scholarly journals Efficacy evaluation of highly purified intra-articular hyaluronic acid (Sinovial®) vs hylan G-F20 (Synvisc®) in the treatment of symptomatic knee osteoarthritis. A double-blind, controlled, randomized, parallel-group non-inferiority study

2011 ◽  
Vol 19 (11) ◽  
pp. 1294-1300 ◽  
Author(s):  
K. Pavelka ◽  
D. Uebelhart
Keyword(s):  
Hyaluronic Acid ◽  
Knee Osteoarthritis ◽  
Efficacy Evaluation ◽  
Double Blind ◽  
Parallel Group ◽  
Symptomatic Knee Osteoarthritis ◽  
Symptomatic Knee

Does the Presence of Neuropathic Pain Influence the Response to Hyaluronic Acid in Patients with Knee Osteoarthritis?

Cartilage ◽  
2020 ◽  
pp. 194760352095450
Author(s):  
Evarice Tiendrebeogo ◽  
Magda Choueiri ◽  
Xavier Chevalier ◽  
Thierry Conrozier ◽  
Florent Eymard
Keyword(s):  
Neuropathic Pain ◽  
Hyaluronic Acid ◽  
Knee Osteoarthritis ◽  
Symptomatic Improvement ◽  
Pain Patient ◽  
Womac Pain ◽  
Double Blind ◽  
Symptomatic Knee Osteoarthritis ◽  
Symptomatic Knee ◽  
The Impact

Objectives Up to 50% of patients with symptomatic knee osteoarthritis (OA) present with neuropathic pain (NP) features. We assessed the impact of NP according to DN4 (Douleurs Neuropathiques 4 questions) score on the response to intra-articular (IA) hyaluronic acid (HA) injections and the effects of HA injections on NP. Materials and Methods We conducted a post hoc analysis from a multicenter, randomized, double-blind, noninferiority trial comparing the efficacy of 2 HA in symptomatic knee OA at 24 weeks. At baseline, demographic, anthropometric, radiologic data, and symptoms were recorded. The symptomatic effect of HA was assessed by VAS pain, patient global assessment (PGA), WOMAC, DN4, and OMERACT-OARSI response. Results A total of 187 patients were included. NP according to DN4 score was present in 20 patients (10.7%) at baseline. Most common positive DN4 items were tingling (36.9%) and burning (36.4%). NP was associated with WOMAC pain score ( P = 0.02). The presence of NP at baseline did not affect the symptomatic improvement after HA injections according to the VAS pain ( P = 0.71), PGA ( P = 050), WOMAC pain ( P = 0.89), WOMAC function ( P = 0.52), and rate of OMERACT-OARSI responders ( P = 0.21). The prevalence of patients with NP decreased by 50% ( n = 10) at 24 weeks after HA injections. Most improved DN4 items were itching (90%), hypoesthesia to pinprick (88%), and burning (50%). Conclusion In our study, NP was associated with pain severity, but did not influence the response to IA HA. On the other hand, HA injections reduced some NP features, especially itching, sting hypoesthesia, and burning.

Clinical Efficacy of Platelet-Rich Plasma Injection and Its Association With Growth Factors in the Treatment of Mild to Moderate Knee Osteoarthritis: A Randomized Double-Blind Controlled Clinical Trial As Compared With Hyaluronic Acid

2021 ◽  
Vol 49 (2) ◽  
pp. 487-496
Author(s):  
Yong-Beom Park ◽  
Jun-Ho Kim ◽  
Chul-Won Ha ◽  
Dong-Hyun Lee
Keyword(s):  
Hyaluronic Acid ◽  
Growth Factors ◽  
Knee Osteoarthritis ◽  
Clinical Outcomes ◽  
Clinical Efficacy ◽  
Global Assessment ◽  
Platelet Rich Plasma ◽  
Patient Global Assessment ◽  
Symptomatic Knee Osteoarthritis ◽  
Symptomatic Knee

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).

scholarly journals 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

2013 ◽  
Vol 6 ◽  
pp. CMAMD.S12743 ◽  
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.

scholarly journals Clinical and cost-effectiveness of bracing in symptomatic knee osteoarthritis management: protocol for a multicentre, primary care, randomised, parallel-group, superiority trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e048196
Author(s):  
Melanie A Holden ◽  
Michael Callaghan ◽  
David Felson ◽  
Fraser Birrell ◽  
Elaine Nicholls ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Analysis Of Covariance ◽  
Written Information ◽  
Parallel Group ◽  
Management Protocol ◽  
Adherence Support ◽  
Symptomatic Knee Osteoarthritis ◽  
Symptomatic Knee

BackgroundBrace effectiveness for knee osteoarthritis (OA) remains unclear and international guidelines offer conflicting recommendations. Our trial will determine the clinical and cost-effectiveness of adding knee bracing (matched to patients’ clinical and radiographic presentation and with adherence support) to a package of advice, written information and exercise instruction delivered by physiotherapists.Methods and analysisA multicentre, pragmatic, two-parallel group, single-blind, superiority, randomised controlled trial with internal pilot and nested qualitative study. 434 eligible participants with symptomatic knee OA identified from general practice, physiotherapy referrals and self-referral will be randomised 1:1 to advice, written information and exercise instruction and knee brace versus advice, written information and exercise instruction alone. The primary analysis will be intention-to-treat comparing treatment arms on the primary outcome (Knee Osteoarthritis Outcomes Score (KOOS)-5) (composite knee score) at the primary endpoint (6 months) adjusted for prespecified covariates. Secondary analysis of KOOS subscales (pain, other symptoms, activities of daily living, function in sport and recreation, knee-related quality of life), self-reported pain, instability (buckling), treatment response, physical activity, social participation, self-efficacy and treatment acceptability will occur at 3, 6, and 12 months postrandomisation. Analysis of covariance and logistic regression will model continuous and dichotomous outcomes, respectively. Treatment effect estimates will be presented as mean differences or ORs with 95% CIs. Economic evaluation will estimate cost-effectiveness. Semistructured interviews to explore acceptability and experiences of trial interventions will be conducted with participants and physiotherapists delivering interventions.Ethics and disseminationNorth West Preston Research Ethics Committee, the Health Research Authority and Health and Care Research in Wales approved the study (REC Reference: 19/NW/0183; IRAS Reference: 247370). This protocol has been coproduced with stakeholders including patients and public. Findings will be disseminated to patients and a range of stakeholders.Trial registration numberISRCTN28555470.

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 ◽  
2016 ◽  
Vol 23 (5) ◽  
pp. 842-848 ◽  
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

scholarly journals 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)

2017 ◽  
Vol 76 (9) ◽  
pp. 1537-1543 ◽  
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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