1;58(2):443-450.
5. CINGAL 13-01, a randomized, double-blind, placebo-controlled, active comparator Phase III study. Anika Therapeutics, Inc.: study sponsor, Dr. Laszlo Hangody: global principal investigator, SynteractHCR: CRO.
6. CINGAL 13-02, an open-label, follow-on study to Cingal 13-01. Anika Therapeutics, Inc.: study sponsor, Dr. Laszlo Hangody: global principal investigator, SynteractHCR: CRO.
7. Mazzara, J., MD. Cortisone Injections. Connecticut Center for Orthopedic Surgery, LLC., Web: http://www.orthoontheweb.com/pdfs/about_cortisone_injections.pdf
8. R009-041, Technical Report, “Chemical Stability Evaluation of Cross-Linked Hyaluronic Acid and Triamcinolone Hexacetonide in Cingal Product”, December 2009. Appendix II of the device dossier.