Showing papers on "WOMAC published in 2020"
TL;DR: Tanezumab 5 mg statistically significantly improved pain, physical function and PGA-OA, but tanezumsumab 2.5mg only achieved two co-primary end points, but there was a statistically significant improvement in WOMAC Pain and Physical Function, but not PGA -OA.
Abstract: Objective Tanezumab, a nerve growth factor inhibitor, was investigated for osteoarthritis (OA) of the hip or knee in a study with 24-week treatment and 24-week safety follow-up. Methods This double-blind, randomised, phase III study enrolled adults in Europe and Japan with moderate-to-severe OA who had not responded to or could not tolerate standard-of-care analgesics. Patients were randomised to tanezumab 2.5 mg or 5 mg subcutaneously or matching placebo every 8 weeks (three doses). Co-primary end points were change from baseline to week 24 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain and Physical Function, and Patient’s Global Assessment of OA (PGA-OA). Joint safety and neurological assessments continued throughout the 48-week study. Results From March 2016 to December 2017, 849 patients were randomised and evaluated (placebo n=282, tanezumab 2.5 mg n=283, tanezumab 5 mg n=284). At week 24, there was a statistically significant improvement from baseline for tanezumab 5 mg compared with placebo for WOMAC Pain (least squares mean difference±SE –0.62±0.18, p=0.0006), WOMAC Physical Function (–0.71±0.17, p Conclusion Tanezumab 5 mg statistically significantly improved pain, physical function and PGA-OA, but tanezumab 2.5 mg only achieved two co-primary end points. RPOA occurred more frequently with tanezumab 5 mg than tanezumab 2.5 mg. TJRs were similarly distributed across all three groups. Trial registration number NCT02709486.
106 citations
TL;DR: Intra-articular SVF injections can significantly decrease knee OA symptoms and pain for at least 12 months and the efficacy and safety demonstrated in this placebo-controlled trial support its implementation as a treatment option for symptomatic knee Oa.
Abstract: Background Currently, there are limited nonoperative treatment options available for knee osteoarthritis (OA). Cell-based therapies have emerged as promising treatments for knee OA. Autologous stromal vascular fraction (SVF) has been identified as an efficient medium for intra-articular administration of progenitor cells and mesenchymal stem cells derived from adipose tissue. Hypothesis Patients receiving intra-articular SVF would show significantly greater improvement than patients receiving placebo injections, and this improvement would be dose dependent. Study design Randomized controlled trial; Level of evidence, 1. Methods This was a multisite prospective double-blinded randomized placebo-controlled clinical trial. Adult patients with symptomatic knee OA were eligible. Thirty-nine patients were randomized to high-dose SVF, low-dose SVF, or placebo (1:1:1). SVF was obtained via liposuction, processed to create the cellular implant, and injected during the same clinical visit. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores and magnetic resonance images were obtained preoperatively and at 6 and 12 months after injection. The Wilcoxon rank sum nonparametric test was utilized to assess statistical significance, and the Hodges-Lehmann location shift was used to assess superiority. Results The median percentage change in WOMAC score at 6 months after injection for the high-dose, low-dose, and placebo groups was 83.9%, 51.5%, and 25.0%, respectively. The high- and low-dose groups had statistically significant changes in WOMAC scores when compared with the placebo group (high dose, P = .04; low dose, P = .02). The improvements were dose dependent. The median percentage change in WOMAC score from baseline to 1 year after injection for the high-dose, low-dose, and placebo groups was 89.5%, 68.2%, and 0%, respectively. The high- and low-dose groups displayed a greater percentage change at 12 months when compared with the placebo group (high dose, P = .006; low dose, P = .009). Magnetic resonance image review revealed no changes in cartilage thickness after treatment. No serious adverse events were reported. Conclusion Intra-articular SVF injections can significantly decrease knee OA symptoms and pain for at least 12 months. The efficacy and safety demonstrated in this placebo-controlled trial support its implementation as a treatment option for symptomatic knee OA. Registration NCT02726945 (ClinicalTrials.gov identifier).
90 citations
TL;DR: High PA level was associated with low BMI and contributes to preventing the clinical consequences of KOA, and strategies to treat KOA should differ by obesity severity.
Abstract: Obesity is one of the most important risk factors of knee osteoarthritis (KOA), but its impact on clinical and functional consequences is less clear. The main objective of this cross-sectional study was to describe the relation between body mass index (BMI) and clinical expression of KOA. Participants with BMI >/= 25 kg/m(2) and KOA completed anonymous self-administered questionnaires. They were classified according to BMI in three groups: overweight (BMI 25-30 kg/m(2)), stage I obesity (BMI 30-35 kg/m(2)) and stage II/III obesity (BMI >/= 35 kg/m(2)). The groups were compared in terms of pain, physical disability, level of physical activity (PA) and fears and beliefs concerning KOA. Among the 391 individuals included, 57.0% were overweight, 28.4% had stage I obesity and 14.6% had stage II/III obesity. Mean pain score on a 10-point visual analog scale was 4.3 (SD 2.4), 5.0 (SD 2.6) and 5.2 (SD 2.3) with overweight, stage I and stage II/III obesity, respectively (p = 0.0367). The mean WOMAC function score (out of 100) was 36.2 (SD 20.1), 39.5 (SD 21.4) and 45.6 (SD 18.4), respectively (p = 0.0409). The Knee Osteoarthritis Fears and Beliefs Questionnaire total score (KOFBEQ), daily activity score and physician score significantly differed among BMI groups (p = 0.0204, p = 0.0389 and p = 0.0413, respectively), and the PA level significantly differed (p = 0.0219). We found a dose-response relation between BMI and the clinical consequences of KOA. Strategies to treat KOA should differ by obesity severity. High PA level was associated with low BMI and contributes to preventing the clinical consequences of KOA.
82 citations
TL;DR: To assess the safety and efficacy of a novel Wnt pathway modulator, lorecivivint (SM04690), for treating pain and inhibiting structural progression in moderately to severely symptomatic knee osteoarthritis (OA).
Abstract: Author(s): Yazici, Yusuf; McAlindon, Timothy E; Gibofsky, Allan; Lane, Nancy E; Clauw, Daniel; Jones, Morgan; Bergfeld, John; Swearingen, Christopher J; DiFrancesco, Anita; Simsek, Ismail; Tambiah, Jeyanesh; Hochberg, Marc C | Abstract: ObjectiveTo assess the safety and efficacy of a novel Wnt pathway modulator, lorecivivint (SM04690), for treating pain and inhibiting structural progression in moderately to severely symptomatic knee osteoarthritis (OA).MethodsSubjects in this 52-week, phase IIa, multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial received a single 2-ml intraarticular injection of lorecivivint (dose of 0.03 mg, 0.07 mg, or 0.23 mg) or placebo. Efficacy was assessed based on change from baseline on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score subscales for pain and function (scale 0-100 for each) and change from baseline in the radiographic medial joint space width (JSW). Baseline-adjusted analysis of covariance with multiple imputation was performed separately to evaluate efficacy. This proof-of-concept study evaluated the intent-to-treat population as well as a prespecified group of subjects with unilateral symptoms of knee OA (designated UNI) and an additional post hoc subgroup of subjects with unilateral symptoms but without widespread pain (designated UNI WP-).ResultsIn this trial, 455 subjects were randomized to a treatment group. The primary end point, significant improvement in the WOMAC pain score compared with placebo at week 13, was not met by any lorecivivint dose group (mean ± SD change from baseline, -23.3 ± 2.2 in the 0.03 mg group, -23.5 ± 2.1 in the 0.07 mg group, -21.3 ± 2.2 in the 0.23 mg group, and -22.1 ± 2.1 in the placebo group; each P g 0.05 versus placebo). All groups (including placebo) demonstrated clinically meaningful (≥20-point) improvements from baseline in the WOMAC pain score. The durability of response was evaluated through week 52. In the prespecified UNI group and post hoc UNI WP- group at week 52, treatment with 0.07 mg lorecivivint significantly improved the WOMAC pain score (between-group difference versus placebo, -8.73, 95% confidence interval [95% CI] -17.44, -0.03 [P = 0.049] and -11.21, 95% CI -20.99, -1.43 [P = 0.025], respectively) and WOMAC function score (between-group difference versus placebo, -10.26, 95% CI -19.82, -0.69 [P = 0.036] and -13.38, 95% CI -24.33, -2.43 [P = 0.017], respectively). Relative to baseline, the mean change in the medial JSW at week 52 was -0.04 mm in the 0.03 mg cohort, -0.09 mm in the 0.07 mg cohort, -0.16 mm in the 0.23 mg cohort, and -0.14 mm in the placebo cohort; no treatment group achieved a significant change in medial JSW compared with placebo at week 52. In both unilateral symptom subgroups, the 0.07 mg lorecivivint dose significantly increased medial JSW compared with placebo at week 52 (medial JSW 0.39 mm, 95% CI 0.06, 0.72 in the UNI group [P = 0.021] and 0.42 mm, 95% CI 0.04, 0.80 in the UNI WP- group [P = 0.032]). Changes observed in the 0.03 mg and 0.23 mg dose groups were not significantly different from those in the placebo group for any of these measures. Lorecivivint appeared safe and well tolerated.ConclusionThis phase IIa, proof-of-concept trial in patients with symptomatic knee OA did not meet its primary end point. Nevertheless, the study identified a target population in whom to evaluate the potential efficacy of lorecivivint for the treatment of knee OA.
77 citations
TL;DR: Compared with intra-articular injection of PRP alone, the combined application of hyaluronic acid and platelet-rich plasma can improve the WOMAC Function Scores, WOMAC Total Score, 6-month follow-up VAS ratings, and Lequesne Index scores, but in terms of the incidence of AEs, PRP combined with HA is not significantly different from PRP or HA alone.
Abstract: Studies have shown that the combined application of hyaluronic acid (HA) and platelet-rich plasma (PRP) can repair degenerated cartilage and delay the progression of knee osteoarthritis (KOA). The purpose of this study was to explore the efficacy and safety of the intra-articular injection of PRP combined with HA compared with the intra-articular injection of PRP or HA alone in the treatment of KOA. The PubMed, Cochrane Library, EMBASE and China National Knowledge Infrastructure (CNKI) databases were searched from inception to December 2019. Randomized controlled trials and cohort studies of PRP combined with HA for KOA were included. Two orthopaedic surgeons conducted the literature retrieval and extracted the data. Outcome indicators included the Western Ontario and McMaster Universities Arthritis Index (WOMAC), the Lequesne Index, the visual analogue scale (VAS) for pain, and adverse events (AEs). Review Manager 5.3 was used to calculate the relative risk (RR) or standardized mean difference (SMD) of the pooled data. STATA 14.0 was used for quantitative publication bias evaluation. Seven studies (5 randomized controlled trials, 2 cohort studies) with a total of 941 patients were included. In the VAS comparison after 6 months of follow-up, PRP combined with HA was more likely to reduce knee pain than PRP alone (SMD: − 0.31; 95% confidence interval (CI): − 0.55 to − 0.06; P = 0.01 0.05). Compared with intra-articular injection of PRP alone, that of PRP combined with HA can improve the WOMAC Function Scores, WOMAC Total Score, 6-month follow-up VAS ratings, and Lequesne Index scores. However, in terms of the incidence of AEs, PRP combined with HA is not significantly different from PRP or HA alone.
72 citations
TL;DR: It is suggested that MSC therapy could serve as an effective and safe therapy for clinical application in OA treatment and have great translational potential in the clinical treatment of various degenerative diseases once optimum formula and explicit target population are identified.
Abstract: Objective Stem cells are considered to be one of the greatest potential treatments to cure degenerative diseases. Stem cells injection for knee osteoarthritis is still a relatively new treatment and has not yet gained popularity. The objective of this study is to evaluate the effectiveness, safety and potential of mesenchymal stem cells (MSCs) for knee osteoarthritis treatment. Methods We collected clinical trials using MSCs as treatment for knee osteoarthritis (OA) (Before April 2019), including randomized controlled trials (RCTs), retrospective studies and cohort studies. To evaluate the effectiveness and safety of MSC in knee osteoarthritis treatment, we applied visual analog scale (VAS) score, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and adverse events. We searched PubMed, EMBASE, Cochrane Library, Web of Science and the ClinicalTrials.gov with keywords (Mesenchymal stem cells (MSCs), Knee osteoarthritis, Effectiveness and Safety), and then performed a systematic review and cumulative meta-analysis of all RCTs and retrospective comparative studies. We included fifteen RCTs, 2 retrospective studies and 2 cohort studies including a total of 584 knee osteoarthritis (OA) patients in this study. Results We demonstrated that MSC treatment could significantly decrease VAS in a 12-month follow-up study compared with controls (P 0.05) in adverse events. Conclusions Based on current evidence, our results suggest that MSCs therapy is effective in relieving pain and improving function in patients with Knee OA. MSCs therapy is also a safe treatment and has great potential as a clinical therapy for patients with knee OA. However, the safety and efficacy must be evaluated with a more rigorous, larger sample size validation in the future before MSCs therapy were large-scale applied in clinical practice. The translational potential of this article This study provided the best available evidence and a wider perspective to MSCs application in the management of knee OA. MSCs therapy will have great translational potential in the clinical treatment of various degenerative diseases once optimum formula and explicit target population are identified.
71 citations
TL;DR: GAE to treat knee pain secondary to OA can be performed safely and demonstrates potential efficacy, and further randomized comparative studies are needed to determine true treatment effect versus placebo effect.
62 citations
TL;DR: Curcuma longa extract was more effective than placebo for knee pain but did not affect knee effusion-synovitis or cartilage composition and Multicenter trials with larger sample sizes are needed to assess the clinical significance.
Abstract: Background Current pharmacologic therapies for patients with osteoarthritis are suboptimal. Objective To determine the efficacy of Curcuma longa extract (CL) for reducing knee symptoms and effusion-synovitis in patients with symptomatic knee osteoarthritis and knee effusion-synovitis. Design Randomized, double-blind, placebo-controlled trial. (Australian New Zealand Clinical Trials Registry: ACTRN12618000080224). Setting Single-center study with patients from southern Tasmania, Australia. Participants 70 participants with symptomatic knee osteoarthritis and ultrasonography-defined effusion-synovitis. Intervention 2 capsules of CL (n = 36) or matched placebo (n = 34) per day for 12 weeks. Measurements The 2 primary outcomes were changes in knee pain on a visual analogue scale (VAS) and effusion-synovitis volume on magnetic resonance imaging (MRI). The key secondary outcomes were change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and cartilage composition values. Outcomes were assessed over 12 weeks. Results CL improved VAS pain compared with placebo by -9.1 mm (95% CI, -17.8 to -0.4 mm [P = 0.039]) but did not change effusion-synovitis volume (3.2 mL [CI, -0.3 to 6.8 mL]). CL also improved WOMAC knee pain (-47.2 mm [CI, -81.2 to -13.2 mm]; P = 0.006) but not lateral femoral cartilage T2 relaxation time (-0.4 ms [CI, -1.1 to 0.3 ms]). The incidence of adverse events was similar in the CL (n = 14 [39%]) and placebo (n = 18 [53%]) groups (P = 0.16); 2 events in the CL group and 5 in the placebo group may have been treatment related. Limitation Modest sample size and short duration. Conclusion CL was more effective than placebo for knee pain but did not affect knee effusion-synovitis or cartilage composition. Multicenter trials with larger sample sizes are needed to assess the clinical significance of these findings. Primary funding source University of Tasmania and Natural Remedies Private Limited.
57 citations
TL;DR: It is reported that MSC infiltrations for knee OA can represent a feasible option, leading to an overall remarkable improvement of all clinical and functional considered outcomes, regardless of the cell source.
Abstract: According to the World Health organization (WHO), more than 10% in people older than 60 years suffer from osteoarthritis (OA). Over the last years, there has been an increased interest around regenerative medicine, especially regarding stem cell treatments and related applications. We hypothesize that stem cell therapies can represent a feasible option for idiopathic knee OA, delaying or even avoiding the joint replacement. To emphasize the potential of percutaneous injections of mesenchymal stem cells for knee OA, a comprehensive systematic review of the literature was conducted. Two independent authors (FM, GC) performed the literature search. This study was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (PRISMA). The main databases were accessed: Pubmed, Embase, Google Scholar, Cochrane Systematic Reviews, Scopus, AMED. For this systematic review, all articles treating percutaneous injections of mesenchymal stem cells for knee OA were considered. Because of the rapid advancements promoted by the scientific progress on stem cell expansion and processing, only articles published within the last five years were included. Solely articles reporting the outcomes of interest across 6- and 12-month follow-up were recruited for eligibility. We included only studies reporting quantitative data under the outcomes of interest. We referred for the quality assessment to the Coleman Methodology Score (CMS). The statistical analysis was performed with Review Manager Software 5.3 (The Nordic Cochrane Centre, Copenhagen). A total of 18 studies were enrolled in the present study, comprising 1069 treated knees. The mean age of the samples was 57.39 ± 7.37 years. 72% of the included studies harvested the stem cells from the iliac crest (bone marrow-derived MSCs), the remaining 28% from the adipose tissue (adipose-derived MSCs). The mean visual analogic scale improved from 18.37 to 30.98 and 36.91 at 6- and 12-month follow-up, respectively. The mean WOMAC score improved from 25.66 to 25.23 and 15.60 at 6- and 12-month follow-up, respectively. The mean walking distance improved from 71.90 to 152.22 and 316.72 at 6- and 12-month follow-up, respectively. The mean Lequesne scale improved from 33.76 to 12.90 at 12-month follow-up. The KOOS score improved from 41.07 to 8.47% and 18.94 at 6- and 12-month follow-up. All the KOOS subscales improved significantly from the baseline. A total of 136 (12.7%) local complications were detected. According to the current evidences and the main findings of this systematic review, we reported that MSC infiltrations for knee OA can represent a feasible option, leading to an overall remarkable improvement of all clinical and functional considered outcomes, regardless of the cell source. Patients treated at earlier-degeneration stages reported statistically significant greater outcomes. The pain and function scores were improved considerably, thus, leading to a significant improvement of patient participation in recreational activities and quality of life.
56 citations
TL;DR: Joint arthroplasty is a highly valuable therapeutic strategy for hip or knee OA patients who do not respond to pharmacological management and could contribute to select an OA population which has a high probability to get an optimal benefit from total joint replacement.
Abstract: To study and identify the determinants of the impact on pain, function, and quality of life of a prosthetic replacement surgery after 5 years of survival in patients with osteoarthritis (OA) of the lower limb. In total, 626 osteoarthritic patients from a University Hospital, divided in 2 groups (according to surgical site), were prospectively followed for 5 years after hip (n = 346) or knee (n = 280) replacement. Validated specific Western Ontario and McMaster Universities Arthritis Index (WOMAC) and generic (SF-36 and EQ) instruments assessing quality of life were used prior to surgery and yearly, thereafter. We defined a good outcome as a clinically relevant improvement in WOMAC greater than or equal to the minimally important difference (MID). Regressions showed the relationships among preoperative, perioperative, and postoperative measures and the evolution of WOMAC scores after 5 years (percent change). We also examined any predictors of good outcomes. The beneficial effect on quality of life observed during the first year after hip and knee arthroplasty (HA and KA) was maintained for up to 5 years. More than 3/4 of the patients in our study experienced a good outcome (86.04% in HA group and 79.91% in KA group). Both the good outcome and the 5-year change in WOMAC are predicted by preoperative (i.e., radiological severity, comorbidities, disability, and level of education), perioperative (i.e., length of hospital stay and place of discharge), and postoperative (i.e., complications) variables in the two groups. Joint arthroplasty is a highly valuable therapeutic strategy for hip or knee OA patients who do not respond to pharmacological management. These results represent a step towards the collection of robust, scientifically sound data that will facilitate the completion of health economic analyses in the field of OA.
56 citations
TL;DR: Intra-articular PRP injection appeared to be more efficacious than HA injection for the treatment of KOA in terms of short-term functional recovery and long-term pain relief and function improvement.
Abstract: This study aimed to evaluate the clinical efficacy of platelet-rich plasma (PRP) injection compared with hyaluronic acid (HA) injection for patients undergoing knee osteoarthritis. We systematically searched electronic databases including PubMed, Embase, Web of Science, and the Cochrane Library on January 23, 2020 to identify relevant studies issued in English languages. The outcomes evaluating the efficacy of knee osteoarthritis (KOA) treatment were Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores (WOMAC pain, function, stiffness, and total scores) at 1, 3, 6, and 12 months; International Knee Documentation Committee (IKDC) scores, Lequesne Index score, Visual Analog Scale (VAS) scores, EQ-VAS scores, and KOOS scores. The pooled data were analyzed by Stata 12.0. A total of 20 RCTs were enrolled in the present meta-analysis. The pooled results demonstrated that platelet-rich plasma (PRP) injection reduced pain more effectively than hyaluronic acid (HA) injection at 6-month and 12-month follow-up evaluated by WOMAC pain scores and VAS scores. EQ-VAS in the patients treated with PRP injection was lower than that in patients with HA injection at 12 months. Moreover, the patients with PRP injection had a better function recovery than those with HA injection at 1-month, 3-month, 6-month, and 12-month follow-up, as evaluated by WOMAC function scores. WOMAC total scores showed significant difference at 6-month and 12-month follow-up. The IKDC scores indicated PRP injection was significantly more effective than HA injection at 3 months and 6 months. However, the Lequesne Index scores, KOOS scores, and adverse events did not show any significant difference between groups. Intra-articular PRP injection appeared to be more efficacious than HA injection for the treatment of KOA in terms of short-term functional recovery. Moreover, PRP injection was superior to HA injection in terms of long-term pain relief and function improvement. In addition, PRP injection did not increase the risk of adverse events compared to HA injection.
TL;DR: Treatment with BM-MSC associated with PRGF® was shown to be a viable therapeutic option for osteoarthritis of the knee, with clinical improvement at the end of follow-up, and could be considered as a OA treatment responders following OARSI criteria.
Abstract: Mesenchymal stromal cells are a safe and promising option to treat knee osteoarthritis as previously demonstrated in different clinical trials. However, their efficacy, optimal dose and addition of adjuvants must be determined. Here, we evaluated the clinical effects of a dose of 100 × 106 bone marrow mesenchymal stromal cells (BM-MSCs) in combination with Platelet Rich Plasma (PRGF®) as adjuvant in a randomized clinical trial. A phase II, multicenter, randomized clinical trial with active control was conducted. Sixty patients diagnosed with knee OA were randomly assigned to 3 weekly doses of PRGF® or intraarticular administration of 100 × 106 cultured autologous BM-MSCs plus PRGF®. Patients were followed up for 12 months, and pain and function were assessed using VAS and WOMAC and by measuring the knee range of motion range. X-ray and magnetic resonance imaging analyses were performed to analyze joint damage. No adverse effects were reported after BM-MSC administration or during follow-up. According to VAS, the mean value (SD) for PRGF® and BM-MSC with PRGF® went from 5 (1.8) to 4.5 (2.2) (p = 0.389) and from 5.3 (1.9) to 3.5 (2.5) (p = 0.01), respectively at 12 months. In WOMAC, the mean (SD) baseline and 12-month overall WOMAC scores in patients treated with PRGF® was 31.9 (16.2) and 22.3 (15.8) respectively (p = 0.002) while that for patients treated with BM-MSC plus PRGF® was 33.4 (18.7) and 23.0 (16.6) (p = 0.053). Although statistical significances between groups have been not detected, only patients being treated with BM-MSC plus PRGF® could be considered as a OA treatment responders following OARSI criteria. X-ray and MRI (WORMS protocol) revealed no changes in knee joint space width or joint damage. Treatment with BM-MSC associated with PRGF® was shown to be a viable therapeutic option for osteoarthritis of the knee, with clinical improvement at the end of follow-up. Further phase III clinical trials would be necessary to confirm the efficacy. Trial registration Clinical Trials.gov identifier NCT02365142. No EudraCT: 2011-006036-23
TL;DR: The COVID-19 lockdown had a significant impact on pain, joint function, physical function, and physical activity in patients with end-stage hip and knee OA.
Abstract: Purpose The purpose of this study was to evaluate pain, functional impairment, mental health, and daily activity in patients with end-stage hip and knee osteoarthritis (OA) during the COVID-19 lockdown. Methods The study included 63 patients, with hip or knee OA, who had been scheduled for arthroplasty that was postponed because of COVID-19. Patients were evaluated by telephone interviews during the first week after lockdown, in the fourth week, and again at the end of the lockdown. Patients rated their pain level on the basis of a visual analog scale (VAS) and completed WOMAC, SF-12 and Tegner activity scale (TAS) questionnaires. Results VAS and WOMAC scores increased significantly during lockdown, while physical activity significantly decreased. At the final evaluation, VAS and WOMAC showed a significant negative correlation with TAS. The SF-12 subscale scores showed a significant decrease of the physical component during the lockdown, while the mental component remained largely unchanged. Patients with knee OA showed a faster progress of pain compared to those with hip OA. 50 patients (79%) stated they wished to have arthroplasty as soon as possible. Conclusion The COVID-19 lockdown had a significant impact on pain, joint function, physical function, and physical activity in patients with end-stage hip and knee OA. Level of evidence II (Prospective cohort study).
TL;DR: Cartilage thickness loss is associated with only a small amount of worsening knee pain, an association mediated in part by worsening synovitis, and demonstrating that chondroprotection reduces knee pain will be extremely challenging and is perhaps unachievable.
Abstract: Objectives Although treatment development in osteoarthritis (OA) focuses on chondroprotection, it is unclear how much preventing cartilage loss reduces joint pain. It is also unclear how nociceptive tissues may be involved. Methods Using data from the Osteoarthritis Initiative, we quantified the relation between cartilage loss and worsening knee pain after adjusting for bone marrow lesions (BMLs) and synovitis, and examined how much these factors mediated this association. 600 knee MRIs were scored at baseline, 12 months and 24 months for quantitative and semiquantitative measures of OA structural features. We focused on change in medial cartilage thickness using an amount similar to that seen in recent trials. Linear models calculated mean change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score with cartilage loss, adjusted for baseline BMLs, synovitis and covariates. Mediation analysis tested whether change in synovitis or BMLs mediated the cartilage loss–pain association. We carried out a subanalysis for knees with non-zero baseline WOMAC pain scores and another for non-valgus knees. Results Cartilage thickness loss was significantly associated with a small degree of worsening in pain over 24 months. For example, a loss of 0.1 mm of cartilage thickness over 2 years was associated with a 0.32 increase in WOMAC pain (scale 0–20). The association of cartilage thickness loss with pain was mediated by synovitis change but not by BML change. Subanalysis results were similar. Conclusions Cartilage thickness loss is associated with only a small amount of worsening knee pain, an association mediated in part by worsening synovitis. Demonstrating that chondroprotection reduces knee pain will be extremely challenging and is perhaps unachievable.
TL;DR: With appropriate patient selection and prevention of postoperative adhesions, labral reconstruction results in excellent outcomes and high patient satisfaction that is sustained at a minimum 10-year follow-up.
Abstract: Background Labral reconstruction has been shown to result in improved patient-reported outcomes (PROs) at mid-term follow-up in patients with a deficient labrum. The purpose of this study was to determine survivorship and PROs at a minimum 10-year follow-up. Methods A retrospective evaluation of a prospectively collected single-surgeon database included 91 hips (89 patients) that underwent arthroscopic labral reconstruction with iliotibial band autograft between 2006 and 2008. The primary PRO was the Hip Outcome Score (HOS)-activities of daily living (ADL). The modified Harris hip score (mHHS), HOS-sports, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, and patient satisfaction (on a scale of 1 to 10) were also collected at a 10-year minimum follow-up. Survivorship analysis curves were evaluated. Results Eighty-two hips were evaluated at a 10-year minimum follow-up. Overall survivorship, with revision hip arthroscopy or total hip arthroplasty (THA) as the end point, was 70% at 5 years and 61% at 10 years, and the mean survival time was 9 years (95% confidence interval = 7.6 to 10 years). For the patients who did not undergo subsequent surgery, on average the mHHS increased from 60 preoperatively to 82 at the 10-year follow-up (p = 0.001), the HOS-ADL improved from 69 to 90 (p = 0.004), the HOS-sports improved from 43 to 76 (p = 0.001), and the median patient satisfaction was 10 of 10. Eighty percent of the patients achieved the minimal clinically important difference (MCID) in the HOS-ADL, and 87% obtained a patient acceptable symptom state (PASS). Conclusions Following arthroscopic labral reconstruction with iliotibial band autograft, 9% of the hips underwent revision arthroscopy and 27% underwent THA. At 10 years, the survival rate, with revision hip arthroscopy or THA as the end point, was 61%; however, for those with >2 mm of joint space, the current indication for labral reconstruction, the 10-year survival rate was 90%. Excellent PROs and patient satisfaction were reported by those who did not require revision or THA. With appropriate patient selection and prevention of postoperative adhesions, labral reconstruction results in excellent outcomes and high patient satisfaction that is sustained at a minimum 10-year follow-up. Level of evidence Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.
TL;DR: It is suggested that PRP is superior to HA for symptomatic knee pain at 6 and 12 months and ACP appears to be clearly superior over HA for pain at both 6 and12 months.
Abstract: The purpose of this study was to perform a systematic review and meta-analysis comparing intra-articular knee injection of PRP and hyaluronic acid and investigate clinical outcomes and pain at both 6 and 12 months.
A systematic review of Medline, Embase, Scopus, and Google Scholar was performed in the English and German literature reporting on intra-articular knee injections for knee osteoarthritis. All level 1 and 2 studies with a minimum of 6-month follow-up in patients with knee osteoarthritis from 2010 to 2019 were included. Clinical outcome was assessed by WOMAC and IKDC scores and pain by VAS and WOMAC pain scores. Subgroup analysis for autologous platelet-rich plasma (ACP) was performed. Publication bias and risk of bias were assessed using the Cochrane Collaboration’s tools. The GRADE system was used to assess the quality of the body of evidence. Heterogeneity was assessed using χ2 and I2 statistics.
Twelve studies (1,248 cases; 636 PRP, 612 HA) met the eligibility criteria. The pooled estimate demonstrated non-significant differences between PRP and HA for clinical outcomes at 6 months (p = 0.069) and at 12 months (p = 0.188). However, the pooled estimate for pain did demonstrate significant differences in favour of PRP at 6 months (p = 0.001) and 12 months (p = 0.001). For the ACP subgroup (249 cases), the pooled estimate for these studies demonstrated significant differences in favour of PRP (p < 0.0001) at 6 months.
The results of this systematic review and meta-analysis suggest that PRP is superior to HA for symptomatic knee pain at 6 and 12 months. ACP appears to be clearly superior over HA for pain at both 6 and 12 months. There were no advantages of PRP over HA for clinical outcomes at both 6 and 12 months. Level 2; systematic review and meta-analysis.
TL;DR: IL-1β, IL-6 and TNF-α play critical roles in pain in the early stage of KOA and correlate with pain, while catabolic enzymes and neuropeptides measured do not correlate with nociceptive and neuropathic pain.
Abstract: Inflammatory mediators in the synovial fluid (SF) play critical roles in the initiation and development of pain in knee osteoarthritis (KOA). However, data for inflammatory marker expression are conflicting, and the role of SF inflammatory mediators in neuropathic pain is not clear. Therefore, the aim of this study was to identify SF inflammatory mediators associated with nociceptive and neuropathic pain in KOA. Levels of IL-1β, IL-6, TNF-α, macrophage colony-stimulating factor, MMP-3, MMP-13, metalloproteinase with thrombospondin motifs 5, calcitonin gene-related peptide, neuropeptide Y, substance P and bradykinin were measured using enzyme-linked immunosorbent assays in 86 patients. Nociceptive pain was assessed using the numeric rating scale (NRS), visual analog scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score. Neuropathic pain was determined using the PainDETECT questionnaire. Moreover, knee function was evaluated by the WOMAC score and range of motion (ROM) assessments. Radiological grade was defined using the Kellgren-Lawrence (K-L) grading scale. Pain scores measured using different methods correlated highly with each other. A worse K-L grade and knee function were associated with worse pain. Expression of IL-1β and IL-6 was increased in the early stage compared with the late stage. The NRS score correlated positively with age, K-L grade, and the WOMAC score and negatively with ROM and TNF-α expression. The VAS correlated positively with age, K-L grade, and the WOMAC score but negatively with ROM and levels of IL-1β, IL-6 and TNF-α. The WOMAC pain score did not correlate with any of the inflammatory mediators measured; it correlated only with ROM. The PainDETECT score correlated only with the WOMAC score. Expression of other inflammatory mediators did not correlate with any of the pain scores. IL-1β, IL-6 and TNF-α play critical roles in pain in the early stage of KOA and correlate with pain. The catabolic enzymes and neuropeptides measured do not correlate with nociceptive and neuropathic pain. New biomarkers related to pain in the late stage need to be further investigated.
TL;DR: In this study, in addition to the effect of PRP on VAS and WOMAC, there was a significant effect on radiologic characteristics (patellofemoral cartilage volume and synovitis) and a longer study with a larger sample size is recommended.
Abstract: Purpose Few papers have studied the objective effects of PRP on cartilage. In this study, we investigated the effect of PRP on cartilage characteristics by special MRI sequencing in knee osteoarthritis (IRCT registration number: 2014020413442N6). Patients and methods In this double blind randomized clinical trial, patients with bilateral knees osteoarthritis-grade 1, 2, and 3 were included in the study. Each patient's knees were randomly allocated to either control or treatment groups. PRP was injected in two sessions with 4 week intervals in PRP group. The VAS (visual analog scale) and WOMAC (Western Ontario and McMaster Universities Arthritis Index) were utilized and MRI was performed for all patients, before, and 8 months after treatment. The MRI sequences taken were transverse 3D TRUFISP and coronal and sagittal fat saturated proton-density. Imaging was scored according to four cartilage characteristics. Results 46 knees (from 23 patients) were included in this study. 23 knees in the case group and 23 knees in control group were studied. All patients were female with mean age of 57.57±5.9 years. Mean total WOMAC and VAS changes before and after treatment in control group were 11.61±8.5 and 1.3±1.1 respectively. In PRP group, mean total WOMAC and VAS changes showed better improvement with 20±12.3 and 3.2±1.6 respectively (P-value Conclusion In this study, in addition to the effect of PRP on VAS and WOMAC, there was a significant effect on radiologic characteristics (patellofemoral cartilage volume and synovitis). For further evaluation, a longer study with a larger sample size is recommended.
TL;DR: Compared with HA, PRP offers obvious advantages in the conservative treatment of knee osteoarthritis and can reduce long-term pain and improve knee joint function with no additional risks.
17 Jul 2020
TL;DR: Based on current evidence, Boswellia and its extract may be an effective and safe treatment option for patient with OA, and the recommended duration of treatment is at least 4 weeks.
Abstract: Osteoarthritis (OA) is the commonest form of inflammatory joint disease. Unfortunately, to date, there is no appropriate treatment for OA. Boswellia serrata was considered as a potent anti-inflammatory, anti-arthritic and analgesic agent that may be a drug for OA. In this meta-analysis, data from randomized controlled trials were obtained to assess the effects of Boswellia or its extract versus placebo or western medicine in patients with OA. The primary outcomes included visual analogue score (VAS), WOMAC pain, WOMAC stiffness, WOMAC function and lequesne index. Seven trials involving 545 patients were included. Compared with the control group, Boswellia and its extract may relieve the pain [VAS: (WMD -8.33; 95% CI -11.19, − 5.46; P<0.00001); WOMAC pain: (WMD -14.22; 95% CI -22.34, − 6.09; P = 0. 0006)] and stiffness [WOMAC stiffness: (WMD -10.04; 95% CI -15.86, − 4.22; P = 0. 0007)], and improve the joint’s function [WOMAC function: (WMD -10.75; 95% CI -15.06, − 6.43; P<0. 00001); lequesne index: (WMD -2.27; 95% CI -3.08, − 1.45; P<0. 00001)]. Based on current evidence, Boswellia and its extract may be an effective and safe treatment option for patient with OA, and the recommended duration of treatment with Boswellia and its extract is at least 4 weeks.
TL;DR: LimitingPROMs collection to 6 months appears to be cost-efficient owing to increased attrition rates beyond this time interval, and most of the improvement in PROMs after primary TJA occurs within the first 6 months.
Abstract: Background The purpose of this study was to determine the optimal window for collection of patient-reported outcome measures (PROMs) after total joint arthroplasty (TJA). Methods Our prospectively collected institutional joint registry was queried for patients who underwent primary, unilateral TJAs. The primary outcomes were the net changes in WOMAC, SF-12 MCS, SF-12 PCS, OHS, KSCRS, and UCLA activity rating system at 6, 12, and 24 months postoperatively. Secondary outcomes were data acquisition costs and follow-up attrition rates. Results Eight hundred sixty-six procedures (450 total hip arthroplasties, 416 TKAs) were analyzed. A consistent plateau in all PROMs was noted by 6 months postoperatively–except for SF-12 MCS which showed no significant changes at any time interval. For TKA, the percentage of overall improvement achieved by 6 months was 88.7%, 84.5%, 100%, and 90.5% for the WOMAC, SF-12 PCS, UCLA, and KSCRS, respectively. For total hip arthroplasty, these values were 92.7%, 83.5%, 88.0%, and 89.8% for WOMAC, SF-12 PCS, UCLA, and OHS, respectively. There were marginal improvements from 6 to 12 months and no improvement from 12 to 24 months. Follow-up rates at 6, 12, and 24 months were 85%, 69%, and 40%, respectively. Our institutional costs for collecting a complete data set per patient were $128, $158, and $272 for 6, 12, and 24 months, respectively. Conclusions Most of the improvement in PROMs after primary TJA occurs within the first 6 months. In addition, limiting PROMs collection to 6 months appears to be cost-efficient owing to increased attrition rates beyond this time interval.
TL;DR: HTO showed survival and functional results comparable to those of UKA in selected patients when target limb alignment correction was achieved, and a predictive score for results of either procedure would facilitate decision-making.
Abstract: Introduction High tibial osteotomy (HTO) and unicompartmental knee arthroplasty (UKA) are two surgical solutions for isolated medial tibiofemoral osteoarthritis. Results depend on preoperative criteria and patient selection, but also on postoperative factors: implant positioning, limb alignment. Factors for HTO survival need identifying to reduce risk of failure requiring total knee arthroplasty (TKA). Hypothesis Age, gender, weight, osteoarthritis grade, degree of correction, type of osteotomy, technique and intraoperative complications impact HTO survival. Material and method As part of a symposium of the French Society of Arthroscopy (SFA), a multicenter retrospective study compared 2 series. The HTO series comprised 488 patients: 153 female (31.4%); mean age, 55.1 years; mean weight, 83.1 kg; mean body-mass index (BMI), 28.6. The UKA series comprised 284 patients: 172 female (60.6%); mean age, 64.1 years; mean weight, 75.3 kg; mean BMI, 27.6. The main endpoint was comparative survival at 5, 8 and 10 years; secondary endpoints comprised pre- and post-operative hip-knee-ankle (HKA) angle, mechanical femoral angle (mFA) and mechanical tibial angle (mTA), surgical technique, satisfaction, time to and level of return to work, WOMAC and Tegner scores and complications rates. The significance threshold was set at p Results Age > 54 years, male gender, BMI > 25, medial tibiofemoral wear severity Ahlback ≥ 3, ≥ 0.9° varus joint component, HKA correction Conclusion HTO showed survival and functional results comparable to those of UKA in selected patients when target limb alignment correction was achieved. The present study determined selection criteria. A predictive score for results of either procedure would facilitate decision-making. Level of evidence IV, retrospective cohort study.
TL;DR: This article is the first to leverage a deep learning framework to associate MR images of the knee with knee pain from MRI scans with a convolutional Siamese network that had the ability to fuse information from multiple two-dimensional MRI slices from the knees with pain and the contralateral knee of the same individual without pain.
Abstract: It remains difficult to characterize the source of pain in knee joints either using radiographs or magnetic resonance imaging (MRI). We sought to determine if advanced machine learning methods such as deep neural networks could distinguish knees with pain from those without it and identify the structural features that are associated with knee pain. We constructed a convolutional Siamese network to associate MRI scans obtained on subjects from the Osteoarthritis Initiative (OAI) with frequent unilateral knee pain comparing the knee with frequent pain to the contralateral knee without pain. The Siamese network architecture enabled pairwise learning of information from two-dimensional (2D) sagittal intermediate-weighted turbo spin echo slices obtained from similar locations on both knees. Class activation mapping (CAM) was utilized to create saliency maps, which highlighted the regions most associated with knee pain. The MRI scans and the CAMs of each subject were reviewed by an expert radiologist to identify the presence of abnormalities within the model-predicted regions of high association. Using 10-fold cross-validation, our model achieved an area under curve (AUC) value of 0.808. When individuals whose knee WOMAC pain scores were not discordant were excluded, model performance increased to 0.853. The radiologist review revealed that about 86% of the cases that were predicted correctly had effusion-synovitis within the regions that were most associated with pain. This study demonstrates a proof of principle that deep learning can be applied to assess knee pain from MRI scans. • Our article is the first to leverage a deep learning framework to associate MR images of the knee with knee pain.
• We developed a convolutional Siamese network that had the ability to fuse information from multiple two-dimensional (2D) MRI slices from the knee with pain and the contralateral knee of the same individual without pain to predict unilateral knee pain.
• Our model achieved an area under curve (AUC) value of 0.808. When individuals who had WOMAC pain scores that were not discordant for knees (pain discordance < 3) were excluded, model performance increased to 0.853.
TL;DR: Implantation of hUCB-MSCs is effective for treating knee osteoarthritis based on a follow-up lasting a minimum of 2 years, and there were significant differences in the lesion location.
TL;DR: PRP treatment had positive effects on the pain, physical function, and quality of life of patients with knee OA, but it did not increase cartilage thickness.
Abstract: OBJECTIVE The aim of this study was to determine the effects of platelet-rich plasma (PRP) treatment on pain, functionality, quality of life, and cartilage thickness in patients with knee osteoarthritis (OA). METHODS Sixty patients with chronic knee pain were randomly separated into two groups. The first group was administered 4-ml PRP intra-articularly (IA) in three doses at one-week intervals, and the second group had only one dose of a 4-ml saline solution IA. The patients' pain was measured using the Visual Analogue Scale (VAS); functionality was measured using the Western Ontario and McMaster University Osteoarthritis Index (WOMAC). The distal femur cartilage thickness was assessed using ultrasonography (USG). RESULTS All baseline parameters were similar (p> 0.05). In the first and sixth months after the treatment, the VAS scores of the PRP group were significantly low (p< 0.001). In the same group, only the pain sub-score was low in the WOMAC assessment in the first month after treatment. However, in the sixth month, all parameters of the WOMAC score were lower than those of the placebo group (p< 0.05). Cartilage thickness measurements were similar in the two groups (p< 0.05). CONCLUSION PRP treatment had positive effects on the pain, physical function, and quality of life of patients with knee OA, but it did not increase cartilage thickness.
TL;DR: The data indicated that clinical manifestation was ameliorated considerably following the administration ofCurcumin and demonstrated the immunomodulatory effects of curcumin in OA patients.
TL;DR: The short-term clinical effects of intra-articular SVF cell injection on knee OA were excellent and the total WOMAC, VAS, and KOOS scores at 1, 3, 6 and 12 months postoperatively were significantly better than preoperative scores.
Abstract: Adipose-derived stromal vascular fraction (SVF) cells are a mixed cell population that includes cells with multilineage potential, similar to bone marrow-derived mesenchymal stem cells. Our purpose is to investigate the influence of SVF cells in patients with knee osteoarthritis (OA) and the short-term treatment effects. Fifty-seven patients were enrolled and treated with intra-articular injection of 2.5 × 107 SVF cells into the knee joint between September 2017 and March 2018. All patients were followed up for 12 months or longer. Mean age at treatment and follow-up period were 69.4 ± 6.9 years and 13.7 ± 2.0 months, respectively. The mean preoperative hip-knee-ankle angle was 6.7 ± 3.6°. SVF cells were prepared using the Celution®800/CRS system from the patients’ abdominal or breech subcutaneous fat. The mean SVF cell viability was 90.6 ± 2.7%. Clinical evaluations were performed for range of motion, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), visual analog scale (VAS) for pain, and the Knee injury and Osteoarthritis Score (KOOS). Imaging evaluations, which included the hip-knee-ankle angle assessed via radiography, and T2 mapping value using a 1.5-T magnetic resonance imaging unit were also assessed. Both clinical and imaging evaluations were performed preoperatively, 1, 3, 6, and 12 months postoperatively, and compared among all timepoints (p < 0.05). Knee extension angle at 6 and 12 months postoperatively was significantly better than the preoperative angle. Total WOMAC, VAS, and KOOS scores at 1, 3, 6 and 12 months postoperatively were significantly better than preoperative scores. There was no significant difference in hip-knee-ankle angle among the five time periods. T2 mapping values of lateral femur and tibia were significantly higher 12 months postoperatively than preoperatively. The short-term clinical effects of intra-articular SVF cell injection on knee OA were excellent. Intra-articular SVF cell injection is a novel and innovative approach for treating patients with knee OA.
TL;DR: OHS and WOMAC scores can be used to determine clinical meaningful improvement but are limited in their ability to predict patient satisfaction after THA.
Abstract: Background Up to 15% of patients express dissatisfaction after total hip arthroplasty (THA). Preoperative patient-report outcome measures (PROMs) scores can potentially mitigate this by predicting postoperative satisfaction, identifying patients that will benefit most from surgery. The aim of this study was to (1) calculate the minimal clinically important difference (MCID) thresholds for Oxford Hip Score (OHS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Short Form-36 (SF-36) mental component summary (MCS) and physical component summary (PCS) scores and (2) identify the threshold values of these PROMs that could be used to predict patient satisfaction and expectation fulfilment. Methods Prospectively collected registry data of 1334 primary THA patients who returned for 2-year follow-up from 1998 to 2016 were reviewed. All patients were assessed preoperatively and postoperatively at 2 years using the OHS, WOMAC, and SF-36 PCS/MCS scores. The MCID for each PROMs was calculated, and the proportion of patients that attained MCID was recorded. The relationship between satisfaction, expectation fulfilment, and MCID attainment was analyzed using Spearman rank correlation. Optimal threshold scores for each PROM that predicted MCID attainment and satisfaction/expectation fulfilment at 2 years were calculated using receiver operating curve analysis. Results The calculated MCID for OHS, WOMAC, SF-36 PCS, and SF-36 MCS were 5.2, 10.8, 6.7, and 6.2, respectively. A threshold value of 24.5 for the preoperative OHS was predictive of achieving WOMAC MCID at 2 years after THA (area under the curve 0.80, P Conclusion OHS and WOMAC scores can be used to determine clinical meaningful improvement but are limited in their ability to predict patient satisfaction after THA.
TL;DR: Based on the current evidence, PRP appears to be better than HA at achieving pain relief and self-reported functional improvement in Osteoarthritis patients.
Abstract: Osteoarthritis (OA) is an extremely common form of chronic joint disease which can affect the knees and other joints of older adults, leading to debilitating disability in the knee and consequent reduction in quality of life. Intra-articular platelet-rich plasma (PRP) or hyaluronic acid (HA) injections are effective for maintaining long-term beneficial effects without increasing the risk of intra-articular infection. However, few studies have compared the relative value of HA and PRP for OA treatment. PRP is more effective than HA for OA treatment in recent studies of this topic. We systematically searched Medline, SpringerLink, Embase, Pubmed, Clinical Trials.gov, the Cochrane Library, and OVID for all articles published through May 2018. Any study was included that compared the effect of HA and PRP (consistent treatment cycle and frequency of injection) on patient's pain levels and functionality improvements. Review Manager 5.3 was used to analyze data regarding these two primary outcomes. We included 10 total studies in the present meta-analysis. International Knee Documentation Committee (IKDC; MD: 10.37, 95% confidence interval (CI): 9.13 to 11.62, p < 0.00001), Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC; MD: -20.69, 95% CI: -24.50 to -16.89, p < 0.00001, I2 = 94%), and Visual Analogue Scale (VAS; MD: -1.50, 95% CI: -1.61 to -1.38, p < 0.00001, I2 = 90%) differed significantly between the PRP and HA groups. Knee Osteoarthritis Outcome Scores (KOOSs) did not differ significantly (χ2 = 23.53, I2 = 41%, p = 0.11). Our hypothesis appears not to be confirmed because PRP and HA did not differ significantly with respect to KOOS score. However, the IKDC, WOMAC, and VAS scores differed significantly. Thus, based on the current evidence, PRP appears to be better than HA at achieving pain relief and self-reported functional improvement. Ia, meta-analyses of randomized clinical trials.
TL;DR: CRFA-treated subjects demonstrated a significant improvement in pain relief and overall function compared with subjects treated with a single injection of hyaluronic acid.
Abstract: BACKGROUND Knee osteoarthritis is a painful and sometimes debilitating disease that often affects patients for years. Current treatments include short-lasting and often repetitive nonsurgical options, followed by surgical intervention for appropriate candidates. Cooled radiofrequency ablation (CRFA) is a minimally invasive procedure for the treatment of pain related to knee osteoarthritis. This trial compared the efficacy and safety of CRFA with those of a single hyaluronic acid (HA) injection. METHODS Two hundred and sixty subjects with knee osteoarthritis pain that was inadequately responsive to prior nonoperative modalities were screened for enrollment in this multicenter, randomized trial. One hundred and eighty-two subjects who met the inclusion criteria underwent diagnostic block injections and those with a minimum of 50% pain relief were randomized to receive either CRFA on 4 genicular nerves or a single HA injection. One hundred and seventy-five subjects were treated (88 with CRFA and 87 with HA). Evaluations for pain (Numeric Rating Scale [NRS]), function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]), quality of life (Global Perceived Effect [GPE] score and EuroQol-5 Dimensions-5 Level [EQ-5D-5L] questionnaire), and safety were performed at 1, 3, and 6 months after treatment. RESULTS Demographic characteristics did not differ significantly between the 2 study groups. A total of 158 subjects (76 in the CRFA group and 82 in the HA group) completed the 6-month post-treatment follow-up. In the CRFA group, 71% of the subjects had ≥50% reduction in the NRS pain score (primary end point) compared with 38% in the HA group (p < 0.0001). At 6 months, the mean NRS score reduction was 4.1 ± 2.2 for the CRFA group compared with 2.5 ± 2.5 for the HA group (p < 0.0001). The mean WOMAC score improvement at 6 months from baseline was 48.2% in the CRFA group and 22.6% in the HA group (p < 0.0001). At 6 months, 72% of the subjects in the CRFA group reported improvement in the GPE score compared with 40% in the HA group (p < 0.0001). CONCLUSIONS CRFA-treated subjects demonstrated a significant improvement in pain relief and overall function compared with subjects treated with a single injection of HA. No serious adverse events related to either procedure were noted, and the overall adverse-event profiles were similar. LEVEL OF EVIDENCE Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.