Total WOMAC Score Research Articles

Genicular Artery Embolization for the Treatment of Symptomatic Knee Osteoarthritis.

Background:Genicular artery embolization (GAE) is a novel therapy to treat patients with symptomatic knee osteoarthritis (OA) by reducing synovial arterial hypervascularity. This study evaluates the safety and efficacy of GAE for the treatment of symptomatic knee OA.Methods:A prospective, single-center, open-label U.S. Food and Drug Administration-approved investigational device exemption study was conducted. Patients enrolled in the study were 40 to 80 years old, with moderate or severe knee OA (Kellgren-Lawrence grade 2, 3, or 4), who previously had failure of conservative therapy. Baseline pain (visual analog scale [VAS]) and symptom scores (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]) were assessed. After femoral arterial access was achieved, GAE of 1, 2, or 3 genicular arteries supplying the location of the subject’s pain, as determined by digital subtraction angiography and cone-beam computed tomography, was performed using 100-μm particles. Adverse events and symptoms scores were assessed at 1 week, 1 month, 3 months, 6 months, and 1 year after GAE.Results:Over a 10-month period, 40 subjects were enrolled. The median age was 69 years (range, 49 to 80 years). The median body mass index was 29 kg/m2 (range, 19 to 44 kg/m2). Knee OA severity was grade 2 in 18% of the patients, grade 3 in 43%, and grade 4 in 40%. Technical success was achieved in 100% of the subjects. Transient skin discoloration and transient mild knee pain after the procedure were common and expected. Treatment-related adverse events included a groin hematoma requiring overnight observation in 1 subject, self-resolving focal skin ulceration in 7 subjects, and an asymptomatic small bone infarct on magnetic resonance imaging at 3 months in 2 subjects. The WOMAC total and VAS pain scores decreased by 61% and 67% at 12 months from a median baseline of 52 (of 96) and 8 (of 10), respectively. Twenty-seven patients (68%) had a reduction of ≥50% in both WOMAC total and VAS pain scores.Conclusions:This prospective trial demonstrates that GAE is effective and durable in reducing pain symptoms from moderate or severe knee OA that is refractory to other conservative therapy, with an acceptable safety profile.Level of Evidence:Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Clinical Manifestations, Histopathological Changes And Quality Of Life In Patients With Advanced Knee Osteoarthritis Caused By Age, Trauma, Obesity And Their Combination

Objective — to reveal and analyze clinical characteristics, knee joint histopathology, and quality of life in patients at late stages of knee osteoarthritis (OA) triggered by age, trauma, metabolic syndrome, or their combination. Material and methods — We studied 120 subjects with knee OA (sensu Altman R.D., 1991) of Kellgren-Lawrence Grades 3-4. They were distributed among 4 groups (30 participants in each) based on the presence of age-related, post-traumatic, metabolic, or combined phenotypes. Clinical examination of patients with pain and their functional status evaluation (via Visual Analogue Scale, WOMAC, Lequesne index), quality of life assessment (MOS SF-36 questionnaire), along with histopathological study of medial tibial plateau cartilage and synovial membrane, were caried out, followed by statistical data processing. Results — Age-related OA phenotype was characterized by the latest clinical onset [59.5 (54-68) years of age] with the largest average patient age [72.5 (63-77) years], moderate to severe pain and knee dysfunction [total WOMAC score of 160 (127-190) points and Lequesne index of 20 (8-21) points], severe degenerative cartilage lesions [8.5 (6-10) points sensu Mankin] with high-grade synovitis [5 (3-8) points sensu Krenn]. Post-traumatic OA phenotype was distinguished by the lowest pain, stiffness and knee functional limitations [total WOMAC score of 129 (100-166), Lequesne index of 15 (14-19)], the highest quality of life in patients [physical component summary of 34.1 (30.5-36.1) points, mental component summary of 40.4 (32.9-43.8) points] against the background of local severe cartilage lesions [8 (6-8) sensu Mankin] with reparative pattern and synovial fibrosis. For metabolic OA phenotype, the typical traits included female-biased sex ratio (87%), high prevalence of clinical synovitis (77%), severe pain and functional knee disorders [total WOMAC score of 188 (162-207) points, Lequesne index of 20 (19-23) points], the worst quality of life [physical component summary of 28.0 (24.3-31.9) points, mental component summary of 30.9 (26.9-35.9) points], vascular invasion of cartilage, and high-grade synovitis [4 (3-5) points sensu Krenn]. Combined OA phenotype was characterized by variable clinical and histopathological features. Conclusion — Comprehensive comparative clinical and morphological analysis of late-stage knee OA of various origin was completed, and age-related, post-traumatic, metabolic and combined OA phenotypes were studied. The methodological basis for differential approach to treating different categories of OA patients was developed.

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

BackgroundA 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.MethodsRandomised, 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.ResultsKSS 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.ConclusionsThe 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 registrationNCT02417610.Registration, 15/04/2015.ClinicalTrials.gov database link:

Increased patellar bone tracer uptake in preoperative SPECT/CT before medial opening high tibial osteotomy correlates with inferior clinical outcome

PurposeThe purpose of this study was to investigate whether specific bone tracer uptake (BTU) patterns on preoperative SPECT/CT could predict which patients with varus alignment and medial overload would particularly benefit from medial opening-wedge high tibial osteotomy (MOWHTO). It was the hypothesis that an increased preoperative BTU relative to the reference BTU of the femur on SPECT/CT in the lateral and patellar compartments of the knee are predictive factors for inferior clinical outcome and that the clinical outcome correlates with the extent of alignment correction.MethodsTwenty-three knees from 22 patients who underwent MOWHTO for medial compartment overload were investigated preoperatively using Tc-99m-SPECT/CT. BTU was quantified and localised to specific joint areas according to a previously validated scheme. Pre- and postoperative mechanical alignment was measured. Clinical outcome was assessed at a median of 24 months (range 11–30) after MOWHTO by collecting the WOMAC score.ResultsSignificant correlations between BTU in the patellar area and the total WOMAC score and its subcategories pain and stiffness were found. Thus, BTU in the 1sPat area (superior lateral patellar compartment) correlated with total WOMAC (rho = 0.43, p = 0.04), pain subcategory (rho = 0.43, p = 0.04), and stiffness subcategory (rho = 0.59, p = 0.003). No significant correlations were found between alignment correction, age, gender and WOMAC.ConclusionThis study highlights the role of preoperative SPECT in modern knee surgery to obtain information about the loading pattern on different compartments of the knee. Despite the limited number of participants, the present study shows that a preoperative SPECT/CT scan can help the treating surgeons to identify patients who may be at risk of inferior clinical outcome if an MOWHTO is considered, as an elevated BTU in the patellar region on preoperative SPECT/CT appears to be a potential risk factor for postoperative pain and stiffness.Level of evidenceLevel III.

The EPIPHA-KNEE trial: Explaining Pain to target unhelpful pain beliefs to Increase PHysical Activity in KNEE osteoarthritis \u2013 a protocol for a multicentre, randomised controlled trial with clinical- and cost-effectiveness analysis

BackgroundDespite well-established benefits of physical activity for knee osteoarthritis (OA), nine of ten people with knee OA are inactive. People with knee OA who are inactive often believe that physical activity is dangerous, fearing that it will further damage their joint(s). Such unhelpful beliefs can negatively influence physical activity levels. We aim to evaluate the clinical- and cost-effectiveness of integrating physiotherapist-delivered pain science education (PSE), an evidence-based conceptual change intervention targeting unhelpful pain beliefs by increasing pain knowledge, with an individualised walking, strengthening, and general education program.MethodsTwo-arm, parallel-design, multicentre randomised controlled trial involving 198 people aged ≥50 years with painful knee OA who do not meet physical activity guideline recommendations or walk regularly for exercise. Both groups receive an individualised physiotherapist-led walking, strengthening, and OA/activity education program via 4x weekly in-person treatment sessions, followed by 4 weeks of at-home activities (weekly check-in via telehealth), with follow-up sessions at 3 months (telehealth) and 5 and 9 months (in-person). The EPIPHA-KNEE group also receives contemporary PSE about OA/pain and activity, embedded into all aspects of the intervention. Outcomes are assessed at baseline, 12 weeks, 6 and 12 months. Primary outcomes are physical activity level (step count; wrist-based accelerometry) and self-reported knee symptoms (WOMAC Total score) at 12 months. Secondary outcomes are quality of life, pain intensity, global rating of change, self-efficacy, pain catastrophising, depression, anxiety, stress, fear of movement, knee awareness, OA/activity conceptualisation, and self-regulated learning ability. Additional measures include adherence, adverse events, blinding success, COVID-19 impact on activity, intention to exercise, treatment expectancy/perceived credibility, implicit movement/environmental bias, implicit motor imagery, two-point discrimination, and pain sensitivity to activity. Cost-utility analysis of the EPIPHA-KNEE intervention will be undertaken, in addition to evaluation of cost-effectiveness in the context of primary trial outcomes.DiscussionWe will determine whether the integration of PSE into an individualised OA education, walking, and strengthening program is more effective than receiving the individualised program alone. Findings will inform the development and implementation of future delivery of PSE as part of best practice for people with knee OA.Trial registrationAustralian New Zealand Clinical Trials Registry: ACTRN12620001041943 (13/10/2020).

Meta-analysis of clinical trials focusing on hypertonic dextrose prolotherapy (HDP) for knee osteoarthritis.

Hypertonic dextrose prolotherapy (HDP) is an injection of a concentrated dextrose solution for the purpose of local treatment of musculoskeletal pain and possible enhancement of repair mechanisms. This systematic review and meta-analysis examines the clinical utility of HDP injection for treatment of knee osteoarthritis (OA). Randomized controlled trials (RCTs) utilizing HDP to treat knee OA were retrieved from MEDLINE, EMBASE, and Cochrane Library (CENTRAL). Identification and inclusion of RCTs utilizing intra-articular and extra-articular administration of HDP vs administration of other injectate or physical therapy as control for knee OA were included. Primary clinical outcomes were changes in knee WOMAC, pain and function score. Secondary outcomes were adverse events related to HDP. For continuous outcomes with same or different measurements, we calculated, respectively the weighted mean difference (WMD) or the standardized mean difference (SMD), respectively. Results were pooled using DerSimonian and Laird random effect models across the included studies and heterogeneity between studies was estimated using the I2 index. Five studies comprising a total of 319 treated patients met inclusion criteria and were included in the final analysis. At a mean of 22.8weeks follow-up, HDP treatment significantly improved total WOMAC score (WMD = 13.77, 95% CI: 6.75-20.78; p < 0.001; I2 = 90%), pain (SMD = 1.33, 95% CI: 0.49-2.17; p < 0.001; I2 = 91%) and knee function (SMD = 1.30, 95% CI: 0.45-2.14; p < 0.001; I2 = 91%) compared with control group. There were nosevere adverse events related to dextrose injection reported in all the included studies. HDP is a promising treatment for knee OA with a reasonable safety profile. Further research in mechanism of HDP activity and long-term follow-up study will be needed for exploring this novel therapy modality.

Central Sensitization Is an Important Factor in the Outcome of Patients Undergoing Total Knee Arthroplasty

Commentary It is well known that as many as 20% of patients are not satisfied after total knee arthroplasty (TKA), with such patients often reporting persistent pain or dysfunction1. Although there are many possible causes for dissatisfaction after TKA, it has become increasingly recognized in recent years that there are a multitude of factors outside of the surgical procedure that contribute to the overall success of TKA. An emerging area of research has sought to identify the role of central sensitization (CS) on the outcomes of TKA. Prior literature has demonstrated that patients with CS have worse quality of life, functional disability, and dissatisfaction than patients without CS after TKA despite achieving comparable clinical improvements after the surgical procedure2. This begs the question of whether CS impacts the calculation of the minimal clinically important difference (MCID) for outcome measures commonly utilized to evaluate patients who undergo TKA. Kim et al. attempted to answer this question by retrospectively evaluating 422 patients who underwent primary TKA. The authors preoperatively evaluated patients for CS utilizing a validated self-reported inventory for CS syndrome and obtained preoperative and 2-year postoperative Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores for all patients. The MCID was then calculated for patients with and without CS via both anchor-based and distribution methodology, utilizing both the change difference method and the receiver operating characteristic (ROC) curve method for anchor-based analyses. The authors should be commended for utilizing multiple methods for calculating the MCID, as this provides a much more inclusive evaluation of this important end point. One of the more interesting findings of this article was that 1 in 4 patients who underwent TKA in this series met the criteria for CS syndrome. Although this is not a new finding, it further highlights that CS is likely to be commonly encountered by orthopaedic providers caring for patients who undergo TKA. This study also demonstrated that the calculated MCIDs for patients with CS were significantly larger than those for patients without CS. Although the clinical importance of a 2 to 3-point difference in the MCID for the ROC curve and distribution-based methods of calculation has yet to be determined, the MCID was almost 9 points larger for patients with CS (23.4 points) compared with patients without CS (14.7 points) when calculated with the change difference method. This is a quite large and likely clinically important difference in MCID values. The trends from the data presented in the article are evident, and this study clearly demonstrated that patients with CS required larger improvements in clinical outcomes compared with patients without CS to reach a level that was considered a clinically meaningful improvement. This study further highlighted the complexity of caring for patients who underwent TKA and have CS by demonstrating that patients with CS were much less likely than patients without CS to even achieve an MCID after TKA. Depending upon the method of MCID determination, patients with CS achieved an MCID for the total WOMAC score at a rate of 13% to 15% less than patients without CS. Thus, not only do patients with CS require larger improvements in function to reach the MCID, but they are also significantly less likely to reach this outcome threshold. Although this article brings to light the importance of considering CS when evaluating MCIDs after TKA, it would have been helpful if the authors would have also evaluated the impact of CS on other defined clinical outcome thresholds such as the patient acceptable symptom state (PASS) and substantial clinical benefit (SCB), rather than focusing solely on the minimum improvement necessary to define success. This tiered approach to evaluating clinical outcomes scores (MCID, PASS, and SCB) provides a much more comprehensive view of patient outcomes3, and I suspect that the impact of CS would be even more magnified when analyzing higher definitions of clinical success. Nonetheless, Kim et al. demonstrate that CS is commonly encountered in patients who undergo TKA and is an important factor in their outcomes following the surgical procedure. CS should be considered when utilizing an MCID to compare interventions or outcomes between cohorts undergoing TKA going forward. Additionally, future research is now needed to identify ways in which we can intervene for patients with CS to bring their outcomes more closely in line with those of patients without CS.

Higher body mass index is associated with larger postoperative improvement in patient-reported outcomes following total knee arthroplasty

BackgroundTotal knee arthroplasty is known to successfully alleviate pain and improve function in endstage knee osteoarthritis. However, there is some controversy with regard to the influence of obesity on clinical benefits after TKA. The aim of this study was to investigate the impact of body mass index (BMI) on improvement in pain, function and general health status following total knee arthroplasty (TKA).MethodsA single-centre retrospective analysis of primary TKAs performed between 2006 and 2016 was performed. Data were collected preoperatively and 12-month postoperatively using WOMAC score and EQ-5D. Longitudinal score change was compared across the BMI categories identified by the World Health Organization.ResultsData from 1565 patients [mean age 69.1, 62.2% women] were accessed. Weight distribution was: 21.2% BMI < 25.0 kg/m2, 36.9% BMI 25.0–29.9 kg/m2, 27.0% BMI 30.0–34.9 kg/m2, 10.2% BMI 35.0–39.9 kg/m2, and 4.6% BMI ≥ 40.0 kg/m2. All outcome measures improved between preoperative and 12-month follow-up (p < 0.001). In pairwise comparisons against normal weight patients, patients with class I-II obesity showed larger improvement on the WOMAC function and total score. For WOMAC pain improvements were larger for all three obesity classes.ConclusionsPost-operative improvement in joint-specific outcomes was larger in obese patients compared to normal weight patients. These findings suggest that obese patients may have the greatest benefits from TKA with regard to function and pain relief one year post-op. Well balanced treatment decisions should fully account for both: Higher benefits in terms of pain relief and function as well as increased potential risks and complications.Trial registrationThis trial has been registered with the ethics committee of Eastern Switzerland (EKOS; Project-ID: EKOS 2020–00,879)

Superior Functional Outcome and Comparable Health-Related Quality of Life after Enhanced Recovery vs. Conventional THA: A Retrospective Matched Pair Analysis.

Background: The concept of enhanced recovery after total hip arthroplasty is gaining worldwide interest, as it shortens the length of hospital stay without an increase of complications. The aim of the study was to investigate the functional outcome and health-related quality of life 12 months after cementless total hip arthroplasty with the use of an enhanced recovery concept in comparison to a conventional rehabilitation. Material and Methods: 320 patients were retrospectively analyzed who underwent primary cementless total hip arthroplasty (THA). A total of 123 of the patients received an enhanced recovery program (ERAS) and 197 patients a conventional rehabilitation (Non-ERAS). Twelve months postoperatively, a clinical examination was performed regarding satisfaction, function and pain. Results were evaluated using WOMAC, EQ-5D-5L and EQ-VAS. A 1:1 matching was performed to correct for confounding variables, regarding age, sex and ASA score. Finally, 122 patients (n = 61, in each group) were analyzed and compared. Results: Patients showed a significant improvement of WOMAC total score, subscale pain, subscale stiffness and subscale function from preoperative to the follow up after 12 months in both groups, with significantly superior results for the WOMAC total score for the ERAS group (p = 0.042). EQ-5D and EQ-5D VAS showed a significant improvement from preoperative to 12 months postoperative (p < 0.001) for both groups, while no difference regarding the group-comparison was shown. Conclusion: Health-related quality of life and functional outcome increased to excellent values after total hip arthroplasty with the use of an enhanced recovery concept and a conventional rehabilitation, with a superior WOMAC total score for ERAS and a tendency to better results for health-related quality of life for patients with ERAS within the follow up after 12 months.

Effectiveness of Curcuma longa extract versus placebo for the treatment of knee osteoarthritis: A systematic review and meta-analysis of randomized controlled trials.

The aim of this systematic review was to evaluate the efficacy and safety of all types of Curcuma longa extract versus placebo for knee osteoarthritis (OA) treatment. The research was conducted by using the databases of PubMed, Embase, Scopus, and Cochrane Library through April 2021. Randomized controlled trials (RCTs) that compared the effect of Curcuma longa extract with placebo for patients with knee OA were considered eligible. The pooled results were expressed as mean differences or relative risks with 95% confidence intervals. A total of 10 RCTs with 783 patients were eligible for this meta-analysis. The pooled analysis showed that Curcuma longa extract was associated with significantly better pain relief and functional improvement compared with placebo for knee OA. Moreover, the smallest effect sizes of VAS for pain and WOMAC total score exceeded the minimum clinically important differences (MCIDs). Current evidence indicates that, compared with placebo, Curcuma longa extract has more benefit in pain relief and functional improvement for symptomatic knee OA. However, considering the potential heterogeneity in the included studies, more future high-quality RCTs with large sample sizes are necessary to confirm the benefits of Curcuma longa extract on knee OA.

One-Year, Efficacy and Safety Open Label Study, with a Single Injection of a New Hyaluronan for Knee OA: The SOYA Trial.

PurposeTo assess the efficacy and safety of a single injection of a new formulation of hyaluronic acid (MPS-HA2%) in patients with symptomatic knee osteoarthritis after 12 months’ follow-up.Patients and MethodsProspective, single-arm, multicentre, open-label, 12-month follow-up study. Patients with Kellgren–Lawrence (KL) 2–3 and visual analogue scale (VAS) pain scores of ≥40–< 80 mm received a single injection of MPS-HA2%. The primary outcome was the reduction in VAS pain scores from baseline, and the secondary outcomes were the Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index, the minimum clinically important improvement (MCII), and patient and investigator global assessments (PGA, IGA) measured on 5-point Likert scale. Adverse events were recorded throughout the study for safety purposes.ResultsA total of 101 patients (mean age: 68 years; 74% female; and 78% overweight) were included. The mean reduction in pain at 12 months was 37.7%; the total WOMAC score improved by 36.5% and the pain, stiffness and physical function subscores returned improvements of 32.1%, 34.1% and 32.7%, respectively (p=0.0001 with respect to baseline). At 12 months, a statistically significant 62.2% of patients obtained an improvement equal to or greater than the MCII. The mean PGA score at baseline was 2.44 and 1.46 at 12 months (p<0.05), and the mean IGA scores at equivalent timepoints were 2.29 and 1.48 (p<0.05). Fourteen patients received a second injection at the 6-month follow-up visit. Eight patients reported a total of 12 treatment-related adverse events that were local, non-serious and of mild-to-moderate intensity.ConclusionWith just a single intra-articular injection, this not controlled trial suggests that MPS-HA2% is effective 12 months after the procedure in most cases. Patient tolerability and safety were both optimal (NCT03852914).

The Minimal Clinically Important Difference (MCID) for the WOMAC and Factors Related to Achievement of the MCID After Medial Opening Wedge High Tibial Osteotomy for Knee Osteoarthritis

Background: Many approaches have been used to determine the minimal clinically important difference (MCID) in patients undergoing total knee arthroplasty, but the MCID for outcome measures after medial opening wedge high tibial osteotomy (MOWHTO) for the treatment of medial compartment knee osteoarthritis (OA) has not been reported. Purpose: To define the MCID for the Western Ontario and McMaster Universities Arthritis Index (WOMAC) after MOWHTO and to identify risk factors for not achieving the MCID. Study Design: Case-control study; Level of evidence, 3. Methods: Among patients with medial compartment knee OA who underwent MOWHTO, 174 patients who were followed for 2 years were included in the study. The MCID and substantial clinical benefit (SCB) for the WOMAC were determined using the anchor-based method with a 15-item questionnaire. Preoperative OA severity was measured by the Kellgren-Lawrence (K-L) grading system, and the acceptable range of the postoperative weightbearing line ratio was 50% to 70%. Patients were divided into 2 groups based on whether the MCID and SCB were achieved, and then factors related to failure to achieve the MCID and SCB were analyzed using multivariate logistic regression analysis. Results: The MCID for the WOMAC was 4.2 points for the pain subscale, 1.9 points for the stiffness subscale, 10.1 points for the function subscale, and 16.1 points for the total. Additionally, the SCB for the WOMAC was 6.4 for pain, 2.6 for stiffness, 16.4 for function, and 25.3 for the total. Overall, 116 (66.7%), 99 (56.9%), 127 (73.0%), and 128 (73.6%) patients achieved the MCID for the WOMAC pain, stiffness, function, and total, respectively, after MOWHTO. The odds of not achieving the MCID for the WOMAC total were 1.09 times greater (95% CI, 1.05-1.13; P < .001) in patients with a low preoperative WOMAC total score (cutoff values: 10.5 for pain, 3.5 for stiffness, 34.5 for function, and 51.0 for the total), 11.77 times greater (95% CI, 3.68-37.70; P < .001) in patients with K-L grade 4 OA compared with K-L grades 2 or 3 OA, and 8.39 times greater (95% CI, 2.98-23.63; P < .001) in patients with undercorrection or overcorrection. A low preoperative WOMAC score, K-L grade 4 OA, and undercorrection or overcorrection were also associated with not achieving the SCB for the WOMAC total (all P < .05). Conclusion: Patients treated with a MOWHTO require a 16.1-point improvement in the WOMAC total score to achieve a MCID from the procedure. Low preoperative WOMAC scores, severe OA, and undercorrection or overcorrection were related to failure to achieve the MCID.

Electroacupuncture for Knee Osteoarthritis Based on Different Meridian Syndrome: A Randomized Controlled Pilot Trial

Background: We aimed to explore the feasibility of evaluating effectiveness and safety of electroacupuncture (EA) for the treatment of knee osteoarthritis (KOA) based on different meridian syndromes. Methods: A multicenter randomized controlled trial was conducted in Beijing from January 2019 to December 2019. Sixty KOA participants were randomly allocated to either EA (n=30) or SA (n=30) groups. Participants in EA group were treated with semi-standardized on different meridian syndrome, including five obligatory acupoints and three adjunct acupoints. Eight non-acupoints that were separated from conventional acupoints or meridians were used for the SA group. Both groups received 24 sessions within eight weeks. The primary outcome was response rate, defined as a change of ≥50% from baseline in total scores of Western Ontario and McMaster Universities osteoarthritis index (WOMAC) at the end of treatment. Secondary outcomes included function, pain, stiffness, quality of life and acupuncture-related adverse events at four and eight weeks. Results: Of 60 participants randomized, 56 (93.3%) completed the study. Response rates were 60% for the EA group and 30% for the SA group after eight weeks. Significant differences were observed in WOMAC pain and total scores within two groups (P =0.026, P =0.043). Rates of adverse events were low and similarly distributed between groups. Conclusion: EA intervention based on meridian differentiation in KOA was feasible and appeared safe, having a stronger impact on pain than SA. Future studies can be designed with larger sample size, adequately powered, randomization design and less biases. Trial registration number: NCT03274713.

Minimal Clinically Important Differences for Patient-Reported Outcomes After TKA Depend on Central Sensitization.

To our knowledge, it is still unknown if central sensitization (CS) influences the magnitude of the minimal clinically important difference (MCID) for patient-reported outcome measures after total knee arthroplasty (TKA). The purpose of this study was to determine the influence of CS on the MCID for the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score in patients who underwent TKA for knee osteoarthritis. A total of 422 patients who underwent unilateral TKA and completed a 2-year follow-up were enrolled in this study. CS was measured using the Central Sensitization Inventory (CSI). The WOMAC score was used to evaluate preoperative and postoperative patient-reported outcomes. The measurement of the MCID was performed separately for patients with and without CS using both the anchor-based method and the distribution method. The change difference method defined the MCID as the difference in preoperative-to-postoperative change between the minimal-improvement group and the no-change group. In addition, the MCID was calculated using receiver operating characteristic (ROC) curve analysis. The percentage of MCID achievement in each group was also compared. According to the change difference method, the MCID for the WOMAC total score was 23.4 points for patients with CS and 14.7 points for patients without CS. The MCID using the ROC cutoff value for the WOMAC total score was 29.5 points for the patients with CS and 26.5 points for the patients without CS. MCID achievement rates in WOMAC pain, function, and total scores were all found to be significantly higher in the patients without CS through the change difference method and the ROC method (all p < 0.05). The MCID for the WOMAC score of patients with CS after TKA was greater than that for patients without CS. Furthermore, by applying the calculated MCID to the group to which the patients belonged (with or without CS), we determined that patients with CS showed a lower MCID achievement rate than patients without CS. Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Clinical Outcomes After Computed Tomography-Based Total Knee Arthroplasty: A Surgeon's First 1,000 Cases.

Computed tomography scan (CT)-based three-dimensional (3D) modeling operative technologies have been shown to improve upon many perioperative results of manual total knee arthroplasties (TKAs). Although patient satisfaction has been reported for CT-based TKAs, studies evaluating large cohorts are limited. The purpose of this study was to compare the clinical outcomes of a surgeon's first 1,000 CT-based TKAs with manual TKAs during a minimum follow-up time of approximately six months. Specifically, we analyzed: (1) survivorship; (2) functional outcomes; (3) radiographic outcomes (i.e., alignment, progressive radiolucencies); and (4) complications. A total of 1,000 consecutive primary CT-based total knee arthroplasty cases (988 patients) performed by a single surgeon at a single center between July 1, 2016 and July 1, 2021 were compared to a total of 1,000 consecutive manual TKAs (996 patients) completed by the same surgeon between May 18, 2013 and July 1, 2016. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) surveys were collected at approximately six months postoperatively. Subgroup analyses were performed on the physical function and pain scores. Follow-up radiographs were also examined for alignment, progressive radiolucencies, and/or loosenings. There was 100% survivorship at approximately six months follow up. The mean physical function score for the manual cohort and CT-based cohort were 10 ± 4 (range, 0 to 32) and 5 ± 4 (range, 0 to 22), respectively (p<0.05). The mean pain score for the manual cohort and CT-based cohort were 4 ± 4 (range, 0 to 20) and 3 ± 2 (range, 0 to 15), respectively (p<0.05). The mean total WOMAC score for the manual cohort and CT-based cohort were 13 ± 9 (range, 0 to 44) and 8 ± 7 (range, 0 to 33), respectively (p<0.05). None of the manual or CT-based cases exhibited progressive radiolucencies by final follow up. There were no postoperative medical and/or surgical complications at final follow up in the two cohorts. The 1,000 CT-based TKA clinical outcomes from this study continue to support great survivorship and radiographic outcomes, minimal complications, as well as improved physical function, pain, and total WOMAC scores. Therefore, those who undergo CT-based 3D modeling total knee arthroplasties should have the advantage of superior patient satisfaction.

Effect of fire needling on mild to moderate knee osteoarthritis and related serum inflammatory cytokines

To compare the clinical effect of fire needling and filiform needling for mild to moderate knee osteoarthritis (KOA) and observe the influence on related serum inflammatory sytokines. A total of 60 patients with mild to moderate KOA were randomly divided into an observation group (30 cases, 4 cases dropped off) and a control group (30 cases, 4 cases dropped off). Both groups were given basic health management, and the acupoints of the two groups were Liangqiu (ST 34), Xuehai (SP 10), Neixiyan (EX-LE 4), Dubi (ST 35), Yanglingquan (GB 34) and ashi point. The observation group was treated with fire needling, while the control group was treated with filiform needling. Both groups were treated once every other day, 3 times a week for 2 weeks. The Western Ontario and McMaster University osteoarthritis index (WOAMC) scores of the two groups were compared before treatment, in 1, 2 weeks of treatment and 2, 6 weeks of follow-up. ELISA method was used to detect the levels of serum interleukin 1α (IL-1α), tumor necrosis factor α (TNF-α) and matrix metalloproteinase 3 (MMP-3) before treatment and in 2 weeks of treatment. The clinical effect of the two groups was evaluated in 1, 2 weeks of treatment and 2, 6 weeks of follow-up. At each time point of treatment and follow-up, the pain, stiffness, difficulty of daily activities scores and WOMAC total scores of the two groups were lower than those before treatment (P<0.05); the stiffness score of the observation group was lower than that of the control group in 1 week of treatment (P<0.05); the various scores and total scores of the WOMAC scale of the observation group were lower than those of the control group in 1, 2 weeks of treatment and 2, 6 weeks of follow-up (P<0.05). In 2 weeks of treatment, the levels of serum MMP-3 and IL-1α in the observation group and IL-1α in the control group were higher than those before treatment (P<0.05). In 1 week of treatment and 2, 6 weeks of follow-up, the total effective rates of the observation group were higher than those in the control group (P<0.05). Fire needling can improve the pain, stiffness and joint dysfunction of patients with mild to moderate KOA, and increase serum MMP-3 and IL-1α levels. Its short and long term clinical effects are better than filiform needling.

Clinical Efficacy of Cortex Daphnes (Zushima) Patch in Patients With Symptomatic Knee Osteoarthritis: A Multicenter Non-Inferiority Randomized Controlled Clinical Trial.

Background: Osteoarthritis (OA) is imposing substantial burdens on individuals and society with the aging population. Cortex Daphnes patch is widely used for symptomatic knee OA in China with a satisfying clinical efficacy; however, there is scant clinical evidence supporting its use. To evaluate its efficacy, we conducted a multicenter, non-inferiority, randomized, parallel-group study comparing Cortex Daphnes patch with topical nonsteroidal anti-inflammatory drugs in patients with knee OA (NCT02770950). Methods: A total of 264 symptomatic knee OA patients were treated with Cortex Daphnes or indomethacin cataplasms applied to affected sites once daily for 2 weeks. The primary outcome was improvement in knee pain on walking as assessed using a visual analog scale (VAS). The non-inferiority margin based on the full analysis population was set as –5 mm on the pain VAS. The secondary outcomes were changes of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score, WOMAC scores for pain, function and stiffness, the 36-item Short Form Health Survey (SF-36), and global assessment of knees by the patients. Responder rates for pain VAS, WOMAC total score, and WOMAC pain were also included in the secondary outcomes. Results: The Cortex Daphnes patch was non-inferior to indomethacin cataplasms for the primary outcome with a group difference (Cortex Daphnes patch–indomethacin cataplasm) of 2.1 mm (95% confidence interval: 2.1–6.4); similar results were found in the per-protocol population. For all other outcomes, no significant differences were found in the full analysis set or in the per-protocol analysis set, except the responder rates for WOMAC pain was higher in the Cortex Daphnes patch group than in the indomethacin cataplasm group (78.4 vs. 64.7%, p = 0.022) in the per-protocol analysis set. Overall, 28.8% patients in the Cortex Daphnes patch group and 9.8% in the indomethacin cataplasm group reported treatment-related adverse events, the vast majority of which were mild-to-moderate skin irritation, resulting in only 3.8 and 0.8% of patients dropping out, respectively. Conclusion: The Cortex Daphnes patch, which provides satisfactory analgesic efficacy and enhances the physical function of the knee, as well as improving quality of life, may be a promising alternative to knee OA.

Abstract No. 15 Two-year outcomes of comparing Embosphere microspheres versus imipenem–cilastatin for genicular artery embolization in patients with knee osteoarthritis

Genicular artery embolization (GAE) has potential to provide midterm relief of pain for patients with mild-to-moderate knee osteoarthritis resistant to conservative management. The study compares use of trisacryl gelatin microspheres (ES) to imipenem-cilastatin (IMP/CS) particles for GAE on a cohort of patients with two-year of clinical follow-up. In a prospective study, a total of ten patients (15 knees) who had GAE with 100-to 300-μm ES particles were compared with a subsequent cohort of eleven patients (18 knees) who underwent GAE with IMP/CS. Clinical outcomes were evaluated at 6-month and 24-month follow-up and compared to baseline using WOMAC questionnaire. There was no significant difference in sex, age, BMI, duration of pain before the procedure, prior treatment, or Kellgren-Lawrence grade between the 2 cohorts. Baseline median pain WOMAC and total WOMAC scores were 13 (IQR 4) and 46 (IQR 4) in the ES group and 13 (IQR 3) and 47 (IQR 28) in the IMP/CS groups (P = 0.875 and P = 0.738), respectively. The median follow-up was 796 days (range, 736-808). Clinical success (50% reduction in WOMAC pain score vs baseline) was achieved in 69.23% of the embolized knee joints in both groups (P = 1.0) at 6 months, and 61.5% versus 53.8% of in ES and IMP/CS groups, at 2-years of follow-up, respectively (P = 1.0). Both embolic materials resulted in significant decrease in Pain WOMAC and Total WOMAC scores at 6 months (compared to baseline) (P< 0.05) and the effect of GAE on Pain WOMAC and Total WOMAC scores was sustained until the 24-month follow-up visit in both groups (P< 0.05). Minor events included transient cutaneous color change (five patients) or transient leg numbness (one patient) and was only identified after GAE with ES particles (P = 0.00387), which resolved spontaneously at 1-month follow-up (Clavien-Dindo classification grade I). There was no major adverse event. 100- to 300-μm ES particles can be considered for GAE and is comparable to IMP/CS in pain reduction of moderate to severe knee osteoarthritis and with sustained effect up to two-years of follow-up.

Heterotopic Ossification Following Arthroplasty for Femoral Neck Fracture.

Heterotopic ossification (HO) is a frequent complication following hip surgery. Using data from the Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus Hemiarthroplasty (HEALTH) trial, we aimed to (1) determine the prevalence of HO following total hip arthroplasty (THA) for femoral neck fracture in patients ≥50 years of age, (2) identify whether HO is associated with an increased risk of revision surgery within 24 months after the fracture, and (3) determine the impact of HO on functional outcomes. We performed a multivariable Cox regression analysis using revision surgery as the dependent variable and HO as the independent variable. We compared Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores between participants with and those without HO at 24 months. Of 1,441 participants in the study, 287 (19.9%) developed HO within 24 months. HO was not associated with subsequent revision surgery. Grade-III HO was associated with statistically significant and clinically relevant deterioration in the total WOMAC score, which was mainly related to the function component of the score, compared with grade I or II. The impact of grade-III HO on the functional outcomes and quality of life after THA for hip fracture is clinically important, and HO prophylaxis for selected high-risk patients may be appropriate. Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Non-Inferiority of a Single Injection of Sodium Hyaluronate Plus Sorbitol to Hylan G-F20: A 6-Month Randomized Controlled Trial.

IntroductionSeveral viscosupplement treatments are available for patients suffering from painful osteoarthritis (OA) of the knee, but few comparative clinical trials have been conducted. The primary objective of the trial was to demonstrate the non-inferiority of Synolis VA (80 mg hyaluronic acid and 160 mg sorbitol) (Group HA1) to Synvisc-One (48 mg hylan GF-20) (Group HA2) at Day 168 in terms of pain relief efficacy in patients with knee OA (Kellgren and Lawrence radiological stage II or III) in whom oral treatment with analgesics, NSAIDs or weak opioids provided insufficient clinical responses or were poorly tolerated.MethodsThis was a prospective, multicentre, comparative, randomized, double-blinded trial comparing the two previously indicated viscosupplements, HA1 and HA2. The average VAS pain score (1–100) was 62.5 at baseline (Day 0). The patients were randomized into two parallel groups at Day 0 and followed until Day 168. They received one injection of either HA1 or HA2. The primary end point was the evolution of the Western Ontario and McMaster University (WOMAC) pain index at D168 in the groups. One of the secondary end points was the daily assessment of this index by the patient for 7 days following the injection and thereafter at Day 14. The other secondary end points were the WOMAC pain, stiffness, function and total scores assessed at Day 28, Day 84 and Day 168. At Day 168, efficacy and satisfaction were assessed by the evaluator and by the patient using a Likert scale (7 points). Moreover, the number of strict responders in each group was evaluated according to the The Osteoarthritis Research Society International (OARSI) Standing Committee for Clinical Trials Response Criteria Initiative and the Outcome Measures in Rheumatology (OMERACT) criteria (OMERACT-OARSI). The per protocol (PP) population was used for the primary analysis.ResultsA total of 202 patients were randomized. The patients were predominantly female (66%). The median age of the whole population was 65 years, and the median body mass index was 27.4 kg/m2. No statistically significant differences between the two treatment groups were observed for any of the demographic criteria. At Day 168, 197 had had no protocol violations (94 in the HA1 group and 103 in the HA2 group). The WOMAC pain score decreased in the two groups: − 29.2 ± 24.1 (SD) in the HA1 group and − 31.6 ± 25.5 (SD) in the HA2 group, confirming the non-inferiority of Synolis VA (P = 0.57 for the difference between groups). Regarding the secondary end points, no significant difference was observed at Day 14, Day 28, Day 84 or Day 168 for all the outcomes except stiffness at Day 28 (P = in favour of treatment received in HA2). The rate of responders was comparable between the two groups: 79% for HA1 and 77% for HA2. Both products were well tolerated. Serious adverse events were reported by four patients in the HA1 group and 3 in the HA2 group.ConclusionIn this trial, we confirmed the non-inferiority of Synolis VA compared to Synvisc-One at Day 168 according to the WOMAC pain score. Safety was satisfying and comparable in the two groups.Trial Registration2017-A00034-49.