scholarly journals Efficacy and safety of a single intra-articular injection of 6 ml Hylan G-F 20 compared to placebo in Chinese patients with symptomatic knee osteoarthritis

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yan Ke ◽  
Wenxue Jiang ◽  
Yongsheng Xu ◽  
Yajun Chen ◽  
Qingsong Zhang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Knee Osteoarthritis ◽  
Clinical Efficacy ◽  
Post Injection ◽  
Efficacy And Safety ◽  
Treatment Groups ◽  
Knee Oa ◽  
Link Type ◽  
Symptomatic Knee Osteoarthritis ◽  
The Mean

Abstract Background Single 6 ml Hylan G-F 20 injection, is indicated for knee osteoarthritis patients who have failed to respond to non-pharmacologic therapy and/or simple analgesics. To obtain more thorough understanding of the clinical efficacy and safety, a randomized clinical trial was conducted comparing intra-articular (IA) administration of single 6 ml Hylan G-F 20 injection versus placebo in knee OA patients of Chinese ethnicity. Methods This was a randomized, multi-center, double-blind, placebo-controlled clinical trial conducted in 21 centers across China. Four hundred forty adults with knee OA received a single 6 ml Hylan G-F 20 or placebo injection and were evaluated for clinical efficacy and safety outcomes over 26 weeks. Western Ontario and McMaster Universities OA (WOMAC) A1 index, treatment-emergent adverse events (TEAEs) and standard safety parameters were measured at pre-injection, and at weeks 1, 4, 8, 12, 16, 20 and 26 post-injection. Results Four hundred forty patients (male: 98 [22.3%]; female: 342 [77.7%]) were randomized. The mean age [standard deviation (SD)] was 61.5 (7.9) years. All patients were of East Asian ethnicity. Mean WOMAC A1 score at baseline was 5.3 (1.2) and 5.2 (1.3) in single 6 ml Hylan G-F 20 injection and placebo groups, respectively. Significant reductions of WOMAC A1 score were observed in both treatment groups when compared to baseline at 26 weeks post-injection, with the mean reduction of [standard error (SE)/percentage] -2.146 (0.108)/− 40.5% and − 2.271 (0.110) /− 43.7% in the single 6 ml Hylan G-F 20 injection and the placebo groups, respectively. Additionally, clinically important reductions in pain at 26 weeks was reported in 67.0 and 68.2% in single 6 ml Hylan G-F 20 injection and placebo groups (p = 0.36). Regarding safety, TEAEs were similar between the two treatment groups (hylan G-F 20 single: 61.5%; placebo: 64.5%). Conclusions While the magnitude of the effect of a single 6 ml Hylan G-F 20 injection in this study is consistent with previously published literature with respect to the efficacy and safety of the drug, the current study shows a strong IA placebo effect and did not established superiority of single 6 ml Hylan G-F 20 injection over IA placebo in Chinese knee OA patients. Trial registration Prospectively registered Jun 16, 2017 at www.clinicaltrials.gov (NCT03190369).

What Is the Price and Claimed Efficacy of Platelet-Rich Plasma Injections for the Treatment of Knee Osteoarthritis in the United States?

2018 ◽  
Vol 32 (09) ◽  
pp. 879-885 ◽  
Author(s):  
Nicolas S. Piuzzi ◽  
Mitchell Ng ◽  
Ariel Kantor ◽  
Kenneth Ng ◽  
Stephanie Kha ◽  
...  
Keyword(s):  
United States ◽  
Standard Deviation ◽  
Knee Osteoarthritis ◽  
Clinical Efficacy ◽  
Health Care Providers ◽  
Platelet Rich Plasma ◽  
The United States ◽  
Care Providers ◽  
Knee Oa ◽  
The Mean

AbstractPlatelet-rich plasma (PRP) injections are often used for the treatment of knee osteoarthritis (OA), despite clinical value and cost-effectiveness not being definitely established. PRP injections are considered as a potential means of reducing pain and improving function in patients with knee OA, in the hope of delaying or avoiding the need for surgical intervention. Centers that offer PRP injections usually charge patients out of pocket and directly market services. Therefore, the purpose of this study was to quantify the current (1) prices and (2) marketed clinical efficacy of autologous PRP injections for knee OA. A prospective cross-sectional study was performed based on 286 centers identified in the United States offering PRP injections for knee OA. A total of 179 (73.4%) centers were successfully contacted via e-mail or phone, using a simulated 52-year-old male patient with knee OA. Scripted questions were asked by the simulated patient to determine the current marketed prices and clinical efficacy, either reported as “good results” or “symptomatic improvement,” claimed by each treating center. The mean price for a single unilateral knee same-day PRP injection was $714 with a standard deviation of $144 (95% confidence interval [CI]: $691–737, n = 153). The mean claim of clinical efficacy was 76% with a standard deviation of 11% (95% CI: 73.5–78.3%, n = 84). Out of the 84 clinics, 10 claimed “90 to 100% efficacy,” 27 claimed “80 to 90%,” 29 claimed “70 to 80%,” 9 claimed “60 to 70%,” 8 claimed “50 to 60%,” and 1 claimed “40 to 60%.” These findings provide a unique perspective on the PRP market for the treatment of knee OA that is valuable to physicians and health care providers in providing better education to patients on the associated costs and purported clinical benefits of PRP injections.

scholarly journals Depression in patients with knee osteoarthritis: risk factors and associations with joint symptoms

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Shuang Zheng ◽  
Liudan Tu ◽  
Flavia Cicuttini ◽  
Zhaohua Zhu ◽  
Weiyu Han ◽  
...  
Keyword(s):  
Risk Factors ◽  
Knee Joint ◽  
Knee Osteoarthritis ◽  
Trial Registration ◽  
Womac Pain ◽  
Knee Oa ◽  
Link Type ◽  
Symptomatic Knee Osteoarthritis ◽  
Symptomatic Knee ◽  
Joint Symptoms

Abstract Background To describe demographic and clinical factors associated with the presence and incidence of depression and explore the temporal relationship between depression and joint symptoms in patients with symptomatic knee osteoarthritis (OA). Methods Three hundred ninety-seven participants were selected from a randomized controlled trial in people with symptomatic knee OA and vitamin D deficiency (age 63.3 ± 7.1 year, 48.6% female). Depression severity and knee joint symptoms were assessed using the patient health questionnaire (PHQ-9) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), respectively, at baseline and 24 months. Results The presence and incidence of depression was 25.4 and 11.2%, respectively. At baseline, having younger age, a higher body mass index (BMI), greater scores of WOMAC pain (PR: 1.05, 95%CI:1.03, 1.07), dysfunction (PR: 1.02, 95%CI:1.01, 1.02) and stiffness (PR: 1.05, 95%CI: 1.02, 1.09), lower education level, having more than one comorbidity and having two or more painful body sites were significantly associated with a higher presence of depression. Over 24 months, being female, having a higher WOMAC pain (RR: 1.05, 95%CI: 1.02, 1.09) and dysfunction score (RR: 1.02, 95%CI: 1.01, 1.03) at baseline and having two or more painful sites were significantly associated with a higher incidence of depression. In contrast, baseline depression was not associated with changes in knee joint symptoms over 24 months. Conclusion Knee OA risk factors and joint symptoms, along with co-existing multi-site pain are associated with the presence and development of depression. This suggests that managing common OA risk factors and joint symptoms may be important for prevention and treatment depression in patients with knee OA. Trial registration ClinicalTrials.gov identifier: NCT01176344. Anzctr.org.au identifier: ACTRN12610000495022.

The Stem-Cell Market for the Treatment of Knee Osteoarthritis: A Patient Perspective

2017 ◽  
Vol 31 (06) ◽  
pp. 551-556 ◽  
Author(s):  
Nicolas Piuzzi ◽  
Mitchell Ng ◽  
Morad Chughtai ◽  
Anton Khlopas ◽  
Kenneth Ng ◽  
...  
Keyword(s):  
Stem Cell ◽  
Standard Deviation ◽  
Knee Osteoarthritis ◽  
Clinical Efficacy ◽  
Symptomatic Improvement ◽  
Stem Cell Therapies ◽  
Cell Therapies ◽  
Musculoskeletal Conditions ◽  
Knee Oa ◽  
The Mean

AbstractThe use of stem-cell therapies for the treatment of various musculoskeletal conditions, especially knee osteoarthritis (OA), is rapidly expanding, despite only low-level evidence to support its use. Centers offering these therapies are often marketing and charging patients out-of-pocket costs for such services. Therefore, the purpose of this study was to determine the current marketed: (1) prices and (2) clinical efficacy of stem-cell therapies for knee OA. This was a prospective cross-sectional study which queried 317 U.S. centers that offered direct-to-consumer stem-cell therapies for musculoskeletal conditions. A total of 273 of 317 centers were successfully contacted via phone or e-mail, using a simulated 57-year-old male patient with knee OA. Scripted questions were asked by the simulated patient to determine the marketed prices and clinical efficacy. Centers generally reported the proportion of patients who had “good results” or “symptomatic improvement.” The mean price of a unilateral (same-day) stem-cell knee injection was $5,156 with a standard deviation of $2,446 (95% confidence interval [CI]: $4,550–5,762, n = 65). The mean proportion of claimed clinical efficacy was 82% with a standard deviation of 9.6% (95% CI: 79.0–85.5%, n = 36). Most American stem-cell centers offer therapies for knee OA. The cost of these therapies averages about $5,000 per injection, and centers claim that 80% of the patients had “good results” or “symptomatic improvement,” denoting a gap between what is documented in the published literature and the marketing claims. These findings offer both patients and physicians insight into the current stem-cell market for knee OA. We hope that with this information, providers can more optimally make patients aware of discrepancies between what is being marketed versus the current evidence-based landscape of these therapies for knee OA.

scholarly journals AB0878 THE COMPARISON EFFECTS OF INTRA-ARTICULAR INJECTION OF PLATELET RICH PLASMA (PRP), PLASMA RICH IN GROWTH FACTOR (PRGF), HYALURONIC ACID (HA), AND OZONE IN KNEE OSTEOARTHRITIS; A ONE YEAR RANDOMIZED CLINICAL TRIAL

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1744.3-1745
Author(s):  
S. A. Raeissadat ◽  
P. Ghazi Hosseini ◽  
M. H. Bahrami ◽  
R. Salman Roghani ◽  
M. Fathi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Knee Osteoarthritis ◽  
Randomized Clinical Trial ◽  
Platelet Rich Plasma ◽  
Therapeutic Effects ◽  
Short Term ◽  
Knee Oa ◽  
The Mean

Background:Knee osteoarthritis (OA) as a common progressive degenerative condition is one of the most important leading causes of disability and relative dependence. Worldwide prevalence of symptomatic knee OA has estimated 3.8%. It affects more than 20% of over 45-year-old population. Among the minimally invasive methods recommended for knee OA management is intra-articular injections for which a large array of products have been used. Despite all the existing options, there is still no general consensus on the choice and priority of the best intra-articular injection in knee osteoarthritis.Objectives:Our study compare the short and long-term efficacy of the intra articular injections (IAIs) of hyaluronic acid (HA), platelet-rich plasma (PRP), plasma rich in growth factors (PRGF), and ozone in patients with knee osteoarthritis (OA).Methods:In this single-blinded randomized clinical trial, 238 patients with mild to moderate knee OA were randomized into4 groups of IAIs: HA (3 doses weekly), PRP (2 doses with 3 weeks interval), PRGF (2 doses with 3 weeks interval), and Ozone (3 doses weekly). Our outcome measures were the mean changes from baseline until 2,6, and 12 months post intervention in scores of visual analog scale, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Lequesne index.Results:A total of 200 patients enrolled final analysis. The mean age of patients was 56.9 ± 6.3 years, and69.5% were women. In 2 months follow up, significant improvement of pain, stiffness, and function were seen in all groups compared to the baseline, but the ozone group had the best results(P<0.05). In 6 month follow up HA, PRP, and PRGF groups demonstrated better therapeutic effects in all scores in comparison with ozone (P<0.05).At the end of the 12th month, only PRGF and PRP groups had better results versus HA and ozone groups in all scores (P<0.05).Despite the fact that ozone showed better early results, its effects begin to wear off earlier than other products and ultimately disappear in 12 months.Conclusion:Ozone injection had rapid effects and better short-term results after 2 months, but its therapeutic effects did not persist after 6 months and at the 6-month follow up, PRP,PRGF and HA were superior to ozone. Only patients in PRP and PRGF groups improved symptoms persisted for 12 months. Therefore, these products could be the preferable choices for long-term management.References:[1]Wang-Saegusa A, Cugat R, Ares O, Seijas R, Cuscó X, Garcia-Balletbó M. Infiltration of plasma rich in growth factors for osteoarthritis of the knee short-term effects on function and quality of life. Archives of orthopaedic and trauma surgery. 2011;131(3):311-7.[2]De La Mata J. Platelet rich plasma.A new treatment tool for the rheumatologist?ReumatologíaClínica (English Edition). 2013;9(3):166-71.[3]Raeissadat SA, Rayegani SM, Sedighipour L, Bossaghzade Z, Abdollahzadeh MH, Nikray R, et al. The efficacy of electromyographic biofeedback on pain, function, and maximal thickness of vastus medialis oblique muscle in patients with knee osteoarthritis: a randomized clinical trial. Journal of pain research. 2018;11:2781.[4]Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, et al. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States: Part II. Arthritis & Rheumatism. 2008;58(1):26-35.[5]Tehrani-Banihashemi A, Davatchi F, Jamshidi AR, Faezi T, Paragomi P, Barghamdi M. Prevalence of osteoarthritis in rural areas of I ran: a WHO-ILAR COPCORD study. International journal of rheumatic diseases. 2014;17(4):384-8.[6]Rayegani SM, Raeissadat SA, Heidari S, Moradi-Joo M. Safety and effectiveness of low-level laser therapy in patients with knee osteoarthritis: a systematic review and meta-analysis. Journal of lasers in medical sciences. 2017;8(Suppl 1):S12.Disclosure of Interests:None declared

scholarly journals Long-Term (1-Year) Safety and Efficacy of a Single 6-mL Injection of Hylan G-F 20 in Indian Patients with Symptomatic Knee Osteoarthritis

2014 ◽  
Vol 8 (1) ◽  
pp. 54-68 ◽  
Author(s):  
Sarvajeet Pal ◽  
Sreedhar Thuppal ◽  
K.J Reddy ◽  
Sachin Avasthi ◽  
Anish Aggarwal ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Knee Osteoarthritis ◽  
Medication Use ◽  
Treatment Phase ◽  
Safety And Efficacy ◽  
Knee Oa ◽  
Indian Patients ◽  
Symptomatic Knee Osteoarthritis ◽  
Symptomatic Knee

Introduction: The prevalence of symptomatic knee osteoarthritis (OA) among Asians ≥65 years is estimated to double by 2040. This study was designed to evaluate the safety and efficacy of a single, 6-mL intra-articular injection of hylan G-F 20 in Indian patients with knee OA at 26 weeks through to 52 weeks. Methods: This study was an open-label, multicentre, phase 4 clinical trial. Enrolled patients (N=394) were ≥30 years old with Kellgren-Lawrence grade 1–3 OA; all patients received hylan G-F 20. WOMAC, SF-12, PTGA, and COGA scores, and OA medication use were evaluated at weeks 1, 4, 12, 26, 39, and 52 (initial treatment phase). At 26, 39, or 52 weeks, eligible patients could participate in a repeat treatment phase. McNemar-Bowkers, paired t-tests and ANOVA analyses were performed (alpha=0.05). Results: At 26 weeks, statistically significant changes from baseline were observed in all efficacy parameters, including the primary efficacy endpoint of WOMAC A1 (p<0.0001). Improvements continued for 52 weeks. No significant changes occurred in concomitant medication use. Eleven patients (2.8%) were re-injected at week 26 or 52. After repeat injection, statistically significant decreases were observed in WOMAC A1, WOMAC C and PTGA scores (p≤0.028). Twenty-three (5.8%) patients reported 26 local target knee AEs. Conclusion: Among Indian patients within this study, a 6-mL hylan G-F 20 injection was well tolerated and effective in treating symptomatic knee OA with significant long-term (1 year) improvement of outcomes. When needed, repeat treatment was safe and efficacious for 4 weeks. Trial Registration: Clinical Trial Registry of India (CTRI/2010/091/000052) www.ctri.nic.in/Clinicaltrials/login.php.

THE EFFECT OF A TRIPOD CANE ON THE FUNCTIONAL MOBILITY OF PATIENTS WITH KNEE OSTEOARTHRITIS

2020 ◽  
Vol 5 (1) ◽  
pp. 29
Author(s):  
Nelson Sudiyono
Keyword(s):  
Knee Osteoarthritis ◽  
Cross Sectional Study ◽  
Functional Mobility ◽  
Cross Sectional ◽  
Knee Oa ◽  
Walking Aids ◽  
Symptomatic Knee Osteoarthritis ◽  
Symptomatic Knee ◽  
Contralateral Hand ◽  
Painful Knee

Background: Canes have been recommended as walking aids for knee osteoarthritis to reduce the loading on the affected knee. Patients are usually recommended to hold the cane in the contralateral hand to the affected knee. Nevertheless, some patients prefer to hold the cane ipsilateral to the affected knee. However, the effect of using ipsilateral or contralateral tripod cane on functional mobility in patients with knee osteoarthritis is still unknown Objective: To compare the immediate effect of ipsilateral and contralateral tripod cane usage on functional mobility in patients with symptomatic knee osteoarthritis Method: This cross-sectional study involved 30 overweight or obese patients with symptomatic unilateral or bilateral knee osteoarthritis (Kellgren Lawrence grade 2 and 3) who never use a cane. Functional mobility was evaluated with Time Up and Go test in three conditions; without walking aid, with tripod cane contralateral and ipsilateral to the more painful knee. Results: The TUG time of aid-free walking is 4.75 (p < 0.001, 95% CI 3.79 - 5.71) seconds faster than ipsilateral cane use and 6.69 (p < 0.001, 95%CI 5.35 - 8.03) seconds faster than contralateral cane use. The TUG time of ipsilateral cane use is 1,94 (95% CI, 1.13 - 2.79) seconds faster than contralateral. Conclusion: Patients with symptomatic knee OA who use tripod cane ipsilateral to the more painful knee have higher functional mobility than the contralateral.

scholarly journals Efficacy and safety of early target-controlled plasma volume replacement with a balanced gelatine solution versus a balanced electrolyte solution in patients with severe sepsis/septic shock: study protocol, design, and rationale of a prospective, randomized, controlled, double-blind, multicentric, international clinical trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Gernot Marx ◽  
Kai Zacharowski ◽  
Carole Ichai ◽  
Karim Asehnoune ◽  
Vladimír Černý ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Septic Shock ◽  
Severe Sepsis ◽  
Plasma Volume ◽  
Volume Replacement ◽  
Efficacy And Safety ◽  
Volume Responsiveness ◽  
Double Blind ◽  
Link Type ◽  
Icu Discharge

Abstract Background Sepsis is associated with capillary leakage and vasodilatation and leads to hypotension and tissue hypoperfusion. Early plasma volume replacement is required to achieve haemodynamic stability (HDS) and maintain adequate tissue oxygenation. The right choice of fluids to be used for plasma volume replacement (colloid or crystalloid solutions) is still a matter of debate, and large trials investigating the use of colloid solutions containing gelatine are missing. This study aims to investigate the efficacy and safety of plasma volume replacement using either a combined gelatine-crystalloid regime (1:1 ratio) or a pure crystalloid regime. Methods This is a prospective, controlled, randomized, double-blind, international, multicentric phase IV study with two parallel groups that is planned to be conducted at European intensive care units (ICUs) in a population of patients with hypovolaemia in severe sepsis/septic shock. A total of 608 eligible patients will be randomly assigned to receive either a gelatine-crystalloid regime (Gelaspan® 4% and Sterofundin® ISO, B. Braun Melsungen AG, in a 1:1 ratio) or a pure crystalloid regime (Sterofundin® ISO) for plasma volume replacement. The primary outcome is defined as the time needed to achieve HDS. Plasma volume replacement will be target-controlled, i.e. fluids will only be administered to volume-responsive patients. Volume responsiveness will be assessed through passive leg raising or fluid challenges. The safety and efficacy of both regimens will be assessed daily for 28 days or until ICU discharge (whichever occurs first) as the secondary outcomes of this study. Follow-up visits/calls will be scheduled on day 28 and day 90. Discussion This study aims to generate evidence regarding which regimen—a gelatine-crystalloid regimen or a pure crystalloid regimen—is more effective in achieving HDS in critically ill patients with hypovolaemia. Study participants in both groups will benefit from the increased safety of target-controlled plasma volume replacement, which prevents fluid administration to already haemodynamically stable patients and reduces the risk of harmful fluid overload. Trial registration The European clinical trial database EudraCT 2015-000057-20 and the ClinicalTrials.gov Protocol Registration and Results System ClinicalTrials.gov NCT02715466. Registered on 17 March 2016.

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).

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