Showing papers on "WOMAC published in 2007"

Quality of life following femoral head-neck osteochondroplasty for femoroacetabular impingement.

Abstract: Background: Femoroacetabular impingement has been recently described as a common cause of hip pain and labral tears in young adults. We evaluated the early clinical results and quality of life after osteochondroplasty of the femoral head-neck junction for the treatment of femoroacetabular impingement. Methods: Thirty-seven hips in thirty-four patients with persistent hip pain and a mean age of 40.5 years underwent surgical dislocation of the hip and osteochondroplasty of the femoral head-neck junction for the treatment of camtype femoroacetabular impingement. All of the patients had had preoperative evidence of pathological changes in the labrum on imaging. The clinical course and the quality of life were assessed postoperatively. Results: The mean score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) increased from 61.2 points preoperatively to 81.4 points at a mean of 3.1 years postoperatively (p < 0.001), the mean University of California at Los Angeles (UCLA) activity score increased from 4.8 to 7.5 points (p < 0.001), the mean Short Form-12 (SF-12) physical component score increased from 37.3 to 45.6 points (p < 0.001), and the mean SF-12 mental component score increased from 46.4 to 51.2 points (p = 0.031). None of the hips underwent additional reconstructive surgery. There were no cases of osteonecrosis. Nine patients underwent screw removal from the greater trochanter because of persistent bursitis. Six of the thirty-four patients were dissatisfied with the outcome. Conclusions: Cam-type femoroacetabular impingement is associated with insufficient concavity at the anterolateral head-neck junction and with pathological changes in the labrum. Osteochondroplasty of the femoral head-neck junction following surgical dislocation of the hip joint is safe and effective and can provide a significant improvement in the overall quality of life of most patients. Level of Evidence: Therapeutic Level IV. See Instructions to Authors for a complete description of levels of evidence.

Acupuncture treatment for chronic knee pain: a systematic review

Abstract: and study validity was assessed using a modification of a previously published instrument. Results. Thirteen RCTs were included, of which eight used adequate acupuncture and provided WOMAC outcomes, so were combined in meta-analyses. Six of these had validity scores of more than 50%. Combining five studies in 1334 patients, acupuncture was superior to sham acupuncture for both pain (weighted mean difference in WOMAC pain subscale score ¼ 2.0, 95% CI 0.57–3.40) and for WOMAC function subscale (4.32, 0.60–8.05). The differences were still significant at long-term follow-up. Acupuncture was also significantly superior to no additional intervention. There were insufficient studies to compare acupuncture with other sham or active interventions. Conclusions. Acupuncture that meets criteria for adequate treatment is significantly superior to sham acupuncture and to no additional intervention in improving pain and function in patients with chronic knee pain. Due to the heterogeneity in the results, however, further research is required to confirm these findings and provide more information on long-term effects.

Glucosamine sulfate in the treatment of knee osteoarthritis symptoms: A randomized, double‐blind, placebo‐controlled study using acetaminophen as a side comparator

Abstract: Objective To assess the effects of the prescription formulation of glucosamine sulfate (1,500 mg administered once daily) on the symptoms of knee osteoarthritis (OA) during a 6-month treatment course. Methods Three hundred eighteen patients were enrolled in this randomized, placebo-controlled, double-blind trial in which acetaminophen, the currently preferred medication for symptomatic treatment of OA, was used as a side comparator. Patients were randomly assigned to receive oral glucosamine sulfate 1,500 mg once daily (n = 106), acetaminophen 3 gm/day (n = 108), or placebo (n = 104). The primary efficacy outcome measure was the change in the Lequesne index after 6 months. Secondary parameters included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and response according to the Osteoarthritis Research Society International criteria. These outcome measures were assessed using an intent-to-treat analysis. Results At baseline, the study patients had moderately severe OA symptoms (mean Lequesne index ∼11 points). Glucosamine sulfate was more effective than placebo in improving the Lequesne score, with a final decrease of 3.1 points, versus 1.9 with placebo (difference between glucosamine sulfate and placebo −1.2 [95% confidence interval −2.3, −0.8]) (P = 0.032). The 2.7-point decrease with acetaminophen was not significantly different from that with placebo (difference −0.8 [95% confidence interval −1.9, 0.3]) (P = 0.18). Similar results were observed for the WOMAC. There were more responders to glucosamine sulfate (39.6%) and acetaminophen (33.3%) than to placebo (21.2%) (P = 0.004 and P = 0.047, respectively, versus placebo). Safety was good, and was comparable among groups. Conclusion The findings of this study indicate that glucosamine sulfate at the oral once-daily dosage of 1,500 mg is more effective than placebo in treating knee OA symptoms. Although acetaminophen also had a higher responder rate compared with placebo, it failed to show significant effects on the algofunctional indexes.

Risk factors associated with the loss of cartilage volume on weight-bearing areas in knee osteoarthritis patients assessed by quantitative magnetic resonance imaging: a longitudinal study

Abstract: The objective of this study was to identify, on a symptomatic knee osteoarthritis (OA) cohort, the risk factors associated with the progression of the disease. More specifically, we investigated the correlation between knee cartilage volume loss from subregions over the span of 24 months by means of quantitative magnetic resonance imaging (qMRI) with demographic, clinical, radiological, and MRI structural changes. A cohort of 107 patients with knee OA selected from a large trial evaluating the effect of a bisphosphonate underwent x-rays and MRI of the knee at baseline and 24 months. Joint space width (JSW) and joint space narrowing (JSN) and cartilage volume loss over time in subregions of the tibial plateaus and femoral condyles were quantitated. Structural changes in the subchondral bone (hypersignal) and in the menisci (tear and extrusion) were also evaluated. The greatest cartilage volume loss was found in the medial compartment, and risk factors included female gender, JSW, meniscal lesions, and bone changes at baseline. Subregion analysis revealed that the greatest cartilage volume loss at 24 months was found in the central area of the medial tibial plateau (15%; p < 0.0001) and of the medial femoral condyle (12%; p < 0.0001). These findings were associated with the presence at baseline of meniscal extrusion, particularly severe meniscal extrusion, medial and severe meniscal tear, bone hypersignal, high body mass index (BMI), smaller JSW, increases in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and patient global scores over time, and greater JSN. Parameters predicting medial central femoral condyle cartilage volume loss at 24 months were lateral meniscal tear, SF-36 and BMI at baseline, and JSN. At the medial central tibial plateau, the parameters were severe meniscal extrusion, severe lateral meniscal tear, and bone hypersignal in the lateral compartment at baseline, and WOMAC pain change. Meniscal damage and bone changes are the features most closely associated with the greatest subregional cartilage volume loss. Interestingly, for the first time, JSN was strongly associated with cartilage loss in the central areas of plateaus and condyles. This study also further confirms the correlation between cartilage volume loss and JSN and symptomatic changes at 24 months.

Clinical effectiveness of a rehabilitation program integrating exercise, self-management, and active coping strategies for chronic knee pain: a cluster randomized trial.

Abstract: OBJECTIVE: Chronic knee pain is a major cause of disability and health care expenditure, but there are concerns about efficacy, cost, and side effects associated with usual primary care. Conservative rehabilitation may offer a safe, effective, affordable alternative. We compared the effectiveness of a rehabilitation program integrating exercise, self-management, and active coping strategies (Enabling Self-management and Coping with Arthritic Knee Pain through Exercise [ESCAPE-knee pain]) with usual primary care in improving functioning in persons with chronic knee pain. METHODS: We conducted a single-blind, pragmatic, cluster randomized controlled trial. Participants age >/=50 years, reporting knee pain for >6 months, were recruited from 54 inner-city primary care practices. Primary care practices were randomized to continued usual primary care (i.e., whatever intervention a participant's primary care physician deemed appropriate), usual primary care plus the rehabilitation program delivered to individual participants, or usual primary care plus the rehabilitation program delivered to groups of 8 participants. The primary outcome was self-reported functioning (Western Ontario and McMaster Universities Osteoarthritis Index physical functioning [WOMAC-func]) 6 months after completing rehabilitation. RESULTS: A total of 418 participants were recruited; 76 (18%) withdrew, only 5 (1%) due to adverse events. Rehabilitated participants had better functioning than participants continuing usual primary care (-3.33 difference in WOMAC-func score; 95% confidence interval [95% CI] -5.88, -0.78; P = 0.01). Improvements were similar whether participants received individual rehabilitation (-3.53; 95% CI -6.52, -0.55) or group rehabilitation (-3.16; 95% CI -6.55, -0.12). CONCLUSION: ESCAPE-knee pain provides a safe, relatively brief intervention for chronic knee pain that is equally effective whether delivered to individuals or groups of participants.

Effect of patient characteristics on reported outcomes after total knee replacement

Abstract: Objective To evaluate the effect of pre-intervention factors in patient-reported outcomes at 6 months post-operatively following total knee replacement. Methods A prospective observational study was carried out using two questionnaires sent to patients while they were on the waiting list for surgery: a generic questionnaire, the Medical Outcomes Study Short Form-36 (SF-36), and a specific questionnaire, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Six months after intervention, patients again received the same questionnaires. The dependent variables were the scores of the three domains of the WOMAC and the eight domains of the SF-36. Results We recruited 640 patients. The mean age was 71 yrs and 73.6% of the patients were females. The multivariate analysis, in which the pre-intervention scores for each domain were added as covariates, showed that the most significant pre-intervention predictors were the baseline scores of each domain. Besides that, the social support, low back pain and the baseline score of the mental health domain (SF-36) were the pre-intervention predictors in the three WOMAC domains. With regard to the SF-36 domains the main predictors were the baseline mental health score, comorbidities, low back pain and social support. Conclusions The main predictor of outcome at 6 months post-operatively in all eleven domains was the pre-intervention score of each domain. Presence of social support, absence of low back pain and higher baseline SF-36 mental health score were related to the improvement in the health-related quality of life post-operatively.

Impact of psychological distress on pain and function following knee arthroplasty.

Abstract: Background: Preoperative psychological distress has been reported to be an important risk factor for poor outcome following lower-extremity arthroplasty. We determined the independent impact of preoperative psychological distress on three, twelve, and twenty-four-month WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain and function scores and on change scores over those time periods. Methods: Data were obtained from an international group of 952 patients in thirteen centers participating in the Kinemax Outcomes Study. Patients completed the WOMAC and Short Form-36 (SF-36) questionnaires. The mental health (MH) scale of the SF-36 was used to quantify the impact of psychological distress on WOMAC pain and function scores. We also dichotomized patients into groups with and without psychological distress on the basis of evidence-based cut-points. Repeated-measures models were used to derive mean preoperative and three, twelve, and twenty-four-month WOMAC pain and function scores and general linear models were used to derive change scores for patients with and without psychological distress after adjustment for covariates. Results: Psychological distress, when examined on a continuous scale, was found to predict pain and function at all time-points. WOMAC pain scores for psychologically distressed patients were 3 to 5 points lower, depending on the time-frame, than the scores for the non-distressed patients, after adjustment for covariates. WOMAC function scores did not differ significantly between the two groups following surgery. The changes in the WOMAC pain and function scores for the psychologically distressed patients were not significantly different from those for the non-distressed patients. Conclusions: Many patients with psychological distress demonstrate a substantial decrease in that distress following surgery. Patients who are distressed have slightly worse pain preoperatively and for up to two years following knee arthroplasty as compared with patients with no psychological distress. With the exception of preoperative scores, these differences are not likely to be measurable at the individual patient level. WOMAC pain and function change scores do not differ between patients with and without distress after adjustment for covariates. Level of Evidence: Prognostic Level I. See Instructions to Authors for a complete description of levels of evidence.

Acupuncture and Knee Osteoarthritis: A Three-Armed Randomized Trial

Abstract: Background Despite the popularity of acupuncture, evidence of its efficacy for reducing pain remains equivocal. Objective To assess the efficacy and safety of traditional Chinese acupuncture (TCA) compared with sham acupuncture (needling at defined nonacupuncture points) and conservative therapy in patients with chronic pain due to osteoarthritis of the knee. Design Randomized, controlled trial. Setting: 315 primary care practices staffed by 320 practitioners with at least 2 years’ experience in acupuncture. Patients 1007 patients who had had chronic pain for at least 6 months due to osteoarthritis of the knee (American College of Rheumatology [ACR] criteria and Kellgren–Lawrence score of 2 or 3). Interventions Up to 6 physiotherapy sessions and as-needed anti-inflammatory drugs plus 10 sessions of TCA, 10 sessions of sham acupuncture, or 10 physician visits within 6 weeks. Patients could request up to 5 additional sessions or visits if the initial treatment was viewed as being partially successful. Measurements Success rate, as defined by at least 36% improvement in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 26 weeks. Additional end points were WOMAC score and global patient assessment. Results Success rates were 53.1 % for TCA, 51.0 % for sham acupuncture, and 29.1 % for conservative therapy. Acupuncture groups had higher success rates than conservative therapy groups (relative risk for TCA compared with conservative therapy, 1.75 [95 % CI, 1.43 to 2.13]; relative risk for sham acupuncture compared with conservative therapy, 1.73 [CI, 1.42 to 2.11]). There was no difference between TCA and sham acupuncture (relative risk, 1.01 [CI, 0.87 to 1.17]). Limitations There was no blinding between acupuncture and traditional therapy and no monitoring of acupuncture compliance with study protocol. In general, practitioner–patient contacts were less intense in the conservative therapy group than in the TCA and sham acupuncture groups. Conclusions Compared with physiotherapy and as-needed anti-inflammatory drugs, addition of either TCA or sham acupuncture led to greater improvement in WOMAC score at 26 weeks. No statistically significant difference was observed between TCA and sham acupuncture, suggesting that the observed differences could be due to placebo effects, differences in intensity of provider contact, or a physiologic effect of needling regardless of whether it is done according to TCA principles.

Association of hospital and surgeon procedure volume with patient‐centered outcomes of total knee replacement in a population‐based cohort of patients age 65 years and older

Abstract: Objective To study the association between procedure volume and patient-centered outcomes such as functional status. Methods We performed an observational study of a stratified random sample of Medicare beneficiaries who underwent primary total knee replacement (TKR) in 2000. Low-volume surgeons were defined as surgeons performing ≤6 TKRs per year in the Medicare population, and low-volume centers were defined as those in which ≤25 TKRs per year were performed. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) functional status score (0–100 scale; 100 = best) 2 years after TKR. We defined a WOMAC functional status score of <60 as a poor functional outcome. Analyses were adjusted for sociodemographic factors, preoperative functional status, and comorbidities. Results Fifty-eight percent of 1,597 eligible patients agreed to participate. Twelve percent of participating patients had a WOMAC score <60 2 years following TKR. Patients operated upon by low-volume surgeons in low-volume hospitals were twice as likely to have a poor WOMAC functional status score as patients operated upon by higher volume surgeons and in higher volume hospitals (odds ratio 2.1, 95% confidence interval 1.1–4.2). Conclusion Patients operated upon in low-volume hospitals by low-volume surgeons had worse functional outcomes 2 years after TKR. These findings add a new and important dimension to the discussion of whether to promote selective referral of procedures such as TKR to high-volume centers.

Development of musculoskeletal toxicity without clear benefit after administration of PG-116800, a matrix metalloproteinase inhibitor, to patients with knee osteoarthritis: a randomized, 12-month, double-blind, placebo-controlled study

Abstract: We performed a randomized, double-blind, placebo-controlled, multicenter, parallel-group, dose-response study of the efficacy and safety of the oral administration of PG-116800, a matrix metalloproteinase (MMP) inhibitor, in patients with mild to moderate knee osteoarthritis. The primary efficacy endpoints included the progression of joint space narrowing in the osteoarthritic knee, as measured by microfocal radiography with fluoroscopic positioning, and the reduction of symptoms (pain and stiffness) and/or the improvement of function, as measured by the Western Ontario and McMaster Universities osteoarthritis index (WOMAC). Four hundred and one patients were randomly assigned to either placebo (n = 80) or one of fourdoses of PG-116800: 25 mg (n = 81), 50 mg (n = 80), 100 mg (n = 80), or 200 mg (n = 80) taken twice daily for 12 months. During the study, the 200-mg dose was discontinued based on an increased frequency of musculoskeletal adverse effects. After 1 year of treatment, no statistically significant difference was observed between placebo and PG-116800 with regard to mean changes in minimum joint space width of the knee or to WOMAC scores. The most frequent adverse effect was arthralgia (35%). Twenty-three percent of evaluable patients had at least a 30% decrease from baseline of at least onerangeof-motion measurement of either shoulder at a follow-up visit. The percentage of patients with reduction in range of motion was significantly greater in the twohighest dose groups relative to placebo. Thirteen percent of patients, half of whom were in the 200-mg group, reported hand adverse events (oedema, palmar fibrosis, Dupuytren contracture, or persistent tendon thickness or nodules). The threemost frequent shoulder adverse events were reversible arthralgia, stiffness, and myalgia, which mostly affected the twohighest dose groups. The unfavorable risk-benefit balance of the MMP inhibitor PG-116800 in patients with knee osteoarthritis precludes further development of the compound for this indication. This study adds to the weight of evidence suggesting that side effect profiles of MMP inhibitors in general make them unsuitable for use in osteoarthritis. Trial Registration ClinicalTrials.gov NCT00041756.

A randomized crossover trial of a wedged insole for treatment of knee osteoarthritis.

Abstract: Objective In uncontrolled studies, a lateral-wedge insole has reduced knee pain in patients with medial knee osteoarthritis (OA). The aim of this study was to test the efficacy of this simple, low-cost intervention for pain in patients with medial knee OA. Methods We conducted a double-blind, randomized, crossover trial designed to detect a small effect of treatment. Participants were at least 50 years of age and had medial joint space narrowing on posteroanterior semiflexed radiographs and scores indicating moderate pain for 2 of the 5 items on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scale. Participants were randomized to receive a 5° lateral-wedge insole or a neutral insole for 6 weeks. Following a 4-week washout period, participants crossed over to the other treatment for 6 weeks. Knee pain, the primary outcome, was assessed by the WOMAC pain scale (visual analog scale version). Secondary outcomes included the WOMAC disability subscale, overall knee pain, 50-feet walk time, chair-stand time, and use of medications for knee pain. Results Ninety patients were randomized. The mean difference in pain between the 2 treatments was 13.8 points on the WOMAC pain scale (95% confidence interval −3.9, 31.4 [P = 0.13]). We observed similar small effects for the secondary outcomes. Conclusion The effect of treatment with a lateral-wedge insole for knee OA was neither statistically significant nor clinically important.

Evaluation of the Effect of Neptune Krill Oil on Chronic Inflammation and Arthritic Symptoms

Abstract: Objectives: a) To evaluate the effect of Neptune Krill Oil (NKO™) on C-reactive protein (CRP) on patients with chronic inflammation and b) to evaluate the effectiveness of NKO™ on arthritic symptoms. Methods: Randomized, double blind, placebo controlled study. Ninety patients were recruited with confirmed diagnosis of cardiovascular disease and/or rheumatoid arthritis and/or osteoarthritis and with increased levels of CRP (1.0 mg/dl) upon three consecutive weekly blood analysis. Group A received NKO™ (300 mg daily) and Group B received a placebo. CRP and Western Ontario and McMaster Universities (WOMAC) osteoarthritis score were measured at baseline and days 7, 14 and 30. Results: After 7 days of treatment NKO™ reduced CRP by 19.3% compared to an increase by 15.7% observed in the placebo group (p 0.049). After 14 and 30 days of treatment NKO™ further decreased CRP by 29.7% and 30.9% respectively (p 0.001). The CRP levels of the placebo group increased to 32.1% after 14 days and then decreased to 25.1% at day 30. The between group difference was statistically significant; p 0.004 at day 14 and p 0.008 at day 30. NKO™ showed a significant reduction in all three WOMAC scores. After 7 days of treatment NKO™, reduced pain scores by 28.9% (p 0.050), reduced stiffness by 20.3% (p 0.001) and reduced functional impairment by 22.8% (p 0.008). Conclusion: The results of the present study clearly indicate that NKO™ at a daily dose of 300 mg significantly inhibits inflammation and reduces arthritic symptoms within a short treatment period of 7 and 14 days.

Steroid injection for osteoarthritis of the hip: a randomized, double-blind, placebo-controlled trial.

Abstract: Objective To determine the efficacy of fluoroscopically guided corticosteroid injection for hip osteoarthritis (OA) in a randomized, double-blind, placebo-controlled trial Methods Fifty-two patients with symptomatic hip OA were randomly allocated to receive placebo (10 mg bipuvicaine, 2 ml saline) (n = 21) or corticosteroid treatment (10 mg bipuvicaine, 40 mg triamcinolone hexacetonide) (n = 31) Patients were followed up for 1, 2, 3, and 6 months The primary outcome measure was the pain improvement response, defined as a 20% decrease in the Western Ontario and McMaster Universities OA Index (WOMAC) pain score (on 5 100-mm visual analog scales [VAS]) (WOMAC20) from baseline to 2 months postinjection Secondary outcomes were a 50% decrease in the WOMAC pain score (WOMAC50), changes in other WOMAC subscale scores, patient's global assessment of health (on a 100-mm VAS), and Short Form 36 (SF-36) quality of life indices Analyses were based on the intent-to-treat principle Results The mean WOMAC pain score fell 492% (decreasing from 3101 mm to 1574 mm) at 2 months postinjection in patients receiving corticosteroid, compared with a decrease of 25% (from 3143 mm to 3065 mm) in the placebo group (P < 00001) The proportion of WOMAC20 responders at 2 months' followup was significantly higher in the corticosteroid group (677%) compared with the placebo group (238%) (P = 0004); similar proportions of WOMAC50 responders were observed between groups (613% in the corticosteroid group versus 143% in the placebo group; P = 0001) Response differences were maintained at 3 months' followup (581% responders in the corticosteroid group versus 95% responders in the placebo group; P = 0004) Significant differences in the WOMAC stiffness and physical function scores (P < 00001), patient's global health scores (P = 0005), and SF-36 physical component scores (P = 004) were observed, with patients in the corticosteroid group showing greater improvements There were no differences in the frequency of adverse events between groups Conclusion This placebo-controlled trial confirms that corticosteroid injection can be an effective treatment of pain in hip OA, with benefits lasting up to 3 months in many cases Future studies should address questions related to the benefits of repeated steroid injection and the effects of this treatment on disease modification

Influence of patient factors on TKA outcomes at 5 to 11 years followup.

Abstract: Many studies suggest patient factors influence TKA outcomes, but the reported data are controversial, due perhaps in part to using only postoperative scores rather than change in scores from pre- to postoperatively. We examined the effect of gender, age, diagnosis, and obesity on changes in pre- to postoperative outcome measures (Knee Society clinical rating, WOMAC, and SF-12) in a cohort of 843 consecutive knee arthroplasties in 728 patients who received the same implant (Genesis II, Smith & Nephew, Memphis, TN). Minimum followup was 5 years (mean, 9.5 years; range, 5-11 years). Kaplan Meier survivorship was 98% +/- 0.007 with any reoperation as an end point. Male and female patients had similar increases in postoperative scores. Diagnosis and obesity made no difference in postoperative increases. However, less improvement occurred in health-related quality-of-life outcomes scores with advancing age.

Bone marrow edema-like lesions change in volume in the majority of patients with osteoarthritis; associations with clinical features

Abstract: It has been suggested that bone marrow edema-like (BME) lesions in the knee are associated with progression of osteoarthritis (OA). The purpose of our study in patients with OA was to evaluate prospectively changes of BME lesions over 2 years and their relationship with clinical features. Magnetic resonance (MR) images of the knee were obtained from 182 patients (20% male; aged 43–76 years; mean age 59 years) who had been diagnosed with familial symptomatic OA at multiple joint sites. MR images were made at baseline and at 2 years follow-up. BME lesions in 2 years were associated with clinical features assessed by Western Ontario and McMaster Universities Osteoarthritis (WOMAC) scores. A total of 327 BME lesions were recorded. Total size of BME lesions changed in 90 patients (66%). Size of individual lesions changed in 147 foci (45%): new lesions appeared in 69 (21%), existing lesions disappeared in 32 (10%), increased in size in 26 (8%) and decreased in size in 20 (6%) lesions. Increase or decrease of BME lesions, over a 2-year time period, was not associated with severity of WOMAC scores. BME lesions fluctuated in the majority of patients with OA over a 2-year time period. These changes were not associated with severity of WOMAC scores at the study end point.

Efficacy and safety of intraarticular hylan or hyaluronic acids for osteoarthritis of the knee : A randomized controlled trial

Abstract: OBJECTIVE: To compare the efficacy and safety of intraarticular hylan and 2 hyaluronic acids (HAs) in osteoarthritis (OA) of the knee. METHODS: This was a multicenter, patient-blind, randomized controlled trial in 660 patients with symptomatic knee OA. Patients were randomly assigned to receive 1 cycle of 3 intraarticular injections per knee of 1 of 3 preparations: a high molecular weight cross-linked hylan, a non-cross-linked medium molecular weight HA of avian origin, or a non-cross-linked low molecular weight HA of bacterial origin. The primary outcome measure was the change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score at 6 months. Secondary outcome measures included local adverse events (effusions or flares) in injected knees. During months 7-12, patients were offered a second cycle of viscosupplementation. RESULTS: Pain relief was similar in all 3 groups. The difference in changes between baseline and 6 months between hylan and the combined HAs was 0.1 on the WOMAC pain score (95% confidence interval [95% CI] -0.2, 0.3). No relevant differences were observed in any of the secondary efficacy outcomes, and stratified analyses provided no evidence for differences in effects across different patient groups. There was a trend toward more local adverse events in the hylan group than in the HA groups during the first cycle (difference 2.2% [95% CI -2.4, 6.7]), and this trend became more pronounced during the second cycle (difference 6.4% [95% CI 0.6, 12.2]). CONCLUSION: We found no evidence for a difference in efficacy between hylan and HAs. In view of its higher costs and potential for more local adverse events, we see no rationale for the continued use of hylan in patients with knee OA.

Primary and revision hip arthroplasty : 5-Year outcomes and influence of age and comorbidity

Abstract: OBJECTIVE: Revision hip arthroplasty is associated with less favorable short and longterm results than primary total hip arthroplasty (THA). We compared quality of life and satisfaction 5 years after the 2 interventions, to determine the influence of patient characteristics on poorer outcomes after revision, and to analyze if their influence differed for primary and for revision arthroplasty. METHODS: This was a hospital-based prospective cohort study including patients who underwent primary (n = 435) or revision THA (n = 116). Quality of life was measured by Harris Hip Score, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Medical Outcomes Study Short Form-12 questionnaire. Satisfaction was evaluated with a visual analog scale. RESULTS: Patients undergoing a revision were older, more often obese, and had more medical and orthopedic comorbidities. Five years after surgery, 349 patients with primary THA and 85 with revisions were available for followup. Unadjusted quality of life and satisfaction were significantly lower after revision (Harris Hip Score 76.7 vs 88.1; WOMAC pain 66.4 vs 73.3; WOMAC function 61.6 vs 70.0; satisfaction 7.7 vs 8.9). Adjustment for patient characteristics revealed that this difference was partly explained by the greater morbidity and older age of patients undergoing revision. The influence of age, comorbidities, and preoperative function on 5-year outcomes did not substantially differ for the 2 intervention groups. However, obesity was associated with a stronger negative effect on revision surgery. CONCLUSION: Patients and physicians should acknowledge additional risks and consequently lower results associated with revision THA. Better information and medical preparation before surgery may help to improve the success of revision surgery.

Efficacy and safety of epicutaneous ketoprofen in Transfersome (IDEA-033) versus oral celecoxib and placebo in osteoarthritis of the knee: multicentre randomised controlled trial

Abstract: Objective: To compare epicutaneous ketoprofen in Transfersome (ultra-deformable vesicles, IDEA-033) versus oral celecoxib and placebo for relief of signs and symptoms in knee osteoarthritis. Methods: This was a multicentre, randomised, double-blind, controlled trial; 397 patients with knee osteoarthritis participated and 324 completed the trial. They were randomly assigned 110 mg epicutaneous ketoprofen in 4.8 g Transfersome plus oral placebo (n = 138), 100 mg oral celecoxib plus placebo gel (n = 132), or both placebo formulations (n = 127) twice daily for 6 weeks. Primary efficacy outcome measures were the changes from baseline to end of the study on the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index pain subscale, physical function subscale and patient global assessment (PGA) of response. Results: The mean WOMAC pain subscale scores in the intent to treat population were reduced by 18.2 (95% confidence interval −22.1 to −14.3), 20.3 (−24.3 to −16.2) and 9.9 (−13.9 to −5.8) in the IDEA-033, celecoxib and placebo groups, respectively, and the physical function subscale score by 14.6 (−18.1 to −11.0), 16.6 (−20.2 to −13.0) and 10.2 (−13.8 to −6.6), respectively. The mean PGA of response scores were 1.8 (1.6 to 2.1), 1.7 (1.5 to 1.9) and 1.3 (1.1 to 1.5), respectively. The differences in change between IDEA-033 and placebo were statistically significant for pain subscale (p<0.01) and PGA of response (p<0.01). Gastrointestinal adverse events for IDEA-033 were similar to placebo. Conclusion: IDEA-033 is superior to placebo and comparable with celecoxib in relieving pain associated with an acute flare of knee osteoarthritis.

The clinical consequences of flexion gap asymmetry in total knee arthroplasty.

Abstract: This study was carried out to compare femoral component rotation of 18 knees from 18 patients who suffered from lateral flexion instability after total knee arthroplasty (Western Ontario and McMaster University Osteoarthritis (WOMAC), 6.4 points; International Knee Society (IKS) score, 119 points) with 10 asymptomatic controls (WOMAC, 0.1 points; IKS score, 182 points) after total knee arthroplasty. The symptomatic patients showed increased lateral joint laxity as determined by fluoroscopic stress radiography. Femoral component rotation was determined by computed tomography scans. The femoral component rotation was more internally rotated in symptomatic patients (5.58) than in controls (1.08 )( P = .04). Varus laxity in flexion was higher in symptomatic patients (11.08) than in controls (7.08 )( P b .001). Increased lateral flexion laxity is associated with increased internal femoral component rotation and a less favorable clinical outcome. Key words: total knee arthroplasty, femoral component malrotation, flexion gap asymmetry, flexion instability, fluoroscopic stress radiography.

Efficacy and safety of etoricoxib 30 mg and celecoxib 200 mg in the treatment of osteoarthritis in two identically designed, randomized, placebo-controlled, non-inferiority studies

Abstract: OBJECTIVE To compare the efficacy of etoricoxib 30 mg with the generally maximum recommended dose of celecoxib, 200 mg, in the treatment of osteoarthritis (OA) in two identically designed studies. METHODS Two multi-centre, 26-week, double-blind, placebo-controlled, non-inferiority studies were conducted, enrolling patients who were prior non-steroidal anti-inflammatory drug (NSAID) or acetaminophen users. There were 599 patients in study 1 and 608 patients in study 2 randomized 4:4:1:1 to etoricoxib 30 mg qd, celecoxib 200 mg qd or one of two placebo groups for 12 weeks. After 12 weeks, placebo patients were evenly distributed to etoricoxib or celecoxib based on their initial enrollment randomization schedule. The primary hypothesis was that etoricoxib 30 mg would be at least as effective as celecoxib 200 mg for the time-weighted average change from baseline over 12 weeks for Western Ontario and McMaster (WOMAC) Pain Subscale, WOMAC Physical Function Subscale and Patient Global Assessment of Disease Status. Active treatments were also assessed over the full 26 weeks. Adverse experiences were collected for safety assessment. RESULTS In both studies, etoricoxib was non-inferior to celecoxib for all three efficacy outcomes over 12 and 26 weeks; both were superior to placebo (P < 0.001) for all three outcomes in each study over 12 weeks. The safety and tolerability of etoricoxib 30 mg qd and celecoxib 200 mg qd were similar over 12 and 26 weeks. CONCLUSIONS Etoricoxib 30 mg qd was at least as effective as celecoxib 200 mg qd and had similar safety in the treatment of knee and hip OA; both were superior to placebo. ClinicalTrials.gov Identifiers: NCT00092768; NCT00092791.

Outcome at Forty-five Years After Open Reduction and Innominate Osteotomy for Late-Presenting Developmental Dislocation of the Hip

Abstract: BACKGROUND: A consecutive series of seventy-six patients (101 hips) underwent primary open reduction, capsulorrhaphy, and innominate osteotomy for late-presenting developmental dislocation of the hip. They were between 1.5 and five years old at the time of surgery, which was done between 1958 and 1965. The present study was designed to review the outcome of these patients into middle age. METHODS: We located and reviewed the cases of sixty patients (eighty hips), which represents a 79% rate of follow-up at forty to forty-eight years postoperatively. Nineteen patients (twenty-four hips) had undergone total hip replacement, and three (three hips) had died of unrelated causes. The remaining thirty-eight patients (fifty-three hips) were assessed by the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) and Oxford hip score questionnaires, physical examination, and a standing anteroposterior pelvic radiograph. The radiographs were analyzed to determine the minimum joint space width and the Kellgren and Lawrence score. Accepted indices of hip dysplasia were measured. RESULTS: With use of Kaplan-Meier survival analysis and with the end point defined as total hip replacement, the survival rates at thirty, forty, and forty-five years after the reduction were 99% (95% confidence interval, ± 2.4%), 86% (95% confidence interval, ± 6.9%), and 54% (95% confidence interval, ± 16.4%), respectively. The average Oxford hip score and WOMAC score for the surviving hips were 16.8 (range, 0 to 82) and 16.7 (range, 0 to 71), respectively. Of the fifty-one hips for which radiographs were available, thirty-eight demonstrated a minimum joint space width of >2.0 mm and thirteen demonstrated definite osteoarthritis on the basis of this criterion. Osteoarthritis, according to the system of Kellgren and Lawrence, was grade 0 or 1 in twenty-nine hips, grade 2 in seven hips, and grade 3 or 4 in fifteen hips. The average centeredge and acetabular angles were 40° (range, 0° to 61°) and 32° (range, 20° to 43°), respectively. With the numbers studied, no significant association was detected between outcome and the modifiable risk factors of body mass index or age at the time of surgery. Hips in patients with bilateral involvement were at significantly greater risk of failure (p = 0.02). CONCLUSIONS: This method of treatment achieves a 54% rate of survival of the hip at forty-five years. Two-thirds of the surviving hips have an excellent prognosis forty to forty-eight years after the index procedure according to the Kellgren and Lawrence score. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions to Authors for a complete description of levels of evidence. ORIGINAL ABSTRACT CITATION: “Outcome at Forty-five Years After Open Reduction and Innominate Osteotomy for Late-Presenting Developmental Dislocation of the Hip” (2007;89:2341-50).

The Longitudinal Examination of Arthritis Pain (LEAP) study: relationships between weekly fluctuations in patient-rated joint pain and other health outcomes.

Abstract: OBJECTIVE: To examine relationships between weekly fluctuations in self-rated joint pain and other health outcomes among adults with osteoarthritis (OA). METHODS: In this observational study, 287 adults (aged > or = 50 yrs) with hip or knee OA were recruited from 16 medical practices across the United States. Patients were telephoned weekly for 12 weeks to assess pain/stiffness, daily activities/function, productivity, emotional well-being, quality of life, and healthcare utilization. Associations between changes in joint pain levels and other health outcomes were evaluated using a generalized estimating equation model. RESULTS: The mean (SD) pain score at Week 1 was 4.2 (2.1) on the Western Ontario and McMaster Universities OA index (WOMAC) pain subscale (0 = no pain, 10 = extreme pain); during the study, 49% of patients reported a between-week fluctuation of > or = 2 points. A 2-point decrease in WOMAC pain subscale score was associated with a 22% decrease in number of days of limited activity/week (beta = -0.107; 95% confidence interval -0.163, -0.051); a 48% decrease in number of days of missed work/week (beta = -0.217; 95% CI -0.395, -0.039); a 14% decrease in number of nights with pain-related sleep interference/week (beta = -0.068; 95% CI -0.109, -0.027). Patients were 1.6 times more likely to contact a healthcare provider when their pain changed from "acceptable" to "unacceptable." CONCLUSION:Weekly fluctuations in pain levels and other health outcomes were identified among adults with OA. Decreases in patient-reported pain were associated with improvements in daily activities/functioning and decreases in work absenteeism, sleep interference, and healthcare resource use.

OMERACT/OARSI initiative to define states of severity and indication for joint replacement in hip and knee osteoarthritis

Abstract: Objective. Time to theoretical indication of joint replacement surgery has been proposed as a primary outcome for potential structure-modifying interventions for osteoarthritis (OA). The objectives of this OMERACT/OARSI Working Group were to identify pain, physical function, and structure states that represent the progression from early to late disease for individuals with OA of the hip and knee, and to create a composite measure of these 3 domains to define states of OA severity and a surrogate measure of "need for joint replacement surgery." Methods. For pain, focus groups and one-on-one interviews were used. For function, Rasch analysis was performed on existing indices - the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) and the Knee injury and Osteoarthritis Outcome Score (KOOS), each of which subsumes the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) questions. For structure, a comparison of existing indices (Kellgren-Lawrence, OARSI stages, and joint space width) was performed for the hip and the knee. Results. For pain, key features of pain that are most distressing to people with OA from early to late disease were identified. For function, the reduction of the number of items based on the existing indices continues. For structure, the analysis is also ongoing. Conclusion. Preliminary results were presented at OMERACT 8; the final objective will be to combine the 3 domains (pain, function, and structure) and to create a composite index that could define states of severity and "need for total joint replacement," which could be used to evaluate treatment response to disease-modifying drugs in OA clinical trials.

A mixed methods study to investigate needs assessment for knee pain and disability: population and individual perspectives

Abstract: The new Musculoskeletal Services Framework outlines the importance of health care needs assessment Our aim was to provide a model for this for knee pain and disability, describing felt need (individual assessment of a need for health care) and expressed need (demand for health care) This intelligence is required by health care planners in order to implement the new Framework A multi-method approach was used A population survey (n = 5784) was administered to adults aged 50+ registered with 3 general practices The questionnaire contained a Knee Pain Screening Tool to identify the prevalence of knee pain and health care use in the population, and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Survey responders who scored "severe" or "extreme" on at least one item on the pain or physical function scale on the WOMAC were categorised into "severe" groups Qualitative interviews were undertaken with 22 survey responders to explore in detail the experience of living with knee pain and disability A sample of interviewees (n = 10) completed an open format patient diary to explore the experience of knee pain in everyday life The 12-month period prevalence of knee pain was 495%, of which half was severe Severe difficulties were reported with domestic duties, bending, bathing, climbing stairs and getting in or out of a car Some self-care is occurring The majority (53%) of responders with severe pain or disability had not consulted their GP in the last 12 months The qualitative study revealed reasons for this including a perception that knee pain is part of normal ageing, little effective prevention and treatment is available and the use of medications causes side effects and dependency This study adds to previous work by highlighting a gap between felt and expressed need and the reasons for this mismatch There is evidence of self-management, but also missed opportunities for effective interventions (eg lifestyle advice) A targeted and integrated approach between clinicians and health care planners for primary and secondary prevention is required if aspects of the new Musculoskeletal Services Framework are to be successfully implemented

Effects of quadriceps electrical stimulation program on clinical parameters in the patients with knee osteoarthritis.

Abstract: The aim of this study was to evaluate the effects of electrical stimulation program on pain, disability, and quadriceps strength in the patients with knee osteoarthritis. Fifty women diagnosed as knee osteoarthritis were randomized into two groups as electrical stimulation and biofeedback-assisted isometric exercises. Both of the programs were performed 5 days a week, for a duration of 4 weeks. Outcome measures for pain were visual analogue scale pain score and Western Ontario McMaster osteoarthritis index (WOMAC) pain score. Disability and stiffness were assessed with WOMAC physical function and stiffness score. One repetition maximum (RM) and 10 RM were used for measuring quadriceps strength. In addition, 50 m walking time and 10 steps stairs climbing up-down time were evaluated. Both groups showed significant improvements in pain, physical function, and stiffness scores after the therapy. There were statistically significant improvements in 50 m walking time and 10 steps stairs climbing up-down time and 1 RM and 10 RM values indicating the improvement in muscle strength. In addition, there were no significant differences between the groups after the therapy. We conclude that electrical stimulation treatment was as effective as exercise in knee osteoarthritis and electrical stimulation treatment can be suggested especially for the patients who have difficulty in or contraindications to perform an exercise program.