Form-36 Physical Component Summary Scores Research Articles

Prognostic and functional importance of both overt and subclinical left ventricular systolic dysfunction in systemic sclerosis

ObjectivesTo quantify the frequency and clinical implications of systemic sclerosis (SSc)-associated left ventricular function (LV) impairment. MethodsAustralian Scleroderma Cohort Study participants meeting ACR/EULAR criteria for SSc with ≥1 echocardiographic LVEF measurement were included. Overt LV dysfunction was indicated by reduced LV ejection fraction (LVEF) and subclinical LV dysfunction was measured using impaired LV global longitudinal strain (LV-GLS>-16 %). Those with secondary causes of LV dysfunction (myocardial ischaemia, valvulopathy and pulmonary arterial hypertension) were excluded. Chi-squared tests, two-sample t-tests or Wilcoxon rank-sum tests were used for between-group comparison as appropriate. Generalised estimating equations(GEE) were used to model longitudinal data. Kaplan-Meier and Cox proportional hazard models were used for survival analyses. ResultsOf 1141 participants with no co-morbid cardiac disease, 2.4 % ever recorded a LVEF<50 %, while only 0.6 % ever recorded a LVEF≤40 %. LV-GLS data were available for 90 % of participants at one centre (n = 218). Impaired LV-GLS was detected in 21 % despite LVEF≥50 %. Those with a LVEF<50 % were more frequently male (p = 0.01) with dcSSc (p < 0.01), higher inflammatory markers (p < 0.02) and skeletal muscle disease (p < 0.05). In multivariable analyses, recording a LVEF<50 % was associated with increased mortality (HR2.3, 95 %CI1.0–4.8, p = 0.04). Impaired LV-GLS was also associated with poorer survival in univariable analyses (HR3.4, 95 %CI1.0–11.8, p = 0.05). Those with a LVEF<50 % more frequently recorded WHO Class III/IV dyspnoea (OR3.5, 95 %CI1.6–7.7, p < 0.01), with shorter six-minute walk distance (p = 0.01), higher Health Assessment Questionnaire-Disability Index scores (p < 0.01) and lower Short Form-36 Physical Component Summary scores (p = 0.02). Increased dyspnoea (WHO Class III/IV dyspnoea; OR3.6, 95 %CI1.4–9.2, p < 0.01) was also seen in those with impaired LV-GLS. ConclusionsBoth overt and subclinical SSc-associated LV dysfunction are associated with worse survival and impaired physical function. The frequency of abnormal LV-GLS in those with consistently normal LVEF suggests an under-appreciated burden of subtle LV systolic dysfunction in SSc that has a significant impact on patient symptomatology.

Clinical role of crosslink augmentation during short-segment posterior lumbar interbody fusion with total facetectomy: A propensity score-matched analysis

We investigated the clinical role of crosslink augmentation during PLIF with total facetectomy. We retrospectively reviewed 376 patients who underwent one- or two-segment PLIF with unilateral or bilateral total facetectomy between January 2017 and March 2022. The patients were categorized into two groups based on whether a crosslink was instrumented or not. Radiological outcome measurements included fusion status and implant failure rates on 12-month postoperative computed tomography. Patient-reported outcome measures included the Numerical Rating Scale for lower back pain, Oswestry Disability Index, and Short Form-12 Physical Component Summary scores, which were assessed preoperatively and at 12 months postoperatively. Surgery-related complications included surgical site infection, symptomatic implant failure, and epidural hematoma. Propensity score matching was performed to compare both groups after adjusting for confounding factors, including baseline and surgical procedural characteristics. A total of 200 cases were included in the propensity score calculation, and one-to-one matching was performed, resulting in 56 pairs with and without a crosslink. The fusion status (88.7 % vs. 85.5 %), screw loosening (14.3 % vs. 14.3 %), cage subsidence (17.9 % vs. 16.1 %), and cage dislodgement (5.4 % vs. 0 %) showed no significant difference between those with and without a crosslink, respectively. No significant differences were observed in the patient-reported outcomes or surgery-related complication rates between the groups. Crosslink augmentation during PLIF with total facetectomy is not recommended because it does not provide any radiological or clinical benefit and is associated with avoidable expenses.

Management of chronic pain secondary to temporomandibular disorders: a systematic review and network meta-analysis of randomised trials

ObjectiveWe explored the comparative effectiveness of available therapies for chronic pain associated with temporomandibular disorders (TMD).DesignSystematic review and network meta-analysis of randomised clinical trials (RCTs).Data sourcesMEDLINE, EMBASE, CINAHL, CENTRAL, and...

Effect of diabetes mellitus on the outcomes of total ankle arthroplasty: is controlled diabetes mellitus a risk factor?

BackgroundIt is still uncertain whether diabetes mellitus (DM) is a risk factor for poor outcomes and increased complications after total ankle arthroplasty (TAA). The objective of this study was to compare clinical outcomes and complication rates of TAA in patients with and without DM.MethodsThis study enrolled patients with symptomatic end-stage ankle osteoarthritis with a minimum follow-up period of 24 months after TAA. A total of 252 patients (266 ankles) were classified into two groups according to the presence of DM: (1) DM group (59 patients, 67 ankles) and (2) non-DM group (193 patients, 199 ankles). We defined controlled diabetes as (1) HbA1c level < 7.0%, or (2) fasting glucose level < 130 mg/dL with HbA1c level ≥ 7.0% for hospitalization period. Clinical outcomes data (Ankle Osteoarthritis Scale, American Orthopedic Foot and Ankle Society ankle-hindfoot score, Short Form-36 Physical Component Summary score, and visual analog scale for pain) were compared preoperatively and at the final follow-up between the two groups. Complications following TAA were also compared between the two groups.ResultsAll clinical variables had improved in both groups by the final follow-up (mean follow-up = 77.8 months). There was no significant difference in any clinical variable between the two groups at the final follow-up (P > 0.05). Of the 266 ankles, 73 ankles (19 in the DM group, 54 in the non-DM group) developed periprosthetic osteolysis. Although the DM group showed a higher prevalence of aseptic loosening or subsidence, the difference between the two groups was not statistically significant (P = 0.236).ConclusionsIn the intermediate-term follow-up, TAA in patients with controlled DM showed clinical outcomes and complication rates comparable to patients without DM. Our results suggest that TAA can be done safely in diabetic patients if the DM is controlled in the perioperative period.Level of evidence: Therapeutic Level III.

Secukinumab improves physical function and quality of life and inhibits structural damage in patients with PsA with sustained remission or low disease activity: results from the 2-year phase 3 FUTURE 5 study

ObjectiveTo investigate the impact of sustained low disease activity (LDA)/remission (REM) on physical function, quality of life (QoL) and structural outcomes in secukinumab-treated psoriatic arthritis (PsA) patients from the FUTURE...

Efficacy and safety of selective TYK2 inhibitor, deucravacitinib, in a phase II trial in psoriatic arthritis

ObjectiveTo evaluate the efficacy and safety of an oral selective tyrosine kinase 2 (TYK2) inhibitor, deucravacitinib, in patients with active psoriatic arthritis (PsA).MethodsIn this double-blind, phase II trial, 203 patients...

The efficacy of change in limb volume on functional mobility, health-related quality of life, social appearance anxiety, and depression in patients with lower extremity lymphedema.

This study aims to investigate the impact of change in limb volume on the levels of functional mobility, health-related quality of life, social appearance anxiety, and depression before and after complex decongestive physiotherapy in patients with lower extremity lymphedema. Twenty-seven patients with unilateral lower extremity lymphedema were included. The treatment period was 20 sessions. The outcome measures were the limb volume, the Timed Up and Go test, the Short Form-36, the Social Appearance Anxiety Scale, and the Beck Depression Inventory. A statistically significant decrease in the limb volume (p < 0.001) and statistically significant improvements in the Timed Up and Go test performance (p < 0.001), the Short Form-36 Physical Component Summary score (p < 0.01), the Social Appearance Anxiety Scale score (p < 0.001), and the Beck Depression Inventory score (p < 0.001) were found. No statistically significant difference was found on the Short Form-36 Mental Component Summary score (p > 0.05). The decrease in the limb volume improves the functional mobility, physical health-related quality of life, social appearance anxiety, and depression in patients with lower extremity lymphedema, but not the mental health-related quality of life.

Belimumab for systemic lupus erythematosus.

Belimumab, the first biologic approved for the treatment of systemic lupus erythematosus (SLE), has been shown to reduce autoantibody levels in people with SLE and help control disease activity. To assess the benefits and harms of belimumab (alone or in combination) in systematic lupus erythematosus. An Information Specialist carried out the searches ofCENTRAL, MEDLINE, Embase, CINAHL, Web of Science, the World Health Organization (WHO) International Clinical Trials Registry Platform, and clinicaltrials.gov from inception to 25 September 2019. There were no language or date restrictions. We included randomized controlled trials (RCTs) or controlled clinical trials (CCTs) of belimumab (alone or in combination) compared to placebo/control treatment (immunosuppressive drugs, such as azathioprine, cyclosporine, mycophenolate mofetil or another biologic), in adults with SLE. We used standard methodologic procedures expected by Cochrane. Six RCTs (2917 participants) qualified for quantitative analyses. All included studies were multicenter, international or US-based. The age range of the included participants was 22 to 80 years; most were women; and study duration ranged from 84 days to 76 weeks. The risk of bias was generally low except for attrition bias, which was high in 67% of studies. Compared to placebo, more participants on belimumab 10 mg/kg (Food and Drug Administration (FDA)-approved dose) showed at least a 4-point improvement (reduction) in Safety of Estrogen in Lupus National Assessment (SELENA) - Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score, a validated SLE disease activity index: (risk ratio (RR) 1.33, 95% confidence interval (CI) 1.22 to 1.45; 829/1589 in belimumab group and 424/1077 in placebo; I2= 0%; 4 RCTs; high-certainty evidence). Change in health-related quality of life (HRQOL), assessed by Short Form-36 Physical Component Summary score improvement (range 0 to 100), showed there was probably little or no difference between groups (mean difference 1.6 points, 95% CI 0.30 to 2.90;401 in belimumab group and 400 in placebo; I2= 0%; 2 RCTs; moderate-certainty evidence). The belimumab 10 mg/kg group showed greater improvement in glucocorticoid dose, with a higher proportion of participants reducing their dose by at least 50% compared to placebo (RR 1.59, 95% CI 1.17 to 2.15; 81/269 in belimumab group and 52/268 in placebo; I2= 0%; 2 RCTs; high-certainty evidence). The proportion of participants experiencing harm may not differ meaningfully between the belimumab 10 mg/kg and placebo groups: one or more serious adverse event (RR 0.87, 95% CI: 0.68 to 1.11; 238/1700 in belimumab group and 199/1190 in placebo; I2= 48%; 5 RCTs; low-certainty evidence; ); one or more serious infection (RR 1.01, 95% CI: 0.66 to 1.54; 44/1230 in belimumab group and 40/955 in placebo; I2= 0%; 4 RCTs; moderate-certainty evidence); and withdrawals due to adverse events (RR 0.82, 95% CI: 0.63 to 1.07; 113/1700 in belimumab group and 94/1190 in placebo; I2= 0%; 5 RCTs; moderate-certainty evidence). Mortality was rare, and may not differ between belimumab 10 mg/kg and placebo (Peto odds ratio 1.15, 95% CI 0.41 to 3.25; 9/1714 in belimumab group and 6/1203 in placebo; I2= 4%; 6 RCTs; low-certainty evidence). The six studies that provided evidence for benefits and harms of belimumab were well-designed, high-quality RCTs. At the FDA-approved dose of 10 mg/kg, based on moderate to high-certainty data, belimumab was probably associated with a clinically meaningful efficacy benefit compared to placebo in participants with SLE at 52 weeks. Evidence related to harms is inconclusive and mostly of moderate to low-certainty evidence. More data are needed for the longer-term efficacy of belimumab.

Outcomes of Total Ankle Arthroplasty in Ankles with >20° of Coronal Plane Deformity.

A preoperative severe coronal plane deformity of >20° has been considered a contraindication for total ankle arthroplasty. We aimed to evaluate whether outcomes of total ankle arthroplasty in ankles with severe coronal plane deformity (20° to 35° of varus or valgus) are comparable with those with moderate deformity (5° to 15° of varus or valgus). A total of 148 consecutive ankles (142 patients) that underwent primary total ankle arthroplasty using the HINTEGRA prosthesis were included. The overall mean follow-up duration was 74 months (range, 24 to 160 months). We divided all patients into 2 groups according to the preoperative coronal plane tibiotalar angle: the severe group (36 patients, 41 ankles) and the moderate group (106 patients, 107 ankles). Clinical and radiographic outcomes were analyzed for intergroup differences, and multivariable regression was used to adjust for baseline characteristics. Patients in each group showed similar characteristics in mean age, sex, mean body mass index, and median follow-up duration. At a mean follow-up of 74 months, we found no significant intergroup difference in the Ankle Osteoarthritis Scale pain and disability score, American Orthopaedic Foot & Ankle Society ankle-hindfoot score, Short Form-36 Physical Component Summary score, visual analog scale pain score, or ankle range of motion (p > 0.05). However, the final tibiotalar angle, talar tilt angle, and number of outliers were greater in the severe group (p < 0.05). Complication rates did not show a significant difference between the 2 groups (p > 0.05). The overall survival probability of the implant was 91.3% (92.3% in the severe group and 90.7% in the moderate group) (p = 0.354). Total ankle arthroplasty in ankles with preoperative severe coronal plane deformity showed satisfactory and comparable clinical outcomes without increasing complication rates relative to those with moderate deformity in the intermediate-term follow-up. Our results suggested that total ankle arthroplasty may be considered in ankles with deformity of >20°. Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Patient coping and expectations predict recovery after major orthopaedic trauma

Background: Persistent post-surgical pain and associated disability are common after a traumatic fracture repair. Preliminary evidence suggests that patients' beliefs and perceptions may influence their prognosis. MethodsWe used data from the Fluid Lavage of Open Wounds trial to determine, in 1560 open fracture patients undergoing surgical repair, the association between Somatic PreOccupation and Coping (captured by the SPOC questionnaire) and recovery at 1 yr. ResultsOf the 1218 open fracture patients with complete data available for analysis, 813 (66.7%) reported moderate to extreme pain at 1 yr. The addition of SPOC scores to an adjusted regression model to predict persistent pain improved the concordance statistic from 0.66 to 0.74, and found the greatest risk was associated with high (≥74) SPOC scores [odds ratio: 5.63; 99% confidence interval (CI): 3.59–8.84; absolute risk increase 40.6%; 99% CI: 30.8%, 48.6%]. Thirty-eight per cent (484 of 1277) reported moderate to extreme pain interference at 1 yr. The addition of SPOC scores to an adjusted regression model to predict pain interference improved the concordance statistic from 0.66 to 0.75, and the greatest risk was associated with high SPOC scores (odds ratio: 6.06; 99% CI: 3.97–9.25; absolute risk increase: 18.3%; 95% CI: 11.7%, 26.7%). In our adjusted multivariable regression models, SPOC scores at 6 weeks post-surgery accounted for 10% of the variation in short form-12 physical component summary scores and 14% of short form-12 mental component summary scores at 1 yr. ConclusionsAmongst patients undergoing surgical repair of open extremity fractures, high SPOC questionnaire scores at 6 weeks post-surgery were predictive of persistent pain, reduced quality of life, and pain interference at 1 yr. Clinical trial registrationNCT00788398.

Quality of Life in Patients Undergoing Spine Surgery: Systematic Review and Meta-Analysis.

Study Design:Meta-analysis.Objective:Despite the increasing importance of tracking clinical outcomes using valid patient-reported outcome measures, most providers do not routinely obtain baseline preoperative health-related quality of life (HRQoL) data in patients undergoing spine surgery, precluding objective outcomes analysis in individual practices. We conducted a meta-analysis of pre- and postoperative HRQoL data obtained from the most commonly published instruments to use as reference values.Methods:We searched PubMed, EMBASE, and an institutional registry for studies reporting EQ-5D, SF-6D, and Short Form-36 Physical Component Summary scores in patients undergoing surgery for degenerative cervical and lumbar spinal conditions published between 2000 and 2014. Observational data was pooled meta-analytically using an inverse variance-weighted, random-effects model, and statistical comparisons were performed.Results:Ninety-nine articles were included in the final analysis. Baseline HRQoL scores varied by diagnosis for each of the 3 instruments. On average, postoperative HRQoL scores significantly improved following surgical intervention for each diagnosis using each instrument. There were statistically significant differences in baseline utility values between the EQ-5D and SF-6D instruments for all lumbar diagnoses.Conclusions:The pooled HRQoL values presented in this study may be used by practitioners who would otherwise be precluded from quantifying their surgical outcomes due to a lack of baseline data. The results highlight differences in HRQoL between different degenerative spinal diagnoses, as well as the discrepancy between 2 common utility-based instruments. These findings emphasize the need to be cognizant of the specific instruments used when comparing the results of outcome studies.

Comparison of Intermediate to Long-Term Outcomes of Total Ankle Arthroplasty in Ankles with Preoperative Varus, Valgus, and Neutral Alignment

Preoperative ankle coronal malalignment has been considered as a risk factor for poor outcomes and failure after total ankle arthroplasty. The present study evaluated whether intermediate to long-term outcomes of total ankle arthroplasty in ankles with preoperative varus and valgus malalignment (5° to 20°) are comparable with those with neutral alignment (<5°). We enrolled 144 consecutive ankles that underwent primary total ankle arthroplasty (140 patients) using a mobile-bearing HINTEGRA prosthesis with a minimum follow-up of 4 years; the mean overall follow-up duration was 89 months (51 to 145 months). We divided all patients into 3 groups according to the preoperative coronal plane tibiotalar angle: the varus group (59 ankles, 5° to 20° of varus), the valgus group (34 ankles, 5° to 20° of valgus), and the neutral group (51 ankles, <5°). Patients in each group showed similar characteristics in mean age, sex, body mass index, and follow-up period. The mean Ankle Osteoarthritis Scale pain and disability score, American Orthopaedic Foot & Ankle Society ankle-hindfoot score, Short Form-36 Physical Component Summary score, visual analog scale pain score, and ankle range of motion did not differ meaningfully among the 3 groups at the final follow-up. The final tibiotalar angle showed that the degree of coronal alignment of the varus group was significantly less corrected compared with the neutral group (p = 0.010). The varus group had significantly more concomitant procedures (42 procedures [71.2%]) compared with the neutral group (p = 0.003). The prevalence of major complications did not differ among the 3 groups (p = 0.124). The overall probability of implant survivorship was 91.1% (97.7% in the varus group, 81.1% in the valgus group, and 90.9% in the neutral group) at a mean follow-up of 7.3 years. In the intermediate to long-term follow-up, mobile-bearing total ankle arthroplasty showed similarly good outcomes in patients with varus and valgus malalignment up to 20° compared with the neutral alignment group when neutrally aligned ankles were achieved postoperatively. Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Five-Strand Hamstring Autograft in Primary Anterior Cruciate Ligament Reconstruction

The purpose of this study was to describe our surgical technique of using five-strand hamstring autograft with interference screw fixation in primary anterior cruciate ligament (ACL) reconstruction and to report the early postoperative outcomes of this technique. Patients who underwent primary ACL reconstruction using five-strand hamstring autografts with interference screw fixation between December 2014 and June 2016 were included in this study. The five-strand configuration was used in these patients because the four-strand configuration produced a graft diameter of less than 8 mm. Subjective questionnaires, including the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Lysholm Score, were administered preoperatively, as well as at 1- and 2-year follow-ups. Paired t-test was used to compare the pre- and postoperative outcome scores. The study group comprised 25 patients. There were no intraoperative complications. The mean follow-up period was 17.8 months (12-24). There were 19 males and 6 females. The median age was 24 years (16-41), and median body mass index was 23.9 (18.5-30.2). The median diameter of the five-strand graft was 9 mm (8-10 mm), with a mean of 9.06 ± 0.60 mm. This was associated with a median graft length of 90 mm (80-100 mm). The postoperative Lysholm, KOOS symptoms, KOOS Pain, KOOS daily function, KOOS sports function, KOOS quality of life, and Short Form-36 Physical Component Summary scores improved significantly compared with the preoperative scores. The use of the five-strand hamstring graft with interference screw fixation in primary ACL reconstruction is associated with significant improvements in patient-reported outcomes in the early postoperative period. The five-strand graft technique is a useful means of increasing graft diameter when faced with an undersized hamstring graft.

Outcomes After Open Revision Repair of Massive Rotator Cuff Tears With Biologic Patch Augmentation

To assess minimum 2-year clinical outcomes after open revision biologic patch augmentation in patients with massive rotator cuff retears who had deficient rotator cuff tendons with healthy rotator cuff muscles. Patients with massive posterosuperior rotator cuff retears who underwent open revision rotator cuff repair with patch augmentation were identified from a surgical registry. Outcomes data collected included American Shoulder and Elbow Surgeons; Quick Disabilities of the Arm, Shoulder and Hand; Single Assessment Numeric Evaluation; and Short Form-12 Physical Component Summary scores along with postoperative patient satisfaction, and activity modification. There were 10 men and 2 women (13 shoulders, 1 bilateral) with a mean age of 57 years (range, 26 to 68 years). All patients had at least one prior arthroscopic rotator cuff repair. After patch augmentation, there were no complications, no adverse reactions to the patch, and no patients required further surgery. One patient (7.7%) with 4 prior cuff repairs had a documented posterosuperior retear on magnetic resonance imaging 2months after repair. Minimum 2-year outcome scores were available for 12 of 13 (92.3%) shoulders after a mean follow-up period of 2.5 years (range, 2.0 to 4.0 years). The ASES score improved by 21.5 points. Although the pain component of the ASES score and the total ASES score didnot improve significantly, the function component of the ASES score improved significantly when compared withtheirpreoperative baselines (P < .05). Median patient satisfaction at final follow-up was 9/10 (range, 2 to 10). Biologic patch augmentation with human acellular dermal allograft was a safe and effective treatment method for patients with massive rotator cuff retears with deficient posterosuperior rotator cuff tendons in the presence of healthy rotator cuff muscles. Level IV, therapeutic study.

Impact of Prosthesis-Patient Mismatch on Long-term Functional Capacity After Mechanical Aortic Valve Replacement

BackgroundThe impact of prosthesis-patient mismatch (PPM) after aortic valve replacement (AVR) for aortic stenosis on exercise capacity remains controversial. The aim of this study was to analyze the long-term impact of PPM after mechanical AVR on maximal oxygen uptake (VO2max). MethodsThe study included 75 patients who had undergone isolated mechanical AVR for aortic stenosis with normal left ventricular (LV) function between 1994 and 2012. Their functional capacity was evaluated on average 4.6 years after AVR by exercise testing, including measurement of their VO2max, and by determining their New York Heart Association functional class and Short Form-36 score. Two groups were defined by measuring the patients' indexed effective orifice area (iEOA) by transthoracic echocardiography: a PPM group (iEOA < 0.85 cm2/m2) and a no-PPM group (iEOA ≥ 0.85 cm2/m2). ResultsPPM was present in 37.0% of the patients. The percentage of the predicted VO2max achieved was significantly lower in the PPM group (86.7 ± 19.5% vs 97.5 ± 23.0% in the no-PPM group; P = 0.04). Compared with the no-PPM group, the PPM group contained fewer patients in New York Heart Association functional class I and their mean Short Form-36 physical component summary score was significantly lower. The mean transvalvular gradient was significantly higher in the PPM group than in the no-PPM group (P < 0.001). Systolic and diastolic function and LV mass had normalized in both groups. ConclusionsPPM is associated in the long term with moderate but significant impairment of functional capacity, despite optimal LV reverse remodelling and normalization of LV systolic and diastolic function.

Validity and Reliability of a Measurement of Objective Functional Impairment in Lumbar Degenerative Disc Disease: The Timed Up and Go (TUG) Test.

There are few objective measures of functional impairment to support clinical decision making in lumbar degenerative disc disease (DDD). We present the validation (and reliability measures) of the Timed Up and Go (TUG) test. In a prospective, 2-center study, 253 consecutive patients were assessed using the TUG test. A representative cohort of 110 volunteers served as control subjects. The TUG test values were assessed for validity and reliability. The TUG test had excellent intra- (intraclass correlation coefficient: 0.97) and interrater reliability (intraclass correlation coefficient: 0.99), with a standard error of measurement of 0.21 and 0.23 seconds, respectively. The validity of the TUG test was demonstrated by a good correlation with the Visual Analog Scale (VAS) back (Pearson's correlation coefficient [PCC]: 0.25) and VAS (PCC: 0.29) leg pain, functional impairment (Roland-Morris Disability Index [PCC: 0.38] and Oswestry Disability Index [PCC: 0.34]), as well as with health-related quality of life (Short Form-12 Mental Component Summary score [PCC: -0.25], Short Form-12 Physical Component Summary score [PCC: -0.32], and EQ-5D [PCC: -0.28]). The upper limit of "normal" was 11.52 seconds. Mild (lower than the 33rd percentile), moderate (33rd to 66th percentiles), and severe objective functional impairment (higher than the 66th percentile) as determined by the TUG test was <13.4 seconds, 13.4 to 18.4 seconds, and >18.4 seconds, respectively. The TUG test is a quick, easy-to-use, valid, and reliable tool to evaluate objective functional impairment in patients with lumbar degenerative disc disease. In the clinical setting, patients scoring a TUG test time of over 12 seconds can be considered to have functional impairment. BMI, body mass indexDDD, degenerative disc diseaseHRQOL, health-related quality of lifeICC, intraclass correlationLDH, lumbar disc herniationLSS, lumbar spinal stenosisODI, Oswestry Disability IndexOFI, objective functional impairmentPCC, Pearson's correlation coefficientPCS, Physical Component SummaryRMDI, Roland-Morris Disability IndexSF, Short FormVAS, visual analog scale.

Lumbar Spine Surgery in Patients with Parkinson Disease.

Parkinson disease is the second most common neurodegenerative condition. The literature on patients with Parkinson disease and spine surgery is limited, but increased complications have been reported. All patients with Parkinson disease undergoing lumbar spine surgery between 2002 and 2012 were identified. Patients' charts, radiographs, and outcome questionnaires were reviewed. Parkinson disease severity was assessed with use of the modified Hoehn and Yahr staging scale. Complications and subsequent surgeries were analyzed. Risk for reoperation was assessed. Ninety-six patients underwent lumbar spine surgery. The mean patient age was 63.0 years. The mean follow-up duration was 30.1 months. The Parkinson disease severity stage was <2 in thirteen patients, 2 in thirty patients, 2.5 in twenty-three patients, and ≥3 in thirty patients. The primary indication for surgery was spinal stenosis in seventy-two patients, spondylolisthesis in seventeen patients, and coronal and/or sagittal deformity in seven patients. There were nineteen early complications, including postoperative infections requiring surgical irrigation and debridement and long-term antibiotics in ten patients. The visual analog scale for back pain improved from 7.4 cm preoperatively to 1.8 cm postoperatively (p < 0.001). The visual analog scale for lower-limb pain improved from 7.7 cm preoperatively to 2.3 cm postoperatively (p < 0.001). The Oswestry Disability Index score dropped from 54.1 points to 17.7 points at the time of the latest follow-up (p < 0.001). The Short Form-12 Physical Component Summary score improved from 26.6 points preoperatively to 30.5 points postoperatively (p < 0.05). Twenty patients required revision surgery. Risks for further surgery included a Parkinson disease severity stage of ≥3 (p < 0.05), a history of diabetes mellitus, treatment for osteoporosis, and a combined anterior and posterior approach. Despite a higher rate of complications than in the general population, the overall outcome of spine surgery in patients with mild to moderate Parkinson disease is good, with improvement of spine-related pain. A larger prospective study is warranted.

Cervical spondylotic myelopathy surgical trial: randomized, controlled trial design and rationale.

Cervical spondylotic myelopathy (CSM) is the most common cause of spinal cord dysfunction in the world. There are significant practice variation and uncertainty as to the optimal surgical approach for treating CSM. To determine whether ventral surgery is associated with superior Short Form-36 Physical Component Summary outcome at the 1-year follow-up compared with dorsal (laminectomy/fusion or laminoplasty) surgery for the treatment of CSM, to investigate whether postoperative sagittal balance is an independent predictor of overall outcome, and to compare health resource use for ventral and dorsal procedures. The study is a randomized, controlled trial with a nonrandomized arm for patients who are eligible but decline randomization. Two hundred fifty patients (159 randomized) with CSM from 11 sites will be recruited over 18 months. The primary outcome is the Short Form-36 Physical Component Summary score. Secondary outcomes include disease-specific outcomes, overall health-related quality of life (EuroQOL 5-dimension questionnaire), and health resource use. This will be the first randomized, controlled trial to compare directly the health-related quality-of-life outcomes for ventral vs dorsal surgery for treating CSM. A National Institutes of Health-funded (1R13AR065834-01) investigator meeting was held before the initiation of the trial to bring multiple stakeholders together to finalize the study protocol. Study investigators, coordinators, and major stakeholders were able to attend and discuss strengths of, limitations of, and concerns about the study. The final protocol was approved for funding by the Patient-Centered Outcomes Research Institute (CE-1304-6173). The trial began enrollment on April 1, 2014.

Functional Outcomes After Total Shoulder Arthroplasty in Obese Patients

Obesity is increasingly prevalent in the United States. There are several reports of outcomes in obese patients after total knee or hip replacement. The purpose of this study was to compare the functional outcomes and complications of obese patients undergoing shoulder arthroplasty with those of overweight or normal-weight patients. Seventy-six patients who underwent primary total shoulder arthroplasty were grouped according to body mass index. The groups were classified as: normal, which was denoted by a body mass index of <25 kg/m2 (twenty-six patients); overweight, which was denoted by a body mass index of 25 to 29.9 kg/m2 (twenty-five patients); and obese, which was denoted by a body mass index of ≥30 kg/m2 (twenty-five patients). Preoperative demographics and perioperative and postoperative complications were recorded. The American Shoulder and Elbow Surgeons score, Short Form-36, and visual analog scale pain and fatigue scores were evaluated at baseline and at the two-year follow-up visit. In the normal group, the mean scores (and standard deviation) improved for the American Shoulder and Elbow Surgeons score from 38.4 ± 15.5 points preoperatively to 80.2 ± 19.4 points at two years postoperatively (p < 0.001) and for the Short Form-36 Physical Component Summary score from 38.3 ± 6.5 points preoperatively to 53.7 ± 11.3 points at two years postoperatively (p < 0.001); the visual analog scale pain scores decreased from a mean score of 62 points preoperatively to 12 points at two years postoperatively (p < 0.001). In the overweight group, the mean scores (and standard deviation) improved for the American Shoulder and Elbow Surgeons score from 37.4 ± 18.1 points preoperatively to 75.2 ± 24.9 points at two years postoperatively (p < 0.001) and for the Short Form-36 Physical Component Summary score from 36.1 ± 8.0 points preoperatively to 39.8 ± 12.2 points at two years postoperatively (p = 0.21); the visual analog scale pain scores decreased from 68 points to 18 points (p < 0.001). In the obese group, the mean scores (and standard deviation) improved for the American Shoulder and Elbow Surgeons score from 35.8 ± 12.5 points preoperatively to 80.0 ± 20.6 points at two years postoperatively (p < 0.001) and for the Short Form-36 Physical Component Summary score from 36.3 ± 8.4 points preoperatively to 40.7 ± 12.4 points at two years postoperatively (p = 0.15); the visual analog scale pain scores decreased from 66 points preoperatively to 11 points at two years postoperatively (p < 0.001). There was one deep infection in the overweight group that required surgical irrigation and debridement. Two revisions of the components were required in the normal group. Obesity did not have a detrimental effect on the improvement of short-term shoulder function. However, the overall physical function of obese and overweight patients does not significantly improve after total shoulder arthroplasty. In the normal body mass index group, patients did improve overall physical function after total shoulder arthroplasty. Prognostic level II. See Instructions for Authors for a complete description of levels of evidence.

Effects of BG-12 (dimethyl fumarate) on health-related quality of life in patients with relapsing–remitting multiple sclerosis: findings from the CONFIRM study

Multiple sclerosis (MS) has a significant impact on health-related quality of life (HRQoL) with symptoms adversely affecting many aspects of everyday living. BG-12 (dimethyl fumarate) demonstrated significant efficacy in the phase III studies DEFINE and CONFIRM in patients with relapsing–remitting MS. In CONFIRM, HRQoL was worse in patients with greater disability at baseline, and who relapsed during the study, and improved with BG-12 treatment. Mean Short Form-36 Physical Component Summary scores for BG-12 increased over 2 years and scores for placebo decreased. Coupled with clinical and neuroradiological benefits, these HRQoL results further support BG-12 as an effective oral treatment for relapsing MS.