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To compare perioperative outcomes and complications between GreenLight and transurethral resection of the prostate (TURP) for benign prostatic hyperplasia. A systematic review and random effects meta-analysis of randomized trials comparing GreenLight with TURP was completed. Primary outcomes included periprocedural milestones, 12 predefined complications, Clavien-Dindo class III-V complications, reoperations (all-cause), and a composite of reoperations and readmissions. Metaregression assessed the relationship between patient- and study-level factors with periprocedural outcomes and reoperation rates. The review included 13 randomized trials with 1757 patients (839 GreenLight; 918 TURP). Procedure time was 10 minutes (95% CI: 5 to 15; P <.001) longer with GreenLight, while catheterization time (mean difference = −1.3 days; 95% CI: −1.7 to −0.9; P <.001) and hospital stay (mean difference = −2.1 days; 95% CI: −2.5 to −1.7; P <.001) were shorter. Bleeding-related complications, including clot retention (risk ratio [RR] = 0.12; 95% CI: 0.05 to 0.32; P <.001) and transfusion (RR = 0.26; 95% CI: 0.12 to 0.58; P =.001), as well as sexual dysfunction (RR = 0.66; 95% CI: 0.45 to 0.98; P =.04), were less frequent with GreenLight. All other complications occurred at similar frequencies between groups. The risks of reoperation (RR: 1.17; 95% CI: 0.82 to 1.66; P =.38) and reoperation or readmission (RR: 1.05; 95% CI: 0.76 to 1.44; P =.79) did not differ. GreenLight achieved shorter catheterization times and hospital stays with lower rates of sexual dysfunction and bleeding-related complications compared to TURP. [ABSTRACT FROM AUTHOR]

To determine the safety and effectiveness of water vapor thermal therapy (Rezum) in men with large prostate volumes of at least 80 cm3. We performed systematic searches for studies of Rezum therapy in men with prostate volume of at least 80 cm3. Meta-analysis outcomes included the International Prostate Symptom Score (IPSS), IPSS Quality of Life (IPSS-QOL), Qmax, postvoid residual, International Index of Erectile Function-Erectile Function (IIEF-EF), and serious (Clavien-Dindo grade III-V) complications, surgical retreatments. Outcomes were analyzed using a random effects meta-analysis model. The review included 15 studies (11 retrospective) of 471 men with prostate volume at least 80 cm3 treated with Rezum therapy and followed for a median of 6 months (range: 3-17 months). Rezum therapy resulted in statistically significant improvements in IPSS (mean change: − 11.0; 95% CI: − 12.2, − 9.7; P <.001), IPSS-QOL (mean change: − 2.9; 95% CI: − 3.5, − 2.4; P <.001), Qmax (mean change: 6.5 mL/s; 95% CI: 4.8, 8.2 mL/s; P <.001), and postvoid residual (mean change: − 101 mL; 95% CI: − 145, − 57; P <.001). No change in IIEF-EF was observed (mean change: 0.3; 95% CI: − 1.1, 1.6; P =.71). Serious complications occurred in <0.1% (95% CI: 0.0%, 0.4%) and surgical retreatment in 1.2% (95% CI: 0.0%, 3.5%) of patients. Rezum therapy provides a statistically significant and clinically important short-term improvement in lower urinary tract symptoms with low complication rates in men with prostate volume of at least 80 cm3. Long-term outcomes with Rezum therapy in large prostates remain unclear. [ABSTRACT FROM AUTHOR]

The purpose of this study was to determine long-term survival of inflatable penile prosthesis (PP) and identify potential factors that may influence device survival. We performed a systematic review of Medline, Embase, and the Cochrane Central Register of Controlled Trials for studies of men treated with inflatable PP with at least 5 years of device survival data. We performed a random effects meta-analysis to estimate device survival at 1, 3, 5, 10, 15, and 20 years of follow-up. The robustness of the meta-analysis results was evaluated in a 1-study removed sensitivity analysis and sources of heterogeneity among studies were investigated with subgroup analysis. In 12 studies (20,161 patients; median age 57 years), PP device survival was 93.3% at 1 year, 91.0% at 3 years, 87.2% at 5 years, 76.8% at 10 years, 63.7% at 15 years, and 52.9% at 20 years. The results of the meta-analysis were not significantly influenced by single study effects in a 1-study removed sensitivity analysis. In a subgroup analysis, 5-year device survival rates were 90.6% vs 82.1% (P = .01) comparing newer vs older studies; no other patient or study design characteristic was statistically associated with device survival rates. In conclusion, the median device survival time of an inflatable PP is approximately 20 years. The factors responsible for improved device survival in newer studies remain unclear and warrant further study. [ABSTRACT FROM AUTHOR]

Introduction: Urosepsis is a serious potential complication of ureteroscopic procedures for stone disease, yet the risk factors for this complication are not well characterized. The purpose of this systematic review with meta-analysis was to identify potential risk factors for urosepsis after ureteroscopy (URS) for stone disease. Materials and Methods: We performed systematic searches of Medline, Embase, and the Cochrane Central Register of Controlled Trials for studies reporting at least one prospectively defined risk factor for urosepsis after URS. Studies that only reported rates of isolated fever, urinary tract infection (UTI), or pooled infectious complications were excluded. The risk factors evaluated in this review were age, sex, body mass index, diabetes mellitus, ischemic heart disease, recent UTI, pyuria, hydronephrosis, stone history, stone size, preoperative stent placement, preoperative positive urine culture, and procedure time. A random effects meta-analysis model with inverse variance weighting was used where the statistic of interest was the odds ratio for dichotomous variables and the mean difference for continuous outcomes. Results: In 13 studies (5 prospective) with 5597 patients, the pooled incidence of postoperative urosepsis was 5.0% (95% confidence interval: 2.4–8.2). Six risk factors were statistically associated with increased postoperative urosepsis risk—preoperative stent placement (odds ratio = 3.94, p < 0.001, 6 studies), positive preoperative urine culture (odds ratio = 3.56, p < 0.001, 6 studies), ischemic heart disease (odds ratio = 2.49, p = 0.002, 2 studies), older age (mean difference = 2.7 years, p = 0.002, 6 studies), longer procedure time (mean difference = 9 minutes, p = 0.02, 1 study), and diabetes mellitus (odds ratio = 2.04, p = 0.04, 6 studies). Conclusions: Current evidence suggests that among patients undergoing URS for treatment of stone disease, the risk of postoperative urosepsis was 5.0%. Older age, diabetes mellitus, ischemic heart disease, preoperative stent placement, a positive urine culture, and longer procedure time were associated with increased postoperative urosepsis risk. These results will assist urologists with preoperative risk stratification before ureteroscopic procedures. [ABSTRACT FROM AUTHOR]

The objective of this review was to compare the efficacy and safety of conservative surgery with or without adjunctive presacral neurectomy (PN) for chronic endometriosis-related pelvic pain. In a systematic review with meta-analysis, randomized or nonrandomized controlled studies of conservative endometriosis surgery with or without adjunctive PN were included. Main outcomes were treatment failure (the proportion of women in which surgery failed to adequately resolve midline pain) and the frequency of operative and postoperative complications. A total of 7 studies with 8 group comparisons (3 randomized) representing 503 women (250 PN; 253 Control) were included. Over 34 months median follow-up, crude rates of treatment failure were 15.0% with PN and 40.9% with Controls (risk ratio = 0.43, 95% CI = 0.30 to 0.60, p < 0.001). The risk of postoperative constipation was higher with PN vs. Controls (12.5% vs. 0%, p = 0.024). No treatment group differences were observed for the risk of operative complications (0.6% vs. 0%, p = 0.498), reoperation (4.1% vs. 3.0%, p = 0.758) or urinary incontinence (5.0% vs. 0%, p = 0.195). Overall, in well-selected patients, conservative surgery with adjunctive PN may provide greater relief from midline pain and a similarly low rate of operative complications relative to conservative surgery alone but may increase the risk of constipation postoperatively. However, results were derived from mainly older and lower quality studies. Since then, surgical techniques to treat endometriosis have been improved and the effect of PN observed in prior studies should be confirmed in future studies in women in whom radical excision of deep infiltrating lesions is obtained. [ABSTRACT FROM AUTHOR]

Purpose: To determine the safety and effectiveness of limited lumbar discectomy with additional implantation of an annular closure device (ACD) among patients at high risk of herniation recurrence treated in routine clinical practice.Methods: This was a prospective, single-center study of lumbar discectomy for sciatica caused by intervertebral disc herniation with adjunctive ACD implantation to reduce herniation recurrence risk among high-risk patients with large annular defects. Patients returned for follow-up visits at 6 weeks, 12 weeks, 26 weeks, 1 year, and 2 years. Main outcomes included reoperation, herniation recurrence, back pain severity, leg pain severity, and Oswestry Disability Index (ODI). The minimum important difference was defined as ≥ 20 mm decrease relative to baseline for leg pain severity, ≥ 20 mm decrease for back pain severity, and ≥ 15-point decrease for ODI.Results: Among 75 high-risk patients (mean age 45 years, 59% female), the cumulative event incidence through 2 years was 4.0% for reoperation and 1.4% for herniation recurrence. Mean leg pain severity decreased from 73 to 6 (p < 0.001), back pain severity decreased from 51 to 13 (p < 0.001), and ODI decreased from 49 to 7 (p < 0.001). The percentage of patients achieving the minimum important difference was 91% for leg pain, 65% for back pain, and 94% for ODI.Conclusion: In patients at high risk of herniation recurrence following limited lumbar discectomy in routine clinical practice, additional implantation of an ACD was safe and reherniation recurrence rates were low at 2-year follow-up, which is favorably compared to reported rates in high-risk patients. [ABSTRACT FROM AUTHOR]

Objective: To examine the results of an anular closure device for prevention of lumbar disc reherniation in daily routine practice. Methods: Fifty patients with large anular defects were treated with limited discectomy and a bone‐anchored anular closure device. The device physically occludes the defect in the anulus fibrosus and is intended for prevention of lumbar disc reherniation. Pain scores on a visual analogue scale, back function on the Oswestry Disability Index, and neurological status were noted. Symptomatic reherniation and reoperation rates were assessed at each follow‐up. Surgical findings and complications, device‐related and/or procedure‐related, were recorded. Follow‐up was 6, 12, 26, and 52 weeks. Results: Mean anular defect height/width was 4.6 mm/10.1 mm. The overall symptomatic reherniation and reoperation rate was 2%. During the 1‐year follow‐up period, mean back pain decreased from 43 to 8 (P < 0.001), leg pain decreased from 71 to 4 (P < 0.001), and the Oswestry Disability Index decreased from 46 to 5 (P < 0.001). Among 15 patients with preoperative neurological deficits, improvements in neurological function were noted in 14 (93%). There were no serious device‐related complications. Conclusions: The presented study shows promising early results in using the anular closure device. The procedure is safe with significantly fewer reherniations than for patients with large anular defects without anular closure. Further studies with longer follow‐up periods are warranted to prove these findings for long‐term outcomes. [ABSTRACT FROM AUTHOR]

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: The health benefits of regular aerobic exercise are well established, although there is limited high-quality evidence regarding its impact on erectile function. Aim: To determine the effect of aerobic exercise on erectile function in men and to identify factors that may influence this effect. Methods: This systematic review and meta-analysis included randomized controlled trials that evaluated the effects of aerobic exercise on erectile function via the Erectile Function domain of the International Index of Erectile Function (IIEF-EF). The mean difference in IIEF-EF scores between the aerobic exercise and nonexercising control groups was estimated by a random-effects meta-analysis. Meta-regression was used to evaluate the association of moderator variables on meta-analysis results. Outcomes: The IIEF-EF score is reported on a 6-30 scale, with higher values indicating better erectile function. Results: Among 11 randomized controlled trials included in the analysis, aerobic exercise resulted in statistically significant improvements in IIEF-EF scores as compared with controls, with a mean difference of 2.8 points (95% CI, 1.7-3.9; P < .001) and moderate heterogeneity among studies (I2 = 53%). The effect of aerobic exercise on erectile function was greater in men with lower baseline IIEF-EF scores, with improvements of 2.3, 3.3, and 4.9 points for mild, moderate, and severe erectile dysfunction, respectively (P = .02). The meta-analysis results were not influenced by publication bias or individual study effects. Clinical Implications: Health care providers should consider recommending regular aerobic exercise as a low-risk nonpharmacologic therapy for men experiencing erectile difficulties. Strengths and Limitations: The primary strength of this review was the generation of level 1 evidence on a topic of general interest regarding sexual health in men. However, the included studies evaluated diverse groups, which may complicate data interpretation for specific segments of the population. Conclusion: Regular aerobic exercise can improve the erectile function of men, particularly those with lower baseline IIEF-EF scores. [ABSTRACT FROM AUTHOR]

Intra-articular injection of hyaluronic acid (HA) is a controversial treatment for knee osteoarthritis (OA). While clinical efficacy of HA relative to saline injections has been demonstrated in many studies, these results are of limited value in real-world clinical practice since saline injection is not a knee OA treatment. Instead, rigorous postmarket comparative studies of HA versus approved knee OA treatments are encouraged. The conduct of such studies is particularly important given the paucity and heterogeneous nature of current evidence regarding nonsurgical knee OA treatment. Key Points: • Societal guidelines recommend nonsteroidal anti-inflammatory drugs and corticosteroid injections, but not hyaluronic acid injections, for knee osteoarthritis (OA) despite inconsistent supportive data. • This article encourages rigorous comparative post-approval studies to clarify the role of nonsurgical treatments used in clinical practice for knee OA. [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]

Study Design: Systematic review and meta-analysis of comparative studies.Objective: To characterize the association of annular defect width after lumbar discectomy with the risk of symptom recurrence and reoperation.Summary Of Background Data: Large annular defect width after lumbar discectomy has been reported to increase risk of symptom recurrence. However, this association has not been evaluated in a systematic manner.Methods: A systematic literature search of MEDLINE and EMBASE was performed to identify comparative studies of large versus small annular defects following lumbar discectomy that reported symptom recurrence or reoperation rates. Main outcomes were reported with pooled odds ratios (OR) and 95% confidence intervals (CIs). Sensitivity analyses were performed to assess the robustness of the meta-analysis findings.Results: After screening 696 records, we included data from 7 comparative studies involving 1653 lumbar discectomy patients, of whom 499 (30%) had large annular defects and 1154 (70%) had small annular defects. Methodological quality of studies was good overall. The median follow-up period was 2.9 years. The risk of symptom recurrence (OR = 2.5, 95% CI = 1.3-4.5, P = 0.004) and reoperation (OR = 2.3, 95% CI = 1.5-3.7, P < 0.001) was higher in patients with large versus small annular defects. Publication bias was not evident. The associations between annular defect width and risk of symptom recurrence and reoperation remained statistically significant in all sensitivity analyses.Conclusion: Annular defect width after lumbar discectomy is an under-reported modifier of patient outcome. Risk for symptom recurrence and reoperation is higher in patients with large versus small annular defects following lumbar discectomy.Level Of Evidence: 2. [ABSTRACT FROM AUTHOR]

Background Probiotics are commonly recommended for the alleviation of constipation symptoms. The aim of this research was to determine the effects of probiotic-containing products on stool frequency and intestinal transit time (ITT) in constipated adults and to determine the factors that influence the efficacy of these products. Methods We conducted a systematic review of randomized controlled trials that measured weekly stool frequency or ITT in constipated adults receiving probiotic-containing supplements. A random effects meta-analysis was performed; stool frequency was summarized by the mean difference statistic and ITT was summarized by the standardized mean difference (SMD) statistic. Meta-regression and diagnostic model performance testing were used to identify publication bias and sources of heterogeneity. Results A total of 21 studies (23 comparisons) comprising 2656 subjects were included. All studies utilized probiotics containing Lactobacillus or Bifidobacterium species. Probiotic-containing products resulted in a mean increase in weekly stool frequency of 0.83 (95% confidence interval [CI] 0.53-1.14, P<0.001). There was high heterogeneity among the studies (I2=85%, P<0.001) and evidence of significant publication bias (Egger's P-value <0.01). After adjustment for publication bias, the mean difference in weekly stool frequency was reduced from 0.83 to 0.30. The effects on stool frequency were greater in studies where functional constipation was diagnosed using Rome III (P<0.01), or Rome II or III criteria (P<0.05), compared to non-Rome diagnosis techniques. Probiotic-containing products were also efficacious in reducing ITT (SMD=0.65, 95%CI 0.33-0.97, P<0.001). There was high heterogeneity among studies (I²=66%, P<0.01), but no evidence of publication bias (Egger's P-value=0.52). A larger total sample size was associated with greater efficacy as regards ITT (P=0.03). The probiotic species, the number of probiotic strains and the daily probiotic dosage had no influence on the outcomes. Conclusion Supplementation with products containing Lactobacillus or Bifidobacterium species increases stool frequency and reduces ITT in constipated adults. However, since significant heterogeneity in outcomes was detected among the studies analyzed, the results should be interpreted with caution. [ABSTRACT FROM AUTHOR]

When designing clinical trials focused on functional constipation therapies, understanding the normative values of populations selected using the Rome III criteria is important for estimating baseline symptom severity, and for power analysis and sample size calculations. The objective of this review was to determine normative ranges for stool frequency and form in adults with functional constipation (Rome III criteria). Eligible studies reported stool frequency or form; random effects meta-analysis was performed with subgroup analyses to explore sources of heterogeneity. A total of 25 studies (43 groups, 2292 subjects) were included. Pooled estimates were 2.7 (95% CI 2.4-3.0) for weekly stools and 2.4 (95% CI 2.1-2.6) for stool form (Bristol scale). Heterogeneity was high for both outcomes (both I2=96%, P<0.001). Subgroup analysis revealed that weekly bowel movement frequency was higher in larger than in smaller studies (3.1 vs. 2.3, P<0.001) and in studies conducted in Europe compared with those in the Americas (3.1 vs. 2.2, P=0.02). For stool form, the use of a daily diary versus subject recall was the sole explanatory variable (2.5 vs. 2.1, P<0.05). We conclude that adults with functional constipation have significant variation in stool frequency and form, explained in part by geography and study design. [ABSTRACT FROM AUTHOR]

Long-term right ventricular (RV) function, functional capacity, exercise capacity, and quality of life following pulmonary embolism (PE), and the impact of thrombolysis, are unclear. A systematic review of studies that evaluated these outcomes with ⩾ 3-month mean follow-up after PE diagnosis was performed. For each outcome, random effects meta-analyses were performed. Twenty-six studies (3671 patients) with 18-month median follow-up were included. The pooled prevalence of RV dysfunction was 18.1%. Patients treated with thrombolysis had a lower, but not statistically significant, risk of RV dysfunction versus those treated with anticoagulation (odds ratio: 0.51, 95% CI: 0.24 to 1.13, p=0.10). Pooled prevalence of at least mild functional impairment (NYHA II–IV) was 33.2%, and at least moderate functional impairment (NYHA III–IV) was 11.3%. Patients treated with thrombolysis had a lower, but not statistically significant, risk of at least moderate functional impairment versus those treated with anticoagulation (odds ratio: 0.48, 95% CI: 0.15 to 1.49, p=0.20). Pooled 6-minute walk distance was 415 m (95% CI: 372 to 458 m), SF-36 Physical Component Score was 44.8 (95% CI: 43 to 46), and Pulmonary Embolism Quality of Life (QoL) Questionnaire total score was 9.1. Main limitations included heterogeneity among studies for many outcomes, variation in the completeness of data reported, and inclusion of data from non-randomized, non-controlled, and retrospective studies. Persistent RV dysfunction, impaired functional status, diminished exercise capacity, and reduced QoL are common in PE survivors. The effect of thrombolysis on RV function and functional status remains unclear. [ABSTRACT FROM AUTHOR]

Availability of normative patient outcome data may assist in designing experiments and estimating sample sizes. The purpose of this review was to determine normative ranges for colonic transit time (CTT), Patient Assessment of Constipation-Symptoms (PAC-SYM), and Patient Assessment of Constipation-Quality of Life (PAC-QOL) in adults diagnosed with functional constipation per Rome III guidelines. Pooled estimates were derived from random-effects meta-analysis. Meta-regression was used to explore sources of heterogeneity among studies. A total of 24 studies (3786 patients) were included in the review. In 10 studies with 1119 patients, pooled CTT was 58hours (95% confidence interval [CI]: 50-65hours). Publication bias was not evident (Egger P=.51); heterogeneity was high (I2=92%, P<.001). In metaregression, geographical location explained 57% of the between-study variance, with CTT significantly longer in studies conducted in Europe (71hours) compared with Asia (49hours) or the Americas (44hours). In 9 studies with 2061 patients, pooled PAC-SYM was 1.70 (95% CI: 1.58-1.83). Publication bias was not evident (Egger P=.44). Heterogeneity was high (I2=90%, P<.001); however, no study or patient factor influenced PAC-SYM in meta-regression. In 12 studies with 1805 patients, pooled PAC-QOL was 1.97 (95% CI: 1.70-2.24). Publication bias was not evident (Egger P=.28); heterogeneity was high (I2=98%, P<.001). In meta-regression, age explained 52% of the between-study variance, with older age associated with lower PAC-QOL scores. Overall, in adults diagnosed with functional constipation per Rome III criteria, significant heterogeneity in CTT, PAC-SYM, and PAC-QOL exists among studies. Variability among studies may be explained by geography and patient factors. [ABSTRACT FROM AUTHOR]

Pedicle screw fixation is a commonly utilized adjunct for lumbar interbody fusion, yet risks include screw malposition, pullout, loosening, neurovascular injury, and stress transfers leading to adjacent segment degeneration. This report describes the preclinical and initial clinical results of a minimally invasive, metal-free cortico-pedicular fixation device used for supplemental posterior fixation in lumbar interbody fusion. Safety of arcuate tunnel creation was evaluated in cadaveric lumbar (L1–S1) specimens. A finite element analysis study evaluated clinical stability of the device to pedicular screw-rod fixation at L4–L5. Preliminary clinical results were assessed by analysis of Manufacturer and User Facility Device Experience database complications, and 6-month outcomes in 13 patients treated with the device. Among 35 curved drill holes in 5 lumbar specimens, no breaches of the anterior cortex were identified. The mean minimum distance from the anterior surface of the hole to the spinal canal ranged from 5.1 mm at L1–L2 to 9.8 mm at L5–S1. In the finite element analysis study, the polyetheretherketone strap provided comparable clinical stability and reduced anterior stress shielding compared to the conventional screw-rod construct. The Manufacturer and User Facility Device Experience database identified 1 device fracture with no clinical sequelae among 227 procedures. Initial clinical experience showed a 53% decrease in pain severity (P = 0.009), a 50% decrease in Oswestry Disability Index (P < 0.001), and no device-related complications. Cortico-pedicular fixation is a safe and reproducible procedure that may address limitations of pedicle screw fixation. Longer term clinical data in large clinical studies are recommended to confirm these promising early results. [ABSTRACT FROM AUTHOR]

Probiotics are live micro-organisms that confer a health benefit on the host when administered in adequate dosages and have been extensively studied for treatment of gastrointestinal (GI) disorders. While a growing body of evidence from randomized controlled trials supports the use of probiotics for a variety of GI conditions, the media and internet are saturated with advertisements falsely claiming that specific probiotic strains or strain combinations can improve, or even cure, many GI complaints. These unsubstantiated claims regarding probiotic efficacy are rampant and remain largely unregulated. The probiotic industry is strongly encouraged to close the gap between marketing hype and scientific discovery. Additionally, US regulators are encouraged to improve enforcement efforts in response to misleading probiotic advertising. [ABSTRACT FROM AUTHOR]

Plantar fasciitis (PF) is a common, disabling condition affecting millions of patients each year. With early diagnosis and timely application of traditional nonsurgical treatments, symptoms generally resolve over time. However, despite adequate treatment, 20% of patients will experience persistent symptoms. In these patients, minimally invasive therapies that augment local hemodynamics to initiate a regenerative tissue-healing cascade have the greatest potential to resolve long-standing symptoms. We performed a narrative review based on a best evidence evaluation of manuscripts published in Medline-indexed journals to determine the mechanisms involved in soft tissue injury and healing. This evaluation also highlights emerging minimally invasive therapies that exploit these mechanisms in recalcitrant PF. [ABSTRACT FROM AUTHOR]

Clinical trials of therapies intended to alleviate symptoms of irritable bowel syndrome (IBS) are prevalent. However, the ideal study design remains elusive since there is no obvious pathophysiological target and no universally accepted endpoint to assess symptom improvement in IBS. The purpose of this paper is to identify and discuss the most problematic issues in the design of clinical trials intended to evaluate the effectiveness of treatments for IBS symptoms. Lack of standardized diagnostic criteria, symptom variability, heterogeneous subject characteristics, large placebo effects, lack of statistical power, inappropriate endpoint selection, and poorly selected study design are the most critical issues that may confound study outcomes in IBS clinical trials. [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]

Prediction of osteoporotic fractures is currently an imperfect science and new tools are desperately needed to identify at-risk patients at an earlier stage in the disease process. The mechanical response tissue analyser (MRTA) is a novel, non-invasive, radiation-free device that measures the bending stiffness of long bones in vivo, an indicator of a bone's ability to resist deformation under a given load and a strong predictor of long bone structural integrity and strength. Bone bending stiffness measured with the MRTA has been consistently shown to be a stronger predictor of post-mortem and ex vivo bone breaking strength compared to bone mineral measured with dual-energy X-ray absorptiometry. Bone bending stiffness measured with MRTA also decreases with advanced age and disease states and increases with chronic physical activity, independent of bone mineral changes. The MRTA measures different parameters than DXA (bone quality vs bone mineral content and density) and may be a more robust tool for identifying those at risk for fracture. Research initiatives focused on improving long-term repeatability and optimizing the signal-to-noise ratio of the measurement are currently underway to further advance the clinical usefulness of this technology. [ABSTRACT FROM AUTHOR]

Conservative management of medial compartment knee osteoarthritis (OA) is a misleading term used to describe the application of medical, orthotic, and/or rehabilitative therapies exclusive of surgical interventions. The implication of this nomenclature is that these therapies offer satisfactory symptom relief, alter disease progression, and have limited side effects. Unfortunately, conservative therapeutic options possesses few, if any, characteristics of an ideal treatment, namely one that significantly alleviates pain, improves knee function, and reduces medial compartmental loading without adverse side effects. As uncompensated mechanical loading is a primary culprit in the development and progression of knee OA, we propose that the therapeutic perspective of conservative treatment should shift from pharmacological treatments, which have no influence on joint loading, minimal potential to alter joint function, substantial associated risks, and significant financial costs, towards minimally invasive load absorbing therapeutic interventions. A safe and effective minimally invasive medical device specifically engineered for symptomatic relief of medial knee OA by limiting joint contact forces has the potential to reduce the clinical and economic knee OA burden. This review characterizes the current standard of care recommendations for conservative management of medial compartment knee OA with respect to treatment efficacy, risk profile, and economic burden. [ABSTRACT FROM AUTHOR]

Introduction. Hemifacial spasm (HFS) is caused by vascular compression of the VII cranial nerve at its root exit zone from the brainstem. Microvascular decompression (MVD) is the only treatment option that offers the prospect of a definitive cure for HFS. We conducted the first systematic review on the safety and effectiveness of MVD for the treatment of HFS. Methods. English-language studies on MVD for HFS published from 2000 to present were retrieved and summarized. The primary outcomes of interest were treatment success, recurrence rate and adverse events including mortality, stroke, cerebrospinal fluid leak, facial palsy (permanent and transient) and hearing deficit (permanent and transient). Results. Twenty-two papers representing 5685 patients treated with MVD for HFS were included in this review. Complete resolution of symptoms following MVD was reported in 91.1% of patients over a median 2.9-year follow-up period. HFS symptoms recurred in 2.4% of patients and 1.2% underwent repeat MVD during the follow-up period. Transient complications included facial palsy (9.5%), hearing deficit (3.2%) and cerebrospinal fluid leak (1.4%). Permanent complications included hearing deficit (2.3%), facial palsy (0.9%), stroke (< 0.1%) and death (< 0.1%). Conclusions. MVD successfully relieves HFS in approximately 9 of 10 patients with low rates of symptom recurrence. Complications of this surgery are uncommon and generally transient. [ABSTRACT FROM AUTHOR]

A variety of bone grafts and bone graft substitutes, each with distinctly different characteristics, is available to the orthopedic surgeon for various reconstructive procedures. However, adequate reconstruction of osseous defects remains a therapeutic challenge. Each bone graft option has a unique set of benefits and risks that must be considered in relation to the particular pathology, and to patient characteristics and comorbidities, in order to achieve the best possible outcome. The OsteoSponge® allograft consists of 100% demineralized human cancellous bone, with no additional carrier materials. The OsteoSponge is compressible, allowing precise graft placement in most osseous defects; subsequent expansion completely fills the void. The material is prepared using methods that preserve native growth factors, thereby promoting cellular ingrowth, proliferation, and ultimately osteogenesis. Preliminary evidence suggests that the OsteoSponge matrix is safe and effective when used in surgical treatment of osseous defects. This article describes the rationale for, and characteristics of, the OsteoSponge, and summarizes the results from preclinical and human studies. [ABSTRACT FROM AUTHOR]

Osteoarthritis (OA) is a leading cause of disability in middle-aged and older adults with the prevalence expected to increase by 40% by 2025. This dramatic projected increase in OA reflects, in large part, the alarming obesity epidemic. Indeed, it is now well understood that abnormal loading across the knee joint due to malalignment and/or excessive weight gain is responsible for accelerating OA progression. Consequently, there is a therapeutic need for alternative knee OA treatments that directly address joint overload to fill the gap between ineffective conservative care and invasive joint-modifying surgical procedures. We describe two cases that presented with bilateral knee OA resistant to conservative treatments, each with one knee previously and unsuccessfully treated with high tibial osteotomy to improve alignment and the contralateral knee successfully treated with a joint-preserving, load-absorbing implant (Kine Spring Knee Implant System). [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 article presents a study which examines the research results of anterior cervical discectomy and fusion (ACDF) utilizing allograft and ACDF with autograft, ACDF with cage devices, and cervical disc arthroplasty to treat cervical disc disease. The study analyzes patient outcomes such as neck and arm pain, neck disability index (NDI), and physical component summary (PCS). The study found that the four treatment groups demonstrated similar improvements for the treatment of the said disease.

Abstract: The use of blinding strengthens the credibility of randomized controlled trials (RCTs) by minimizing bias. However, there is confusion surrounding the definition of blinding as well as the terms single, double, and triple blind. It has been suggested that these terms should be discontinued due to their broad misinterpretation. We recommend that, instead of abandoning the use of these terms, explicit definitions of blinding should be adopted. We address herein the concept of blinding, propose standard definitions for the consistent use of these terms, and detail when different types of blinding should be utilized. Standardizing the definition of blinding and utilizing proper blinding methods will improve the quality and clarity of reporting in RCTs. [Copyright &y& Elsevier]

A variety of bone grafts and bone graft substitutes is available for treatment of osseous defects although adequate reconstruction of the residual void following fracture, arthroplasty, or tumor/cyst resection remains a therapeutic challenge. This narrative review evaluates the peer-reviewed literature and examines relevant outcomes in patients treated with bone grafts and bone graft substitutes for surgical management of osseous defects. Although autograft, xenograft, and ceramic bone graft substitutes are used for a variety of orthopedic applications, they have distinct limitations in clinical practice. Bone allograft material is a safe and effective adjunct to treatment of osseous defects. [ABSTRACT FROM AUTHOR]

Introduction: The purpose of this study was to describe procedural details of a minimally invasive presacral approach for revision of an L5-S1 Axial Lumbar Interbody Fusion rod.Case Presentation: A 70-year-old Caucasian man presented to our facility with marked thoracolumbar scoliosis, osteoarthritic changes characterized by high-grade osteophytes, and significant intervertebral disc collapse and calcification. Our patient required crutches during ambulation and reported intractable axial and radicular pain. Multi-level reconstruction of L1-4 was accomplished with extreme lateral interbody fusion, although focal lumbosacral symptoms persisted due to disc space collapse at L5-S1.Lumbosacral interbody distraction and stabilization was achieved four weeks later with the Axial Lumbar Interbody Fusion System (TranS1 Inc., Wilmington, NC, USA) and rod implantation via an axial presacral approach.Despite symptom resolution following this procedure, our patient suffered a fall six weeks postoperatively with direct sacral impaction resulting in symptom recurrence and loss of L5-S1 distraction. Following seven months of unsuccessful conservative care, a revision of the Axial Lumbar Interbody Fusion rod was performed that utilized the same presacral approach and used a larger diameter implant. Minimal adhesions were encountered upon presacral re-entry. A precise operative trajectory to the base of the previously implanted rod was achieved using fluoroscopic guidance. Surgical removal of the implant was successful with minimal bone resection required. A larger diameter Axial Lumbar Interbody Fusion rod was then implanted and joint distraction was re-established. The radicular symptoms resolved following revision surgery and our patient was ambulating without assistance on post-operative day one. No adverse events were reported.Conclusions: The Axial Lumbar Interbody Fusion distraction rod may be revised and replaced with a larger diameter rod using the same presacral approach. [ABSTRACT FROM AUTHOR]

Objective. This study assessed the influence of age on the predictors of bone mineral in men. Methods. Middle-age (n = 41, 54 ± 4 yrs) and older (n = 40, 69 ± 5 yrs) men underwent grip and knee extensor strength tests, total body dual-energy X-ray absorptiometry with regional analyses and a graded exercise treadmill test. Results. Bone-free lean mass (BFLM) and, to a lesser extent, fat mass (FM) were correlated with bone mineral variables in middle-age men. In older men, BFLM and, to a lesser extent, FM were related to bone mineral content (BMC) at most sites, but inconsistently to bone mineral density (BMD). Knee extensor strength related to bone mineral (BMC and BMD) at most sites in middle-age men, but none in older men. Grip strength inconsistently related to bone mineral in both groups. Aerobic capacity related to bone mineral in middle-age men, but none in older men. In multiple regression, body weight or BFLM predicted bone mineral in middle-age men (R2 = 0.33-0.68) and BMC in older men (R2 = 0.33-0.50). Predictors of BMD were inconsistent in older men. Conclusions. Relationships of body composition, muscular strength and aerobic capacity to bone mineral are stronger in middle-age versus older men. [ABSTRACT FROM AUTHOR]

Bone mineral content (BMC) and bone mineral density (BMD) are common but imperfect surrogate measures of bone strength. The mechanical response tissue analyzer is a device that measures long bone bending stiffness ( EI), which strongly predicts bone breaking strength. We hypothesized that isokinetic resistance training of the knee flexor and extensor muscles would increase tibial EI, BMC, and BMD in young women. Fifty-two women, aged 18–26 years, performed concentric (CON, n = 30) or eccentric (ECC, n = 22) isokinetic resistance training with the nondominant leg three times per week for 20 weeks. Before and after the training period, subjects were tested for CON and ECC peak torque of the knee flexor and extensor muscles with isokinetic dynamometry, tibial BMC and BMD using dual-energy X-ray absorptiometry, and tibial EI using mechanical response tissue analysis. Both training groups increased CON (15–21%) and ECC (17–31%) peak torque vs. the untrained leg. Tibial EI increased in the entire cohort (26%) and in each training group (CON 34%, ECC 16%) vs. the untrained tibia. Tibial BMC and BMD increased in the trained and untrained tibiae, with no significant differences between limbs. No differential tibial EI or bone mineral outcomes were observed between the CON and ECC training groups. In summary, CON and ECC isokinetic resistance training increased tibial EI, but not BMC or BMD, in young women. [ABSTRACT FROM AUTHOR]

Abstract: Numerous studies have investigated the effects of physical activity on bone health; however, little is known about the effects of isokinetic strength training on bone. While bone mineral density (BMD) is widely used to assess bone health and fracture risk, there are several limitations of this measure that warrant new technology development to measure bone strength. The mechanical response tissue analyzer (MRTA) assesses bone strength by measuring maximal bending stiffness (EI). We hypothesized that isokinetic strength training of the elbow flexors and extensors would increase ulnar EI, BMD, and bone mineral content (BMC) in young women. Fifty-four women trained the nondominant arm 3 times per week for 20 weeks; 32 trained concentrically (CON) and 22 trained eccentrically (ECC). Subjects were assessed for the following variables pre- and post-training: CON and ECC peak torque of the elbow flexors and extensors with isokinetic dynamometry, ulnar mineral content and density using dual-energy X-ray absorptiometry, and ulnar EI using MRTA. Isokinetic training increased CON (17%) and ECC (17%) peak torque, even when controlling for changes in the untrained arm. Eccentric training increased CON and ECC peak torque while CON training improved CON peak torque only. Isokinetic training increased ulnar EI 28%, which was statistically greater than the untrained arm. Ulnar EI increased 25% with CON training and 32% with ECC training. Both training modes resulted in greater EI gains compared to the untrained limb. Isokinetic training increased ulnar BMC (2.7%) and BMD (2.3%), even when controlling for untrained ulna changes. Both training modalities resulted in BMC and BMD increases; however, only CON training yielded gains when controlling for changes in the untrained limb. In conclusion, isokinetic strength training increases ulnar EI, BMC, and BMD in young women; no statistical differences were noted between CON and ECC training modes. [Copyright &y& Elsevier]

This study assessed muscular torque and rate of torque development following concentric (CON) or eccentric (ECC) isokinetic training. Thirty-eight women were randomly assigned to either CON or ECC training groups. Training consisted of knee extension and flexion of the nondominant leg three times per week for 20 weeks (SD = 1). Eccentric training increased ECC knee extension and flexion peak torque more than CON training. The ECC group improved acceleration time and time to peak torque with ECC movements versus the CON group. Slow-velocity ECC isokinetic training yielded greater ECC and similar CON torque development gains versus CON training over the course of 20 weeks in young women. [ABSTRACT FROM AUTHOR]

Study objectives: To examine the effects of 6 weeks of exercise training above or below the lactate threshold (LT) on the slow component (SC) of pulmonary oxygen consumption (VO[sub 2]). Design: Randomized controlled trial. Setting: University human performance laboratory. Participants: Apparently healthy, untrained men (n = 18). Interventions: Subjects were randomized to one of three groups: high-intensity exercise training (HI) [above the LT], moderate-intensity exercise training (MOD) [below the LT], or no exercise training (CON). Exercise groups performed cycle ergometry 4 d/wk for 6 weeks. Total work throughout training was constant between groups. Measurements and results. Maximal cycle ergometry was performed at baseline and after training to assess power output at the LT (WLT), VO[sub 2] at the LT (VO[sub 2]LT), and peak VO[sub 2] (VO[sub 2]PK). High-intensity, constant-load cycling was performed at baseline and weeks 1, 2, 4, and 6 to assess SC adaptations. WLT, VO[sub 2]LT, and VO[sub 2]PK increased after 6 weeks in both exercise groups compared to the CON group (p < 0.05), although there were no differences between the training groups. SC of VO[sub 2] decreased 44% in the HI group following 1 week of exercise training vs MOD (20%, p < 0.05) and CON (12%, p < 0.01) groups. The SC attenuation was more prominent at all time points in the HI group compared to the MOD group. Total SC attenuation over the 6-week training period did not differ between the HI (71%) and MOD (57%) groups. Conclusions: Training at HI or MOD produced similar improvements in the LT, VO[sub 2], and power output at peak exertion when total work output was held constant. Attenuation of the SC with training above and below the LT were similar, although above-LT training promoted faster SC adaptations. [ABSTRACT FROM AUTHOR]

Early knee osteoarthritis poses a therapeutic dilemma to the musculoskeletal clinician. Despite the recent interest in arthroscopic and injectable regenerative therapies intended to repair or restore a focal target such as cartilage, meniscus, or subchondral bone, none have been shown to slow disease progression. A likely cause of these disappointing treatment outcomes is the failure to address chronic and excessive loading of the knee joint. A growing body of evidence suggests that first-line therapies for early knee osteoarthritis should emphasize unloading the knee joint since any potential therapeutic benefit of regenerative therapies will likely be attenuated by excessive mechanical demand at the knee joint. Minimally invasive medical devices such as patient-specific interpositional implants and extracapsular joint unloading implants are currently in development to address this clinical need. [ABSTRACT FROM AUTHOR]

Aortic stenosis (AS) is the most common valvular heart disorder in older adults. Patients with severe AS are generally treated nonsurgically if asymptomatic and referred to aortic valve replacement when symptoms develop. However, patients with severe asymptomatic AS with left ventricular dysfunction may benefit from early aortic valve replacement. Although operative mortality in patients with severe AS and left ventricular dysfunction is greater than in patients with preserved left ventricular function, the overall mortality risk is substantially lower than that of watchful waiting. Operative risk in patients with severe AS and left ventricular dysfunction is often overestimated and, consequently, most are not referred to surgery despite clinical data in support of early aortic valve replacement. Asymptomatic patients with echocardiographic confirmation of severe AS and left ventricular dysfunction should be referred for aortic valve replacement. [ABSTRACT FROM AUTHOR]

This study investigated bone mineral and body composition changes after coronary artery bypass grafting (CABG) in men. Twenty-six men 50 to 79 years of age underwent CABG for multivessel coronary disease. Dual-energy x-ray absorptiometry was performed before surgery and 3 months and 1 year after treatment to assess bone mineral content (BMC), bone mineral density (BMD), and body composition. Through 3 months after treatment, BMD decreased at the total body, arms, and pelvis. BMC of the arm decreased and losses at the total body and legs approached significance. Fat-free mass decreased in the arms and total body but not in the legs. Neither total body nor regional fat mass changed. At the 1-year follow-up visit, 15 of the initial 26 subjects returned for dual-energy x-ray absorptiometry. Compared with before treatment, BMD decreased at the total body and legs, whereas losses at the arms approached significance. Arm BMC decreased over the 1-year post-treatment period. No changes were observed in body composition. In conclusion, CABG and the ensuing convalescence period results in considerable arm bone mineral losses through 1 year after treatment. [Copyright &y& Elsevier]

We compared the safety and effectiveness of minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) to open TLIF (O-TLIF) for lumbar degenerative disease. We systematically searched Medline, Embase, and the Cochrane Central Register of Controlled Trials for randomized trials of MI-TLIF versus O-TLIF. The perioperative outcomes included the procedure time, fluoroscopy time, blood loss, complications, and hospital stay. The midterm outcomes included pseudarthrosis, the Oswestry Disability Index, and pain severity—all reported at 1-year minimum follow-up. A total of 7 randomized trials including 496 patients (246 MI-TLIF; 250 O-TLIF) were included in our review. No statistically significant group differences in procedure time (mean difference [MD], −4 minutes; P = 0.70) were found. However, the fluoroscopy time was significantly longer with MI-TLIF (MD, 48 seconds; P < 0.001). MI-TLIF resulted in less perioperative blood loss (MD, −200 mL; P < 0.001) and shorter hospitalization (MD, −2.2 days; P < 0.001) compared with O-TLIF. The risk of perioperative complications was comparable between the 2 groups (risk ratio, 1.03; P = 0.94). No group differences were found in the incidence of pseudarthrosis at the 1-year minimum follow-up (risk ratio, 0.84; P = 0.67). Pain severity at midterm follow-up was comparable between the 2 groups (MD, −1; P = 0.59), and the ODI was slightly lower in the MI-TLIF group (MD, −3; P = 0.01). Relative to O-TLIF, MI-TLIF was associated with less blood loss, a shorter hospital stay, and slightly less disability, at the expense of longer fluoroscopy times. [ABSTRACT FROM AUTHOR]

The author discusses a meta-analysis that examined randomized controlled trials comparing minimally-invasive versus open approaches to transforaminal lumbar interbody fusion (TLIF). Topics include samples of text that identifies each as a non-randomized study, errors made by the authors in the classification of the included studies, and the association between minimally-invasive TLIF and a shorter hospital stay relative to open TLIF.

Purpose: To characterize patient outcomes following visually directed high-intensity focused ultrasound (HIFU) for focal treatment of localized prostate cancer. Methods: We performed a systematic review of cancer-control outcomes and complication rates among men with localized prostate cancer treated with visually directed focal HIFU. Study outcomes were calculated using a random-effects meta-analysis model. Results: A total of 8 observational studies with 1,819 patients (median age 67 years; prostate-specific antigen 7.1 mg/ml; prostate volume 36 ml) followed over a median of 24 months were included. The mean prostate-specific antigen nadir following visually directed focal HIFU was 2.2 ng/ml (95% CI 0.9–3.5 ng/ml), achieved after a median of 6 months post-treatment. A clinically significant positive biopsy was identified in 19.8% (95% CI 12.4–28.3%) of cases. Salvage treatment rates were 16.2% (95% CI 9.7–23.8%) for focal- or whole-gland treatment, and 8.6% (95% CI 6.1–11.5%) for whole-gland treatment. Complication rates were 16.7% (95% CI 9.9–24.6%) for de novo erectile dysfunction, 6.2% (95% CI 0.0–19.0%) for urinary retention, 3.0% (95% CI 2.1–3.9%) for urinary tract infection, 1.9% (95% CI 0.1–5.3%) for urinary incontinence, and 0.1% (95% CI 0.0–1.4%) for bowel injury. Conclusion: Limited evidence from eight observational studies demonstrated that visually directed HIFU for focal treatment of localized prostate cancer was associated with a relatively low risk of complications and acceptable cancer control over medium-term follow-up. Comparative, long-term safety and effectiveness results with visually directed focal HIFU are lacking. [ABSTRACT FROM AUTHOR]

Background: Pedicle screw loosening and breakage are common causes of revision surgery after lumbar fusion. Thus, there remains a continued need for supplemental fixation options that offer immediate stability without the associated failure modes. This finite element analysis compared the biomechanical properties of a novel cortico-pedicular posterior fixation (CPPF) device with those of a conventional pedicle screw system (PSS). Methods: The CPPF device is a polyetheretherketone strap providing circumferential cortical fixation for lumbar fusion procedures via an arcuate tunnel. Using a validated finite element model, we compared the stability and load transfer characteristics of CPPF to intact conditions under a 415 N follower load and PSS conditions under a 222 N preload. Depending on the instrumented levels, two different interbody devices were used: a lateral lumbar interbody device at L4–5 or an anterior lumbar interbody device at L5-S1. Primary outcomes included range of motion of the functional spinal units and anterior load transfer, defined as the total load through the disk and interbody device after functional motion and follower load application. Results: Across all combinations of interbody devices and lumbar levels evaluated, CPPF consistently demonstrated significant reductions in flexion (ranging from 90 to 98%), extension (ranging from 88 to 94%), lateral bending (ranging from 75 to 80%), and torsion (ranging from 77 to 86%) compared to the intact spine. Stability provided by the CPPF device was comparable to PSS in all simulations (range of motion within 0.5 degrees for flexion–extension, 0.6 degrees for lateral bending, and 0.5 degrees for torsion). The total anterior load transfer was higher with CPPF versus PSS, with differences across all tested conditions ranging from 128 to 258 N during flexion, 89–323 N during extension, 135–377 N during lateral bending, 95–258 N during torsion, and 82–250 N during standing. Conclusion: Under the modeled conditions, cortico-pedicular fixation for supplementing anterior or lateral interbody devices between L4 and S1 resulted in comparable stability based on range of motion measures and less anterior column stress shielding based on total anterior load transfer measures compared to PSS. Clinical studies are needed to confirm these finite element analysis findings. [ABSTRACT FROM AUTHOR]

Background: Radiofrequency ablation (RFA) has emerged as a safe and effective treatment option for women with symptomatic uterine fibroids and can be delivered by laparoscopic, transvaginal, or transcervical approaches. The evidence regarding typical patient outcomes with RFA has not previously been examined in a comprehensive fashion. Materials and Methods: We performed a systematic review of prospective studies for treatment of uterine fibroids with RFA. Main outcomes were procedure time, patient recovery metrics, change in fibroid volume, symptom severity score (SSS), health-related quality of life (HRQL), and reinterventions. Data were analyzed with random effects meta-analysis and metaregression. Results: We identified 32 articles of 1283 unique patients (median age: 42 years) treated with laparoscopic RFA (19 articles), transvaginal RFA (8 articles), or transcervical fibroid ablation (5 articles). Mean procedure time was 49 minutes, time to discharge was 8.2 hours, time to normal activities was 5.2 days, and time to return to work was 5.1 days. At 12 months follow-up, fibroid volume decreased by 66%, HRQL increased by 39 points, and SSS decreased by 42 points (all P < .001 versus baseline). The annual cumulative rate of reinterventions due to fibroid-related symptoms was 4.2%, 8.2%, and 11.5% through 3 years. Conclusions: RFA of uterine fibroids significantly reduces fibroid volume, provides significant durable improvements in fibroid-related quality of life, and is associated with favorable reintervention rates. [ABSTRACT FROM AUTHOR]

Background: Awareness of treatment group assignment in a clinical trial may influence patient behavior and bias outcome reporting. The objective of this study was to compare 2-year clinical outcomes in blinded vs unblinded patients who were treated with lumbar discectomy and a bone-anchored annular closure device (ACD) for prevention of lumbar disc reherniation. Methods: This was a secondary analysis of a randomized trial comparing lumbar discectomy with (n=272) vs without (n=278) implantation of a bone-anchored ACD. Among patients who received ACD implantation, 35 (13%) were blinded and 237 (87%) were unblinded to treatment allocation. In patients treated with ACD, propensity score-matching (1:1) was performed to account for imbalances in patient characteristics between blinded and unblinded groups. Key clinical outcomes were back pain severity (0–100 scale), leg pain severity (0–100 scale), Oswestry Disability Index (ODI, 0–100 scale), symptomatic reherniation, reoperation at the treated lumbar level, and device- or procedure-related serious adverse events (AEs). Outcomes were reported through 2 years of follow-up, which coincided with the time at which blinded patients were unblinded. Results: There were no statistically significant differences in 2-year outcomes between propensity score-matched blinded (n=35) and unblinded (n=35) patients treated with the ACD. In blinded vs unblinded ACD patients compared to baseline, back pain severity decreased by 40 vs 37 points (P=0.61), leg pain severity decreased by 75 points in each group (P>0.99), and ODI decreased by 47 vs 43 points (P=0.19). The risks of symptomatic reherniation (5.7% vs 9.1%; P=0.59), reoperation (8.6% vs 12.2%, P=0.62), and device- or procedure-related serious AEs (5.7% vs 8.9%, P=0.63) were comparably low in blinded and unblinded patients. Conclusion: In patients treated with lumbar discectomy and a bone-anchored ACD, there were no clinically important or statistically significant differences in back pain, leg pain, ODI, symptomatic reherniation, reoperation, or serious AEs over 2 years of follow-up when comparing patients who were blinded vs unblinded to their treatment assignment. The main limitations of this study were the post hoc nature of the analysis and the potential for bias due to surgeon awareness of treatment assignment. [ABSTRACT FROM AUTHOR]

To determine whether presence of a bone-anchored annular closure device (ACD) impacts reoperation strategies and subsequent outcomes. Patients with large annular defects after single-level limited lumbar discectomy were randomly allocated to receive an ACD or discectomy alone (controls) and were followed for at least 3 years. Among 550 patients, reoperation risk was lower with ACD (11.0% vs. 19.3%). The types of reoperations and operative time were similar in each group, and the ACD did not interfere with surgical planning or operative technique. Fusion success was 87% with ACD versus 85% for controls. Perioperative complications occurred in 22% and 19% of reoperations, respectively. Leg pain and back function were improved with ACD versus controls after fusion procedures, and no group differences were observed after non-fusion reoperations. In patients undergoing post-discectomy reoperation, patients with an ACD were treated with similar operative techniques, were not exposed to additional surgical risks, and reported comparable clinical outcomes versus those without an ACD. [ABSTRACT FROM AUTHOR]