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Abstract Immune function declines with advancing age. Probiotic supplementation has been proposed to slow or reverse these age-related changes. The primary objective of this study was to evaluate the effect of probiotic supplementation on cellular innate immune activity in healthy elderly subjects. We hypothesized that probiotic supplementation would enhance immune function. We performed a systematic review and meta-analysis of controlled trials that reported polymorphonuclear cell phagocytic capacity or natural killer (NK) cell tumoricidal activity following short-term probiotic supplementation in the elderly. Effect size was reported as the standardized mean difference (SMD) between probiotic and control groups, where values of 0.2, 0.5, 0.8, and 1.0 corresponded to small, medium, large, and very large effect sizes, respectively. A total of 17 prospective controlled studies (18 comparisons) of 733 subjects were included. Probiotic supplementation duration ranged from 3 to 12 weeks. Probiotic supplementation increased polymorphonuclear phagocytic capacity (SMD = 1.37, 95% confidence interval: 0.86-1.88, P <.001) and NK cell tumoricidal activity (SMD = 0.55, 95% confidence interval: 0.37-0.73, P <.001) relative to controls. In a subgroup analysis of NK cell activity, heterogeneity among studies was not explained by variability in study design or probiotic characteristics. Main limitations of this research were short-term supplementation durations and unclear clinical benefit of the immune changes. In conclusion, short-term probiotic supplementation enhances cellular immune function in healthy elderly adults. [ABSTRACT FROM AUTHOR]

Background and purpose — Systematic comparisons of anterior approach (A) versus posterior approach (P) in primary total hip arthroplasty (THA) have largely focused on perioperative outcomes. In this systematic review with meta-analysis, we compared complication risk of A versus P in studies of primary THA with at least 1-year mean follow-up. Patients and methods — We performed a systematic review of prospective and retrospective studies with at least 1-year mean follow-up that reported complications of A and P primary THA. Complications included infection, dislocation, reoperation, thromboembolic event, heterotopic ossification, wound complication, fracture, and nerve injury. Random effects meta-analysis was used for all outcomes. Complication risk was reported as rate ratio (RR) to account for differential follow-up durations; values >1 indicated higher complication risk with A and values <1 indicated lower risk with A. Results — 19 studies were included; 15 single-center comparative studies with 6,620 patients (2,278 A; 4,342 P) and 4 multicenter registries with 157,687 patients (18,735 A; 138,952 P). Median follow-up was 16 (12-64) months) with A and 18 (12-110) months with P. Anterior approach was associated with lower rate of infection (RR =0.55, p = 0.002), dislocation (RR =0.65, p = 0.03), and reoperation (RR =0.84, p < 0.001). No statistically significant differences were observed in rate of thromboembolic event (RR =0.59, p = 0.5), heterotopic ossification (RR =0.63, p = 0.1), wound complication (RR =0.93, p = 0.8), or fracture (RR =1.0, p = 0.9). There was a higher rate of patient-reported nerve injury with A (RR =2.3, p = 0.01). Interpretation — Comparing A with P in primary THA, A was associated with lower risk of reoperation, dislocation, and infection, but higher risk of patient-reported nerve injury. [ABSTRACT FROM AUTHOR]

Objective: Iron deficiency is the most common nutrient deficiency in the world. While deficiency can often be resolved through dietary supplementation with iron, adverse events are common and frequently preclude compliance. The objective of this study was to determine whether a food-derived dietary supplement containing a low dose of iron and nutrients that increase iron absorption could resolve iron deficiency with fewer adverse events than reported at higher doses.Methods: A pilot clinical trial (NCT02683369) was conducted among premenopausal women with nonanemic iron deficiency that was verified by blood screening. Participants consumed a dietary supplement (Blood Builder®/Iron Response®) once daily for 8 weeks containing 26 mg of iron, vitamin C, folate, and other food-derived nutrients. Primary outcomes were markers of iron status (serum ferritin, hemoglobin, soluble transferrin receptor, total body iron stores) and secondary outcomes were self-reported fatigue and energy. All outcomes were assessed at baseline and 8 weeks. Adverse events were monitored with questionnaires, daily diaries, and contact with a physician. Dependent samples t test and Wilcoxon signed-rank test were used to analyze outcomes.Results: Twenty-three participants enrolled in the study. Iron deficiency was resolved in the sample (mean serum ferritin: baseline = 13.9 μg/L, 8 weeks = 21.1 μg/L, p < 0.001). All other markers of iron status, fatigue, and energy also improved during the study (p < 0.04). No adverse events were reported.Conclusions: While larger and controlled studies are needed to confirm these findings, a food-derived dietary supplement with a low dose of iron and absorption-enhancing nutrients resolved iron deficiency and improved all other markers of iron status without any adverse events. [ABSTRACT FROM AUTHOR]

The increasing adoption of minimally invasive techniques for spine surgery in recent years has led to significant advancements in instrumentation for lumbar interbody fusion. Percutaneous pedicle screw fixation is now a mature technology, but the role of expandable cages is still evolving. The capability to deliver a multiexpandable interbody cage with a large footprint through a narrow surgical cannula represents a significant advancement in spinal surgery technology. The purpose of this report is to describe a multiexpandable lumbar interbody fusion cage, including implant characteristics, intended use, surgical technique, preclinical testing, and early clinical experience. Results to date suggest that the multiexpandable cage allows a less invasive approach to posterior/transforaminal lumbar interbody fusion surgery by minimizing iatrogenic risks associated with static or vertically expanding interbody prostheses while providing immediate vertebral height restoration, restoration of anatomic alignment, and excellent early-term clinical results. [ABSTRACT FROM AUTHOR]

Chronic sacroiliac (SI) joint-related low back pain (LBP) is a common, yet under-diagnosed and undertreated condition due to difficulties in accurate diagnosis and highly variable treatment practices. In patients with debilitating SI-related LBP for at least 6 months duration who have failed conservative management, arthrodesis is a viable option. The SImmetry® SI Joint Fusion System is a novel therapy for SI joint fusion, not just fixation, which utilizes a minimally invasive surgical approach, instrumented fixation for immediate stability, and joint preparation with bone grafting for a secure construct in the long term. The purpose of this report is to describe the minimally invasive SI Joint Fusion System, including patient selection criteria, implant characteristics, surgical technique, postoperative recovery, and biomechanical testing results. Advantages and limitations of this system will be discussed. [ABSTRACT FROM AUTHOR]

Purpose: To report outcomes from a 5-year real-world clinical experience with a multimodal treatment program in patients with symptomatic knee osteoarthritis (OA). Methods: Patients with symptomatic, radiographically conirmed knee OA resistant to traditional conservative treatments underwent a supervised 8-week multimodal treatment program consisting of low-impact aerobic exercise, muscle lexibility exercises, joint mobilization, physical therapy modalities, muscle strengthening and functional training, patient education, and a series of 3 or 5 weekly hyaluronic acid injections. Patients were evaluated at admission, 4 weeks, and 8 weeks. Patient-reported outcomes included knee pain severity using an 11-point (0-10) numerical scale and the Western Ontario and McMaster Universities Osteoarthritis Index. Results: A total of 3,569 patients completed an 8-week treatment course between January 2008 and April 2013 at 66 dedicated treatment centers in the United States. Knee pain severity assessed on a numeric scale decreased 59% on average, from 5.4±2.9 to 2.2±2.2 (P<0.001). Western Ontario and McMaster Universities Osteoarthritis Index subscores decreased by 44% to 51% (all P?0.001) during the 8-week program. The percentage of patients achieving the threshold for Western Ontario and McMaster Universities Osteoarthritis Index minimally perceptible clinical improvement was 79% for the Pain subscale, 75% for Function, and 76% for Stiffness. Favorable patient outcomes were reported in all subgroups, regardless of age, sex, body mass index, disease severity, or number of treatment cycles. Discussion: A real-world 8-week multimodal treatment program results in clinically meaningful improvements in knee OA symptoms, with excellent generalizability across a broad range of patient characteristics. [ABSTRACT FROM AUTHOR]

A prospective, randomized, controlled trial was conducted to compare clinical outcomes in patients treated with an investigational interspinous spacer (Superion) versus those treated with an FDA-approved spacer (X-STOP). One hundred sixty-six patients with moderate lumbar spinal stenosis (LSS) unresponsive to conservative care were treated randomly with the Superion (n = 80) or X-STOP (n = 86) interspinous spacer. Study subjects were followed through 6 months posttreatment. Zurich Claudication Questionnaire (ZCQ) symptom severity scores improved 30% with Superion and 25% with X-STOP (both P < 0.001). Similar changes were noted in ZCQ physical function with improvements of 32% with Superion and 27% with X-STOP (both P < 0.001). Mean ZCQ patient satisfaction score ranged from 1.7 to 2.0 in both groups at all follow-up visits. The proportion of subjects that achieved at least two of three ZCQ clinical success criteria at 6 months was 75% with Superion and 67% with X-STOP. Axial pain decreased from 55 ± 27mm at pretreatment to 22 ± 26mm at 6 months in the Superion group (P < 0.001) and from 54 ± 29mm to 32 ± 31mm with X-STOP (P < 0.001). Extremity pain decreased from 61 ± 26mm at pretreatment to 18 ± 27mm at 6 months in the Superion group (P < 0.001) and from 64 ± 26mm to 22 ± 30mm with X-STOP (P < 0.001). Back function improved from 38 ± 13% to 21 ± 19% with Superion (P < 0.001) and from 40 ± 13% to 25 ± 16% with X-STOP (P < 0.001). Preliminary results suggest that the Superion interspinous spacer and the X-STOP each effectively alleviate pain and improve back function in patients with moderate LSS who are unresponsive to conservative care. [ABSTRACT FROM AUTHOR]

The purpose of this study was to (1) evaluate joint pain and function in knee osteoarthritis (OA) patients treated with a joint-sparing, extracapsular implant and (2) identify patient characteristics that influenced clinical outcomes. This study included 99 patients with symptomatic medial knee OA refractory to conservative care who were treated with the KineSpring Knee Implant System and followed for a mean of 17 months (range, 1.5 to 48 months). All devices were successfully implanted and activated with no intra­operative complications. Statistically significant mean improvements of 56%, 50%, and 38% were observed for Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain, Function, and Stiffness scales, respectively (all P < 0.001). Regardless of gender, age group, body mass index classification, or disease severity, all WOMAC domain scores significantly improved during the postoperative follow-up period. WOMAC clinical success rates were 77.8% for Pain, 77.8% for Function, and 68.7% for Stiffness. Neither gender, age group, body mass index classification, nor disease severity predicted clinical success in any WOMAC domain. In conclusion, the KineSpring System yields clinically meaningful improvements in joint pain and function in patients with medial knee OA. Additionally, unlike joint-altering procedures such as knee arthroplasty or high tibial osteotomy, patient characteristics had little association with postoperative clinical outcomes. [ABSTRACT FROM AUTHOR]

Study Design: A prospective, multicenter, randomized, controlled, investigational device exemption (IDE) noninferiority trial.Objective: The aim of this study was to evaluate the comparative safety and effectiveness of lumbar total disc replacement (TDR) in the treatment of patients with symptomatic degenerative disc disease (DDD) who are unresponsive to nonsurgical therapy.Summary Of Background Data: Lumbar TDR has been used to alleviate discogenic pain and dysfunction while preserving segmental range of motion and restoring stability. There is a paucity of data available regarding the comparative performance of lumbar TDR.Methods: Patients presenting with symptomatic single-level lumbar DDD who failed at least 6 months of nonsurgical management were randomly allocated (2:1) to treatment with an investigational TDR device (activL, n = 218) or FDA-approved control TDR devices (ProDisc-L or Charité, n = 106). The hypothesis of this study was that a composite effectiveness outcome at 2 years in patients treated with activL would be noninferior (15% delta) to that in controls.Results: The primary composite endpoint of this study was met, which demonstrated that the activL TDR was noninferior to control TDR (P < 0.001). A protocol-defined analysis of the primary composite endpoint also confirmed that activL was superior to controls (P = 0.02). Radiographic success was higher with activL versus controls (59% vs. 43%; P < 0.01). Mean back pain severity improved by 74% with activL and 68% with controls. Oswestry Disability Index scores decreased by 67% and 61% with activL and controls, respectively. Patient satisfaction with treatment was over 90% in both groups at 2 years. Return to work was approximately 1 month shorter (P = 0.08) with activL versus controls. The rate of device-related serious adverse events was lower in patients treated with activL versus controls (12% vs. 19%; P = 0.13). Surgical reintervention rates at the index level were comparable (activL 2.3%, control 1.9%).Conclusion: The single-level activL TDR is safe and effective for the treatment of symptomatic lumbar DDD through 2 years.Level Of Evidence: 2. [ABSTRACT FROM AUTHOR]