Showing papers on "WOMAC published in 2017"

Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Meta-analysis of Randomized Controlled Trials.

Abstract: Purpose To use meta-analysis techniques to evaluate the efficacy and safety of platelet-rich plasma (PRP) injections for the treatment knee of osteoarthritis (OA). Methods We performed a systematic literature search in PubMed, Embase, Scopus, and the Cochrane database through April 2016 to identify Level I randomized controlled trials that evaluated the clinical efficacy of PRP versus control treatments for knee OA. The primary outcomes were Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function scores. The primary outcomes were compared with their minimum clinically important differences (MCID)—defined as the smallest difference perceived as important by the average patient. Results We included 10 randomized controlled trials with a total of 1069 patients. Our analysis showed that at 6 months postinjection, PRP and hyaluronic acid (HA) had similar effects with respect to pain relief (WOMAC pain score) and functional improvement (WOMAC function score, WOMAC total score, International Knee Documentation Committee score, Lequesne score). At 12 months postinjection, however, PRP was associated with significantly better pain relief (WOMAC pain score, mean difference −2.83, 95% confidence interval [CI] −4.26 to −1.39, P = .0001) and functional improvement (WOMAC function score, mean difference −12.53, 95% CI −14.58 to −10.47, P P = .01) than HA, and the effect sizes of WOMAC pain and function scores at 12 months exceeded the MCID (−0.79 for WOMAC pain and −2.85 for WOMAC function score). Compared with saline, PRP was more effective for pain relief (WOMAC pain score) and functional improvement (WOMAC function score) at 6 months and 12 months postinjection, and the effect sizes of WOMAC pain and function scores at 6 months and 12 months exceeded the MCID. We also found that PRP did not increase the risk of adverse events compared with HA and saline. Conclusions Current evidence indicates that, compared with HA and saline, intra-articular PRP injection may have more benefit in pain relief and functional improvement in patients with symptomatic knee OA at 1 year postinjection. Level of Evidence Level I, meta-analysis of Level I studies.

The Temporal Effect of Platelet-Rich Plasma on Pain and Physical Function in the Treatment of Knee Osteoarthritis: Systematic Review and Meta-Analysis of Randomized Controlled Trials

Abstract: Quite a few randomized controlled trials (RCTs) investigating the efficacy of platelet-rich plasma (PRP) for treatment of knee osteoarthritis (OA) have been recently published. Therefore, an updated systematic review was performed to evaluate the temporal effect of PRP on knee pain and physical function. Pubmed, Embase, Cochrane library, and Scopus were searched for human RCTs comparing the efficacy and/or safety of PRP infiltration with other intra-articular injections. A descriptive summary and quality assessment were performed for all the studies finally included for analysis. For studies reporting outcomes concerning Western Ontario and McMaster Universities Arthritis Index (WOMAC) or adverse events, a random-effects model was used for data synthesis. Fourteen RCTs comprising 1423 participants were included. The control included saline placebo, HA, ozone, and corticosteroids. The follow-up ranged from 12 weeks to 12 months. Risk of bias assessment showed that 4 studies were considered as moderate risk of bias and 10 as high risk of bias. Compared with control, PRP injections significantly reduced WOMAC pain subscores at 3, 6, and 12 months follow-up (p = 0.02, 0.004, <0.001, respectively); PRP significantly improved WOMAC physical function subscores at 3, 6, and 12 months (p = 0.002, 0.01, <0.001, respectively); PRP also significantly improved total WOMAC scores at 3, 6 and 12 months (all p < 0.001); nonetheless, PRP did not significantly increased the risk of post-injection adverse events (RR, 1.40 [95% CI, 0.80 to 2.45], I 2 = 59%, p = 0.24). Intra-articular PRP injections probably are more efficacious in the treatment of knee OA in terms of pain relief and self-reported function improvement at 3, 6 and 12 months follow-up, compared with other injections, including saline placebo, HA, ozone, and corticosteroids. PROSPERO CRD42016045410 . Registered 8 August 2016.

Choice of intra-articular injection in treatment of knee osteoarthritis: platelet-rich plasma, hyaluronic acid or ozone options.

Abstract: This study was performed to compare the efficacy of treatment in three groups of patients with knee osteoarthritis (OA) given an intra-articular injection of platelet-rich plasma (PRP), hyaluronic acid (HA) or ozone gas. A total of 102 patients with mild–moderate and moderate knee OA who presented at the polyclinic with at least a 1-year history of knee pain and VAS score ≥4 were randomly separated into three groups. Group 1 (PRP group) received intra-articular injection of PRP × 2 doses, Group 2 (HA group) received a single dose of HA, and Group 3 (Ozone group) received ozone × four doses. Weight-bearing anteroposterior–lateral and Merchant’s radiographs of both knees were evaluated. WOMAC and VAS scores were applied to all patients on first presentation and at 1, 3, 6 and 12 months. At the end of the 1st month after injection, significant improvements were seen in all groups. In the 3rd month, the improvements in WOMAC and VAS scores were similar in Groups 1 and 2, while those in Group 3 were lower (p < 0.001). At the 6th month, while the clinical efficacies of PRP and HA were similar and continued, the clinical effect of ozone had disappeared (p < 0.001). At the end of the 12th month, PRP was determined to be both statistically and clinically superior to HA (p < 0.001). In the treatment of mild–moderate knee OA, PRP was more successful than HA and ozone injections, as the application alone was sufficient to provide at least 12 months of pain-free daily living activities. Therapeutic study, Level I.

Survivorship of the Bernese Periacetabular Osteotomy: What Factors are Associated with Long-term Failure?

Abstract: The Bernese periacetabular osteotomy (PAO) continues to be a commonly performed nonarthroplasty option to treat symptomatic developmental hip dysplasia, but there are few long-term followup studies evaluating results after PAO. (1) What is the long-term survivorship of the hip after PAO? (2) What were the validated outcomes scores among patients who had PAO more than 14 years ago? (3) What factors are associated with long-term failure? One hundred fifty-eight dysplastic hips (133 patients) underwent PAO between May 1991 and September 1998 by a single surgeon. Of those, 37 hips (34 patients [26%]) were lost to followup; an additional seven patients (5% [eight hips]) had not been seen in the last 5 years. The 121 hips (in 99 patients) were retrospectively evaluated at a mean of 18 years (range, 14–22 years). Survivorship was assessed using Kaplan-Meier analysis with total hip arthroplasty (THA) as the endpoint. Hips were evaluated for activity, pain, and general health using the UCLA Activity Score, modified Harris hip score, WOMAC, and Hip disability and Osteoarthritis Outcome Score (HOOS). Failure was defined as a WOMAC pain subscale score ≥ 10 or having undergone THA. Hips were divided into three groups: asymptomatic (did not meet any failure criteria at any point in time), symptomatic (met WOMAC pain failure criteria at previous or most recent followup), and replaced (having undergone THA). A multinomial logistic regression model using a general estimating equations approach was used to assess factors associated with failure. Kaplan-Meier analysis with THA as the endpoint revealed a survival rate (95% confidence interval [CI]) of 74% (66%–83%) at 18 years. Twenty-six hips (21%) underwent THA at an average of 9 ± 5 years from the surgery. Sixty-four hips (53%) remained asymptomatic and did not meet any failure criteria at most recent followup. Thirty-one hips (26%) were symptomatic and considered failed based on a WOMAC pain score of ≥ 10 with a mean ± SD of 11 ± 4 out of 20 at most recent followup. Although some failed initially by pain, their most recent WOMAC score may have been < 10. Of the 16 symptomatic hips that failed early by pain (reported a WOMAC pain subscale score ≥ 10 in the prior study), two were lost to followup, two underwent THA at 16 and 17 years, four still failed because of pain at most recent followup, and the remaining eight had WOMAC pain scores < 10 at most recent followup. Asymptomatic hips reported better UCLA Activity Scores (asymptomatic: mean ± SD, 7 ± 2; symptomatic: 6 ± 2, p = 0.001), modified Harris hip scores (pain, function, and activity sections; asymptomatic: 80 ± 11; symptomatic: 50 ± 15, p < 0.001), WOMAC (asymptomatic: 2 ± 2, symptomatic: 11 ± 4, p < 0.001), and HOOS (asymptomatic: 87 ± 11, symptomatic: 52 ± 20, p < 0.001) compared with symptomatic hips at long-term followup. Age older than 25 years at the time of PAO (symptomatic: odds ratio [OR], 3.6; 95% CI, 1.3–9.8; p = 0.01; replaced: OR, 8.9; 95% CI, 2.6–30.9; p < 0.001) and a preoperative joint space width ≤ 2 mm (replaced: OR, 0.3; 95% CI, 0.12–0.71; p = 0.007) or ≥ 5 mm (replaced: OR, 0.121; 95% CI, 0.03–0.56; p = 0.007) were associated with long-term failure while controlling for poor or fair preoperative joint congruency. This study demonstrates the durability of the Bernese PAO at long-term followup. In a subset of patients, there was progression to failure over time. Factors of progression to THA or more severe symptoms include age older than 25 years, poor or fair preoperative hip congruency, and a preoperative joint space width that is less than 2 mm or more than 5 mm. Future studies should focus on evaluating the two failure groups that we have identified in our study: those that failed early and went on to THA and those that are symptomatic at long-term followup. Level III, therapeutic study.

Clinical efficacy and safety of mesenchymal stem cell transplantation for osteoarthritis treatment: A meta-analysis.

Abstract: Purpose The aim of this study was to evaluate the therapeutic efficacy and safety of mesenchymal stem cells (MSCs) for the treatment of patients with knee osteoarthritis (OA). Materials We performed a meta-analysis of relevant published clinical studies. An electronic search was conducted for randomized controlled trials (RCTs) of MSC-based therapy in knee OA. The visual analogue scale (VAS), International Knee Documentation Committee (IKDC) form, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lequesne algofunctional indices (Lequesne), Lysholm knee scale (Lysholm), Tegner activity scale (Tegner) and adverse events (AEs) were evaluated. Results Eleven eligible trials with 582 knee OA patients were included in the present meta-analysis. We demonstrated that MSC treatment could significantly decrease VAS and increase IKDC scoresafter a 24-month follow-up compared with controls (P<0.05). MSC therapy also showed significant decreases in WOMAC and Lequesne scores after the 12-month follow-up (P<0.01). Analysis of Lysholm (24-month) and Tegner (12- and 24-month) scores also demonstrated favorable results for MSC treatment (P<0.05). Conclusion Overall, MSC transplantation treatment was shown to be safe and has great potential as an efficacious clinical therapy for patients with knee OA.

Impact of total knee replacement practice: cost effectiveness analysis of data from the Osteoarthritis Initiative

Abstract: Objectives To evaluate the impact of total knee replacement on quality of life in people with knee osteoarthritis and to estimate associated differences in lifetime costs and quality adjusted life years (QALYs) according to use by level of symptoms. Design Marginal structural modeling and cost effectiveness analysis based on lifetime predictions for total knee replacement and death from population based cohort data. Setting Data from two studies—Osteoarthritis Initiative (OAI) and the Multicenter Osteoarthritis Study (MOST)—within the US health system. Participants 4498 participants with or at high risk for knee osteoarthritis aged 45-79 from the OAI with no previous knee replacement (confirmed by baseline radiography) followed up for nine years. Validation cohort comprised 2907 patients from MOST with two year follow-up. Intervention Scenarios ranging from current practice, defined as total knee replacement practice as performed in the OAI (with procedural rates estimated by a prediction model), to practice limited to patients with severe symptoms to no surgery. Main outcome measures Generic (SF-12) and osteoarthritis specific quality of life measured over 96 months, model based QALYs, costs, and incremental cost effectiveness ratios over a lifetime horizon. Results In the OAI, total knee replacement showed improvements in quality of life with small absolute changes when averaged across levels of confounding variables: 1.70 (95% uncertainty interval 0.26 to 3.57) for SF-12 physical component summary (PCS); −10.69 (−13.39 to −8.01) for Western Ontario and McMaster Universities arthritis index (WOMAC); and 9.16 (6.35 to 12.49) for knee injury and osteoarthritis outcome score (KOOS) quality of life subscale. These improvements became larger with decreasing functional status at baseline. Provision of total knee replacement to patients with SF-12 PCS scores Conclusion Current practice of total knee replacement as performed in a recent US cohort of patients with knee osteoarthritis had minimal effects on quality of life and QALYs at the group level. If the procedure were restricted to more severely affected patients, its effectiveness would rise, with practice becoming economically more attractive than its current use.

Patient Satisfaction Outcomes after Robotic Arm-Assisted Total Knee Arthroplasty: A Short-Term Evaluation

Abstract: Robotic arm-assisted total knee arthroplasty (RATKA) presents a potential, new added value for orthopedic surgeons. In today's health care system, a major determinant of value can be assessed by patient satisfaction scores. Therefore, the purpose of the study was to analyze patient satisfaction outcomes between RATKA and manual total knee arthroplasty (TKA). Specifically, we used the Western Ontario and McMaster Universities Arthritis Index (WOMAC) to compare (1) pain scores, (2) physical function scores, and (3) total patient satisfaction outcomes in manual and RATKA patients at 6 months postoperatively. In this study, 28 cemented RATKAs performed by a single orthopedic surgeon at a high-volume institution were analyzed. The first 7 days were considered as an adjustment period along the learning curve. Twenty consecutive cemented RATKAs were matched and compared with 20 consecutive cemented manual TKAs performed immediately. Patients were administered a WOMAC satisfaction survey at 6 months postoperatively. Satisfaction scores between the two cohorts were compared and the data were analyzed using Student's t-tests. A p-value

Benefits of Resistance Training with Blood Flow Restriction in Knee Osteoarthritis

Abstract: PurposeEvaluate the effects of a low-intensity resistance training (LI-RT) program associated with partial blood flow restriction on selected clinical outcomes in patients with knee osteoarthritis (OA).MethodsForty-eight women with knee OA were randomized into one of the three groups: LI-RT

Intra-articular injection in the knee of adipose derived stromal cells (stromal vascular fraction) and platelet rich plasma for osteoarthritis

Abstract: Stromal vascular fraction (SVF) can easily be obtained from a mini-lipoaspirate procedure of fat tissue and platelet rich plasma (PRP) can be obtained from peripheral blood. We evaluated the safety and preliminary efficacy of administering SVF and PRP intra-articularly into patients with osteoarthritis grade 1 and 2. A total of ten patients underwent a local tumescent liposuction procedure to remove approximately 100 ml of fat tissue from the abdomen. SVF was isolated using an enzyme digestion and resuspended in PRP for intra-articular injection in the knee. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score and six-minute walk distance (6MWD) were used to evaluate clinical effects and included measure of patient’s subjective assessment of pain, joint mobility, and physical disability. WOMAC score, 6MWD and laboratory tests were repeated at 3 and 6 months and 1, 1.5 and 2 years. XRAY and MRI were completed at 1 year. The average total WOMAC score was 64 at baseline and significantly reduced to 52 at 3 months, 46 at 6 months, 42 at 1 year, 38 at 1.5 years, and 41 at 2 years. Patients walked an average of 1310 feet at baseline and demonstrated a statistically significant improvement at 3 and 6 months and 1, 1.5, and 2 years post treatment. Cartilage thickness as determined by MRI improved by at least 0.2 mm in six patients, was unchanged in two patients and decreased by at least 0.2 mm in two patients. Overall, all of the patients were pleased with the treatment results. They reported a reduction in pain levels, especially after 3 months. More importantly, the procedure demonstrated a strong safety profile with no severe adverse events or complications reported. Trial registration NCT03089762; Name of registry: http://www.clinicaltrials.gov

Knee Extensor Strength and Risk of Structural, Symptomatic, and Functional Decline in Knee Osteoarthritis: A Systematic Review and Meta-Analysis.

Abstract: Objective To perform a systematic review and meta-analysis on the association between knee extensor strength and the risk of structural, symptomatic, or functional deterioration in individuals with or at risk of knee osteoarthritis (KOA). Methods We systematically identified and methodologically appraised all longitudinal studies (≥1-year followup) reporting an association between knee extensor strength and structural (tibiofemoral, patellofemoral), symptomatic (self-reported, knee replacement), or functional (subjective, objective) decline in individuals with or at risk of radiographic or symptomatic KOA. Results were pooled for each of the above associations using meta-analysis, or if necessary, summarized according to a best-evidence synthesis. Results Fifteen studies were included, evaluating >8,000 participants (51% female), with a followup time between 1.5 and 8 years. Meta-analysis revealed that lower knee extensor strength was associated with an increased risk of symptomatic (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC] pain: odds ratio [OR] 1.35, 95% confidence interval [95% CI] 1.10–1.67) and functional decline (WOMAC function: OR 1.38, 95% CI 1.00–1.89, and chair-stand task: OR 1.03, 95% CI 1.03–1.04), but not increased risk of radiographic tibiofemoral joint space narrowing (JSN) (OR 1.15, 95% CI 0.84–1.56). No trend in risk was observed for KOA status (present versus absent). Best-evidence synthesis showed inconclusive evidence for lower knee extensor strength being associated with increased risk of patellofemoral deterioration. Conclusion Meta-analysis showed that lower knee extensor strength is associated with an increased risk of symptomatic and functional deterioration, but not tibiofemoral JSN. The risk of patellofemoral deterioration in the presence of knee extensor strength deficits is inconclusive.

Telephone Coaching to Enhance a Home-Based Physical Activity Program for Knee Osteoarthritis: A Randomized Clinical Trial

Abstract: Objective To investigate whether simultaneous telephone coaching improves the clinical effectiveness of a physiotherapist-prescribed home-based physical activity program for knee osteoarthritis (OA). Methods A total of 168 inactive adults ages ≥50 years with knee pain on a numeric rating scale ≥4 (NRS; range 0–10) and knee OA were recruited from the community and randomly assigned to a physiotherapy (PT) and coaching group (n = 84) or PT-only (n = 84) group. All participants received five 30-minute consultations with a physiotherapist over 6 months for education, home exercise, and physical activity advice. PT+coaching participants also received 6–12 telephone coaching sessions by clinicians trained in behavioral-change support for exercise and physical activity. Primary outcomes were pain (NRS) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC; score range 0–68]) at 6 months. Secondary outcomes were these same measures at 12 and 18 months, as well as physical activity, exercise adherence, other pain and function measures, and quality of life. Analyses were intent-to-treat with multiple imputation for missing data. Results A total of 142 (85%), 136 (81%), and 128 (76%) participants completed 6-, 12-, and 18-month measurements, respectively. The change in NRS pain (mean difference 0.4 unit [95% confidence interval (95% CI) −0.4, 1.3]) and in WOMAC function (1.8 [95% CI −1.9, 5.5]) did not differ between groups at 6 months, with both groups showing clinically relevant improvements. Some secondary outcomes related to physical activity and exercise behavior favored PT+coaching at 6 months but generally not at 12 or 18 months. There were no between-group differences in most other outcomes. Conclusion The addition of simultaneous telephone coaching did not augment the pain and function benefits of a physiotherapist-prescribed home-based physical activity program.

Efficacy of tailored exercise therapy on physical functioning in patients with knee osteoarthritis and comorbidity : A randomized controlled trial

Abstract: Objective: To evaluate the efficacy on physical functioning and safety of tailored exercise therapy in patients with knee osteoarthritis (OA) and comorbidities. Methods: In a randomized controlled trial, 126 participants were included with a clinical diagnosis of knee OA and at least 1 of the following target comorbidities: coronary disease, heart failure, type 2 diabetes mellitus, chronic obstructive pulmonary disease, or obesity (body mass index ≥30 kg/m2), with severity score ≥2 on the Cumulative Illness Rating Scale. The intervention group received a 20-week, individualized, comorbidity-adapted exercise program consisting of aerobic and strength training and training of daily activities. The control group received their current medical care for knee OA and were placed on a waiting list for exercise therapy. Primary outcome measures were the Western Ontario and McMaster Universities Osteoarthritis Index, subscale physical functioning (WOMAC-pf), and the 6-minute walk test (6MWT). Measurements were performed at baseline, after 20 weeks (directly posttreatment), and at 3 months posttreatment. Results: Statistically significant physical functioning differences over time were found between the intervention and control group (WOMAC: B = −7.43 [95% confidence interval (95% CI) −9.99, −4.87], P < 0.001; and 6MWT: B = 34.16 [95% CI 17.68, 50.64], P < 0.001) in favor of the intervention group. At 3 months followup, the mean improvements in the intervention group were 33% on the WOMAC scale and 15% on the 6MWT. These improvements are of clinical relevance. No serious adverse events occurred during the intervention. Conclusion: This is the first study showing that tailored exercise therapy is efficacious in improving physical functioning and safe in patients with knee OA and severe comorbidities.

Combined Treatment With Chondroitin Sulfate and Glucosamine Sulfate Shows No Superiority Over Placebo for Reduction of Joint Pain and Functional Impairment in Patients With Knee Osteoarthritis: A Six-Month Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Abstract: Objective To assess the efficacy and safety of combination therapy with chondroitin sulfate (CS) and glucosamine sulfate (GS) compared to placebo in patients with symptomatic knee osteoarthritis (OA). Methods A multicenter, randomized, double-blind, placebo-controlled study was performed in 164 patients with Kellgren/Lawrence grade 2 or grade 3 radiographic knee OA and moderate-to-severe knee pain (mean ± SD global pain score 62.1 ± 11.3 mm on a 100-mm visual analog scale [VAS]). Patients were randomized to receive either combined treatment with CS (1,200 mg) plus GS (1,500 mg) or placebo in a single oral daily dose for 6 months. The mean change from baseline in the VAS global pain score was set as the primary end point. Secondary outcomes included the mean change in the investigator's global assessment of disease activity, total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), pain and function subscale scores on the WOMAC, responder rates based on the Outcome Measures in Rheumatology (OMERACT)–Osteoarthritis Research Society International (OARSI) 2004 response criteria, and rescue medication use. Adverse events were also recorded. A Data and Safety Monitoring Board was instituted to ensure patient safety and data accuracy. Results Intriguingly, in the modified intent-to-treat (mITT) population, CS/GS combination therapy was inferior to placebo in the reduction of joint pain (mean ± SD change in VAS global pain score over 6 months −11.8 ± 2.4 mm [19% reduction] in patients receiving CS plus GS versus −20.5 ± 2.4 mm [33% reduction] in patients receiving placebo; peak between-group difference in global pain score at 6 months 8.7 mm [14.2%], P < 0.03), but no between-group differences were seen in the per-protocol completers. Both placebo treatment and CS/GS combination treatment improved to a similar extent the total WOMAC score as well as the pain and function WOMAC subscale scores, both in the mITT population and in the per-protocol completers. Neither the OMERACT–OARSI responder rate nor the frequency of rescue medication use differed between the treatment groups. Severe adverse events were uncommon and equally distributed. Conclusion The results of this trial demonstrate a lack of superiority of CS/GS combination therapy over placebo in terms of reducing joint pain and functional impairment in patients with symptomatic knee OA over 6 months. Further research might fully elucidate the suitability of CS/GS combination therapy in patients with OA.

Microarray analysis of bone marrow lesions in osteoarthritis demonstrates upregulation of genes implicated in osteochondral turnover, neurogenesis and inflammation

Abstract: Objective Bone marrow lesions (BMLs) are well described in osteoarthritis (OA) using MRI and are associated with pain, but little is known about their pathological characteristics and gene expression. We evaluated BMLs using novel tissue analysis tools to gain a deeper understanding of their cellular and molecular expression. Methods We recruited 98 participants, 72 with advanced OA requiring total knee replacement (TKR), 12 with mild OA and 14 non-OA controls. Participants were assessed for pain (using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)) and with a knee MRI (using MOAKS). Tissue was then harvested at TKR for BML analysis using histology and tissue microarray. Results The mean (SD) WOMAC pain scores were significantly increased in advanced OA 59.4 (21.3) and mild OA 30.9 (20.3) compared with controls 0.5 (1.28) (p Conclusion Our study is the first to employ detailed histological analysis and microarray techniques to investigate knee OA BMLs. BMLs demonstrated areas of high metabolic activity expressing pain sensitisation, neuronal, extracellular matrix and proinflammatory signalling genes that may explain their strong association with pain.

Application of minimal important differences in degenerative knee disease outcomes: a systematic review and case study to inform BMJ Rapid Recommendations

Abstract: Objectives To identify the most credible anchor-based minimal important differences (MIDs) for patient important outcomes in patients with degenerative knee disease, and to inform BMJ Rapid Recommendations for arthroscopic surgery versus conservative management Design Systematic review. Outcome measures Estimates of anchor-based MIDs, and their credibility, for knee symptoms and health-related quality of life (HRQoL). Data sources MEDLINE, EMBASE and PsycINFO. Eligibility criteria We included original studies documenting the development of anchor-based MIDs for patient-reported outcomes (PROs) reported in randomised controlled trials included in the linked systematic review and meta-analysis and judged by the parallel BMJ Rapid Recommendations panel as critically important for informing their recommendation: measures of pain, function and HRQoL. Results 13 studies reported 95 empirically estimated anchor-based MIDs for 8 PRO instruments and/or their subdomains that measure knee pain, function or HRQoL. All studies used a transition rating (global rating of change) as the anchor to ascertain the MID. Among PROs with more than 1 estimated MID, we found wide variation in MID values. Many studies suffered from serious methodological limitations. We identified the following most credible MIDs: Western Ontario and McMaster University Osteoarthritis Index (WOMAC; pain: 12, function: 13), Knee injury and Osteoarthritis Outcome Score (KOOS; pain: 12, activities of daily living: 8) and EuroQol five dimensions Questionnaire (EQ-5D; 0.15). Conclusions We were able to distinguish between more and less credible MID estimates and provide best estimates for key instruments that informed evidence presentation in the associated systematic review and judgements made by the Rapid Recommendation panel. Trial registration number CRD42016047912.

Differences in Patient-Reported Outcomes Between Unicompartmental and Total Knee Arthroplasties: A Propensity Score-Matched Analysis

Abstract: Background The purpose of this study was to compare the patient-reported outcomes regarding joint awareness, function, and satisfaction after unicompartmental knee arthroplasty (UKA) and total knee arthroplasty (TKA). Methods We identified all patients who underwent a UKA or TKA at our institution between September 2011 and March 2014, with a minimum follow-up of 2 years. Propensity score matching was performed for age, gender, body mass index, operation side, and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. One hundred UKAs to 100 TKAs were matched. Each knee was evaluated according to the WOMAC score, Forgotten Joint Score (FJS), High Flexion Knee Score (HFKS) and patient's satisfaction at postoperative 2 years. Results There was no significant difference in WOMAC score at postoperative 2 years between UKA and TKA groups. However, the FJS of the UKA group was significantly higher than that of the TKA group (67.3 ± 19.8 and 60.6 ± 16.6, respectively; P = .011). The HFKS was also significantly higher in the UKA group compared with the TKA group (34.4 ± 6.4 and 31.3 ± 5.2, respectively; P P = .027). Conclusion Patients who underwent UKA had higher FJS, HFKS, and satisfaction rate when compared with patients who underwent TKA, indicating that UKA facilitated less knee awareness and better function and satisfaction than TKA.

The effect of probiotic Lactobacillus casei Shirota on knee osteoarthritis: a randomised double-blind, placebo-controlled clinical trial.

Abstract: Knee osteoarthritis (OA) treatment is challenging due to inefficacy and adverse effects of current medications. Probiotic treatment has been shown to promote bone metabolism, reduce pain and inflammatory responses of age-related musculoskeletal disorders, including OA. We aimed to investigate the effect of probiotic Lactobacillus casei Shirota (LcS) on patients with knee OA. 537 patients with knee OA were enrolled in this double-blind, placebo-controlled trial, who were randomised to receive skimmed milk containing either LcS or placebo daily for 6 months. Primary outcome was defined as changes in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) and VAS (visual analog scale) scores. Secondary outcome was defined as changes in serum levels of high sensitivity C-reactive protein (hs-CRP). After 6 months of treatment, both WOMAC and VAS scores were significantly improved in the LcS groups of patients compared to the placebo group. Serum levels of hs-CRP were also significantly lower in ...

Early High-Intensity Versus Low-Intensity Rehabilitation After Total Knee Arthroplasty: A Randomized Controlled Trial

Abstract: Objective To examine the safety and efficacy of a high-intensity (HI) progressive rehabilitation protocol beginning 4 days after total knee arthroplasty (TKA) compared to a low-intensity (LI) rehabilitation protocol. Methods A total of 162 participants (mean ± SD ages 63 ± 7 years; 89 women) were randomized to either the HI group or LI group after TKA. Key components of the HI intervention were the use of progressive resistance exercises and a rapid progression to weight-bearing exercises and activities. Both groups were treated in an outpatient setting 2 to 3 times per week for 11 weeks (26 total sessions). Outcomes included the stair climbing test (SCT; primary outcome), timed-up-and-go (TUG) test, 6-minute walk (6MW) test, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), 12-item Short Form health survey (SF-12), knee range of motion (ROM), quadriceps and hamstring strength, and quadriceps activation. Outcomes were assessed preoperatively and at 1, 2, 3 (primary end point), 6, and 12 months postoperatively. Results There were no significant differences between groups at 3 or 12 months in SCT, TUG, 6MW, WOMAC scores, knee ROM, quadriceps and hamstrings strength, quadriceps activation, or adverse event rates. By 12 months, outcomes on the 6MW, TUG, WOMAC, SF-12, quadriceps and hamstring strength, and quadriceps activation had improved beyond baseline performance in both groups. Conclusion Both the HI and LI interventions were effective in improving strength and function after TKA. HI progressive rehabilitation is safe for individuals after TKA. However, its effectiveness may be limited by arthrogenic muscular inhibition in the early postoperative period.

Comparison between intra-articular ozone and placebo in the treatment of knee osteoarthritis: A randomized, double-blinded, placebo-controlled study.

Abstract: Objective The aim of the trial was to determine the effectiveness of oxygen-ozone injections on knee osteoarthritis concerning pain reduction, joint functional improvement, and quality of life. Methods In this randomized, double-blinded, placebo controlled clinical trial, 98 patients with symptomatic knee osteoarthritis (OA) were randomized into two groups receiving intra-articular 20 μg/ml of ozone (OZ) or placebo (PBO) for 8 weeks. The efficacy outcomes for knee OA were the Visual Analogue Scale (VAS), Lequesne Index, Timed Up and Go Test (TUG Test), SF-36, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Geriatric Pain Measure (GPM). Results After 8 weeks of treatment, ozone was more effective than the placebo: VAS [mean difference (MD) = 2.16, p < 0.003 (CI 95% 0.42–3.89)], GPM [MD = 18.94, p < 0.004 (CI 95% 3.43–34.44)], LEQ [MD = 4.05, p < 0.001 (CI 95% 1.10–7.00)], WOMAC (P) [median of diff = 9.999, p = 0.019 (CI 95% 0.000–15.000)], WOMAC (JS) [median of diff = 12.499, p < 0.001 (CI 95% 0.000–12.500)], WOMAC (PF) = [median of diff = 11.760, p = 0.003 (CI 95% 4.409–19.119)], TUG (no statistical difference) and SF-36 (FC) [(MD = -25.82, p < 0.001 (CI 95% 33.65–17.99)], SF-36 (PH) [MD = -40.82, p < 0.001 (CI 95% -54.48–27.17)], SF-36 (GSH) [MD = -3.38, p < 0.001 (CI 95% -4.83–1.93)], SF-36 (SA) [MD = 2.17, p < 0.001 (CI 95% -19.67–8.24), SF-36 (EA) [MD = -35.37, p < 0.001 (CI 95% -48.86–21.89)]. Adverse events occurred in 3 patients (2 in the placebo group and 1 in the ozone group) and included only puncture accidents. Conclusions The study confirms the efficacy of ozone concerning pain relief, functional improvement, and quality of life in patients with knee osteoarthritis. Trial registration International Standard Randomized Controlled Trial Number Register ISRCTNR55861167

Celecoxib for osteoarthritis

Abstract: Background Osteoarthritis (OA) is the most common form of arthritis and is caused by degeneration of the joint cartilage and growth of new bone, cartilage and connective tissue. It is often associated with major disability and impaired quality of life. There is currently no consensus on the best treatment to improve OA symptoms. Celecoxib is a selective non-steroidal anti-inflammatory drug (NSAID). Objectives To assess the clinical benefits (pain, function, quality of life) and safety (withdrawals due to adverse effects, serious adverse effects, overall discontinuation rates) of celecoxib in osteoarthritis (OA). Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and clinical trials registers up to April 11, 2017, as well as reference and citation lists of included studies. Pharmaceutical companies and authors of published articles were contacted. Selection criteria We included published studies (full reports in a peer reviewed journal) of prospective randomized controlled trials (RCTs) that compared oral celecoxib versus no intervention, placebo or another traditional NSAID (tNSAID) in participants with clinically- or radiologically-confirmed primary OA of the knee or hip, or both knee and hip. Data collection and analysis Two authors independently performed data extraction, quality assessment, and compared results. Main analyses for patient-reported outcomes of pain and physical function were conducted on studies with low risk of bias for sequence generation, allocation concealment and blinding of participants and personnel. Main results We included 36 trials that provided data for 17,206 adults: 9402 participants received celecoxib 200 mg/day, and 7804 were assigned to receive either tNSAIDs (N = 1869) or placebo (N = 5935). Celecoxib was compared with placebo (32 trials), naproxen (6 trials) and diclofenac (3 trials). Studies were published between 1999 and 2014. Studies included participants with knee, hip or both knee and hip OA; mean OA duration was 7.9 years. Most studies included predominantly white participants whose mean age was 62 (± 10) years; most participants were women. There were no concerns about risk of bias for performance and detection bias, but selection bias was poorly reported in most trials. Most trials had high attrition bias, and there was evidence of selective reporting in a third of the studies. Celecoxib versus placebo Compared with placebo celecoxib slightly reduced pain on a 500-point Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain scale, accounting for 3% absolute improvement (95% CI 2% to 5% improvement) or 12% relative improvement (95% CI 7% to 18% improvement) (4 studies, 1622 participants). This improvement may not be clinically significant (high quality evidence). Compared with placebo celecoxib slightly improved physical function on a 1700-point WOMAC scale, accounting for 4% absolute improvement (95% CI 2% to 6% improvement), 12% relative improvement (95% CI 5% to 19% improvement) (4 studies, 1622 participants). This improvement may not be clinically significant (high quality evidence). There was no evidence of an important difference for withdrawals due to adverse events (Peto OR 0.99, 95% CI 0.85 to 1.15) (moderate quality evidence due to study limitations). Results were inconclusive for numbers of participants experiencing any serious AEs (SAEs) (Peto OR 0.95, 95% CI 0.66 to 1.36), gastro-intestinal events (Peto OR 1.91, 95% CI 0.24 to 14.90) and cardiovascular events (Peto OR 3.40, 95% CI 0.73 to 15.88) (very low quality evidence due to serious imprecision and study limitations). However, regulatory agencies have warned of increased cardiovascular events for celecoxib. Celecoxib versus tNSAIDs There were inconclusive results regarding the effect on pain between celecoxib and tNSAIDs on a 100-point visual analogue scale (VAS), showing 5% absolute improvement (95% CI 11% improvement to 2% worse), 11% relative improvement (95% CI 26% improvement to 4% worse) (2 studies, 1180 participants, moderate quality evidence due to publication bias). Compared to a tNSAID celecoxib slightly improved physical function on a 100-point WOMAC scale, showing 6% absolute improvement (95% CI 6% to 11% improvement) and 16% relative improvement (95% CI 2% to 30% improvement). This improvement may not be clinically significant (low quality evidence due to missing data and few participants) (1 study, 264 participants). Based on low or very low quality evidence (downgraded due to missing data, high risk of bias, few events and wide confidence intervals) results were inconclusive for withdrawals due to AEs (Peto OR 0.97, 95% CI 0.74 to 1.27), number of participants experiencing SAEs (Peto OR 0.92, 95% CI 0.66 to 1.28), gastro-intestinal events (Peto OR 0.61, 0.15 to 2.43) and cardiovascular events (Peto OR 0.47, 95% CI 0.17 to 1.25). In comparisons of celecoxib and placebo there were no differences in pooled analyses between our main analysis with low risk of bias and all eligible studies. In comparisons of celecoxib and tNSAIDs, only one outcome showed a difference between studies at low risk of bias and all eligible studies: physical function (6% absolute improvement in low risk of bias, no difference in all eligible studies). No studies included in the main comparisons measured quality of life. Of 36 studies, 34 reported funding by drug manufacturers and in 34 studies one or more study authors were employees of the sponsor. Authors' conclusions We are highly reserved about results due to pharmaceutical industry involvement and limited data. We were unable to obtain data from three studies, which included 15,539 participants, and classified as awaiting assessment. Current evidence indicates that celecoxib is slightly better than placebo and some tNSAIDs in reducing pain and improving physical function. We are uncertain if harms differ among celecoxib and placebo or tNSAIDs due to risk of bias, low quality evidence for many outcomes, and that some study authors and Pfizer declined to provide data from completed studies with large numbers of participants. To fill the evidence gap, we need to access existing data and new, independent clinical trials to investigate benefits and harms of celecoxib versus tNSAIDs for people with osteoarthritis, with longer follow-up and more direct head-to-head comparisons with other tNSAIDs.

Comparative Clinical Observation of Arthroscopic Microfracture in the Presence and Absence of a Stromal Vascular Fraction Injection for Osteoarthritis

Abstract: Osteoarthritis (OA) is a degenerative cartilage disease that is characterized by a local inflammatory reaction. Consequently, many studies have been performed to identify suitable prevention and treatment interventions. In recent years, both arthroscopic microfracture (AM) and stem cell therapy have been used clinically to treat OA. This study aimed to evaluate the clinical effects of AM in the presence and absence of a stromal vascular fraction (SVF) injection in the management of patients with OA. Thirty patients with grade 2 or 3 (Lawrence scale) OA of the knee participated in this study. Placebo group patients (n = 15) received AM alone; treatment group patients (n = 15) received AM and an adipose tissue-derived SVF injection. The SVF was suspended in platelet-rich plasma (PRP) before injection into the joint. Patient groups were monitored and scored with the Western Ontario and McMaster Universities Arthritis Index (WOMAC), Lysholm, Visual Analog Pain Scale (VAS), and modified Outerbridge classifications before treatment and at 6, 12, and 18 months post-treatment. Bone marrow edema was also assessed at these time points. Patients were evaluated for knee activity (joint motion amplitude) and adverse effects relating to surgery and stem cell injection. Treatment efficacy was significantly different between placebo and treatment groups. All treatment group patients had significantly reduced pain and WOMAC scores, and increased Lysholm and VAS scores compared with the placebo group. These findings suggest that the SVF/PRP injection efficiently improved OA for 18 months after treatment. This study will be continuously monitored for additional 24 months. Stem Cells Translational Medicine 2017;6:187-195.

The effects of tourniquet use in total knee arthroplasty: a randomized, controlled trial

Abstract: Tourniquets are still widely used in total knee arthroplasty (TKA), although they may be associated with several adverse effects. An observer-blinded, randomized, controlled trial was performed to evaluate the effects of tourniquet use in TKA. Fifty participants who underwent staged bilateral TKA were recruited for this study. The first-side TKA was randomly allocated to either long-duration tourniquet use or short-duration tourniquet use followed by a 3-month washout period and crossover to the other tourniquet strategy for the opposite-side TKA. Blood loss was monitored perioperatively. The operating time, allogeneic blood transfusion rate, thigh pain, knee pain, limb swelling, clinical outcome as measured by the Likert-type Western Ontario and McMaster University (WOMAC) score, straight leg raising and knee active range of motion (ROM) were also recorded. The long-duration tourniquet group exhibited reduced total blood loss [−99.1 ml, 95 % confidence interval (CI) −168.1 to −30.1, P = 0.0411] and intraoperative blood loss (−225.2 ml, 95 % CI −369.5 to −80.9, P = 0.0071) compared with the short-duration tourniquet group. However, there were greater postoperative blood loss (69.6 ml, 95 % CI 21.1 to 118.2, P = 0.0282) and hidden blood loss (52.8 ml, 95 % CI 10.5 to 95.1, P = 0.0332) in the long-duration tourniquet group. The short-duration tourniquet group showed better outcomes for thigh and knee pain, limb swelling, WOMAC score at 6-week follow-up, straight leg raising and knee ROM. Similar allogeneic blood transfusion rates were observed for both groups. Total and intraoperative blood losses were reduced with the long-duration tourniquet use, whereas the short-duration tourniquet use would reduce postoperative and hidden blood losses without increasing the allogeneic blood transfusion rate. In addition, short-duration tourniquet use would result in faster recovery and less pain during the early rehabilitation period following TKA. I.

Outcome After Tibial Plateau Fracture: How Important Is Restoration of Articular Congruity?

Abstract: OBJECTIVES Does restoration of articular congruity have any effect on long-term outcome following tibial plateau fracture? DESIGN Cohort study. SETTING A secondary hospital in New Zealand, which services a population of 150,000. PATIENTS All patients with a depressed tibial plateau fracture seen over a 6 year period were invited to participate in the study. There were 41 patients (average age 54 years) recruited from an eligible population of 97. Average follow-up was 3.9 years after injury. INTERVENTION Patients had either been treated operatively or nonoperatively after depressed tibial plateau fracture. MAIN OUTCOME MEASUREMENTS The primary outcome analyzed was residual articular depression (as measured on coronal plane tomogram) and its effect on clinical outcome [Oxford Knee Score, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, Knee injury and Osteoarthritis Outcome Score (KOOS), Iowa knee score, and a visual analogue satisfaction score] and functional outcome (knee range of motion) at a minimum of 12 months after fracture. Patients were divided into 3 groups based on the amount of articular depression: <2.5, 2.5-5.0, and ≥5.0 mm. The secondary outcome analyzed was mechanical axis (as measured on weightbearing long leg alignment radiographs) and its effect on clinical and functional outcomes. RESULTS Statistical analysis found that patients with <2.5 mm of articular depression had significantly smaller losses in knee range of motion (P = 0.000), better Oxford (P = 0.006), Iowa (P = 0.003), and KOOS symptom (P = 0.011) and pain (P = 0.001) scores. We found that there was no significant relationship between restoration of mechanical axis and loss in range of motion (P = 0.126), Oxford (P = 0.584), WOMAC (P = 0.101), IOWA (P = 0.418), Visual Analogue Score (VAS) (P = 0.466) or any subgroup within the KOOS survey other than activities of daily living (P = 0.029). CONCLUSIONS This study found that patients with smaller amounts of residual articular depression at a minimum of 12 months after tibial plateau fracture had significantly smaller losses in knee range of motion and better functional outcomes than those with greater amounts of articular depression. LEVEL OF EVIDENCE Prognostic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Formal Physical Therapy After Total Hip Arthroplasty Is Not Required: A Randomized Controlled Trial.

Abstract: The value of formal physical therapy after total hip arthroplasty is unknown. With substantial changes that have occurred in surgical and anesthesia techniques, self-directed therapy may be efficacious in restoring function to patients undergoing total hip arthroplasty. We conducted a single-center, randomized trial of 120 patients undergoing primary, unilateral total hip arthroplasty who were eligible for direct home discharge. The experimental group followed a self-directed home exercise program for 10 weeks. The control group received the standard protocol for physical therapy that included in-home visits with a physical therapist for the first 2 weeks followed by formal outpatient physical therapy for 8 weeks. Functional outcomes were measured using validated instruments including the Harris hip score (HHS), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Short Form-36 Health Survey (SF-36) preoperatively, at 1 month postoperatively, and at 6 to 12 months postoperatively. Of 120 randomized patients, 108 were included in the final analysis. Ten patients (19%) were randomized to unsupervised home exercise and 20 patients (37%) were randomized to formal outpatient therapy crossed over between groups. There was no significant difference in any of the measured functional outcomes between patients receiving formal therapy (n = 54) and those participating in unsupervised home exercise (n = 54) at any time point (HHS, p = 0.82; WOMAC, p = 0.80; and SF-36 physical health, p = 0.90). This randomized trial suggests that unsupervised home exercise is both safe and efficacious for a majority of patients undergoing total hip arthroplasty, and formal physical therapy may not be required. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.