Short-term effect of the combination of hyaluronic acid, chondroitin sulfate, and keratin matrix on early symptomatic knee osteoarthritis

Background: Although platelet-rich plasma (PRP) has potential as a regenerative treatment for knee osteoarthritis, its efficacy varies. Compositional differences among types of PRP could affect clinical outcomes, but the biological characterization of PRP is lacking. Purpose: To assess the efficacy of intra-articular PRP injection in knee osteoarthritis as compared with hyaluronic acid (HA) injection and to determine whether the clinical efficacy of PRP is associated with its biological characteristics. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 110 patients with symptomatic knee osteoarthritis received a single injection of leukocyte-rich PRP (1 commercial kit) or HA. Clinical data were assessed at baseline and at 6 weeks and 3 and 6 months after injection. The primary endpoint was an improvement in the International Knee Documentation Committee (IKDC) subjective score at 6 months, and the secondary endpoints were improvements in scores based on the Patient Global Assessment, the visual analog scale (VAS) for pain, the Western Ontario and McMaster Universities Osteoarthritis Index, and the Samsung Medical Center patellofemoral score. Cell counts and concentrations of growth factors and cytokines in the injected PRP were assessed to determine their association with clinical outcomes. Results: PRP showed significantly improvement in IKDC subjective scores at 6 months (11.5 in the PRP group vs 6.3 in the HA group; P = .029). There were no significant differences between groups in other clinical outcomes. The Patient Global Assessment score at 6 months was better in the PRP group ( P = .035). The proportion of patients who scored above the minimal clinically important difference (MCID) for VAS at 6 months was significantly higher in the PRP group ( P = .044). Within the PRP group, the concentrations of platelet-derived growth factors were high in patients with a score above the MCID for VAS at 6 months. The incidence of adverse events did not differ between the groups ( P > .05). Conclusion: PRP had better clinical efficacy than HA. High concentrations of growth factors were observed in patients who scored above the MCID for clinical outcomes in the PRP group. These findings indicate that concentration of growth factors needs to be taken into consideration for future investigations of PRP in knee osteoarthritis. Registration: NCT02211521 (ClinicalTrials.gov identifier).

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Safety and efficacy of intra articular injections of a combination of hyaluronic acid and mannitol (HAnOX-M) in patients with symptomatic knee osteoarthritis. Results of a double-blind, controlled, multicenter, randomized trial

Osteoarthritis and Cartilage ◽

10.1016/j.joca.2016.01.966 ◽

2016 ◽

Vol 24 ◽

pp. S528

Author(s):

T. Conrozier ◽

N. Afif ◽

R. Lecurieux ◽

A. Walliser ◽

X. Chevalier

Keyword(s):

Hyaluronic Acid ◽

Knee Osteoarthritis ◽

Randomized Trial ◽

Double Blind ◽

Safety And Efficacy ◽

Multicenter Randomized Trial ◽

Symptomatic Knee Osteoarthritis ◽

Symptomatic Knee

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Periarticular hypertonic dextrose vs intraarticular hyaluronic acid injections: a comparison of two minimally invasive techniques in the treatment of symptomatic knee osteoarthritis

Open Access Rheumatology Research and Reviews ◽

10.2147/oarrr.s215576 ◽

2019 ◽

Vol Volume 11 ◽

pp. 269-274

Author(s):

Behnam Hosseini ◽

Mehrdad Taheri ◽

Reza Pourroustaei Ardekani ◽

Siamak Moradi ◽

Morteza Kazempour Mofrad

Keyword(s):

Hyaluronic Acid ◽

Minimally Invasive ◽

Knee Osteoarthritis ◽

Minimally Invasive Techniques ◽

Symptomatic Knee Osteoarthritis ◽

Symptomatic Knee ◽

Invasive Techniques ◽

Hypertonic Dextrose

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Short-Term Effect of a New Oral Sodium Hyaluronate Formulation on Knee Osteoarthritis: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial

Diseases ◽

10.3390/diseases8030026 ◽

2020 ◽

Vol 8 (3) ◽

pp. 26

Author(s):

Arrigo F. G. Cicero ◽

Nicolò Girolimetto ◽

Crescenzio Bentivenga ◽

Elisa Grandi ◽

Federica Fogacci ◽

...

Keyword(s):

Clinical Trial ◽

Knee Osteoarthritis ◽

Sodium Hyaluronate ◽

Womac Score ◽

Term Effect ◽

Controlled Clinical Trial ◽

Short Term ◽

Double Blind ◽

Oral Supplementation ◽

Short Term Effect

Objective: the aim of this pilot study was to test the short-term effect of oral supplementation with a sodium hyaluronate with a large spectrum of molecular weights (FS-HA®) on the symptoms and functionality of knee osteoarthritis (OA). Methods: 60 subjects affected by clinical and/or radiological diagnosis of symptomatic knee OA were consecutively enrolled in a randomized, double blind, placebo-controlled, clinical trial. At randomization visit, at day 28 (visit 2), and day 56 (visit 3), the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC), the Lequesne Functional Index (LFI) and the Visual Analogue Scale (VAS) for pain (VAS-p) were administered to the enrolled patients. Then, patients were asked how many times they used rescue medications (non-steroidal antinflammatory drugs–NSAIDs and/or anti-pain drugs) during the previous 4 weeks. Finally, the range of knee joint motion (ROM) was also instrumentally measured. Results: In FS-HA® treated subjects, VAS-p, pain and total WOMAC score, LFI and ROM significantly improved compared to the baseline values (p < 0.05). At 60 days, the VAS-p and the pain WOMAC score were significantly lower after FS-HA® treatment when compared with placebo as well (p < 0.05). The FS-HA® treated subjects significantly reduced the weekly use of NSAIDs and/or antipain drugs when compared to the placebo-treated ones (p < 0.05). Conclusion: the oral supplementation with a FS-HA® characterized by a large spectrum of molecular weight was associated with a short-term improvement in symptomatology and functionality of osteoarthritis-affected knees, and associated with a reduction in the use of NSAIDS and anti-pain drugs.

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US-Approved Intra-Articular Hyaluronic Acid Injections are Safe and Effective in Patients with Knee Osteoarthritis: Systematic Review and Meta-Analysis of Randomized, Saline-Controlled Trials

Clinical Medicine Insights Arthritis and Musculoskeletal Disorders ◽

10.4137/cmamd.s12743 ◽

2013 ◽

Vol 6 ◽

pp. CMAMD.S12743 ◽

Cited By ~ 91

Author(s):

Larry E. Miller ◽

Jon E. Block

Keyword(s):

Systematic Review ◽

Hyaluronic Acid ◽

Knee Osteoarthritis ◽

Knee Pain ◽

Meta Analysis ◽

Controlled Trials ◽

Serious Adverse Events ◽

Safety Outcome ◽

Symptomatic Knee Osteoarthritis ◽

Symptomatic Knee

We conducted a systematic review and meta-analysis of randomized saline-controlled trials to determine the safety and efficacy of US-approved intra-articular hyaluronic acid (IAHA) injections for symptomatic knee osteoarthritis. A total of 29 studies representing 4,866 unique subjects (IAHA: 2,673, saline: 2,193) were included. IAHA injection resulted in very large treatment effects between 4 and 26 weeks for knee pain and function compared to pre-injection values, with standardized mean difference (SMD) values ranging from 1.07–1.37 (all P < 0.001). Compared to saline controls, SMDs with IAHA ranged from 0.38–0.43 for knee pain and 0.32–0.34 for knee function (all P < 0.001). There were no statistically significant differences between IAHA and saline controls for any safety outcome, including serious adverse events (SAEs) ( P = 0.12), treatment-related SAEs ( P = 1.0), study withdrawal ( P = 1.0), and AE-related study withdrawal ( P = 0.46). We conclude that intra-articular injection of US-approved HA products is safe and efficacious in patients with symptomatic knee osteoarthritis.

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Safety and efficacy of intra-articular injections of a combination of hyaluronic acid and mannitol (HAnOX-M) in patients with symptomatic knee osteoarthritis

The Knee ◽

10.1016/j.knee.2016.05.015 ◽

2016 ◽

Vol 23 (5) ◽

pp. 842-848 ◽

Cited By ~ 6

Author(s):

Thierry Conrozier ◽

Florent Eymard ◽

Naji Afif ◽

Jean-Charles Balblanc ◽

Virginie Legré-Boyer ◽

...

Keyword(s):

Hyaluronic Acid ◽

Knee Osteoarthritis ◽

Safety And Efficacy ◽

Symptomatic Knee Osteoarthritis ◽

Symptomatic Knee

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Pharmaceutical-grade Chondroitin sulfate is as effective as celecoxib and superior to placebo in symptomatic knee osteoarthritis: the ChONdroitin versus CElecoxib versus Placebo Trial (CONCEPT)

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2016-210860 ◽

2017 ◽

Vol 76 (9) ◽

pp. 1537-1543 ◽

Cited By ~ 39

Author(s):

Jean-Yves Reginster ◽

Jean Dudler ◽

Tomasz Blicharski ◽

Karel Pavelka

Keyword(s):

Placebo Group ◽

Knee Osteoarthritis ◽

Chondroitin Sulfate ◽

Controlled Trial ◽

European Medicines Agency ◽

Double Blind ◽

Knee Oa ◽

Symptomatic Knee Osteoarthritis ◽

Symptomatic Knee ◽

Secondary Endpoints

ObjectivesChondroitin sulfate 800 mg/day (CS) pharmaceutical-grade in the management of symptomatic knee osteoarthritis consistent with the European Medicines Agency guideline.MethodsA prospective, randomised, 6-month, 3-arm, double-blind, double-dummy, placebo and celecoxib (200 mg/day)-controlled trial assessing changes in pain on a Visual Analogue Scale (VAS) and in the Lequesne Index (LI) as coprimary endpoints. Minimal-Clinically Important Improvement (MCII), Patient-Acceptable Symptoms State (PASS) were used as secondary endpoints.Results604 patients (knee osteoarthritis) diagnosed according to American College of Rheumalogy (ACR) criteria, recruited in five European countries and followed for 182 days. CS and celecoxib showed a greater significant reduction in pain and LI than placebo. In the intention-to-treat (ITT) population, pain reduction in VAS at day 182 in the CS group (−42.6 mm) and in celecoxib group (−39.5 mm) was significantly greater than the placebo group (−33.3 mm) (p=0.001 for CS and p=0.009 for celecoxib), while no difference observed between CS and celecoxib. Similar trend for the LI, as reduction in this metric in the CS group (−4.7) and celecoxib group (−4.6) was significantly greater than the placebo group (−3.7) (p=0.023 for CS and p=0.015 for celecoxib), no difference was observed between CS and celecoxib. Both secondary endpoints (MCII and PASS) at day 182 improved significantly in the CS and celecoxib groups. All treatments demonstrated excellent safety profiles.ConclusionA 800 mg/day pharmaceutical-grade CS is superior to placebo and similar to celecoxib in reducing pain and improving function over 6 months in symptomatic knee osteoarthritis (OA) patients. This formulation of CS should be considered a first-line treatment in the medical management of knee OA.

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