scholarly journals Safety and efficacy of single CHAP Hyaluronan injection versus three injections of linear Hyaluronan in pain relief for knee osteoarthritis: a prospective, 52-week follow-up, randomized, evaluator-blinded study

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Teng-Le Huang ◽  
Chun-Hao Tsai
Keyword(s):  
Hyaluronic Acid ◽  
Pain Relief ◽  
Adverse Events ◽  
Knee Osteoarthritis ◽  
Pain Score ◽  
Single Injection ◽  
Analysis Of Covariance ◽  
Knee Oa ◽  
Link Type ◽  
Pain Scores

Abstract Background The hyaluronic acid (HA) injections are widely used in knee osteoarthritis (OA) patients. We conducted the study comparing the efficacy and safety of single injection of Crosslinked Hyaluronic Acid Platform Hyaluronan (CHAP-HA) with 3-injection of linear hyaluronan in knee OA patients. Methods This was a randomized two-arms, evaluator-blinded, controlled, single-center study. Participants with knee OA received single CHAP-HA or three-injection of linear-HA. The 140 patients aged 35–85 years with radiographically confirmed knee OA were enrolled. At week 4, 12, 26, 39, and 52, visual analog scale (VAS) pain score, Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index, timed up and go (TUG) and subject’s adverse events (AE) of these 2 groups were recorded. Primary outcome of the differences of VAS pain score at week 26 between groups was analyzed with analysis of covariance (ANCOVA). At week 52, those who met the inclusion criteria could receive a CHAP-HA injection and being followed-up for the adverse events for 4 weeks. Results The trial was conducted from September 2015 to April 2017. A total 140 subjects were available for analysis (71 in the CHAP-HA group and 69 in the linear-HA group). At 26th week, there were significant more improvements in VAS pain scores in CHAP-HA compared with linear-HA. Both CHAP-HA and linear-HA showed significant improvements in the VAS pain score at week 26 compared with the baseline, and the occurrence of adverse events during the study period showed no between-group difference. In subjects with KL = 2, both groups showed significant improvements in VAS pain scores within 26 weeks. In patients with KL = 3, only CHAP-HA group showed significant improvement in VAS pain from 4 to 39 weeks. No unexpected or severe AEs were reported. Conclusions A single injection of CHAP-HA may be safe and more effective for 26 weeks in patients with knee OA by comparing to linear-HA; moreover, the pain relief effect of CHAP-HA may remain until 52 weeks. For patients with more severe OA, CHAP-HA was demonstrated to be more preferable to relieve OA pain. Furthermore, repeat treatment of CHAP-HA or using CHAP-HA after a three-injection HA was proved to be safe. Trial registration ClinicalTrials.gov: NCT03643588. Date: August 23, 2018 (retrospectively registered). Level of Evidence: Therapeutic Level I.

scholarly journals Randomised, double-blind comparison of a fixed co-formulation of intra-articular polynucleotides and hyaluronic acid versus hyaluronic acid alone in the treatment of knee osteoarthritis: two-year follow-up

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Cesare Stagni ◽  
Martina Rocchi ◽  
Alessandro Mazzotta ◽  
Nicolandrea Del Piccolo ◽  
Nicola Rani ◽  
...  
Keyword(s):  
Hyaluronic Acid ◽  
Knee Osteoarthritis ◽  
Treatment Cycle ◽  
Fixed Combination ◽  
Knee Function ◽  
First Year ◽  
Double Blind ◽  
Knee Oa ◽  
Link Type ◽  
Point Reduction

Abstract Background A first-year interim analysis of this two-year study suggested that intra-articular injections of highly purified, natural-origin polynucleotides and hyaluronic acid (HA) as a fixed combination (PNHA) might improve knee function and joint pain more effectively than HA alone in patients with knee osteoarthritis (OA). The purpose of the second-year analysis herein described was to verify whether the first-year interim outcomes persist over the whole two-year period. Methods Randomised, double-blind, HA-controlled clinical trial in 100 knee OA patients (98 randomised, 79 completing the study) in a high-specialisation tertiary care setting. The hypothesised difference of efficacy between PNHA and HA for the original sample size estimate is 20%. Treatment cycle: three intra-articular knee injections of either PNHA or HA, at baseline and weekly for two weeks. Evaluations: Western Ontario and McMaster Universities (WOMAC) score and Knee Society Score (KSS) as, respectively, primary and secondary endpoints, evaluated at baseline and after 2, 6, 12, and 24 months; synovial fluid levels of mediators (at baseline and the end of the treatment cycle). Adverse effects investigated at each control visit. Statistical analysis: Kruskal-Wallis test for independent samples (nonparametric one-way analysis of variance) after correction of means for age, Body Mass Index and Kellgren-Lawrence grade. If significant, pairwise post-hoc Sidak multiple comparisons. Results KSS total score and KSS pain item: significant improvement in both groups, with significantly more pain improvement in patients treated with PNHA (2-point reduction) than HA (1-point reduction). Both groups experienced significant long-term reductions in WOMAC total scores: significantly stronger in PNHA-treated patients after 24 months with a steady difference of 16% favouring PNHA in WOMAC pain subscore. No clinically significant adverse events in either group. Conclusions The outcomes of the 2-year study confirmed that a short cycle of intra-articular treatment (3 weekly double-blind injections) with polynucleotides (long-acting viscosupplementation properties, chondrocyte activation, pain-relieving properties) in fixed combination with high molecular weight hyaluronic acid is more effective in improving knee function and pain in knee OA patients than HA alone. PNHA may be elective for viscosupplementation in knee OA patients with fastidious and resistant pain and worsening disease. Trial registration NCT02417610. Registration, 15/04/2015. ClinicalTrials.gov database link:

Safety of Intra-Articular Hyaluronic Acid for Knee Osteoarthritis: Systematic Review and Meta-Analysis of Randomized Trials Involving More than 8,000 Patients

Cartilage ◽  
2019 ◽  
pp. 194760351988878
Author(s):  
Larry E. Miller ◽  
Samir Bhattacharyya ◽  
William R. Parrish ◽  
Michael Fredericson ◽  
Brad Bisson ◽  
...  
Keyword(s):  
Systematic Review ◽  
Hyaluronic Acid ◽  
Adverse Events ◽  
Knee Osteoarthritis ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Knee Oa ◽  
Randomized Controlled ◽  
Symptomatic Knee

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.

scholarly journals Risk of Severe Acute Localized Reactions for Different Intraarticular Hyaluronic Acid Knee Injections in a Real-World Setting

Cartilage ◽  
2021 ◽  
pp. 194760352110258
Author(s):  
Kevin L. Ong ◽  
Jack Farr ◽  
Andrew S. Gudeman ◽  
Iain R. Murray ◽  
Louis F. McIntyre ◽  
...  
Keyword(s):  
Hyaluronic Acid ◽  
Knee Osteoarthritis ◽  
Single Injection ◽  
Case Reports ◽  
Clear Correlation ◽  
Multiple Injection ◽  
Incision And Drainage ◽  
Weekly Injection ◽  
Knee Oa ◽  
Real World Setting

Objective: Case reports of severe acute localized reactions (SALR) following intraarticular (IA) hyaluronic acid (HA) injections for knee osteoarthritis (OA) have been described. We compared surrogate SALR measures between patients using hylan G-F 20 and specific non-hylan G-F 20 HA products. Design: Knee OA patients were identified from the Optum Clinformatics dataset (January 2006 to June 2016), stratified into hylan G-F 20 and non-hylan G-F 20 HA users, matched by single or multiple injection products. Occurrences of surrogate SALR measures including inflammation/infection, intraarticular corticosteroid (CS) injections, arthrocentesis/aspiration, arthrotomy/incision and drainage, and arthroscopy were evaluated within 3 days post-HA. Results: Based on 694,404 HA injections, inflammation/infection rate was rare within 3 days of HA (up to 0.03%), with no statistical differences between hylan G-F 20 and non-hylan G-F 20 groups (matched by single or multiple injection products). The risk of knee arthrotomy/incision and drainage, arthroscopy, or arthrocentesis for hylan G-F 20 (2 mL) 3 weekly injection patients was lower than Hyalgan/Supartz and Orthovisc patients, but greater than Euflexxa patients. Overall, we found that Hylan G-F 20 (2 mL) 3 weekly injection had lower SALR rates compared to Hyalgan/Supartz and Orthovisc. However, Hylan G-F 20 (2 mL) 3 weekly injection had slightly higher rates of SALR when compared to Euflexxa. Among the single injection products, Hylan G-F 20 (6 mL) single injection had lower rates of SALR than Monovisc and Gel-One. Conclusions: This study shows no clear correlation between avian-derived or cross-linked products and SALR and provides evidence against avian-derived products or crosslinking as a source for these reactions.

scholarly journals SAT0121 PAIN AND OTHER PATIENT-REPORTED OUTCOMES IN PATIENTS WITH RHEUMATOID ARTHRITIS WHO DID OR DID NOT ACHIEVE TREATMENT RESPONSE BASED ON IMPROVEMENT IN SWOLLEN JOINTS IN TOCILIZUMAB CLINICAL TRIALS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 994.2-995
Author(s):  
A. Sebba ◽  
J. Han ◽  
S. Mohan
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Pain Score ◽  
Patient Reported Outcomes ◽  
Component Score ◽  
Link Type ◽  
Pain Scores ◽  
Sf 36 ◽  
Patient Reported ◽  
Nonresponder Group

Background:Significant improvements in pain and other patient-reported outcomes (PROs) have been shown in large clinical trials in patients with rheumatoid arthritis (RA) who receive tocilizumab (TCZ) compared with placebo (PBO). Recent data suggest that pain in RA may be noninflammatory as well as inflammatory, and improvement in pain scores and other PROs may be seen in patients who do not respond to treatment based on disease activity measures that evaluate inflammation.Objectives:To assess changes in pain scores and other PROs in patients with RA who did or did not achieve ≥ 20% improvement in SJC in TCZ clinical trials.Methods:Data from patients with active RA who received intravenous TCZ 8 mg/kg + MTX or PBO + MTX in 3 Phase III studies (OPTION [NCT00106548], TOWARD [NCT00106574] and LITHE [NCT00109408]) were included. All patients had moderate to severe RA with an inadequate response or intolerance of MTX (OPTION, LITHE) or conventional synthetic disease-modifying antirheumatic drugs (csDMARDs; TOWARD). Changes in pain (visual analog scale [VAS], 0-100 mm), Health Assessment Questionnaire Disability Index (HAQ-DI, 0-3), 36-Item Short Form Survey (SF-36) physical component score (PCS) and mental component score (MCS; 0-50) and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score (0-52) from baseline to Week 24 were evaluated. Results were compared between patients receiving TCZ + MTX and those receiving PBO + MTX in both patients who achieved ≥ 20% improvement in SJC (responders) and those who did not (nonresponders). The changes from baseline were analyzed using a mixed model with repeated measures, including the following covariates and interactions: treatment, visit, baseline of endpoint, region, baseline DAS28 and interactions of visit with treatment and baseline of endpoint.Results:Data from 1254 responders (TCZ + MTX, n = 831; PBO + MTX, n = 423) and 620 nonresponders (TCZ + MTX, n = 225; PBO + MTX, n = 395) were included. Patients receiving TCZ + MTX had significantly greater improvement in pain scores and HAQ-DI compared with PBO + MTX in the responder group (–27.19 vs –16.77 and –0.55 vs –0.34, respectively;P< 0.0001 for both) and nonresponder group (–9.59 vs 2.53 and –0.20 vs 0.01;P< 0.0001 for both) at Week 24 (Figure 1). Similar results were seen at Week 16 in the nonresponder group (–11.06 vs –2.38 and –0.23 vs –0.04;P< 0.0001 for both) prior to initiation of rescue treatment. At Week 24 in the responder group, patients receiving TCZ + MTX had significantly greater improvements compared with PBO + MTX in SF-36 PCS and MCS (9.16 vs 5.71 and 6.55 vs 3.79, respectively;P< 0.0001 for both) (Figure 2) and FACIT-Fatigue (8.39 vs 5.11;P< 0.0001). In the nonresponder group, patients receiving TCZ + MTX had significantly greater improvements compared with PBO + MTX in SF-36 PCS at Week 16 (3.81 vs 1.65;P= 0.0006) and Week 24 (4.42 vs 1.01;P< 0.0001) (Figure 2) and FACIT-Fatigue at Week 16 (3.82 vs 1.32;P= 0.0039) and Week 24 (3.90 vs 1.40;P= 0.0111).Conclusion:Patients with RA who received TCZ + MTX had significantly greater improvements in pain score and other PROs than those who received PBO + MTX regardless of whether they achieved ≥ 20% improvement in SJC. Clinical outcome at Week 24 correlated well with PROs, with a relatively larger improvement in pain score and other PROs in the responder group than in the nonresponder group; relative to PBO + MTX, these improvements appear numerically similar in the responder and nonresponder groups with consistently smaller difference between the groups in TCZ-treated arms. The consistent effect of TCZ on PROs in both responder and nonresponder groups warrants further study on the impact of TCZ on sources of pain independent of that caused by joint inflammation.Figure:Acknowledgments:This study was sponsored by Genentech, Inc. Support for third-party writing assistance, furnished by Health Interactions, Inc, was provided by Genentech, Inc.Disclosure of Interests:Anthony Sebba Consultant of: Genentech, Gilead, Lilly, Regeneron Pharmaceuticals Inc., Sanofi, Speakers bureau: Lilly, Roche, Sanofi, Jian Han Shareholder of: Genentech, Inc., Employee of: Genentech, Inc., Shalini Mohan Shareholder of: Genentech, Inc., Employee of: Genentech, Inc.

scholarly journals AB0864 DO CORTICOSTEROIDS AND HYALURONIC ACID INJECTIONS CAUSE INFECTIONS? A SYSTEMATIC REVIEW OF LITERATURE ON ADVERSE EFFECTS AND INFECTION RATES OF INTRA-ARTICULAR CORTICOSTEROID AND HYALURONIC ACID INJECTIONS IN PATIENTS WITH KNEE OSTEOARTHRITIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1739.2-1739
Author(s):  
C. Hatzantonis
Keyword(s):  
Systematic Review ◽  
Hyaluronic Acid ◽  
Adverse Effects ◽  
Adverse Events ◽  
Knee Osteoarthritis ◽  
Adverse Reactions ◽  
Infection Rates ◽  
Management Options ◽  
Cochrane Reviews ◽  
Number Of Patients

Background:Knee osteoarthritis has been a leading cause of chronic pain and disability in our increasingly aging population. Conservative management options of physiotherapy and oral analgesics offer some relief, but delivery of intra-articular injections such as corticosteroids or hyaluronic acid has increasingly become the mainstay of pain management of knee osteoarthritis. In a clinical setting, intra-articular injections offer a means to delay a total knee replacement. Despite the abundance of literature on corticosteroids and hyaluronic acid, there is no known percentage of infection rates or adverse effects that clinicians may use to inform patients prior to obtaining consent for the injection.Objectives:To determine a rate of adverse events and infection rates in patients undergoing intra-articular injections of corticosteroids or hyaluronic acid.Methods:A systematic review of current literature including studies involving patients ranging from 45 patients (Carmona L, 2018) to Cochrane reviews of 1767 patients (Campbell Kirk, 2015). From these studies, the number of patients, adverse reactions (i.e. pain, erythema) and serious adverse reactions (infections) were calculated.Results:Within our study, there was a large variation of numbers of adverse effects of hyaluronic acid and corticosteroids amongst studies, with percentages as variable as 0-9.3%. Corticosteroids demonstrated 11-26% reduction of adverse events compared to hyaluronic acid. However, confidence intervals were found to not be statistically significant.Conclusion:Intra-articular injections of corticosteroids and hyaluronic acid, although deemed clinically effective, continue to demonstrate variable rates of adverse effects and infection amongst patients with progressive knee osteoarthritis.Disclosure of Interests:None declared

Synovitis is associated with constant pain in knee osteoarthritis: a cross-sectional study of OMERACT knee ultrasound scores

2021 ◽  
pp. jrheum.210285
Author(s):  
Holly T. Philpott ◽  
Trevor B. Birmingham ◽  
Ryan Pinto ◽  
Codie A. Primeau ◽  
Dominique Arsenault ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Multinomial Logistic Regression ◽  
Cross Sectional Study ◽  
Cross Sectional ◽  
Logistic Regression Models ◽  
Knee Oa ◽  
Pain Scores ◽  
Constant Pain ◽  
Secondary Analyses ◽  
Pain Experiences

Objective To examine the association between ultrasound (US)-detected knee inflammation and intermittent and constant pain experiences in patients with knee osteoarthritis (OA). Methods Participants with radiographically early- (KL ≤ 2) and late-stage (KL ≥ 3) disease and frequent symptoms underwent musculoskeletal US measures of inflammation using the OMERACT knee US scoring system. Pain experiences were captured using the Intermittent and Constant OA Pain (ICOAP) tool. We assessed the association between US-synovitis and ICOAP pain experiences using a series of linear, logistic, or multinomial logistic regression models (as appropriate for each variable), while adjusting for age, sex, body mass index (BMI), and radiographic stage. Secondary analyses were performed similarly by radiographic stage. Results Pain and synovitis measures from 248 patients (453 knees) were included. Worse synovitis was associated with higher ICOAP constant pain scores (β 8.05 [95%CI 0.67, 15.43]), but not intermittent pain scores. Moderate-to-severe synovitis was associated with a 4.73-fold increased relative risk [95%CI 1.06, 8.80] of a constant pain pattern. In secondary analyses, moderate-to-severe synovitis in early radiographic OA was associated with 2.70-higher odds [95%CI 1.04, 7.02] of any constant pain, 3.28-higher odds [95%CI 1.43, 7.52] of any intermittent pain, and with higher intermittent (β 10.47 [95%CI 1.03, 19.91]) and constant (β 12.62 [95%CI 3.02, 22.23]) pain scores. No associations identified for synovitis in those with late radiographic OA. Conclusion In patients with knee OA, moderate-to-severe synovitis is most strongly associated with constant pain. Inflammation may play context-specific roles across pain experiences, especially in earlier radiographic stages of knee OA.

scholarly journals Effect of Intra-articular Ketorolac Versus Corticosteroid Injection for Knee Osteoarthritis: A Retrospective Comparative Study

2020 ◽  
Vol 8 (4) ◽  
pp. 232596712091112
Author(s):  
Jianda Xu ◽  
Yuxing Qu ◽  
Huan Li ◽  
Aixiang Zhu ◽  
Tao Jiang ◽  
...  
Keyword(s):  
Pain Relief ◽  
Knee Osteoarthritis ◽  
Sodium Hyaluronate ◽  
Knee Oa ◽  
Symptomatic Knee ◽  
Group A ◽  
Successful Outcomes ◽  
Group B ◽  
Corticosteroid Injections

Background: Intra-articular corticosteroid injections have been widely used and are considered a mainstay in the nonoperative treatment of symptomatic knee osteoarthritis (OA). However, their increased use can have negative implications, including chondral toxicity and a high risk of infections. As a result, nonsteroidal anti-inflammatory drugs have been considered as an alternative. Purpose: To determine the pain relief and safety of ketorolac versus a corticosteroid to supplement an intra-articular sodium hyaluronate injection for the treatment of symptomatic knee OA. Study Design: Cohort study; Level of evidence, 3. Methods: A total of 84 patients with unilateral symptomatic knee OA receiving 5 weekly injections were enrolled in this retrospective study. Group A (n = 42) received 3 weekly intra-articular corticosteroid injections (0.5% lidocaine, 25 mg of triamcinolone acetonide, and 25 mg of sodium hyaluronate, followed by 2 weekly injections of 0.5% lidocaine and 25 mg of sodium hyaluronate), while group B (n = 42) received 5 weekly ketorolac injections (0.5% lidocaine, 10 mg of ketorolac, and 25 mg of sodium hyaluronate). The following parameters were used to evaluate pain relief and safety: visual analog scale (VAS) for pain, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and side effects before the injection and at 1, 2, and 5 weeks after treatment commencement as well as 3 months after the last injection. Results: Patients from both groups had a significant improvement in VAS and WOMAC scores from the first injection to final follow-up at 3 months. In the first week, the VAS score was lower in group A ( P = .041), but no significant between-group differences were found for either the VAS or the WOMAC score at the other time points. Of the 42 patients in group A, 34 (81.0%) and 25 (59.5%) achieved successful outcomes at 5 weeks after treatment commencement and 3 months after the last injection, respectively. In group B, 32 (76.2%) and 24 (57.1%) patients achieved successful outcomes at 5 weeks after treatment commencement and 3 months after the last injection, respectively. At final follow-up, no significant difference was found in the successful treatment rate between the groups ( P = .825). Conclusion: The current study demonstrated that intra-articular ketorolac and corticosteroid injections produce the same pain relief and functional improvement.

scholarly journals A Randomized Controlled Single-Blind Study Demonstrating Superiority of Amniotic Suspension Allograft Injection Over Hyaluronic Acid and Saline Control for Modification of Knee Osteoarthritis Symptoms

2019 ◽  
Vol 32 (11) ◽  
pp. 1143-1154 ◽  
Author(s):  
Jack Farr ◽  
Andreas H. Gomoll ◽  
Adam B. Yanke ◽  
Eric J. Strauss ◽  
Katie C. Mowry ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hyaluronic Acid ◽  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Saline Control ◽  
Knee Oa ◽  
Randomized Controlled ◽  
Symptomatic Knee ◽  
Multicenter Randomized Controlled Trial ◽  
Patient Reported

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.

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