scholarly journals Treatment Efficacy with a Novel Hyaluronic Acid-Based Hydrogel for Osteoarthritis of the Knee

2021 ◽  
Vol 11 (4) ◽  
pp. 303
Author(s):  
Octav Marius Russu ◽  
Tudor Sorin Pop ◽  
Andrei Marian Feier ◽  
Cristian Trâmbițaș ◽  
Zsuzsanna Incze-Bartha ◽  
...  

Background: Prior trials investigating the treatment of symptomatic osteoarthritis (OA) with hyaluronic-acid-derived products injections have provided optimistic results. The study was directed to assess the effectiveness of an innovative hyaluronic-acid-based hydrogel (Hymovis®) in the treatment of symptomatic knee OA. Methods: A prospective, single-center, clinical trial was performed. Thirty-five patients with degenerative knee OA were included. Inclusion criteria were: age between 45–80, radiographic Kellgren grade II or III osteoarthritis, minimum 35 mm score on the Visual Analogue Scale (VAS), pain for at least 6 months and agreement to participate in the study. Patients received two injections at a one-week interval. The evaluator assessed the patients using the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) and VAS. Evaluation was performed before, at 2 and 6 months after the injections. Results: A significant improvement on the WOMAC Index pain subscale was observed at 6 months after the injection. At two months, pain subscale score decreased from 10.34 to 9.34. At six months, a significant decrement in pain parameters compared to baseline was observed (from 10.34 to 7.72; p = 0.0004). Median points on VAS significantly ameliorated after 6 months (from 74.2 to 57.3 cm; p < 0.0001). Regarding physical function, a statistically significant difference compared to baseline was observed at the end of the study (from 29.74 to 25.18; p = 0.0025). WOMAC Index stiffness component did not differ from baseline at any time during follow-up. Conclusions: Pain relief installed with a delayed on-set but had a prolonged duration. The novel hyaluronic acid-based hydrogel (Hymovis®) had effective results, particularly after six months post-injections and offers a therapeutic advancement in the treatment of moderate to severe osteoarthritis.

2020 ◽  
Vol 28 (4) ◽  
pp. 31-35
Author(s):  
Muthanna Abdul Razaq ◽  
Anmar Ahmed Qasim ◽  
Thamer Mohammed Assim ◽  
Ramzi Ramzi

The study aimed to determine the effectiveness of monthly intra-articular injection of combination of PRP and hyaluronic acid in improvement of outcome of knee OA. It was conducted as open clinical trial on a convenient sample of 17 patients with unilateral or bilateral symptomatic knee OA in rheumatology and orthopedic clinics at Al-Jumhoori Teaching Hospital in Mosul, Iraq during 1st of Jan to 30th Jun, 2018. The patients received intra-articular injection of combination of plate rich plasma (PRP) and hyaluronic acid (HA) monthly for three months. The outcome assessment was carried out 4 weeks after the last injection using WOMAC index. The results revealed that WOMAC index subscales was reduced significantly (p <0.001) after treatment by followings mean differences: 3.88 in pain (95% CI: 3.18-4.58); 1.29 in stiffness (95% CI: 0.85-1.73); 9.29 in physical function (95% CI: 6.70-11.88); and 14.47 in total score (95% CI: 11.20-17.73). The intervention effect size were as follows: 1.23 in pain; 1.49 in stiffness; 1.11 in physical function, and 1.20 in total WOMAC score. Overall, effect size of combination of PRP and HA intra-articular injection is classified as large effect size (> 0.8) in improving outcome of knee OA. A combination of PRP and HA has large synergistic effect size in improving outcome of moderate and severe OA of knee.


2021 ◽  
Vol 11 (18) ◽  
pp. 8711
Author(s):  
Dalila Scaturro ◽  
Fabio Vitagliani ◽  
Pietro Terrana ◽  
Daniele Cuntrera ◽  
Vincenzo Falco ◽  
...  

Background: A BMI > 25 is the most decisive, albeit modifiable, risk factor for knee osteoarthritis (KOA). This study aimed at assessing the efficacy of intra-articular injections of hybrid hyaluronic acid (HA) complexes (Sinovial® H-L) for the treatment of KOA in overweight patients in terms of disease severity, cardiocirculatory capacity, and quality of life. Materials: In this single-site, open-label, prospective trial, 37 patients with symptomatic knee OA were assessed at baseline and 3 months after ultrasound-guided intra-articular injection of hybrid HA complexes (Sinovial® H-L). Results: Primary variables displaying a statistically significant improvement after treatment were pain (VAS), disease severity (WOMAC), and cardiopulmonary capacity (6 min walk test). Among secondary variables, quality of life (SF-12) improved significantly, as did analgesic intake for pain control. No statistically significant difference was observed in body fat and muscle mass percentage measured by bioelectrical impedance analysis. Conclusions: Intra-articular hybrid HA injections are significantly effective in improving OA-related disease severity, cardiopulmonary function, and analgesic intake. This supports the role of hybrid HA viscosupplementation as a nonpharmacological treatment to relieve pain, reduce disability, improve quality of life, and limit the risk of polypharmacy in overweight patients with knee OA.


2021 ◽  
Author(s):  
Haoyang Wang ◽  
Wei Wang ◽  
Yongsheng Xu ◽  
Jianan Li ◽  
Kang Liu ◽  
...  

Abstract BackgroundIntra-articular injection of hyaluronic acid (HA) has favorable effects on pain relief and knee function along with the low incidence of serious adverse reactions. Although various HA products are available for the treatment of knee osteoarthritis, it is still controversial whether differences in HA products have any clinically significant difference in efficacy and safety. In light of the above, the efficacy and safety of intra-articular injection of biological fermentation–derived high-molecular-weight HA (NRD101) was investigated in a double-blind comparative manner in Chinese patients with knee osteoarthritis.MethodA multicenter, prospective, randomized, double-blind, parallel, active control, non-inferiority study was conducted in Chinese patients with knee osteoarthritis. Patients were randomized to receive five consecutive weekly injections of either NRD101 or Artz (a non-crosslinked low-molecular-weight HA derived from combs of roosters) followed by 4 weeks follow-up. The primary efficacy endpoint was the change from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) NRS pain subscale score at Week 5. Secondary efficacy endpoints included WOMAC stiffness and physical function subscale score, local pain, range of joint motion, and overall improvement.ResultsAmong 267 randomized patients, 259 patients completed the study. The change from baseline in WOMAC NRS pain subscale score at Week 5 was −2.98 ± 0.193 in the NRD101 group and −2.66 ± 0.194 in the Artz group, and the trial met the non-inferiority criteria. Efficacy in the NRD101 group tended to be consistently higher than in the Artz group for most items of WOMAC. Several subgroup analyses also showed differences between the two groups, tending to favor NRD101. Adverse events were seen in 26.0% (34/131) of patients in the NRD101 group and 38.3% (51/133) in the Artz group.ConclusionsNRD101 improved knee pain in Chinese patients with osteoarthritis after five consecutive weekly injections. NRD101 tended to be somewhat more effective than Artz. No new safety concerns were identified.Trial registration: JapicCTI, JapicCTI-173531. Registered 10 March 2017, https://www.clinicaltrials.jp/cti-user/trial/Search.jsp


2010 ◽  
Vol 37 (3) ◽  
pp. 650-655 ◽  
Author(s):  
JEANNIE CHAO ◽  
CHRISTOPHER WU ◽  
BOB SUN ◽  
MICHAL KALLI HOSE ◽  
ANNA QUAN ◽  
...  

Objective.To assess whether inflammation on ultrasound is predictive of clinical response to intraarticular (IA) corticosteroid injections in patients with knee osteoarthritis (OA).Methods.Patients with symptomatic knee OA were randomized to receive either an IA injection of 40 mg triamcinolone acetonide in the treatment group or 1 cc 0.9% saline in the placebo group. Clinical response was assessed by changes in baseline Western Ontario and McMaster Universities (WOMAC) index scores and physician global assessment at 4 and 12 weeks. Ultrasounds were performed at each visit. Patients and assessors were blinded to treatment status.Results.Seventy-nine patients were enrolled into the study. Four-week data were available for 67 patients in the primary analysis comparing change in WOMAC pain score from baseline to 4 weeks. There was almost no change in the WOMAC pain subscale score from baseline to 4 weeks in the control group, but there was a significant improvement in WOMAC pain subscale score from 10.8 (SD ± 3.2) at baseline to 8.75 (SD ± 4.0) at 4 weeks in the treatment group (adjusted p = 0.001). Of the 34 patients in the treatment group; 16 (47%) had inflammatory disease and 18 (53%) had noninflammatory disease as determined by ultrasound. There was no difference in the change in WOMAC pain score between the inflammatory and noninflammatory patients in the treatment group at 4 weeks. There was a statistically significant greater improvement in pain subscale scores among noninflammatory patients than among inflammatory patients at 12 weeks.Conclusion.Intraarticular corticosteroid injections are an effective short-term treatment for symptomatic knee OA compared to placebo. Patients with noninflammatory characteristics on ultrasound had a more prolonged benefit from IA corticosteroids compared to inflammatory patients.


KYAMC Journal ◽  
2017 ◽  
Vol 7 (2) ◽  
pp. 750-757
Author(s):  
Md Firoze Hasan ◽  
Muhammad Alamgir Mandal ◽  
Md Afzalur Rahman ◽  
Mohammad Moniruzzaman ◽  
Md Jahidul Islam ◽  
...  

Background: Osteoarthritis (OA) is the most common form of arthritis accounting for about 30% of general physician visits. Objectives: To detect the effects of ultrasound therapy on patients with osteoarthritis of the knee joint.Methodology: It was a prospective non randomized clinical study, conducted in the Department of Physical Medicine and Rehabilitation, Bangabandhu Sheikh Mujib Medical University, Shahbagh, Dhaka during the periods of 1st March, 2012 to 31st August, 2012. Fifty four patients between 35-75 years of age without consideration of gender with a history of not less than three months knee pain with radiographic confirmation of primary osteoarthritis were selected purposefully. Then they were divided randomly in group A & group B. Group A received g NSAID [Aceclofenac 100mg B.D.-10 days]+Omeprazol (20mg B.D.-10days) + Therapeutic exercise + ADL and Group B received gUST+NSAID [Aceclofenac 100mg B.D.-10 days]+ Omeprazol (20mg B.D.-10days) + Therapeutic exercise + ADL. In both groups the patients were observed for six weeks. Outcome measured by VAS, ROM, 50 feet walking time and WOMAC index.Results: Mean ± SD of age in group A and group B were 52.33 ± 9.62 years and 52.29 ± 9.67 years respectively. Among the 27 patients in group A 9 (33.3%) were male and 18 (66.7%) were female. Among the 27 patients in group B 10 (37.0%) were male and 18 (63.0%) were female. Mean ± SD of VAS during pre treatment in group A and group B were 6.22 ± 1.60 and 7.15 ± 1.56 respectively. Mean ± SD of ROM during pre treatment in group A and group B were 117.33 ± 13.05 and 112.37 ± 19.01 respectively. Mean ± SD of time taken to walk 50 feet during pre treatment in group A and group B were 18.22 ± 2.39 and 18.81 ± 2.13 minutes respectively. Mean ± SD of WOMAC index in group A and group B were 60.85 ± 15.86 and 67.33 ± 16.33 minutes respectively. After treatment in both groups VAS, time taken to walk 50 feet and WOMAC index gradually decreased and ROM gradually increased.Conclusion: Although the study conducted with small sample size in a single centre in Dhaka city which may not be representative for the whole country it was found that there was statistically significant difference found in VAS, ROM, and time taken to walk 50 feet and WOMAC index between the groups.KYAMC Journal Vol. 7, No.-2, Jan 2017, Page 750-757


2019 ◽  
Vol 32 (11) ◽  
pp. 1143-1154 ◽  
Author(s):  
Jack Farr ◽  
Andreas H. Gomoll ◽  
Adam B. Yanke ◽  
Eric J. Strauss ◽  
Katie C. Mowry ◽  
...  

AbstractPlacental-derived tissues are a known source of anti-inflammatory and immune modulating factors. Published pilot data on amniotic suspension allograft (ASA) for the treatment of osteoarthritis (OA) demonstrated safety and trends for improved pain and function. A multicenter randomized controlled trial was designed to evaluate the efficacy of symptom modulation with ASA compared with saline and hyaluronic acid (HA) in subjects with knee OA. A total of 200 subjects were randomized 1:1:1 to ASA, HA, or saline, with subjects blinded to their allocation. Changes from baseline of patient-reported outcomes (PROs)—EQ-5D-5L, Knee Osteoarthritis Outcome Score (KOOS), visual analog scale (VAS), Tegner, and Single Assessment Numerical Evaluation (SANE)—were compared between groups. Patients reporting unacceptable pain at 3 months were considered treatment failures and withdrawn from the study. Statistical analysis was completed by comparing changes in PROs from baseline to 3 and 6 months for all groups. Comparison of demographics between treatment groups showed no significant differences between groups. Patients reporting unacceptable pain at 3 months in each group were ASA (13.2%), HA (68.8%), and saline (75%). Patients receiving ASA demonstrated significantly greater improvements from baseline for overall pain (VAS), KOOS pain, and KOOS-activities of daily living scores compared with those in the HA group (3 months) and both groups (6 months). ASA patients had significantly greater improvements in KOOS symptom scores compared with HA and saline at 3 and 6 months, respectively. OMERACT-OARSI responder rates for ASA, HA, and saline groups were 69.1, 39.1, and 42.6%, respectively (p = 0.0007). Subjects receiving ASA treatment showed greater improvements in PROs and fewer patients reported unacceptable pain compared with HA and saline. The evidence presented in this Level I Randomized Controlled Trial suggests that ASA injection is an effective treatment for the nonoperative management of symptomatic knee OA.


2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Adesola C. Odole ◽  
Oluwatobi D. Ojo

This study investigated effect of a 6-week telephysiotherapy programme on quality of life (QoL) of patients with knee osteoarthritis (OA). Fifty patients with knee OA were randomly and equally assigned into two treatment groups: clinic group (CG) and telephysiotherapy group (TG). The CG received physiotherapist-administered osteoarthritis-specific exercises in the clinic thrice weekly for 6 weeks while the TG received structured telephone monitoring with self-administered osteoarthritis-specific exercises for the same duration at home. Participants’ QoL was assessed using WHOQoL-Bref at baseline, second, fourth, and sixth week of intervention. Data were analyzed using ANOVA and independent Student’st-test. Within-group comparison showed significant improvements in physical health domain (P=0.00*for TG and CG) and psychological domain (P=0.02*for TG;P=0.00*for CG) of WHOQoL following six-week intervention. However, there were no significant differences (P>0.05) in TG and CG’s social relationship and environment domains. Between-group comparison showed no significant differences (P>0.05) between CG and TG’s physical health, psychological, and social relationships domains of WHOQoL following 6-week intervention. However, there was significant difference in the environment domain (P<0.05). Telephysiotherapy using telephone medium improved QoL in patients with knee OA comparable to clinic based treatment.


2016 ◽  
Vol 6 (1) ◽  
Author(s):  
Regina WS Sit ◽  
Vincent CH Chung ◽  
Kenneth D. Reeves ◽  
David Rabago ◽  
Keith KW Chan ◽  
...  

Abstract Hypertonic dextrose injections (prolotherapy) is an emerging treatment for symptomatic knee osteoarthritis (OA) but its efficacy is uncertain. We conducted a systematic review with meta-analysis to synthesize clinical evidence on the effect of prolotherapy for knee OA. Fifteen electronic databases were searched from their inception to September 2015. The primary outcome of interest was score change on the Western Ontario and McMaster Universities Arthritis Index (WOMAC). Three randomized controlled trials (RCTs) of moderate risk of bias and one quasi–randomized trial were included, with data from a total of 258 patients. In the meta-analysis of two eligible studies, prolotherapy is superior to exercise alone by a standardized mean difference (SMD) of 0.81 (95% CI: 0.18 to 1.45, p = 0.012), 0.78 (95% CI: 0.25 to 1.30, p = 0.001) and 0.62 (95% CI: 0.04 to 1.20, p = 0.035) on the WOMAC composite scale; and WOMAC function and pain subscale scores respectively. Moderate heterogeneity exists in all cases. Overall, prolotherapy conferred a positive and significant beneficial effect in the treatment of knee OA. Adequately powered, longer-term trials with uniform end points are needed to better elucidate the efficacy of prolotherapy.


2021 ◽  
Vol 12 ◽  
Author(s):  
Nicola Veronese ◽  
Sinisa Stefanac ◽  
Ai Koyanagi ◽  
Nasser M. Al-Daghri ◽  
Shaun Sabico ◽  
...  

Recent literature suggests that sarcopenia, often represented by low lower limbs muscle mass and strength, can be considered a potential risk factor for knee osteoarthritis (OA), but the available literature is still limited. We therefore aimed to investigate whether sarcopenia is associated with a higher risk of radiographic (ROA) and symptomatic knee OA (SxOA) in a large cohort of North American people in the context of the OA initiative. Sarcopenia at baseline was diagnosed in case of low skeletal muscle mass (i.e., lower skeletal mass index) and poor performance in the chair stands test. The outcomes of interest for this study included ROA (radiographical osteoarthritis) if a knee developed a Kellgren and Lawrence (KL) grade ≥2 at follow-up, and SxOA (symptomatic osteoarthritis) defined as new onset of a combination of painful knee OA. Altogether, 2,492 older participants (mean age: 68.4 years, 61.4% females) were included. At baseline, sarcopenia was present in 6.1% of the population. No significant difference in ROA prevalence was observed between those with and without sarcopenia (p=0.76), whilst people with sarcopenia reported a significant higher prevalence of SxOA (p&lt;0.0001). Using a logistic regression analysis, adjusting for potential confounders at baseline and the diagnosis of sarcopenia during follow-up, sarcopenia was associated with a higher incidence of knee SxOA (odds ratio, OR=2.29; 95%CI [confidence interval]: 1.42-3.71; p=0.001), but not knee ROA (OR=1.48; 95%CI: 0.53-4.10; p=0.45). In conclusion, sarcopenia could be associated with a higher risk of negative knee OA outcomes, in particular symptomatic forms.


Cartilage ◽  
2019 ◽  
pp. 194760351988878
Author(s):  
Larry E. Miller ◽  
Samir Bhattacharyya ◽  
William R. Parrish ◽  
Michael Fredericson ◽  
Brad Bisson ◽  
...  

Objective The objective of this systematic review and meta-analysis was to report the safety of intra-articular hyaluronic acid (IAHA) in patients with symptomatic knee osteoarthritis (OA). Methods We identified randomized controlled trials reporting the safety of IAHA versus IA saline in adults with symptomatic knee OA. Main safety outcomes were adverse events (AEs), local AEs, serious adverse events (SAEs), study withdrawals, and AE-related study withdrawals. Results A total of 35 randomized controlled trials with 38 group comparisons comprising 8,078 unique patients (IAHA: 4,295, IA saline: 3,783) were included in the meta-analysis. Comparing IAHA with IA saline over a median of 6 months follow-up, there were no differences in the risk of AEs (42.4% vs. 39.7%, risk ratio [RR] = 1.01, 95% CI = 0.96-1.07, P = 0.61), SAEs (1.8% vs. 1.2%, RR = 1.44, 95% CI = 0.91-2.26, P=0.12), study withdrawals (12.3% vs. 12.7%, RR = 0.99, 95% CI = 0.87-1.12, P = 0.83), or AE-related study withdrawals (2.7% vs. 2.1%, RR = 1.37, 95% CI = 0.97-1.93, P = 0.08). Local AEs, all of which were nonserious, were more common with IAHA vs. IA saline (14.5% vs. 11.7%, RR = 1.21, 95% CI = 1.07-1.36, P = 0.003) and typically resolved within days. Conclusion IAHA was shown to be safe for use in patients with symptomatic knee OA. Compared with IA saline, IAHA is associated with an increased risk of nonserious, transient local reactions. There was no evidence to suggest any additional safety risks of IAHA.


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