Accuracy of cup placement compared with preoperative surgeon targets in primary total hip arthroplasty using standard instrumentation and techniques: a global, multicenter study.

BACKGROUND: Acetabular cup positioning in total hip arthroplasty (THA) is closely related to outcomes. The literature has suggested cup parameters defined by the Lewinnek safe zone; however, the validity of such measures is in question. Several studies have raised concerns about the benefits of using the Lewinnek safe zone as a predictor of success. In this study we elected to use prospective surgeon targets as the basis for comparison to see how successful surgeons are positioning their cup using standard instruments and techniques. METHODS: A prospective, global, multicenter study was conducted. Cup positioning success was defined as a composite endpoint. Both cup inclination and version needed to be within 10° of the surgeon target to be considered a success. Radiographic analysis was conducted by a third-party reviewer. RESULTS: In 170 subjects, inclination, target versus actual, was 44.8° [standard deviation (SD 0.9°)] and 43.1° (SD 7.6°), respectively (p = 0.0029). Inclination was considered successful in 84.1% of cases. Mean version, target versus actual, was 19.4° (SD 3.9°) and 27.2° (SD 5.6°), respectively (p < 0.0001). Version was considered successful in 63.4% of cases, and combined position (inclination and version) was considered successful in 53.1%. CONCLUSION: This study shows that with traditional methods of placing the cup intraoperatively, surgeons are only accurate 53.1% of the time compared with a predicted preoperative plan. This study suggests that the inconsistency in cup positioning based on the surgeon's planned target is potentially another important variable to consider while using a mechanical guide or in freehand techniques for cup placement in THA. TRIAL REGISTRATION: This study is registered on ClinicalTrials.gov, NCT03189303.

Heat acclimation training with intermittent and self-regulated intensity may be used as an alternative to traditional steady state and power-regulated intensity in endurance cyclists.

The study aimed to determine the effects of self-regulated and variable intensities sustained during short-term heat acclimation training on cycling performance. Seventeen competitive-level male athletes performed a 20-km cycling time trial before (TT-PRE), immediately after (TT-POST1) and one week after (TT-POST2) a 5-day acclimation training program, including either RPE-regulated intermittent (HA-HIT, N = 9) or fixed and low-intensity (HA-LOW, N = 8) training sessions in the heat (39 °C; 40% relative humidity). Total training volume was 23% lower in HA-HIT compared to HA-LOW. Physiological responses were evaluated during a 40-min fixed-RPE cycling exercise performed before (HST-PRE) and immediately after (HST-POST) heat acclimation. All participants in HA-LOW group tended to improve mean power output from TT-PRE to TT-POST1 (+8.1 ± 5.2%; ES = 0.55 ± 0.23), as well as eight of the nine athletes in HA-HIT group (+4.3 ± 2.0%; ES = 0.29 ± 0.31) without difference between groups, but TT-POST2 results showed that improvements were dissipated one week after. Similar improvements in thermal sensation and lower elevations of core temperature in HST-POST following HA-LOW and HA-HIT training protocols suggest that high intensity and RPE regulated bouts could be an efficient strategy for short term heat acclimation protocols, for example prior to the competition. Furthermore, the modest impact of lowered thermal sensation on cycling performance confirms that perceptual responses of acclimated athletes are dissociated from physiological stress when exercising in the heat.

Nutrition for Master Athletes: Is There a Need for Specific Recommendations?

Master athletes are often considered exemplars of successful aging, thanks to their capacity to maintain a high sports performance during their entire life. A high training capacity, regular participation in sporting competitions, and delayed alterations in body composition and physiological capacities have been listed among the main factors contributing to impressive master athletes' performances. However, there is a paucity of data on the metabolism and dietary habits of master athletes, and the question of whether they need to adapt their nutrition to the aging process remains open. Herein, the authors presented a contemporary overview of the metabolic challenges associated with aging, including the risk of low energy availability, anabolic resistance, and periods of metabolic crisis due to forced immobilization. After assembling scientific evidence to show that master athletes must adapt their dietary intake, the authors proposed a summary of nutritional recommendations for master athletes and suggested the next stage of research.

Primary Results of the Multicenter ARISE II Study (Analysis of Revascularization in Ischemic Stroke With EmboTrap).

BACKGROUND AND PURPOSE: EmboTrap is a novel stent retriever designed to achieve rapid and substantial flow restoration in acute ischemic stroke secondary to large-vessel occlusions. Here, we evaluated EmboTrap's safety and efficacy compared with established stent retrievers. METHODS: ARISE II (Analysis of Revascularization in Ischemic Stroke With EmboTrap) was a single-arm, prospective, multicenter study, comparing the EmboTrap device to a composite performance goal criterion derived using a Bayesian meta-analysis from the pivotal SWIFT (Solitaire device) and TREVO 2 (Trevo device) trials. Patients at 11 US and 8 European sites were eligible for inclusion if they had large-vessel occlusions and moderate-to-severe neurological deficits within 8 hours of symptom onset. The primary efficacy end point was achievement of modified Thrombolysis in Cerebral Ischemia (mTICI) reperfusion scores of ≥2b within 3 EmboTrap passes as adjudicated by the core laboratory. The primary safety end point was a composite of symptomatic intracerebral hemorrhage and serious adverse device effects. Secondary end points included functional independence (modified Rankin Scale, 0-2) and all-cause mortality at 90 days. RESULTS: Between October 2015 and February 2017, 227 patients were enrolled and treated with the EmboTrap device. The primary efficacy end point (mTICI ≥2b within 3 passes) was achieved in 80.2% (95% confidence interval, 74%-85% versus 56% performance goal criterion; P value, <0.0001), and mTICI 2c/3 was 65%. After all interventions, mTICI 2c/3 was achieved in 76%, and mTICI ≥2b was 92.5%. The rate of first pass (mTICI ≥2b following a single pass) was 51.5%. The primary safety end point composite rate of symptomatic intracerebral hemorrhage or serious adverse device effects was 5.3%. Functional independence and all-cause mortality at 90 days were 67% and 9%, respectively. CONCLUSIONS: The EmboTrap stent-retriever mechanical thrombectomy device demonstrated high rates of substantial reperfusion and functional independence in patients with acute ischemic stroke secondary to large-vessel occlusions. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02488915.

Interactions between perceived exertion and thermal perception in the heat in endurance athletes.

INTRODUCTION: The study aimed to investigate how a distortion of perceived exertion in the heat may affect, during a self-paced cycling exercise preceded by prior cognitive task, the thermal perception and the subsequent regulation of power output in high level athletes. METHODS: Eleven endurance trained male athletes completed four experimental sessions including a 30-min fixed-RPE (15-Hard) cycling exercise in neutral (TMP-22 °C) and hot (HOT-37 °C) conditions, following a 60-min incongruent Stroop task (EXP) or passively watching documentary films (CON). Central and peripheral performances of the knee extensors were assessed before the cognitive task and after the exercise. RESULTS: Although mental demand and effort were higher in EXP (P < 0.05), no effect of prior cognitive task was observed on subjective feelings of mental fatigue or decline in power output at a fixed RPE. Average exercise intensity was lower in HOT than TMP (3.14 ±â€¯0.09 W⋅kg-1vs. 3.42 ±â€¯0.10 W⋅kg-1 respectively, P < 0.05). Skin temperature and warmth sensations were higher in HOT throughout the exercise (P < 0.05) but not thermal comfort. Central and peripheral parameters were not affected more in HOT than in TMP. CONCLUSION: Although the effects of combined stressors on the distortion of perceived exertion could not be verified, the greater decline in power output recorded in HOT than TMP suggest a high contribution of both perceptual and cardiovascular responses in the regulation of work rate when the subject is in mild hyperthermia.

Comparison of the influence of age on cycling efficiency and the energy cost of running in well-trained triathletes.

INTRODUCTION: Locomotive efficiency is cited as an important component to endurance performance; however, inconsistent observations of age-related changes in efficiency question its influence in the performance of masters athletes. PURPOSE: This study examined locomotive efficiency in young and masters triathletes during both a run and cycle test. METHODS: Twenty young (28.5 ± 2.6 years) and 20 masters (59.8 ± 1.3 years) triathletes completed an incremental cycling and running test to determine maximal aerobic consumption (VO2max) and the first ventilatory threshold (VT1). Participants then completed 10-min submaximal running and cycling tests at VT1 during which locomotive efficiency was calculated from expired ventilation. Additionally, body fat percentage was determined using skin-fold assessment. RESULTS: During the cycle and run, VO2max was lower in the masters (48.3 ± 5.4 and 49.6 ± 4.8 ml kg(-1) min(-1), respectively) compared with young (61.6 ± 5.7 and 62.4 ± 5.2 ml kg(-1) min(-1), respectively) cohort. Maximal running speed and the cycling power output corresponding to VO2max were also lower in the masters (15.1 ± 0.8 km h(-1) and 318.6 ± 26.0 W) compared with the young (19.5 ± 1.3 km h(-1) and 383.6 ± 35.0 W) cohort. Cycling efficiency was lower (-11.2%) in the masters compared with young cohort. Similar results were observed for the energy cost of running (+10.8%); however, when scaled to lean body mass, changes were more pronounced during the run (+22.1%). CONCLUSIONS: Within trained triathletes, ageing can influence efficiency in both the run and cycle discipline. While disregarded in the past, efficiency should be considered in research examining performance in ageing athletes.

Age difference in efficiency of locomotion and maximal power output in well-trained triathletes.

PURPOSE: The aim of this study was to examine the influence of age on cycling efficiency and sprint power output in well-trained endurance masters athletes. METHODS: The investigation was conducted on 60 healthy well-trained triathletes separated into six separate groups (n = 10) depending on age: 20-29 years old; 30-39 years old; 40-49 years old; 50-59 years old; 60-69 years old; 70 years old. Each participant attended the laboratory on three separate occasions to perform (1) an incremental cycling test, (2) maximal peak sprint power test, involving three 5-s sprint efforts (3) and a 10-min sub-maximal cycling test for determination of cycling efficiency. RESULTS: Cycling efficiency decreased beyond 50 years (50-59 years compared with 20-29 years: -7.3 ± 1.8%; p < 0.05) and continued to decrease beyond 60 years (60-69 years compared with 50-59 years: -10.7 ± 2.4%; p < 0.05), no further decrease was observed after 70 years. A continuous impairment in maximal sprint power output was observed after the age of 50 years leading to an overall decrease of 36% between 20-29 years and >70 years. Significant positive relationships were observed between maximal sprint power output and both cycling efficiency (r(2) = 0.64, p < 0.05) and maximal aerobic power (r(2) = 0.42 and p < 0.05). CONCLUSION: The present data indicates a significant effect of ageing on cycling efficiency and maximal sprint power output after 50 years and a significant relationship was found between these two parameters.

Early functional recovery outcomes and return to work after primary total hip arthroplasty: a novel patient reported outcomes questionnaire.

PURPOSE: Clinical and patient reported outcomes are often collected before and after the procedure to benchmark and study outcomes for patients. These outcomes and scores are useful for tracking patient outcomes after surgery, however, the fact that these commonly used measures typically provide information about a patient's level of pain and function at a single point in time is a limitation. METHODS: We present early functional recovery and return to work outcomes after primary THA from a novel questionnaire administered in a global, multi-center, prospective clinical study. RESULTS: By 6 and 12 weeks post-op, a large proportion of study subjects were able to perform functional recovery outcomes after their THA: walk without an aid (74%; 94%); drive (76%; 97%); basic activities of daily living (94%; 99%); perform light household duties (91%; 96%); perform moderate-to-heavy household duties (54%; 86%); go up and down a flight of stairs (92%; 99%); put on socks/stockings (77%; 93%); bend down to pick up an object from the floor (87%; 97%); stand up from a chair (96%; 99%); perform leisure recreational activities (54%; 84%); perform primary goal identified pre-THA (69%; 86%). 60% were able to return to work by 12 weeks post-op. These questions showed strong association with the Forgotten Joint Score. CONCLUSION: Excellent patient reported early functional recovery outcomes and satisfaction were observed at 6- and 12-weeks post-op in this cohort and is the first reported data using a novel PRO. CLINICAL TRIAL REGISTRATION: NCT03189303, registered June 14, 2017.

Use of an Automated Surgical Impactor Reduces Femoral Broaching Time in Direct Anterior Approach Total Hip Arthroplasty: Results From a Randomized, Multicenter Study.

Background: Impaction in total hip arthroplasty has typically been conducted using a mallet. A surgical automated impactor has been developed with the goal of reducing surgeon variability, fatigue, and injury. There is also potential to reduce the variability of each impaction step in which automated impaction is used, through reproducible and consistent application of force. Methods: Patients were randomized into either the mallet control group, or the automated impaction study group (1:1 randomization). The primary endpoint analysis was conducted to demonstrate that femoral broaching time (in minutes) with an automated impactor is noninferior to femoral broaching time with manual instruments (mallet) under a noninferiority (NI) margin of 1.25 minutes, with a subsequent test of superiority. A total of 218 patients were randomized and treated (109 in each group). Results: Mean femoral broaching time was 5.8 minutes in the automated impaction study group (automated), and 8.1 minutes in the mallet control group (mallet), a 28.4% reduction (P = .0005). However, there was not a difference in surgery duration between the groups. Three fractures were reported in the mallet group and 1 in the automated group. Conclusions: In this randomized multicenter study, an automated impactor was shown to reduce femoral broaching time in primary total hip arthroplasty, with no increase in fractures, but no decrease in operating room time was noted.

Age-related changes in cardio-respiratory responses and muscular performance following an Olympic triathlon in well-trained triathletes.

The aim of the present study was to compare the maximal isometric torque and cardio-respiratory parameters in well-trained young and master triathletes prior to and following an Olympic distance triathlon. One day before and 24 h following the event, participants performed three maximum voluntary isometric knee extensions and flexions and an incremental running test on a treadmill to determine the maximal isometric torque, maximal oxygen uptake VO(2max), speed at VO(2max) (vVO(2)max), speed at ventilatory thresholds (VT1 and VT2) and submaximal running economy. Prior to the event VO(2max), vVO(2)max, speed at ventilatory thresholds and running economy were significantly lower in master athletes, but maximal voluntary torque was similar between the groups. 24 h following the race, a similar significant decrease in VO(2max) (-3.1% in masters, and -6.2% in young, p < 0.05), and vVO(2)max (-9.5% in masters, and -5.6% in young, p < 0.05) was observed in both the groups. The speed at VT2 significantly decreased only in master athletes (-8.3%, p < 0.05), while no change was recorded in maximal voluntary torque or submaximal running economy following the event. The results indicate that for well-trained subjects, the overall relative exercise intensity during an Olympic distance triathlon and the fatigue 24 h following the event seem to be independent of age.

Pacing strategy during the initial phase of the run in triathlon: influence on overall performance.

The aim of the present study was to determine the best pacing strategy to adopt during the initial phase of a short distance triathlon run for highly trained triathletes. Ten highly trained male triathletes completed an incremental running test to determine maximal oxygen uptake, a 10-km control run at free pace and three individual time-trial triathlons (1.5-km swimming, 40-km cycling, 10-km running) in a randomised order. Swimming and cycling speeds were imposed as identical to the first triathlon performed and the first run kilometre was done alternatively 5% faster (Tri-Run(+5%)), 5% slower (Tri-Run(-5%)) and 10% slower (Tri-Run(-10%)) than the control run (C-Run). The subjects were instructed to finish the 9 remaining kilometres as quickly as possible at a free self-pace. Tri-Run(-5%) resulted in a significantly faster overall 10-km performance than Tri-Run(+5%) and Tri-Run(-10%) (p < 0.05) but no significant difference was observed with C-Run (p > 0.05) (2,028 +/- 78 s vs. 2,000 +/- 72 s, 2,178 +/- 121 s and 2,087 +/- 88 s, for Tri-Run(-5%), C-Run, Tri-Run(+5%) and Tri-Run(-10%), respectively). Tri-Run(+5%) strategy elicited higher values for oxygen uptake, ventilation, heart rate and blood lactate at the end of the first kilometre than the three other conditions. After 5 and 9.5 km, these values were higher for Tri-Run(-5%) (p < 0.05). The present results showed that the running speed achieved during the cycle-to-run transition is crucial for the improvement of the running phase as a whole. Triathletes would benefit to automate a pace 5% slower than their 10-km control running speed as both 5% faster and 10% slower running speeds over the first kilometre involved weaker overall performances.

Age-related decline in olympic triathlon performance: effect of locomotion mode.

This study describes the decline in performance with age during Olympic triathlon Age Groups World Championships among the different locomotion modes. Mean performance of top 10 performers were analyzed for each group of age using the exponential model proposed by Baker, Tang, and Turner (2003, Experimental Aging Research, 29, 47-65). Comparison in performance decline was done between locomotion modes. Decline in performance in triathlon as a function of age follows an exponential model. A significant interaction effect between age and locomotion mode was observed on performance values. In swimming, a significant decrease was observed close to 5% per year after 45 years. Decline in performance was less pronounced in cycling until 60 years. Analysis of the effect of age in the different locomotion modes of a triathlon could provide information for maintaining quality of life with aging.

Retraining and Nutritional Strategy of an Endurance Master Athlete Following Hip Arthroplasty: A Case Study.

Retraining and resuming competition following surgery is challenging for athletes due to the prolonged period of reduced physical activity and subsequent alteration of body composition and physical performance. This is even more challenging for master athletes who endure the additional effect of aging. Within this context, the purpose of this study was to evaluate the feasibility and benefits that evidence-based nutritional and training recommendations could have on the time course of reconditioning and retraining following hip arthroplasty in an endurance master triathlete. During 38 weeks (from 6 weeks prior to surgery through to the return to competition in week 32), the athlete was provided with detailed training and nutritional recommendations. Dietary intake (via the remote food photographic method), body composition (via DXA), peak oxygen uptake (VO2peak), peak power output (PPO), cycling efficiency (GE), and energy availability (EA) were assessed 6 weeks pre- and 8, 12, 18, 21, and 25-weeks post-surgery. Training load was quantified (via TRIMP score and energy expenditure) daily during the retraining. Total body mass increased by 8.2 kg (attributable to a 3.5-4.6 kg increase in fat mass and lean mass, respectively) between week -6 and 8 despite a reduction in carbohydrate (CHO) intake post-surgery (<3.0 g/kg body mass/day). This was accompanied with a decrease in VO2peak, PPO, and GE due to a drop in training load. From week 7, the athlete resumed training and was advised to increase gradually CHO intake according to the demands of training. Eventually the athlete was able to return to competition in week 32 with a higher PPO, improved VO2peak, and GE. Throughout retraining, EA was maintained around 30 kcal/kg Lean Body Mass/day, protein intake was high (~2 g/kg/day) while CHO intake was periodized. Such dietary conditions allowed the athlete to maintain and even increase lean mass, which represents a major challenge with aging. Data reported in this study show, for the first time, the conditions required to recover and return to endurance competition following hip surgery.

General Guidelines for Sample Preparation Strategies in HR-µMAS NMR-based Metabolomics of Microscopic Specimens.

The study of the metabolome within tissues, organisms, cells or biofluids can be carried out by several bioanalytical techniques. Among them, nuclear magnetic resonance (NMR) is one of the principal spectroscopic methods. This is due to a sample rotation technique, high-resolution magic angle spinning (HR-MAS), which targets the analysis of heterogeneous specimens with a bulk sample mass from 5 to 10 mg. Recently, a new approach, high-resolution micro-magic angle spinning (HR-µMAS), has been introduced. It opens, for the first time, the possibility of investigating microscopic specimens (<500 µg) with NMR spectroscopy, strengthening the concept of homogeneous sampling in a heterogeneous specimen. As in all bioanalytical approaches, a clean and reliable sample preparation strategy is a significant component in designing metabolomics (or -omics, in general) studies. The sample preparation for HR-µMAS is consequentially complicated by the µg-scale specimen and has yet to be addressed. This report details the strategies for three specimen types: biofluids, fluid matrices and tissues. It also provides the basis for designing future µMAS NMR studies of microscopic specimens.

Influence of gender on pacing adopted by elite triathletes during a competition.

The aim of this study was to compare the pacing strategies adopted by women and men during a World Cup ITU triathlon. Twelve elite triathletes (6 females, 6 males) competed in a World Cup Olympic distance competition where speed and heart rate (HR) were measured in the three events. The power output (PO) was recorded in cycling to determine the time spent in five intensity zones ([0-10% VT1]; [10% VT1-VT1]; [VT1-VT2]; [VT2-MAP] and > or =MAP) [ventilatory threshold (VT); maximal aerobic power (MAP)]. Swimming and running speeds decreased similarly for both genders (P < 0.05) and HR values were similar through the whole race (92 +/- 2 and 92 +/- 3% of maximal HR for women and men, respectively). The distribution of time spent in the five zones during the cycling leg was the same for both genders. The men's speed and PO decreased after the first bike lap (P < 0.05) and the women spent relatively more time above MAP in the hilly sections (45 +/- 4 vs. 32 +/- 4%). The men's running speed decreased significantly over the whole circuit, whereas the women slowed only over the uphill and downhill sections (P < 0.05). This study indicates that both female and male elite triathletes adopted similar positive pacing strategies during swimming and running legs. Men pushed the pace harder during the swim-to-cycle transition contrary to the women and female triathletes were more affected by changes in slope during the cycling and running phases.

Influence of cognitive load on the dynamics of neurophysiological adjustments during fatiguing exercise.

We aimed to determine the neurophysiological mechanisms associated with reduced endurance performance during cognitive-motor dual task at different levels of cognitive load, compared to a motor task alone. Eighteen healthy men performed isometric quadriceps contractions at 15% of maximal voluntary contraction (blocks of 170 s interspaced by neuromuscular evaluations) until exhaustion. This task was performed on three separate days: (a) in the absence of concomitant cognitive task, (b) with concomitant 1-back task, and (c) with concomitant 2-back task. Autonomic nervous system activity, perceived exertion, and cognitive performance were continuously monitored. Peripheral and central determinants of neuromuscular function were assessed at rest, between each block, and at task failure using femoral nerve stimulation. Endurance time was shorter during 2-back (982 ± 545 s) and 1-back (1,128 ± 592 s) conditions, compared with control (1,306 ± 836 s). Voluntary activation level was lower in 2-back (87.1%; p < 0.001) and 1-back (88.6%; p = 0.04) conditions compared to control (91.2%) at isotime (100% of the shortest test duration). Sympathetic activity showed a greater increase in 2-back condition compared to control. Perceived muscular exertion was higher during 2-back than during control. Cognitive performance decreased similarly with time during both cognitive-motor dual task but was always lower during 2-back condition. Motor performance is reduced when adding a concomitant demanding memory task to a prolonged isometric exercise. This can be explained by the interaction of various psychological and neurophysiological factors including higher perceived exertion, greater perturbations of autonomic nervous system activity, and cerebral impairments leading to earlier onset of central fatigue.

Five-Year Reoperation Rates of 2-Level Lumbar Total Disk Replacement Versus Fusion: Results of a Prospective, Randomized Clinical Trial.

STUDY DESIGN: Long-term analysis of prospective randomized clinical trial data. SUMMARY OF BACKGROUND DATA: Lumbar total disk replacement (TDR) has been found to have equivalent or superior clinical outcomes compared with fusion and decreased radiographic incidence of adjacent level degeneration in single-level cases. OBJECTIVE: The purpose of this particular analysis was to determine the incidence and risk factors for secondary surgery in patients treated with TDR or circumferential fusion at 2 contiguous levels of the lumbar spine. METHODS: A total of 229 patients were treated and randomized to receive either TDR or circumferential fusion to treat degenerative disk disease at 2 contiguous levels between L3 and S1 (TDR, n=161; fusion, n=68). RESULTS: Overall, at final 5-year follow-up, 9.6% of subjects underwent a secondary surgery in this study. The overall rate of adjacent segment disease was 3.5% (8/229). At 5 years, the percentage of subjects undergoing secondary surgeries was significantly lower in the TDR group versus fusion (5.6% vs. 19.1%, P=0.0027).Most secondary surgeries (65%, 17/26) occurred at the index levels. Index level secondary surgeries were most common in the fusion cohort (16.2%, 11/68 subjects) versus TDR (3.1%, 5/161 subjects, P=0.0009). There no statistically significant difference in the adjacent level reoperation rate between TDR (2.5%, 4/161) and fusion (5.9%, 4/68). The most common reason for index levels reoperation was instrumentation removal (n=9). Excluding the instrumentation removals, there was not a significant difference between the treatments in index level reoperations or in reoperations overall. CONCLUSIONS: There were significantly fewer reoperations in TDR patients compared with fusion patients. However, most of the secondary surgeries were instrumentation removal in the fusion cohort. Discounting the instrumentation removals, there was no significant difference in reoperations between TDR and fusion. These results are indicative that lumbar TDR is noninferior to fusion.

Seven-year cost-effectiveness of ProDisc-C total disc replacement: results from investigational device exemption and post-approval studies.

OBJECTIVE The purpose of this study was to evaluate the 7-year cost-effectiveness of cervical total disc replacement (CTDR) versus anterior cervical discectomy and fusion (ACDF) for the treatment of patients with single-level symptomatic degenerative disc disease. A change in the spending trajectory for spine care is to be achieved, in part, through the selection of interventions that have been proven effective yet cost less than other options. This analysis complements and builds upon findings from other cost-effectiveness evaluations of CTDR through the use of long-term, patient-level data from a randomized study. METHODS This was a 7-year health economic evaluation comparing CTDR versus ACDF from the US commercial payer perspective. Prospectively collected health care resource utilization and treatment effects (quality-adjusted life years [QALYs]) were obtained from individual patient-level adverse event reports and SF-36 data, respectively, from the randomized, multicenter ProDisc-C total disc replacement investigational device exemption (IDE) study and post-approval study. Statistical distributions for unit costs were derived from a commercial claims database and applied using Monte Carlo simulation. Patient-level costs and effects were modeled via multivariate probabilistic analysis. Confidence intervals for 7-year costs, effects, and net monetary benefit (NMB) were obtained using the nonparametric percentile method from results of 10,000 bootstrap simulations. The robustness of results was assessed through scenario analysis and within a parametric regression model controlling for baseline variables. RESULTS Seven-year follow-up data were available for more than 70% of the 209 randomized patients. In the base-case analysis, CTDR resulted in mean per-patient cost savings of $12,789 (95% CI $5362-$20,856) and per-patient QALY gains of 0.16 (95% CI -0.073 to 0.39) compared with ACDF over 7 years. CTDR was more effective and less costly in 90.8% of probabilistic simulations. CTDR was cost-effective in 99.8% of sensitivity analysis simulations and generated a mean incremental NMB of $20,679 (95% CI $6053-$35,377) per patient at a willingness-to-pay threshold of $50,000/QALY. CONCLUSIONS Based on this modeling evaluation, CTDR was found to be more effective and less costly over a 7-year time horizon for patients with single-level symptomatic degenerative disc disease. These results are robust across a range of scenarios and perspectives and are intended to support value-based decision making.

Habitual physical activity in children and adolescents during school and free days.

PURPOSE: The purpose of this study was to analyze habitual physical activity (HPA) of boys and girls from primary school to high school. METHODS: One hundred eighty-two schoolchildren and teenagers (6-20 yr) were studied at primary school (PS, N= 64), junior high school (JHS, N= 67), and senior high school (SHS, N= 51). HR was continuously monitored during the whole week to assess HPA during school days and free days. Total physical activity (TPA), low physical activity (LPA), moderate physical activity (MPA), and vigorous physical activity (VPA) were evaluated from the time spent each day above 50%HR reserve (HRR), below 50%HRR, between 50% and 70%HRR, and above 70%HRR, respectively. RESULTS: During school days, TPA decreased by 69% in male subjects (P< 0.05) and by 36% in female subjects (N= 0.058) from PS to SHS. In contrast, TPA did not vary significantly during free days (male subjects, PS: 62 +/- 37 min x d, SHS: 63 +/- 67 min x d; female subjects, PS: 75 +/- 59 min x d, SHS: 62 +/- 44 min x d ). Gender differences were only observed during school days at PS for TPA (male subjects: 121 +/- 37 min x d vs female subjects: 92 +/- 44 min x d, P< 0.05) and VPA (male subjects: 38 +/- 21 min x d vs female subjects: 18 +/- 12 min x d, P< 0.05). Male and female subjects were more inactive during free days than during school days at PS (P< 0.05). No effect of the type of day and gender was observed for all indices of HPA at high schools. CONCLUSIONS: Our results highlight the importance of taking into account the type of day (school day vs free day) in the analysis of children and adolescents' HPA.

Drafting during swimming improves efficiency during subsequent cycling.

PURPOSE: The aim of the present study was to investigate the effects of drafting (i.e., swimming directly behind a competitor) while swimming with a wet suit on physiological parameters and cadence during subsequent cycling. METHODS: Eight well-trained male triathletes underwent two submaximal sessions conducted in a counterbalanced order. One of these sessions (SAC) consisted of a 750-m swim, performed at competition pace, followed by a 15-min ride on a bicycle ergometer at 75% of maximal aerobic power and at a freely chosen cadence. During the other session (SDC) the subjects swam 750 m in a drafting position at the same pace as during SAC and then performed the 15-min cycling test at the same intensity as during SAC. RESULTS: The main result indicated that cycling efficiency was significantly improved when the cycling session was preceded by a swimming bout performed in drafting position compared with an isolated swimming bout (+4.8%, P < 0.05). CONCLUSION: These results could be partly explained by the lower relative intensity observed during swimming in the SDC trial when compared with the SAC trial. This study suggests the relative importance of swimming condition and highlights the advantage of drafting during the swimming portion of a sprint triathlon.