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Effectiveness of Intra-Articular Injections of Sodium Hyaluronate- Chondroitin Sulfate in Knee Osteoarthritis: a Multicenter Prospective Study

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Effectiveness of Intra-Articular Injections of Sodium Hyaluronate- Chondroitin Sulfate in Knee Osteoarthritis: a Multicenter Prospective Study J Orthopaed Traumatol (2016) 17:27–33 DOI 10.1007/s10195-015-0388-1 ORIGINAL ARTICLE Effectiveness of intra-articular injections of sodium hyaluronate- chondroitin sulfate in knee osteoarthritis: a multicenter prospective study 1,9 2,3 4 4 Fabrizio Rivera • Luca Bertignone • Giancarlo Grandi • Roberto Camisassa • 5 6 7 7 Guido Comaschi • Diego Trentini • Marco Zanone • Giuseppe Teppex • 7 8 Gabriele Vasario • Giorgio Fortina Received: 16 September 2015 / Accepted: 28 October 2015 / Published online: 14 November 2015 Ó The Author(s) 2015. This article is published with open access at Springerlink.com Abstract month 6 (P \ 0.0001). The mean subscore was already Background Intra-articular injection of hyaluronic acid is significantly decreased 1 month after the last injection at a well-established therapy for the treatment of knee 25.7 (P \ 0.0001). Pain relief and consumption of anal- osteoarthritis. The aim of the study was to assess the gesic drugs, both assessed with visual analogic scale effectiveness and safety of the use of Arthrum HCSÒ (VAS), consistently decreased. The investigators were (40 mg hyaluronic acid and 40 mg chondroitin sulfate in satisfied/very satisfied as regards the therapeutic effec- 2 mL). tiveness of sodium hyaluronate-chondroitin sulfate in Materials and methods This was an open, multicenter, reducing pain (77 %), improving mobility (78 %) and prospective study. Men or women over 40 years of age reducing the consumption of analgesics (74 %). Only one with documented knee osteoarthritis and WOMAC sub- adverse effect was reported by one patient (knee score A (severity of pain) C25 were enrolled. They tumefaction). received three weekly intra-articular injections of sodium Conclusion These results suggest that intra-articular hyaluronate 2 % and chondroitin sulfate 2 % in combina- injections of Arthrum HCSÒ (sodium hyaluronate plus tion. WOMAC subscore A was assessed at 1, 3 and chondroitin sulfate) in patients with knee osteoarthritis are 6 months after the last injection. efficient and safe. These results should be confirmed in a Results One hundred and twelve patients were included randomized controlled study. (women, 66 %). The mean (SD) WOMAC subscore A Level of evidence IV. decreased from 52.1 (15.2) at inclusion to 20.5 (19.7) at Keywords Knee osteoarthritis Á Intra-articular injection Á Sodium hyaluronate Á Chondroitin sulfate & Fabrizio Rivera [email protected] 1 Department of Orthopedic Trauma, SS Annunziata Hospital, Introduction Savigliano, CN, Italy 2 Sant’Anna Clinic, Casale Monferrato, AL, Italy It is estimated that around 250 million people in the world 3 Eporediese Hospital, Ivrea, TO, Italy are affected by knee osteoarthritis [1]. Knee pain has an 4 La Vialarda Clinic, Biella, Italy important impact by limiting activity and impairing quality 5 of life. Thus, knee osteoarthritis has been identified as one Sestri Ponente Hospital, Genova, Italy of the medical conditions (with stroke, depression, hip 6 Department of Orthopedics and Traumatology, IRCCS fracture and heart disease) accounting for more physical A.O.U. San Martino-IST, Genova, Italy disability than other diseases in people 65 years of age or 7 Department of Orthopedics and Traumatology, AO CTO older [2]. Moreover, knee osteoarthritis has a major impact Hospital, Turin, Italy on healthcare costs [3–6]. 8 Santa Rita Clinic, Vercelli, Italy The management of osteoarthritis should be hierarchi- 9 Via Servais 200 A 16, Turin, Italy cal, with non pharmacological methods as first 123 28 J Orthopaed Traumatol (2016) 17:27–33 interventions (weight loss, exercise and braces), followed improvement, together with the changes of the ultrasound by analgesic drugs [nonsteroidal anti-inflammatory drugs parameters and biomarkers of cartilage metabolism and (NSAIDs) and other analgesics], local therapies (topical joint inflammation, suggested a non-placebo effect. These NSAIDs, intra-articular corticosteroids and hyaluronic results prompted us to assess in a prospective multicenter acid), and surgery as a last resort [7–10]. study the effectiveness and safety of the use of hyaluronic Administration of exogenous hyaluronic acid (visco- acid when combined with chondroitin sulfate in patients supplementation) directly into the joint is available as a with knee osteoarthritis. treatment for the symptoms of knee osteoarthritis. The purpose of viscosupplementation is to overcome the qual- itative and quantitative deficiency of hyaluronic acid that is Materials and methods associated with osteoarthritis. Hyaluronic acid is a polysaccharide that is the main constituent of cartilage and Study design synovial fluid; it is responsible for the mechanical prop- erties of the joint by allowing shock absorption, lubrication This was an open, multicenter, prospective study, assessing and cartilage protection [11]. In osteoarthritis patients, the effectiveness of three intra-articular injections of synovial hyaluronate is depolymerized and is cleared at sodium hyaluronate plus chondroitin sulfate (40 mg of higher rates compared to normal subjects due to inflam- each compound in 2 mL) in the symptomatic treatment of mation [12]. Intra-articular injections of hyaluronic acid knee osteoarthritis. have been shown to be as effective as NSAIDs with fewer The study was conducted prospectively by office or systemic adverse events [13]; this therapy has a delayed hospital specialists (orthopedic surgeons, rehabilitation onset of action in comparison with intra-articular corti- medicine physicians) from October 2012 to December costeroids, but a longer-lasting benefit [14]. Younger 2013. patients and patients at an earlier stage of the disease are Written informed consent was obtained from each more likely to benefit from viscosupplementation [15]. patient. The protocol was conducted in accordance with the Arthrum HCSÒ (LCA Pharmaceutical, Chartres, France) Declaration of Helsinki and Guidelines on Good Clinical is a new specialty for viscosupplementation combining Practice and approved by a local ethics committee. sodium hyaluronate and chondroitin sulfate. Chondroitin sulfate—a sulfated glycosaminoglycan—is an important Inclusion criteria structural component of the extracellular cartilage matrix. On the articular system, chondroitin sulfate links to Men or women over 40 years of age were eligible to par- monomers with high molecular weights. The proteoglycan ticipate if they: (1) had documented knee osteoarthritis aggregate exhibits viscoelastic and hydration properties evidenced with X-rays over the past 6 months with Kell- and an ability to interact with the surrounding tissue gren-Lawrence score grade II or III [20]; (2) had pain and through electric charges, leading to protection of the car- functional impairment for at least 3 months and Western tilaginous tissues. Furthermore, chondroitin sulfates are Ontario and McMaster Universities Osteoarthritis Index inhibitors of extracellular proteases involved in the meta- (WOMAC) [21] subscore A (severity of pain) C25 (on a bolism of connective tissues and stimulate proteoglycan scale of 100); and (3) needed hyaluronic acid injections production by chondrocytes in vitro; they also inhibit car- after the failure or intolerance to first-line analgesics or non tilage cytokine production and induce apoptosis of articular steroidal anti-inflammatory drugs. The main exclusion cri- chondrocytes [16]. Preliminary clinical trials were in favor teria were: severe hydrarthrosis; inflammatory rheumatism; of the effectiveness of intra-articular injections of sodium history of knee trauma in the past 6 months; history of hyaluronate-chondroitin sulfate. Thus, in a 3-month mul- arthroplasty or major surgery on the target knee in the past ticentric pilot study, a series of three weekly injections of a 6 months; history of arthroscopy or surgery on the target combination of hyaluronic acid-chondroitin sulfate was knee in the past 3 months; planned knee surgery during the well tolerated and decreased pain in patients with knee study; history of septic arthritis of the knee; knee wound or osteoarthritis [17]. A recent clinical study suggested that a skin condition; crural or sciatic radiculalgia of the lower single injection of sodium hyaluronate-chondroitin sulfate limb; tendinopathy; symptomatic homolateral or contralat- in patients with lateral epicondylitis offer better pain ben- eral hip disease; venous or lymphatic stenosis of the lower efits for 6 months after injection than intra-articular corti- limb; medical history of venous thromboembolism (in- costeroids [18]. In an exploratory study, the effectiveness cluding pulmonary embolism) or patient with high risk of of intra-articular injections of a solution combining hya- venous thromboembolism; patient with a history of auto- luronic acid and chondroitin sulfate was assessed in 40 immune disease; treatment with diacerein, avocado soy patients with knee osteoarthritis [19]. The clinical unsaponifiables, glucosamine sulfate/chondroitin starting 123 J Orthopaed Traumatol (2016) 17:27–33 29 less than 3 months previously or with dosage modified Comparisons were made using Student’s t test for during the past 3 months; recurrent episodes of chondro- quantitative criteria and Chi2 test for non-ordinal qualita- calcinosis; previous treatment with viscosupplementation; tive variables (or Fisher’s exact test) and Wilcoxon’s test injection of corticosteroids into the knee under study less for ordinal data. The threshold for significance was set at than 3 months previously; known hypersensitivity to hya- 5%.
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