Short Form Health Survey Scores Research Articles

Periprosthetic Bone Remodeling After Novel Short-Stem Neck-Sparing Total Hip Arthroplasty

BackgroundShort femoral stems have been designed with the aims of reducing proximal bone loss, improving load transfer, and increasing compressive loads at the medial proximal femoral calcar. This study examines bone mineral density (BMD) changes associated with a novel neck sparing short femoral stem design. MethodsThe study was a prospective, single-center, multi-investigator consecutive series, which assessed bone-remodeling changes after insertion of the MSA Stem (Global Orthopaedic Technology). Dual-energy X-ray absorptiometry scans were performed preoperatively and postoperatively at 6, 12, and 24 months assessing the BMD at the 7 Gruen zones. The secondary objectives assessed were the Harris Hip Score, 12-Item Short Form Health Survey preoperatively, and perioperative complications. ResultsThirty-nine total hip arthroplasties were performed on 37 patients, with 27 patients completing the 24-month dual-energy X-ray absorptiometry scan. The overall preoperative baseline BMD was 0.2. At 6 months, the Gruen zone BMD had increased significantly in all zones in comparison to the preoperative mean BMD. Between 6 months and 24 months, there were only slight changes in the Gruen zones, with small gains in zones 1-2 and zones 4-6, with no zone showing a significant decrease. The Harris Hip Score improved from a preoperative mean of 39.7-75.3, whereas the 12-Item Short Form Health Survey score also improved from 32.6 to 49 at 24 months. However, 5 patients had aseptic loosening requiring revision surgery (4 femoral and 1 acetabular component). ConclusionShort-stem neck-sparing femoral stem prosthesis has the capacity to address the stress-shielding problem identified in femoral stems. However, the high early revision rate is a significant issue.

Treatment of degenerative lumbar spondylolisthesis by using minimally invasive transforaminal lumbar interbody fusion and percutaneous pedicle screw fixation

Objective To discuss clinical therapeutic effects of minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) combined with percutaneous pedicle screw fixation for degenerative lumbar spondylolisthesis (DLS). Methods A total of 32 DLS patients treated by MIS-TLIF and percutaneous pedicle screw fixation from January 2013 to September 2015 in Xuanwu Hospital, Capital Medical University were retrospectively reviewed. Visual Analogue Scale (VAS), Oswestry Disability Index (ODI) and Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) scores were assessed and compared between preoperation and one week, 3 months after operation and in the last follow-up. Lumbar lordosis angle, coronal Cobb angle, coronal and sagittal body shifting, complication, the degree of spondylolisthesis (Meyerding classification) and the rate of spondylolisthesis were measured according to preoperative and postoperative spinal X-ray examination. Fusion rate was evaluated according to X-rays or CT in the last follow-up, and MRI was used to assess the degree of decompression. Results Thirty-two patients were under test with mean operation time 160 min, intraoperative blood loss 120 ml, postoperative hospital stay 7.22 d and follow-up 10.83 months. Decompression and fusion levels ranged from L2-S1 and interbody fusion was performed in 32 patients and 41 levels were fused. Compared with preoperation, the VAS and ODI scores were significantly increased at one week, 3 months after operation and in the last follow-up ( P = 0.000, for all), while SF-36 score ( P = 0.002, 0.000, 0.000), lumbar lordotic angle ( P = 0.000, for all), coronal Cobb angle ( P = 0.000, for all) and slippage rate ( P = 0.000, for all) were significantly decreased. The fusion rate was 92.22%, and the improvement rate of ODI was (80.51 ± 6.02)% in the last follow-up. There were 3 cases appeared complications, including one case of infection and 2 cases of cerebrospinal fluid (CSF) fistula, and were cured after treatment. Neurological defects, internal fixation failure, breakage of pedicle screw or titanium rod, or Cage displacement were not found in 32 cases. There was no death. Conclusions MIS-TLIF combined with percutaneous pedicle screw fixation is an effective technique for treatment of DLS patients, with less injury, less intraoperative blood loss, low complication incidence rate, good scoliosis correction and definite therapeutic effects, even this method needs more operation time, longer learning curve and more radiation. DOI: 10.3969/j.issn.1672-6731.2016.03.003

Radiographic Severity of Arthritis Affects Functional Outcome in Total Ankle Replacement (TAR).

It has been previously demonstrated that radiographic severity of arthritis predicts outcome following knee replacement. In certain circumstances, patients may undergo arthroplasty without severe radiographic disease. An example may be the patient with significant chondral damage unsuccessfully treated with arthroscopy. This patient may proceed to joint replacement when their radiographs would not normally merit such intervention. We investigated whether these findings were also applicable to total ankle replacements (TARs). We retrospectively reviewed a single-surgeon, single-implant series of 178 TARs in 170 patients. Of them, 124 patients who took part in the hospital joint registry with a minimum 2-year follow-up were included for this study. The radiographic severity of arthritis was graded using the Kellgren-Lawrence classification. Preoperative weight-bearing radiographs were reviewed for severity of arthritis by 2 blinded observers: the first author and an independent colleague from the radiology department. Patients were grouped into 4 subgroups based on degree of severity of radiographic grading for arthritis-A, B, C, and D (for grades 1, 2, 3, and 4 grades, respectively). Data collected included Foot and Ankle Outcome Score (FAOS; pain, function, and stiffness), MOS 36-item Short-Form Health Survey (SF-36) scores, and patient satisfaction scores collected prospectively and at 1 and 2 years postoperation. Groups were similar in terms of demographic data (P > .1) and preoperative FAOS scores (P > .89) for pain, function and stiffness. Group D had the biggest improvement in all domains of FAOS. This reached significance in each domain when compared to group C. No significant differences were demonstrated in SF-36 scores. Overall, 91.1% of patients in group D were satisfied at 2 years, compared with 50.0% of patients in groups A, B, and C (P < .001). In addition, 93.9% of patients in group D felt that their quality of life had been improved by the surgery, compared to 47% of patients with groups A, B, and C (P < .001). Further, 77.3% of patients from group D said they would have the operation again, vs only 52.2% of patients with grade III or less (P = .014). Patients who were "very satisfied" or "somewhat satisfied" postoperatively had an average Kellgren-Lawrence (KL) grade of 3.9 preoperatively. In contrast the "very dissatisfied" and "somewhat dissatisfied" patients had an average KL grade of 2.9 (P < .05). Although this study does not explain all of the dissatisfaction in TAR, radiologic severity is an important factor that surgeons must consider when planning how best to treat their patients. There may be a different pathophysiology in this patient group that is not well served by arthroplasty. Level III, retrospective comparative series.

Reaming Does Not Affect Functional Outcomes After Open and Closed Tibial Shaft Fractures: The Results of a Randomized Controlled Trial.

We sought to determine the effect of reaming on 1-year 36-item short-form general health survey (SF-36) and short musculoskeletal function assessment (SMFA) scores from the Study to Prospectively Evaluate Reamed Intramedullary Nails in patients with Tibial Fractures. Prospective randomized controlled trial.1319 patients were randomized to reamed or unreamed nails. Fractures were categorized as open or closed. Twenty-nine academic and community health centers across the US, Canada, and the Netherlands. One thousand three hundred and nineteen skeletally mature patients with closed and open diaphyseal tibia fractures. Reamed versus unreamed tibial nails. SF-36 and the SMFA. Outcomes were obtained during the initial hospitalization to reflect preinjury status, and again at the 2-week, 3-month, 6-month, and 1-year follow-up. Repeated measures analyses were performed with P < 0.05 considered significant. There were no differences between the reamed and unreamed groups at 12 months for either the SF-36 physical component score [42.9 vs. 43.4, P = 0.54, 95% Confidence Interval for the difference (CI) -2.1 to 1.1] or the SMFA dysfunction index (18.0 vs. 17.6, P = 0.79. 95% CI, -2.2 to 2.9). At one year, functional outcomes were significantly below baseline for the SF-36 physical componentf score, SMFA dysfunction index, and SMFA bothersome index (P < 0.001). Time and fracture type were significantly associated with functional outcome. Reaming does not affect functional outcomes after intramedullary nailing for tibial shaft fractures. Patients with open fractures have worse functional outcomes than those with a closed injury. Patients do not reach their baseline function by 1 year after surgery. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Outcomes of reverse total shoulder arthroplasty as primary versus revision procedure for proximal humerus fractures

Reverse total shoulder arthroplasty (RTSA) has been shown to be an effective treatment for proximal humerus fracture (PHF). This study evaluates outcomes of all patients with PHF treated with RTSA as a primary procedure for acute PHF, a delayed primary procedure for symptomatic PHF malunion or nonunion, a revision procedure for failed PHF hemiarthroplasty (HA), or a revision procedure for failed open reduction and internal fixation (ORIF). Patients who underwent RTSA for PHF were evaluated for active range of motion and Shoulder Pain and Disability Index (SPADI), Simple Shoulder Test-12, American Shoulder and Elbow Surgeons (ASES), University of California-Los Angeles (UCLA) shoulder rating scale, Constant, and 12-Item Short Form Health Survey scores. Scaption and external rotation (ER) strength were also assessed. RTSA was performed in 49 patients with PHF; 13 patients underwent RTSA for acute PHF, 13 for malunion or nonunion, 12 for failed PHF HA, and 11 for failed PHF ORIF. ER range of motion, SPADI, ASES, UCLA, and Constant scores achieved significance. The acute fracture group significantly outperformed the failed HA group in SPADI, ASES, and UCLA scores. The malunion/nonunion group significantly outperformed the failed HA group in ASES and UCLA scores. The acute fracture and malunion/nonunion groups each had significantly greater ER than the failed HA group. RTSA is an effective treatment option for PHF as both a primary and a revision procedure. Primary RTSA outperformed RTSA done as a revision procedure. RTSA for acute PHF is comparable to RTSA for malunions and nonunions. Our outcomes of revision RTSA for failed HA and ORIF are more promising than previously published.

Long-Term Functioning of Patients with Aneurysmal Subarachnoid Hemorrhage: A 4-yr Follow-up Study.

The aim was to study changes over time for multiple outcomes based on the International Classification of Functioning, Disability, and Health in patients with aneurysmal subarachnoid hemorrhage and to compare long-term outcomes with norms. A prospective cohort study with 4-yr follow-up was conducted. Main outcome measures were as follows: Center for Epidemiologic Studies-Depression Scale, Fatigue Severity Scale, Trail Making Test A and B, Barthel Index, Sickness Impact Profile-68, Impact on Participation and Autonomy Questionnaire, Social Support List-12, Multidimensional Health Locus of Control Scales, COOP-WONCA Charts, and Short Form-36 Health Survey. Seventy-six patients with aneurysmal subarachnoid hemorrhage were included. Measurements were done at T1 = 0.4 yrs (SD, 0.3 yrs) and T2 = 3.9 yrs (SD, 0.7 yrs) after onset. Significant improvements over time were found for Barthel Index (T1 = 18.5; T2 = 19.5; P = 0.023), Trail Making Test B (T1 = 119.4; T2 = 104.6; P = 0.025), Social Support List-12 total score (T1 = 31.1; T2 = 32.7; P = 0.042) and esteem support (T1 = 10.2; T2 = 10.9; P = 0.027), Multidimensional Health Locus of Control Scales (physician-orientation) (T1 = 21.8; T2 = 19.2; P = 0.020), and Short Form-36 Health Survey (role-emotional) (T1 = 54.6; T2 = 73.9; P = 0.048). Center for Epidemiologic Studies-Depression Scale, Fatigue Severity Scale, Sickness Impact Profile-68, and Short Form-36 Health Survey scores remained stable over time. A decline was found for COOP-WONCA (overall-health) (T1 = 2.3; T2 = 2.7; P = 0.021). At 4-yr follow-up, proportions of depression (27%) and fatigue (60%) were larger and scores on the Fatigue Severity Scale (mean [SE], 4.3 [0.2]), Trail Making Test A (mean [SE], 51.3 [3.9]), and Trail Making Test B (mean [SE], 104.4 [0.2]) were significantly worse than norm scores. Many patients with aneurysmal subarachnoid hemorrhage had fairly good long-term outcomes, but problems in executive functioning, mood, and fatigue still exist at long-term follow-up.

Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study.

BackgroundCT-P13 (Remsima®, Inflectra®) is a biosimilar of the infliximab reference product (RP; Remicade®) and is approved in Europe and elsewhere, mostly for the same indications as RP. The aim of this study was to compare the 54-week efficacy, immunogenicity, pharmacokinetics (PK) and safety of CT-P13 with RP in patients with ankylosing spondylitis (AS), with a focus on patient-reported outcomes (PROs).MethodsThis was a multinational, double-blind, parallel-group study in patients with active AS. Participants were randomized (1:1) to receive CT-P13 (5 mg/kg) or RP (5 mg/kg) at weeks 0, 2, 6 and then every 8 weeks up to week 54. To assess responses, standardized assessment tools were used with an intention-to-treat analysis of observed data. Anti-drug antibodies (ADAs), PK parameters, and safety outcomes were also assessed.ResultsOf 250 randomized patients (n = 125 per group), 210 (84.0 %) completed 54 weeks of treatment, with similar completion rates between groups. At week 54, Assessment of Spondylo Arthritis international Society (ASAS)20 response, ASAS40 response and ASAS partial remission were comparable between treatment groups. Changes from baseline in PROs such as mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI; CT-P13 −3.1 versus RP −2.8), Bath Ankylosing Spondylitis Functional Index (BASFI; −2.9 versus –2.7), and Short Form Health Survey (SF-36) scores (9.26 versus 10.13 for physical component summary; 7.30 versus 6.54 for mental component summary) were similar between treatment groups. At 54 weeks, 19.5 % and 23.0 % of patients receiving CT-P13 and RP, respectively, had ADAs. All observed PK parameters of CT-P13 and RP, including maximum and minimum serum concentrations, were similar through 54 weeks. The influence of ADAs on PK was similar in the two treatment groups. Most adverse events were mild or moderate in severity. There was no notable difference between treatment groups in the incidence of adverse events, serious adverse events, infections and infusion-related reactions.ConclusionsCT-P13 and RP have highly comparable efficacy (including PROs) and PK up to week 54. Over a 1-year period, CT-P13 was well tolerated and displayed a safety profile comparable to RP; no differences in immunogenicity were observed.Trial registrationClinicalTrials.gov identifier: NCT01220518. Registered 4 October 2010.Electronic supplementary materialThe online version of this article (doi:10.1186/s13075-016-0930-4) contains supplementary material, which is available to authorized users.

Health‐related quality of life as a predictor of recurrent falling in Parkinson's disease: 1‐year follow‐up study

The aim of this study was to assess whether various domains related to health-related quality of life could be predictive of recurrent falls among persons with Parkinson's disease (PD) during a 1-year follow-up study. A total of 120 consecutive persons with PD who had denied falling in past 6 months were recruited at regular check-ups at the Department of Movement Disorders, Neurology Clinic, Clinical Center of Serbia in Belgrade, from 15 August 2011 to 15 December 2012. At baseline, study participants were clinically assessed. Health-related quality of life was evaluated with the generic 36-item Short Form Health Survey. Participants were prospectively followed for 1 year, and occurrence of falls was registered. The median age of subjects was 60.0 years, with a median disease duration of 4.0 years. Of 120 persons with PD, 42 (35%) experienced falls during the 12-month study period, including 23 (19.2%) who fell repeatedly. After adjustment for gender, age, PD duration, levodopa dosage, Hoehn and Yahr stage, Unified Parkinson's Disease Rating Scale I-IV, Hamilton Depression Rating Scale, and Hamilton Anxiety Rating Scales, we identified the 36-item Short Form Health Survey domains of role physical (P = 0.033) and vitality (P = 0.019) as being associated with recurrent falls of persons with PD within the 1-year follow-up period. Baseline 36-item Short Form Health Survey scores regarding both the physical and mental components of overall health may be related to recurrent falling among persons with PD. These HRQoL domains could be considered as potential markers for persons with PD who are prone to recurrent falls.

Efficacy of electroacupuncture at the Hegu (LI4) and Taichong (LV3) acupoints in the treatment of migraine: study protocol for a randomized controlled trial

Background: Acupuncture is a relatively safe treatment for pain, and its analgesic effects have been confirmed. Electroacupuncture (EA) has been widely used to treat migraine because of its continuous and highly controllable stimulation. However, few rigorously designed randomized controlled trials have evaluated the efficacy of EA at the Hegu (LI4) and Taichong (LV3) acupoints in the treatment of migraine. Methods/Design: A prospective, single-center, single-blind randomized controlled trial will be performed at Longhua Hospital, Shanghai University of Traditional Chinese Medicine. Ninety-two patients with migraine will be randomly assigned to either undergo EA treatment (20 EA stimulations at the Hegu and Taichong acupoints; EA group, n = 46) or receive oral flunarizine (control group, n = 46). The primary outcome will be the Migraine Disability Assessment questionnaire score after 10 and 20 EA stimulations. The secondary outcomes will be the Medical Outcomes Study 36-item short form health survey score, Visual Analogue Scale score, and peripheral blood concentrations of plasma nitric oxide, calcitonin gene-related peptide, and nuclear factor-kappa B after 10 and 20 EA stimulations. Discussion: This trial is powered to investigate the efficacy of EA at the Hegu and Taichong acupoints in alleviating headache symptoms in patients with migraine and the interventional effects of this therapy on quality of life and social functioning to search for a more effective method of treating migraine. Trial registration: This trial protocol was registered at ClinicalTrial.gov (identifier: NCT02580968) on 30 July 2015. It was approved by the ethics committee of Longhua Hospital of Shanghai University of Traditional Chinese Medicine, China (approval No. 14401971300).

Safety and efficacy of WeChat combined with Yi Jin Jing exercise for the treatment of cervical spondylosis in white-collar workers: study protocol for a prospective open label randomized controlled trial

Background: Yi Jin Jing (changing tendon exercise) is a traditional Chinese exercise. Yi Jin Jing can reportedly prevent cervical spondylosis in financial professionals. In the absence of effective supervision and follow-up training, Yi Jin Jing self-exercise does not become habitual, reducing the efficacy of the technique. WeChat is an online text and voice messaging communication service developed by Tencent in China, and can be used as an interactive platform for doctors and patients. We hypothesized that WeChat could be used to guide Yi Jin Jing exercise, potentially enhancing the preventative and therapeutic benefits for cervical spondylosis in white-collar workers. Methods/Design: 120 financial professionals with cervical spondylosis working at the Bank Card Industrial Park in Pudong New Area, Shanghai, China will be enrolled in this prospective, open label, randomized controlled trial. Participants will be equally and randomly divided into two groups. In the intervention group, participants will undertake conventional Yi Jin Jing training followed by a group chat using WeChat to provide interactive guidance. In the control group, participants will undertake conventional Yi Jin Jing training alone. The primary ontcome will be the Cervical Spondylosis Symptoms scale measured 1, 3, 6 and 12 months after training. The secondary outcomes will be the 36-item Short Form Health Survey score, Visual Analog Scale score for pain intensity, medical expenses and the number of days absent from work. Discussion: This study will examine whether on-going interactive Yi Jin Jing exercise using the WeChat platform will improve outcomes in participants with cervical spondylosis. Trial registration: This trial was registered with the Chinese Clinical Trial Registry (identifier: ChiCTR-OCH-13003426) on 6 August 2013. Ethical approval: Written approval for this project was obtained from the Ethics Committee of Wanggang Community Health Center, Shanghai Pudong New Area, Shanghai, China (approval number WG2013 0709001). All patients will be informed of the protocols and will provide written informed consent.

Reliability and validity of the Korean version of the Short Musculoskeletal Function Assessment questionnaire for patients with musculoskeletal disorder.

[Purpose] The purpose of this study was to establish the reliability and validity of the Short Musculoskeletal Function Assessment questionnaire, which was translated into Korean, for patients with musculoskeletal disorder. [Subjects and Methods] Fifty-five subjects (26 males and 29 females) with musculoskeletal diseases participated in the study. The Short Musculoskeletal Function Assessment questionnaire focuses on a limited range of physical functions and includes a dysfunction index and a bother index. Reliability was determined using the intraclass correlation coefficient, and validity was examined by correlating short musculoskeletal function assessment scores with the 36-item Short-Form Health Survey (SF-36) score. [Results] The reliability was 0.97 for the dysfunction index and 0.94 for the bother index. Validity was established by comparison with Korean version of the SF-36. [Conclusion] This study demonstrated that the Korean version of the Short Musculoskeletal Function Assessment questionnaire is a reliable and valid instrument for the assessment of musculoskeletal disorders.

A Long-Term Study of the Effect of Subtalar Arthrodesis on the Ankle and Hindfoot Joints.

Subtalar arthrodesis is a common therapy for subtalar joint disorders. In this article, we evaluate the effect of subtalar arthrodesis on the ankle and hindfoot joints. Fifty patients (33 men and 17 women) underwent subtalar arthrodesis between January 1, 1996, and August 31, 2011. The 36-item Short-Form Health Survey and American Orthopaedic Foot and Ankle Society ankle hindfoot scores were used for clinical evaluation. Radiographic analysis included assessment of degenerative changes and ankle and hindfoot joint function in the frontal and sagittal planes. Thirty-seven patients (27 men and 10 women; mean age, 42.6 years) were followed up for an average of 9.2 years (range, 2-17 years). The mean ± SD 36-item Short-Form Health Survey score improved from 30.21 ± 7.19 before surgery to 78.50 ± 12.23, and the American Orthopaedic Foot and Ankle Society ankle hindfoot score increased from 50.32 ± 12.39 to 73.14 ± 15.44. Degenerative changes in the talonavicular, calcaneocuboid, metatarsocuboid, and ankle joints occurred. The talar-vertical angle was positively related to the tibial-plantar minimal angle (affected side: r = 0.56; P < .01; healthy side: r = 0.46; P < .01). The difference in hindfoot height is positively related to the difference in tibial-plantar minimal angle (r = 0.54; P < .01). Subtalar arthrodesis is effective treatment for subtalar joint disease but could induce joint degeneration and ankle joint motion limitation related to talar declination and hindfoot height.

Use of a Central Splitting Approach and Near Complete Detachment for Insertional Calcific Achilles Tendinopathy Repaired With an Achilles Bridging Suture

After 3 to 6 months of conservative management for insertional calcific Achilles tendinopathy, operative intervention might be warranted. Despite a success rate of 75% to 100% with surgery, no consensus has been reached on the amount of acceptable detachment of the Achilles tendon. The present case series reports on the results of a central splitting approach with 80% to 90% detachment of the Achilles insertion repaired with a double-row bridging suture device. A total of 14 patients (16 heels) for whom nonoperative management for insertional calcific Achilles tendinopathy had previously failed were enrolled in the present study they had undergone surgical management. The patients were followed up for a mean of 18 (range 11 to 25) months postoperatively and were evaluated using the American Orthopaedic Foot and Ankle Society Hind Foot scoring system, 36-item Short Form Health Survey questionnaire, and pre- and postoperative visual analog pain scale. The mean visual analog pain scale core had decreased 5.84 (range 1 to 9) points postoperatively (p < .001). The mean postoperative American Orthopaedic Foot and Ankle Society Hind Foot score was 87 ± 19.7 (range 52 to 105) points. One patient reported moderate pain with no limitation of activities. The mean 36-item Short-Form Health Survey score for physical functioning was 77.7 (range 30 to 100) points postoperatively in 11 patients. No patient reported incisional discomfort. All 14 patients (16 heels) reported being satisfied and had returned to their previous functional status. Thus, the central splitting Achilles approach with anchoring of the Achilles insertion using the double-row suture device is a safe and reasonable option in the operative treatment of insertional calcific Achilles tendinopathy.

Assessment of Quality of Life in Young Patients with Single Ventricle after the Fontan Operation

To assess self-reported quality of life (QOL) in a large multicenter cohort of adolescent and young adults surviving Fontan. Cross-sectional. The Pediatric Quality of Life Inventory (PedsQL) was administered to 408 survivors of Fontan ages 13-25 years enrolled in the Pediatric Heart Network Fontan Follow-up Study. Subjects also completed either the Child Health Questionnaire (age <19 years) or Short Form Health Survey (age ≥ 19 years). PedsQL data were compared with matched controls without a chronic health condition. Correlations between the measures were examined. Mean PedsQL scores for subjects receiving Fontan were significantly lower than those for the control group for physical and psychosocial QOL (P < .001). Overall, 45% of subjects receiving Fontan had scores in the clinically significant impaired range for physical QOL with 30% in the impaired range for psychosocial QOL. For each 1 year increase in age, the physical functioning score decreased by an average of 0.76 points (P = .004) and the emotional functioning score decreased by an average of 0.64 points (P = .03). Among subjects ≥19 years of age, the physical functioning score decreased by an average of 2 points for each year increase in age (P = .02). PedsQL scale scores were significantly correlated with conceptually related Child Health Questionnaire (P < .001) and Short Form Health Survey scores (P < .001). Survivors of Fontan are at risk for significantly impaired QOL which may decline with advancing age. Routine assessment of QOL is essential to inform interventions to improve health outcomes. The PedsQL allowed QOL assessment from pediatrics to young adulthood. ClinicalTrials.gov: NCT00132782.

Effect of Acupuncture on Pain and Quality of Life in Patients with Lumbar Spinal Stenosis: A Case Series Study

Lumbar spinal stenosis (LSS) is a major cause of debilitation in adults, and acupuncture is a recommended treatment. We assessed the effect of acupuncture on pain and quality of life in patients with LSS. Twenty-four patients with LSS who had symptoms of neurogenic claudication were randomly selected and underwent 10 sessions of acupuncture. Pain and quality of life were evaluated before and immediately after the intervention and 6 weeks later using a visual analogue scale and Short Form-36 Health Survey. Paired t tests and repeated measure tests were used to analyze the data. The mean age of the patients was 48.2 ± 10.8 years. The mean visual analogue scale scores before and immediately after intervention (7.9 ± 1.3 and 4.3 ± 2.1) were statistically different (p < 0.001), as was the mean score (3.08 ± 2.3) 6 weeks later (p = 0.01). Five aspects of the Short Form-36 Health Survey score were associated with significant improvements immediately after acupuncture (p < 0.05). Comparisons of the scores before and 6 weeks after intervention showed significant improvements in emotions, vitality, general health, bodily pain, and physical well-being. Therefore, acupuncture had a significant short-term effect on pain and quality of life in patients with LSS.

Balloon tibioplasty for reduction of depressed tibial plateau fractures: Preliminary radiographic and clinical results.

In vitro studies have shown promising results for balloon-guided inflation tibioplasty. It was our hypothesis that this technique may be safe and effective for use in depressed lateral tibial plateau fracture. We performed a prospective study of all patients suffering from a depressed lateral tibial plateau fracture, managed in our institution with inflation tibioplasty and a resorbable calcium phosphate bone substitute injection, between January 2012 and December 2013. Twenty patients, mean age 54.3 ± 12. 8years, suffering from a depressed lateral tibial plateau fracture (Schatzker type II and III) were included. We then aimed to evaluate at a minimum follow-up of one year: (1) the rate of complications, (2) the clinical outcome (Knee Injury and Osteoarthritis Outcome (KOO) and 12-Item Short Form Health Survey (SF-12) scores); and (3) the radiographic outcome (evaluated by CT-scan). No peri-operative complications occurred. In one patient, calcium phosphate substitute was found in the infrapatellar fat pad on post-operative radiography with no clinical or radiographic consequences at one year. At one year after surgery, the KOO subscores were: Pain 80 (range 64-93), other symptoms 81.3 (69-93), daily living activities 81.9 (46-99), sport 65.83 (20-100), and quality of life 67.04 (31-100). The SF-12 activity component was 40.4 (28.6-52.2) and SF-12 mental component 47.71 (28 - 67.1). The mean depressed step-off of the lateral joint decreased from 10.7± 4.8 mm pre-operatively to 2.7 ± 1.7mm post-operatively (p < 0.0001). Our observations suggest that the use of balloon-guided inflation tibioplasty with injection of a resorbable bone substitute is safe, and results in a high rate of anatomic reduction and good clinical outcomes in patients with depressed tibial plateau fractures. Therapeutic Level IV.

Response of patients with indolent systemic mastocytosis to tamoxifen citrate

We examined whether tamoxifen citrate at 20mg/day for 1 year had a beneficial effect on laboratory findings, bone marrow mastocytosis, common clinical symptoms, or quality-of-life assessment for 5 women and 2 men with indolent systemic mastocytosis. Tamoxifen was well tolerated. We found significant reductions in the platelet count, serum alkaline phosphatase, and 24-h urinary excretion of N-methylhistamine and significant increases in serum lactate dehydrogenase and (excluding 2 patients taking aspirin) in 24-h urinary excretion of 11β-prostaglandin F2α. Overall, no change occurred in percent involvement of bone marrow by mastocytosis. Symptom scores were mild and did not change during the treatment. The 36-Item Short Form Health Survey scores for quality of life physical and mental components showed no marked changes. Tamoxifen, an older, nonhematotoxic medication, has limited activity in systemic mastocytosis at the dosage used in this study.

Effect of golimumab and pamidronate on clinical efficacy and MRI inflammation in axial spondyloarthritis: a 48-week open randomized trial

Objectives: To compare the effect of golimumab (GLM) and pamidronate (PAM) on clinical efficacy and magnetic resonance imaging (MRI) inflammation in axial spondyloarthritis (aSpA).Method: Patients who fulfilled the Assessment of SpondyloArthritis Society (ASAS) criteria for aSpA and had active disease [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4] were randomized in a 2:1 ratio to receive either GLM (50 mg) or PAM (60 mg) 4 weekly for 48 weeks. Clinical efficacy was assessed at intervals. Inflammation of the spine and sacroiliac joints (SIJs) on MRI was graded by the Spondyloarthritis Research Consortium of Canada (SPARCC) scoring system.Results: Twenty patients were assigned to GLM and 10 to PAM (83% men; age 33.4 ± 10.9 years; disease duration 4.4 ± 3.4 years). The baseline characteristics of the two groups were similar. At week 48, the proportions of patients who achieved an ASAS20 response were not significantly different between the GLM and PAM groups (65% vs. 56%; p = 0.69). Although there were no differences in BASDAI, spinal pain, and Medical Outcomes Study 36-item Short Form Health Survey (SF-36) scores between the two groups at week 48, the Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath AS Functional Index (BASFI), C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) levels were significantly lower in GLM-treated patients. The SPARCC scores of the spine and SIJs decreased significantly in GLM- but not in PAM-treated patients. The differences in SPARCC scores between the two groups at week 48 were statistically significant. The frequency of adverse events (AEs) was similar in both arms.Conclusions: In patients with aSpA, the clinical response rate and improvement in pain and quality of life (QoL) were similar between GLM and PAM groups after 48 weeks. However, significant reduction in inflammatory markers and MRI inflammation was only observed with GLM treatment.

A retrospective clinical study on 37 subtalar arthrodesis patients of nine years follow-up.

Subtalar arthrodesis is a common therapy for subtalar joint disorders. In this article, we evaluate the effect of subtalar arthrodesis on the ankle and hindfoot joints. Fifty patients (33 men and 17 women) underwent subtalar arthrodesis between January 1, 1996, and August 31, 2011. The 36-item Short-Form Health Survey and American Orthopaedic Foot and Ankle Society ankle hindfoot scores were used for clinical evaluation. Radiographic analysis included assessment of degenerative changes and ankle and hindfoot joint function in the frontal and sagittal planes. Thirty-seven patients (27 men and 10 women; mean age, 42.6 years) were followed up for an average of 9.2 years (range, 2-17 years). The mean ± SD 36-item Short-Form Health Survey score improved from 30.21 ± 7.19 before surgery to 78.50 ± 12.23, and the American Orthopaedic Foot and Ankle Society ankle hindfoot score increased from 50.32 ± 12.39 to 73.14 ± 15.44. Degenerative changes in the talonavicular, calcaneocuboid, metatarsocuboid, and ankle joints occurred. The talar-vertical angle was positively related to the tibial-plantar minimal angle (affected side: r = 0.56; P < .01; healthy side: r = 0.46; P < .01). The difference in hindfoot height is positively related to the difference in tibial-plantar minimal angle (r = 0.54; P < .01). Subtalar arthrodesis is effective treatment for subtalar joint disease but could induce joint degeneration and ankle joint motion limitation related to talar declination and hindfoot height.

Cervical disc arthroplasty with PRESTIGE LP disc versus anterior cervical discectomy and fusion: a prospective, multicenter investigational device exemption study.

OBJECT This study compared the safety and efficacy of treatment with the PRESTIGE LP cervical disc versus a historical control anterior cervical discectomy and fusion (ACDF). METHODS Prospectively collected PRESTIGE LP data from 20 investigational sites were compared with data from 265 historical control ACDF patients in the initial PRESTIGE Cervical Disc IDE study. The 280 investigational patients with single-level cervical disc disease with radiculopathy and/or myelopathy underwent arthroplasty with a low-profile artificial disc. Key safety/efficacy outcomes included Neck Disability Index (NDI), Neck and Arm Pain Numerical Rating Scale scores, 36-Item Short Form Health Survey (SF-36) score, work status, disc height, range of motion, adverse events (AEs), additional surgeries, and neurological status. Clinical and radiographic evaluations were completed preoperatively, intraoperatively, and at 1.5, 3, 6, 12, and 24 months postoperatively. Predefined Bayesian statistical methods with noninformative priors were used, along with the propensity score technique for controlling confounding factors. Analysis by independent statisticians confirmed initial statistical findings. RESULTS The investigational and control groups were mostly similar demographically. There was no significant difference in blood loss (51.0 ml [investigational] vs 57.1 ml [control]) or hospital stay (0.98 days [investigational] vs 0.95 days [control]). The investigational group had a significantly longer operative time (1.49 hours vs 1.38 hours); 95% Bayesian credible interval of the difference was 0.01-0.21 hours. Significant improvements versus preoperative in NDI, neck/arm pain, SF-36, and neurological status were achieved by 1.5 months in both groups and were sustained at 24 months. Patient follow-up at 24 months was 97.1% for the investigational group and 84.0% for the control group. The mean NDI score improvements versus preoperative exceeded 30 points in both groups at 12 and 24 months. SF-36 Mental Component Summary superiority was established (Bayesian probability 0.993). The mean SF-36 PCS scores improved by 14.3 points in the investigational group and by 11.9 points in the control group from baseline to 24 months postoperatively. Neurological success at 24 months was 93.5% in the investigational group and 83.5% in the control group (probability of superiority ~ 1.00). At 24 months, 12.1% of investigational and 15.5% of control patients had an AE classified as device or device/surgical procedure related; 14 (5.0%) investigational and 21 (7.9%) control patients had a second surgery at the index level. The median return-to-work time for the investigational group was 40 days compared with 60 days for the control group (p = 0.020 after adjusting for preoperative work status and propensity score). Following implantation of the PRESTIGE LP device, the mean angular motion was maintained at 12 months (7.9°) and 24 months (7.5°). At 24 months, 90.0% of investigational and 87.7% of control patients were satisfied with the results of surgery. PRESTIGE LP superiority on overall success (without disc height success), a composite safety/efficacy end point, was strongly supported with 0.994 Bayesian probability. CONCLUSIONS This device maintains mean postoperative segmental motion while providing the potential for biomechanical stability. Investigational patients reported significantly improved clinical outcomes compared with baseline, at least noninferior to ACDF, up to 24 months after surgery.