Search

Lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) are highly prevalent in older men. The long-term clinical utility of lifestyle modification and oral medications for LUTS is limited. There is a great clinical need for safe, effective, and durable BPH therapies for men who unsuccessfully attempt conservative measures. Enthusiasm for transurethral resection of the prostate has declined due to surgical risk, high rates of postoperative sexual dysfunction, and the perceived invasive nature therein. Consequently, interest has grown in developing minimally invasive surgical treatments (MISTs) that are efficacious but with a more favorable risk profile in order to better align with patient preferences. This review evaluates currently available MISTs for BPH. Further, we critically examine a "Leave Nothing Behind" philosophy in MIST for BPH since implantation of permanent metallic devices may be associated with increased long-term failure rates. [ABSTRACT FROM AUTHOR]

Background: Since the first occurrence of coronavirus disease 2019 (Covid-19), a number of online tools have become available to assist with tracking Covid-19 prevalence. Yet we are unaware of resources that provide country-specific Covid-19 incidence data. Methods: We undertook a descriptive analysis of the global impact of Covid-19 using data reported on March 17, 2020. The prevalence of Covid-19 cases, fatalities attributed to Covid-19, and the case fatality rate for each of the 238 countries were accessed from the World Health Organization global Covid-19 tracking site, and we additionally calculated Covid-19 incidence based on country-specific population data. We determined the country-specific point prevalence and incidence of Covid-19 and associated deaths while using geocoded data to display their spatial distribution with geographic heat maps. Results: The analysis included 193,197 Covid-19 cases and 7859 associated deaths. The point prevalence was highest in China (80,881), Italy (31,506), Iran (16,169), and Spain (11,312); no other country reported more than 10,000 cases. The incidence (per million population) was highest in San Marino (3389) followed by Iceland (645) and Italy (521); no other country had an incidence above 400 per million population. Conclusion: Countries with a high Covid-19 prevalence may not have a high incidence, and vice versa. Public health agencies that provide real-time infection tracking tools should report country-specific Covid-19 incidence metrics, in addition to prevalence data. [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]

Lumbar discectomy procedure in patients with largedefects in the annulusfibrosus lowers the Intent-to-treat population consisted of 272 patients with attempted ACD implant and 278 patients assigned to Control. Figure 8 Percentage of patients achieving the minimal clinically important difference in patient-reported outcomes over 4 years of follow-up. Annular closure device, annulus fibrosus, disc herniation, lumbar discectomy, randomized controlled trial, reoperation, sciatica. [Extracted from the article]

Background: Perioperative health care utilization and costs in patients undergoing elective fast-track vs standard endovascular aneurysm repair (EVAR) remain unclear.Methods: The fast-track EVAR group included patients treated with a 14 Fr stent graft, bilateral percutaneous access, no general anesthesia or intensive care monitoring, and next-day hospital discharge. The standard EVAR group was identified from Medicare administrative claims using a matching algorithm to adjust for imbalances in patient characteristics. Hospital outcomes included operating room time, intensive care monitoring, hospital stay, secondary interventions, and major adverse events (MAEs). Perioperative outcomes occurring from hospital discharge to 30 days postdischarge included MAE, secondary interventions, and unrelated readmissions.Results: Among 1000 matched patients (250 fast-track; 750 standard), hospital outcomes favored the fast-track EVAR group, including shorter operating room time (2.30 vs 2.83 hrs, P<0.001), shorter hospital stay (1.16 vs 1.69 d, P<0.001), less need for intensive care monitoring (4.4% vs 48.0%, P<0.001), and lower secondary intervention rate (0% vs 2.4%, P=0.01). Postdischarge outcomes also favored fast-track EVAR with a lower rate of MAE (0% vs 7.2%, P<0.001) and all-cause readmission (1.6% vs 6.8%, P=0.001). The total cost to the health care system during the perioperative period was $26,730 with fast-track EVAR vs $30,730 with standard EVAR. Total perioperative health care costs were $4000 (95% CI: $3130-$4830) lower with fast-track EVAR vs standard EVAR, with $2980 in savings to hospitals and $1030 savings to health care payers.Conclusion: A fast-track EVAR protocol using a 14 Fr stent graft resulted in shorter procedure time, lower intensive care utilization, faster discharge, lower incidence of MAE, lower readmission rates, and lower perioperative costs compared to standard EVAR. [ABSTRACT FROM AUTHOR]

Background: Lumbar discectomy is a common surgical procedure in middle-aged adults. However, outcomes of lumbar discectomy among older adults are unclear. Methods: Lumbar discectomy patients with an annular defect ≥6 mm width were randomized to receive additional implantation with a bone-anchored annular closure device (ACD, n=272) or no additional implantation (controls, n=278). Over 3 years follow-up, main outcomes were symptomatic reherniation, reoperation, and the percentage of patients who achieved the minimum clinically important difference (MCID) without a reoperation for leg pain, Oswestry Disability Index (ODI), SF-36 Physical Component Summary (PCS) score, and SF-36 Mental Component Summary (MCS) score. Results were compared between older (≥60 years) and younger (<60 years) patients. We additionally analyzed data from two postmarket ACD registries to determine consistency of outcomes between the randomized trial and postmarket, real-world results. Results: Among all patients, older patients suffered from crippling or bed-bound preoperative disability more frequently than younger patients (57.9% vs 39.1%, p=0.03). Among controls, female sex, higher preoperative ODI, and current smoking status, but not age, were associated with greater risk of reherniation and reoperation. Compared to controls, the ACD group had lower risk of symptomatic reherniation (HR=0.45, p<0.001) and reoperation (HR=0.54, p=0.008), with risk reductions comparable in older vs younger patients. The percentage of patients achieving the MCID without a reoperation was higher in the ACD group for leg pain (81% vs 72%, p=0.04), ODI (82% vs 73%, p=0.03), PCS (85% vs 75%, p=0.01), and MCS (59% vs 46%, p=0.007), and this benefit was comparable in older versus younger patients. Comparable benefits in older patients were observed in the postmarket ACD registries. Conclusion: Outcomes with lumbar discectomy and additional bone-anchored ACD are superior to lumbar discectomy alone. Older patients derived similar benefits with additional bone-anchored ACD implantation as younger patients. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this study was to determine whether in-hospital outcomes are different with anterior approach (AA) or posterior approach (PA) in primary total hip arthroplasty (THA). Methods: We performed a systematic review with random-effects meta-analysis of randomized controlled trials (RCTs) comparing AA with PA in primary THA. Hospital outcomes were reported as odds ratio (OR), weight mean difference, or standardized mean difference (SMD). Results: A total of seven RCTs with 609 patients were included. Outcomes favoring AA included 1.4 cm shorter incision (p=0.045), 0.5 days shorter hospital stay (p=0.01), 0.5 points less pain on a 0–10 scale (p=0.007), and less opioid use (SMD=-0.39 corresponding to 12 fewer morphine equivalents per day, p=0.01). The procedure time was 16 minutes longer with AA vs. PA (p=0.002). There were no statistical differences between AA and PA in operative blood loss (mean difference =19 mL, p=0.71), transfusions (9.7% vs. 16.2%, OR=0.45, p=0.39), or complications (5.5% vs. 4.1%, OR=1.42, p=0.62). Conclusion: While the AA to primary THA may take longer time compared with the PA, the incision is shorter, and patients report slightly less pain, require less opioid medication, and leave the hospital earlier. The clinical relevance of these differences during longer-term follow-up is uncertain. The choice of surgical approach in primary THA should also consider factors such as experience of the surgeon and preferences of the surgeon and patient. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this study was to evaluate perioperative complications of lumbar discectomy with or without bone-anchored annular closure device (ACD) implant in patients at high risk of recurrent disc herniation. Methods: This was a post hoc analysis of a randomized controlled trial that compared outcomes of lumbar discectomy with or without additional placement of an ACD. Patients presented with imaging evidence of lumbar disc herniation and radicular pain that was unresponsive to conservative care. Randomization occurred intraoperatively following discectomy completion and confirmation of annular defect width ≥6 mm. Main outcomes included serious adverse events (SAEs) from any cause, device- or procedure-related SAEs, and reoperations at the index level. The perioperative period included all outcomes occurring between the day of surgery and 90 days following hospital discharge. Results: Analyses were performed on a modified intention-to-treat population consisting of 272 patients treated with ACD and 278 patients treated with lumbar discectomy only (controls). Mean patient age was 44 years, 59% were men, and mean body mass index was 26 kg/m2. Baseline patient characteristics and operative outcomes were comparable between groups. The risks of all-cause SAE (9.7% vs 16.3%, p=0.056), device- or procedure-related SAE (4.5% vs 10.2%, p=0.02), and index-level reoperation (1.9% vs 5.4%, p=0.03) were lower with ACD vs controls. In multivariable logistic regression, control group assignment and female gender were independently associated with higher risk of device- or procedure-related SAE and index-level reoperation, respectively. Conclusion: In patients undergoing lumbar discectomy to treat symptomatic intervertebral disc herniation, adjunctive placement of an ACD reduces the risk for perioperative complications occurring through 90 days following hospital discharge. [ABSTRACT FROM AUTHOR]

Background: Given the poor long-term effectiveness of focused nonsurgical knee osteoarthritis (OA) treatments, alternative therapies are needed for patients who have unsuccessfully exhausted nonsurgical options. Methods: A telephone interview was conducted in patients who participated in a single 8-week multimodal knee OA treatment program (mean follow-up: 3.7 years, range: 2.7-4.9 years). The program consisted of five intra-articular knee injections of sodium hyaluronate (Hyalgan®), with each injection given 1 week apart, structured physical therapy, knee bracing, and patient education. Clinical outcomes included knee pain severity, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscores, current medication use, and history of total knee arthroplasty. Base-case, subgroup, and sensitivity analyses were conducted to determine the incremental cost-effectiveness ratio (ICER) of the treatment program with comparisons made to historical literature controls undergoing usual care. Results: A total of 218 patients (54%) provided long-term follow-up data. Knee pain severity decreased 60% and WOMAC subscores decreased 33%-42% compared to baseline (all p<0.001). Total knee arthroplasty was performed in 22.8% (81/356) of knees during followup. The treatment program was highly cost-effective compared to usual care with a base-case ICER of $6,000 per quality-adjusted life year (QALY). Results of subgroup analyses, one-way deterministic sensitivity analyses, and second-order probabilistic sensitivity analyses resulted in ICERs ranging from $3,996 to $10,493 per QALY. The percentage of simulations with an ICER below willingness-to-pay limits was 97.2%, 98.9%, and 99.4% for the $50,000, $100,000, and $150,000 per QALY thresholds, respectively. Conclusion: Participation in a single 8-week knee OA treatment program, which included one cycle of five intra-articular knee injections of sodium hyaluronate given at weekly intervals, is highly cost-effective and provides clinically meaningful reductions in patient symptoms that are maintained over 3.7 years mean follow-up. [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]

Although the concept of equivalence for drugs (generics) and biologics (biosimilars) has been readily adopted, the concept of equivalence or indistinguishable characteristics for class III medical devices has yet to be specifically addressed regarding a defined regulatory approval process in the US. In September 2015, GenVisc 850® (sodium hyaluronate), a hyaluronic acid approved for the treatment of knee osteoarthritis, was approved by the US Food and Drug Administration (FDA) based upon indistinguishable characteristics in comparison to an approved branded hyaluronic acid (Supartz®/Supartz FX?). The purpose of this paper is to review the methodology and report the main outcomes used to demonstrate clinical comparability of GenVisc 850 with Supartz/Supartz FX. The FDA approval was collectively attained using prospectively defined methods for preclinical, physical, and chemical testing, as well as noninferiority in clinical performance comparisons. Evidence from five randomized controlled studies of Supartz/Supartz FX vs saline control injections (used for Supartz approval), two randomized controlled trials of GenVisc 850 vs saline control injections, and one randomized controlled study of GenVisc 850 vs Supartz/Supartz FX provided evidence of safety for GenVisc 850. Efficacy was further assessed based on assessment of the same Supartz studies and three prospectively identified GenVisc 850 studies. A Bayesian network meta-analysis was used to demonstrate that the clinical efficacy of GenVisc 850 was noninferior to Supartz/Supartz FX and superior to saline control. Overall, safety of GenVisc 850 was similar to that of Supartz/ Supartz FX and saline control injections, while efficacy of GenVisc 850 was noninferior to that of Supartz/Supartz FX and superior to saline control injections. [ABSTRACT FROM AUTHOR]

Degeneration of the lumbar intervertebral discs is a leading cause of chronic low back pain in adults. Treatment options for patients with chronic lumbar discogenic pain unresponsive to conservative management include total disc replacement (TDR) or lumbar fusion. Until recently, only two lumbar TDRs had been approved by the US Food and Drug Administration - the Charité Artificial Disc in 2004 and the ProDisc-L Total Disc Replacement in 2006. In June 2015, a next-generation lumbar TDR received Food and Drug Administration approval - the activL® Artificial Disc (Aesculap Implant Systems). Compared to previous-generation lumbar TDRs, the activL® Artificial Disc incorporates specific design enhancements that result in a more precise anatomical match and allow a range of motion that better mimics the healthy spine. The results of mechanical and clinical studies demonstrate that the activL® Artificial Disc results in improved mechanical and clinical outcomes versus earlier-generation artificial discs and compares favorably to lumbar fusion. The purpose of this report is to describe the activL® Artificial Disc including implant characteristics, intended use, surgical technique, postoperative care, mechanical testing, and clinical experience to date. [ABSTRACT FROM AUTHOR]

Background: Powered exoskeletons are designed to safely facilitate ambulation in patients with spinal cord injury (SCI). We conducted the first meta-analysis of the available published research on the clinical effectiveness and safety of powered exoskeletons in SCI patients. Methods: MEDLINE and EMBASE databases were searched for studies of powered exoskeleton-assisted walking in patients with SCI. Main outcomes were analyzed using fixed and random effects meta-analysis models. Results: A total of 14 studies (eight ReWalk™, three Ekso™, two Indego®, and one unspecified exoskeleton) representing 111 patients were included in the analysis. Training programs were typically conducted three times per week, 60-120 minutes per session, for 1-24 weeks. Ten studies utilized flat indoor surfaces for training and four studies incorporated complex training, including walking outdoors, navigating obstacles, climbing and descending stairs, and performing activities of daily living. Following the exoskeleton training program, 76% of patients were able to ambulate with no physical assistance. The weighted mean distance for the 6-minute walk test was 98 m. The physiologic demand of powered exoskeleton-assisted walking was 3.3 metabolic equivalents and rating of perceived exertion was 10 on the Borg 6-20 scale, comparable to self-reported exertion of an able-bodied person walking at 3 miles per hour. Improvements in spasticity and bowel movement regularity were reported in 38% and 61% of patients, respectively. No serious adverse events occurred. The incidence of fall at any time during training was 4.4%, all occurring while tethered using a first-generation exoskeleton and none resulting in injury. The incidence of bone fracture during training was 3.4%. These risks have since been mitigated with newer generation exoskeletons and refinements to patient eligibility criteria. Conclusion: Powered exoskeletons allow patients with SCI to safely ambulate in real-world settings at a physical activity intensity conducive to prolonged use and known to yield health benefits. [ABSTRACT FROM AUTHOR]

Background: Intra-articular injection of hyaluronic acid is a common, yet controversial, therapeutic option for patients with knee osteoarthritis (OA). The purpose of this research was to determine the safety and efficacy of US-approved viscosupplements for symptomatic knee OA. Methods: We searched MedLine and EMBase for randomized, sham-controlled trials evaluating safety and/or clinical efficacy of US-approved viscosupplements in patients with symptomatic knee OA. Knee pain severity and knee joint function were assessed at 4 to 13 weeks and 14 to 26 weeks. Safety outcomes included serious adverse events, treatment-related serious adverse events, patient withdrawal, and adverse event-related patient withdrawal occurring at any time during follow-up. Results: A total of 29 studies representing 4,866 unique patients (active: 2,673, control: 2,193) were included. All sham-controlled trials used saline injections as a control. Viscosupplementation resulted in very large treatment effects between 4 and 26 weeks for knee pain and function compared to preinjection values, with standardized mean difference values ranging from 1.07 to 1.37 (all P,0.001). Compared to controls, standardized mean difference with viscosupplementation ranged from 0.38 to 0.43 for knee pain and 0.32 to 0.34 for knee function (all P,0.001). There were no statistically significant differences between viscosupplementation and controls for any safety outcome, with absolute risk differences of 0.7% (95% confidence interval [CI]: -0.2 to 1.5%) for serious adverse events, 0% (95% CI: -0.4 to 0.4%) for treatment-related serious adverse events, 0% (95% CI: -1.6 to 1.6%) for patient withdrawal, and 0.2% (95% CI: -0.4 to 0.8%) for adverse event-related patient withdrawal. Conclusion: Intra-articular injection of US-approved viscosupplements is safe and efficacious through 26 weeks in patients with symptomatic knee OA. [ABSTRACT FROM AUTHOR]

Background: Knee osteoarthritis (OA) is largely attributable to chronic excessive and aberrant joint loading. The purpose of this pilot study was to quantify radiographic changes in subchondral bone after treatment with a minimally invasive joint unloading implant (KineSpring® Knee Implant System). Methods: Nine patients with unilateral medial knee OA resistant to nonsurgical therapy were treated with the KineSpring System and followed for 2 years. Main outcomes included Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, function, and stiffness subscores and independent core laboratory determinations of joint space width and fractal signature of the tibial cortex. Results: WOMAC scores, on average, improved by 92% for pain, 91% for function, and 79% for stiffness over the 2-year follow-up period. Joint space width in the medial compartment of the treated knee significantly increased from 0.9 mm at baseline to 3.1 mm at 2 years; joint space width in the medial compartment of the untreated knee was unchanged. Fractal signatures of the vertically oriented trabeculae in the medial compartment decreased by 2.8% in the treated knee and increased by 2.1% in the untreated knee over 2 years. No statistically significant fractal signature changes were observed in the horizontally oriented trabeculae in the medial compartment or in the horizontal or vertical trabeculae of the lateral compartment in the treated knee. Conclusion: Preliminary evidence suggests that the KineSpring System may modify knee OA disease progression by increasing joint space width and improving subchondral bone trabecular integrity, thereby reducing pain and improving joint function. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented in response to article "Clinical effectiveness and safety of powered exoskeleton-assisted walking in patients with spinal cord injury: systematic review with meta-analysis" by L. E. Miller in the March 2016 issue, along with authors response on the same.

Background: Constipation is a common complaint in adults. Lactitol is an osmotic disaccharide laxative that increases fecal volume and stimulates peristalsis. In this paper, we present the first meta-analysis on the efficacy and tolerance of lactitol for adult constipation. Methods: We searched MEDLINE® and Embase, with no date or language restrictions, for studies of lactitol supplementation on adult constipation. A random-effects meta-analysis was performed on pre- to posttreatment changes in stool frequency and consistency with lactitol among all studies, as well as a comparison of efficacy and tolerance outcomes in randomized controlled trials (RCTs) of lactitol versus lactulose. Results: A total of eleven studies representing 663 distinct patients were included in the final analysis, including five single-arm studies, four RCTs comparing lactitol with lactulose, one RCT comparing lactitol with placebo, and one nonrandomized controlled trial comparing lactitol with stimulant laxatives. Weekly stool frequency was significantly increased with lactitol compared with baseline (standardized mean difference [SMD]: 1.56, P<0.001). Stool consistency also improved over the supplementation period with lactitol (SMD: 1.04, P<0.001). Approximately one-third of patients experienced an adverse event; however, symptoms were generally mild and rarely (5%) resulted in study withdrawal. In RCTs of lactitol versus lactulose, lactitol was slightly more effective than lactulose in increasing weekly stool frequency (SMD: 0.19, P=0.06). No statistically significant differences between lactitol and lactulose were identified in any other efficacy or tolerance outcome. Lactitol demonstrated favorable efficacy and tolerance in individual studies when compared to stimulant laxatives and placebo. Conclusion: Lactitol supplementation is well tolerated and improves symptoms of adult constipation. The efficacy and tolerance of lactitol and lactulose are similar, with a trend for more frequent stools with lactitol. Limited evidence suggests lactitol is superior to stimulant laxatives and placebo for relieving constipation symptoms. [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]

Traumatic knee injury is common in young adults and strongly contributes to premature development of knee osteoarthritis (OA). Post-traumatic knee OA poses a therapeutic dilemma to the physician, since no known therapy has an acceptable safety profile, effectively relieves joint pain, and enjoys reasonable patient acceptance. Consequently, these young patients will ultimately be faced with the decision to either undergo surgical intervention, despite prosthesis durability concerns, or to continue with ineffective nonsurgical treatment. Emerging therapies, such as biologics, disease-modifying drugs, partial joint resurfacings, and minimally invasive joint-unloading implants are currently being studied to fill this therapeutic void in the young patient with post-traumatic knee OA. [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]

Background: The purpose of this paper was to assess the feasibility of Micro-Mobile Compression® (MMC) on lactate clearance following exhaustive exercise and on subsequent exercise performance. Methods: Elite male cyclists were randomized to MMC (n = 8) or passive recovery (control, n = 8). MMC is incorporated into a sandal that intermittently compresses the venous plexus during non-weight bearing to augment venous return. On day 1, subjects performed a graded exercise test on a cycle ergometer followed by 60 minutes of seated recovery, with or without MMC. Blood lactate concentration ([La-]) was measured during exercise and recovery. Subjects returned home for 3 more hours of seated recovery, with or without MMC. On days 2 and 3, subjects exercised to exhaustion in a fixed-load cycle ergometer test at 85% peak power and then repeated the day 1 post-exercise recovery procedures. Lactate clearance data after the time to exhaustion tests on days 2 and 3 were averaged to adjust for interday variation. Results: On the day after MMC or control recovery, mean time to exhaustion was 15% longer (mean difference, 2.1 minutes) in the MMC group (P = 0.30). The standardized mean difference of MMC for time to exhaustion was 0.55, defined as a moderate treatment effect. Following the graded exercise test, area under the 60-minute lactate curve was nonsignificantly lower with MMC (3.2 ± 0.4 millimolar [mM]) versus control (3.5 ± 0.4 mM, P = 0.10) and times from end of exercise to 4mM and 2mM were 2.1 minutes (P = 0.58) and 7.2 minutes (P = 0.12) shorter, although neither achieved statistical significance. Following time to exhaustion testing, the area under the 60-minute lactate curve was lower with MMC (3.2 ± 0.2 mM) versus control (3.5 ± 0.2 mM, P = 0.02) and times from end of exercise to 4mM and 2mM were 4.4 minutes (P = 0.02) and 7.6 minutes (P < 0.01) faster. The standardized mean difference of MMC on most lactate clearance parameters was >0.8, defined as a large treatment effect. Conclusion: MMC yields large treatment effects on lactate clearance following high-intensity exercise and moderate treatment effects on subsequent exercise performance in elite male cyclists. [ABSTRACT FROM AUTHOR]

Introduction: Previous studies have confirmed the benefits and limitations of the presacral retroperitoneal approach for L5-S1 interbody fusion. The purpose of this study was to determine the safety and effectiveness of the minimally invasive axial lumbar interbody approach (AxiaLIF) for L4-S1 fusion. Methods: In this retrospective series, 52 patients from four clinical sites underwent L4-S1 interbody fusion with the AxiaLIF two-level system with minimum 2-year clinical and radiographic follow-up (range: 24-51 months). Outcomes included back pain severity (on a 10-point scale), the Oswestry Disability Index (ODI), and Odom's criteria. Flexion and extension radiographs, as well as computed tomography scans, were evaluated to determine fusion status. Longitudinal outcomes were assessed with repeated measures analysis of variance. Results: Mean subject age was 52 ± 11 years and the male:female ratio was 1:1. Patients sustained no intraoperative bowel or vascular injury, deep infection, or neurologic complication. Median procedural blood loss was 220 cc and median length of hospital stay was 3 days. At 2-year follow-up, mean back pain had improved 56%, from 7.7 ± 1.6 at baseline to 3.4 ± 2.7 (P , 0.001). Back pain clinical success (ie, $30% improvement from baseline) was achieved in 39 (75%) patients at 2 years. Mean ODI scores improved 42%, from 60% ± 16% at baseline to 35% ± 27% at 2 years (P , 0.001). ODI clinical success (ie, $30% improvement from baseline) was achieved in 26 (50%) patients. At final follow-up, 45 (87%) patients were rated as good or excellent, five as fair, and two as poor by Odom's criteria. Interbody fusion observed on imaging was achieved in 97 (93%) of 104 treated interspaces. During follow-up, five patients underwent reoperation on the lumbar spine, including facet screw removal (two), laminectomy (two), and transforaminal lumbar interbody fusion (one). Conclusion: The AxiaLIF two-level device is a safe, effective treatment adjunct for patients with L4-S1 disc pathology resistant to conservative treatments. [ABSTRACT FROM AUTHOR]

Almost 4 million Americans are within the knee osteoarthritis (OA) treatment gap, the period from unsuccessful exhaustion of conservative treatment to major surgical intervention. New treatment alternatives for symptomatic knee OA are greatly needed. The purpose of this report was to assess outcomes of a joint-unloading implant (KineSpring® Knee Implant System) in patients with symptomatic medial knee OA. A total of 100 patients enrolled in three clinical trials were treated with the KineSpring System and followed for a minimum of 1 year. All devices were successfully implanted and activated, with no operative complications. Knee pain severity improved 60% (P, 0.001) at 1 year, with 76% of patients reporting a minimum 30% improvement in pain severity. All Western Ontario and McMaster Universities Arthritis Index (WOMAC) subscores significantly improved at 1 year, with a 56% improvement in pain, 57% improvement in function, and a 39% improvement in stiffness (all P < 0.001). The percentage of patients experiencing a minimum 20% improvement in WOMAC subscores was 74% for pain, 83% for function, and 67% for stiffness. During follow-up, six (6%) patients required additional surgery, including four total knee arthroplasties and two high tibial osteotomies. The KineSpring System effectively bridges the treatment gap between failed conservative care and surgical joint-modifying procedures. [ABSTRACT FROM AUTHOR]

Introduction: The aim of this study is to report our 6-year single-center experience with L5-S1 axial lumbar interbody fusion (AxiaLIF). Methods: A total of 131 patients with symptomatic degenerative disc disease refractory to nonsurgical treatment were treated with AxiaLIF at L5-S1, and were followed for a minimum of 1 year (mean: 21 months). Main outcomes included back and leg pain severity, Oswestry Disability Index score, working status, analgesic medication use, patient satisfaction, and complications. Computed tomography was used to determine postoperative fusion status. Results: No intraoperative complications, including vascular, neural, urologic, or bowel injuries, were reported. Back and leg pain severity decreased by 51% and 42%, respectively, during the follow-up period (both P < 0.001). Back function scores improved 50% compared to baseline. Clinical success, defined as improvement ⩾30%, was 67% for back pain severity, 65% for leg pain severity, and 71% for back function. The employment rate increased from 47% before surgery to 64% at final follow-up (P < 0.001). Less than one in four patients regularly used analgesic medications postsurgery. Patient satisfaction with the AxiaLIF procedure was 83%. The fusion rate was 87.8% at final follow-up. During follow-up, 17 (13.0%) patients underwent 18 reoperations on the lumbar spine, including pedicle screw fixation (n = 10), total disc replacement of an uninvolved level (n = 3), facet screw fixation (n = 3), facet screw removal (n = 1), and interbody fusion at L4-L5 (n = 1). Eight (6.1%) reoperations were at the index level. Conclusion: Single-level AxiaLIF is a safe and effective means to achieve lumbosacral fusion in patients with symptomatic degenerative disc disease [ABSTRACT FROM AUTHOR]

Minimally invasive approaches for lumbar interbody fusion have been popularized in recent years. The retroperitoneal transpsoas approach to the lumbar spine is a technique that allows direct lateral access to the intervertebral disc space while mitigating the complications associated with traditional anterior or posterior approaches. However, a common complication of this procedure is iatrogenic injury to the psoas muscle and surrounding nerves, resulting in postsurgical motor and sensory deficits. The TranS1 VEO system (TranS1 Inc, Raleigh, NC, USA) utilizes a novel, minimally invasive transpsoas approach to the lumbar spine that allows direct visualization of the psoas and proximal nerves, potentially minimizing iatrogenic injury risk and resulting clinical morbidity. This paper describes the clinical uses, procedural details, and indications for use of the TranS1 VEO system. [ABSTRACT FROM AUTHOR]

Background: The sacroiliac joint is a common but under-recognized source of low back and gluteal pain. Patients with degenerative sacroiliitis or sacroiliac joint disruption resistant to nonsurgical treatments may undergo open surgery with sacroiliac joint arthrodesis, although outcomes are mixed and risks are significant. Minimally invasive sacroiliac joint arthrodesis was developed to minimize the risk of iatrogenic injury and to improve patient outcomes compared with open surgery. Methods: Between April 2009 and January 2013, 5319 patients were treated with the iFuse SI Joint Fusion System® for conditions including sacroiliac joint disruption and degenerative sacroiliitis. A database was prospectively developed to record all complaints reported to the manufacturer in patients treated with the iFuse device. Complaints were collected through spontaneous reporting mechanisms in support of ongoing mandatory postmarket surveillance efforts. Results: Complaints were reported in 204 (3.8%) patients treated with the iFuse system. Pain was the most commonly reported clinical complaint (n = 119, 2.2%), with nerve impingement (n = 48, 0.9%) and recurrent sacroiliac joint pain (n = 43, 0.8%) most frequently cited. All other clinical complaints were rare (0.2%). Ninety-six revision surgeries were performed in 94 (1.8%) patients at a median follow-up of four (range 0-30) months. Revisions were typically performed in the early postoperative period for treatment of a symptomatic malpositioned implant (n = 46, 0.9%) or to correct an improperly sized implant in an asymptomatic patient (n = 10, 0.2%). Revisions in the late postoperative period were performed to treat symptom recurrence (n = 34, 0.6%) or for continued pain of undetermined etiology (n = 6, 0.1%). Conclusion: Analysis of a postmarket product complaints database demonstrates an overall low risk of complaints with the iFuse SI Joint Fusion System in patients with degenerative sacroiliitis or sacroiliac joint disruption. [ABSTRACT FROM AUTHOR]

Symptomatic medial compartment knee osteoarthritis (OA) is the leading cause of musculoskeletal pain and disability in adults. Therapies intended to unload the medial knee compartment have yielded unsatisfactory results due to low patient compliance with conservative treatments and high complication rates with surgical options. There is no widely available joint-unloading treatment for medial knee OA that offers clinically important symptom alleviation, low complication risk, and high patient acceptance. The KineSpring® Knee Implant System (Moximed, Inc, Hayward, CA, USA) is a first-of-its-kind, implantable, extra-articular, extra-capsular prosthesis intended to alleviate knee OA-related symptoms by reducing medial knee compartment loading while overcoming the limitations of traditional joint-unloading therapies. Preclinical and clinical studies have demonstrated excellent prosthesis durability, substantial reductions in medial compartment and total joint loads, and clinically important improvements in OA-related pain and function. The purpose of this report is to describe the KineSpring System, including implant characteristics, principles of operation, indications for use, patient selection criteria, surgical technique, postoperative care, preclinical testing, and clinical experience. The KineSpring System has potential to bridge the gap between ineffective conservative treatments and irreversible surgical interventions for medial compartment knee OA. [ABSTRACT FROM AUTHOR]

Purpose: Traditional balloon kyphoplasty (BK) is a common treatment for symptomatic vertebral compression fractures. The purpose of this study was to compare a novel vertebral augmentation technique, radiofrequency-targeted vertebral augmentation (RF-TVA), to BK for restoration of vertebral height, cavity creation, and polymethylmethacrylate (PMMA) delivery and interdigitation into the surrounding trabeculae. Methods: This ex vivo biomechanical pilot study utilized 16 osteoporotic cadaveric vertebral bodies in a standardized fracture model to compare unipedicular RF-TVA (n = 8) to bipedicular BK (n = 8). Four specimens from each group were tested in loaded and unloaded conditions. All specimens were imaged, assessed for height restoration, and sectioned to observe PMMA distribution. A subset of specimens underwent computed tomography scanning to assess cavity creation and trabecular architecture prior to cement delivery. Results: Anterior height restoration was greater with RF-TVA (median: 84%, interquartile range: 62%-95%) compared to BK (median: 69%, interquartile range: 60%-81%), although the difference did not achieve statistical significance (P = 0.16). Anterior height restoration was numerically greater under loaded (median: 70% versus 66%) and unloaded (median: 94% versus 77%) conditions with RF-TVA versus BK. RF-TVA produced more discrete cavities and less native trabecular destruction compared to marked trabecular destruction observed with BK. RF-TVA consistently showed a well-identified focal area of PMMA with an extensive peripheral zone of PMMA interdigitation, providing mechanical interlock into the adjacent intact trabecular matrix. In contrast, BK yielded little evidence of PMMA interdigitation beyond the boundaries created by the balloon tamp due to the crushed trabecular bone peripherally. Conclusion: RF-TVA achieves favorable vertebral height restoration with targeted PMMA delivery and less trabecular destruction compared to BK. RF-TVA has potential clinical utility in the aging population with painful osteoporotic vertebral fracture. [ABSTRACT FROM AUTHOR]

Few nonsurgical treatment options are available to the patient with debilitating knee osteoarthritis (OA) that is refractory to conservative care. The KineSpring® System joint unloading implant is a unique device that reduces the load carried by the medial compartment of the knee joint by up to 13 kilograms during the stance phase of gait. We report a case of a male patient who underwent implant with the KineSpring System for symptomatic knee OA but subsequently required revision due to local infection. We performed a novel two-stage revision procedure where the absorber unit was removed in the first phase and a new absorber was placed 3 months later after the infection resolved. A key finding of this case was that knee OA pain resolved with the KineSpring System, returned following explant of the absorber unit, and resolved again following implant of the new absorber. Another important aspect of this case was that the femoral and tibial bases of the KineSpring System remained in situ, which simplified each phase of the revision procedure. [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]

Background: Laminectomy/laminotomy and foraminotomy are well established surgical techniques for treatment of symptomatic lumbar spinal stenosis. However, these procedures have significant limitations, including limited access to lateral and foraminal compression and postoperative instability. The purpose of this cadaver study was to compare bone, ligament, and soft tissue morphology following lumbar decompression using a minimally invasive MicroBlade Shaver® instrument versus hemilaminotomy with foraminotomy (HL). Methods: The iO-Flex® system utilizes a flexible over-the-wire MicroBlade Shaver instrument designed for facet-sparing, minimally invasive "inside-out" decompression of the lumbar spine. Unilateral decompression was performed at 36 levels in nine human cadaver specimens, six with age-appropriate degenerative changes and three with radiographically confirmed multilevel stenosis. The iO-Flex system was utilized on alternating sides from L2/3 to L5/S1, and HL was performed on the opposite side at each level by the same investigator. Spinal canal, facet joint, lateral recess, and foraminal morphology were assessed using computed tomography. Results: Similar increases in soft tissue canal area and decreases in ligamentum flavum area were noted in nondiseased specimens, although HL required removal of 83% more laminar area (P , 0.01) and 95% more bone resection, including the pars interarticularis and facet joints (P , 0.001), compared with the iO-Flex system. Similar increases in lateral recess diameter were noted in nondiseased specimens using each procedure. In stenotic specimens, the increase in lateral recess diameter was significantly (P = 0.02) greater following use of the iO-Flex system (43%) versus HL (7%). The iO-Flex system resulted in greater facet joint preservation in nondiseased and stenotic specimens. In stenotic specimens, the iO-Flex system resulted in a significantly greater increase in foraminal width compared with HL (24% versus 4%, P = 0.01), with facet joint preservation. Conclusion: The iO-Flex system resulted in significantly better decompression of the lateral recess and foraminal areas compared with HL, while preserving posterior spinal elements, including the facet joint [ABSTRACT FROM AUTHOR]

Intra-articular corticosteroid and hyaluronic acid injections provide short-term symptom amelioration for arthritic conditions involving structural damage or degenerative changes in the knee. Conventional palpation-guided anatomical injections frequently result in inaccurate needle placement into extra-articular tissue and adjacent structures. The purpose of this review was to determine the effect of ultrasound guidance on the accuracy of needle placement, clinical outcomes, and cost-effectiveness in comparison with anatomical landmarkguided intra-articular large joint injections, with particular emphasis on the knee. A total of 13 relevant studies were identified; five studied the knee, seven studied the shoulder, one used both the knee and shoulder, and none studied the hip. Ultrasound was used in seven studies; the remaining studies utilized air arthrography, fluoroscopy, magnetic resonance arthrography, or magnetic resonance imaging. Across all studies (using all imaging modalities and all joints), needle placement accuracy ranged from 63% to 100% with ultrasound and from 39% to 100% with conventional anatomical guidance. Imaging guidance improved the accuracy of intraarticular injections of the knee (96.7% versus 81.0%, P , 0.001) and shoulder (97.3% versus 65.4%, P , 0.001). In particular, ultrasound guidance of knee injections resulted in better accuracy than anatomical guidance (95.8% versus 77.8%, P , 0.001), yielding an odds ratio of 6.4 (95% confidence interval 2.9-14). Ultrasound guidance notably improves injection accuracy in the target intra-articular joint space of large joints including the knee. The enhanced injection accuracy achieved with ultrasound needle guidance directly improves patient-reported clinical outcomes and cost-effectiveness [ABSTRACT FROM AUTHOR]

Introduction: Vertebral metastases are associated with significant pain, disability, and morbidity. Open surgery for fracture stabilization is often inappropriate in this population due to a poor risk-benefit profile, particularly if life expectancy is short. Percutaneous vertebroplasty and kyphoplasty are appealing adjunctive procedures in patients with malignancy for alleviation of intractable pain. However, these patients have higher risk of serious complications, notably cement extravasation. Described in this report is a case of a painful osteolytic vertebral metastasis that was successfully treated by a novel percutaneous vertebral augmentation system. Case presentation: A 42-year-old Caucasian female presented with a history of metastatic lung cancer unresponsive to radiation and chemotherapy with symptoms inadequately controlled by opiates over the previous 6 months. Magnetic resonance imaging and spiral computed tomography with two-dimensional reconstruction showed an osteolytic vertebral metastasis with complete involvement of the T10 vertebral body, extending to the cortical vertebral wall anteriorly and posteriorly. The patient was treated with percutaneous vertebral augmentation (Kiva® VCF Treatment System, Benvenue Medical, Inc, Santa Clara, CA) utilizing a novel coilshaped polyetheretherketone implant designed to minimize the risk of cement extravasation. After the minimally invasive procedure, bone cement distribution within the vertebral body was ideal, with no observed cement extravasation. No complications were reported, pain completely resolved within 24 hours, and use of intravenous narcotics was progressively diminished within 1 week. Complete pain relief was maintained throughout 4 months of follow-up. Conclusion: The Kiva System represents a novel and effective minimally invasive treatment option for patients suffering from severe pain due to osteolytic vertebral metastasis. [ABSTRACT FROM AUTHOR]

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]

Hyaluronic acid (HA) is a commonly prescribed treatment for knee pain resulting from osteoarthritis (OA). Although numerous HA products have been approved for use by the US Food and Drug Administration, the efficacy of HA injections for knee OA remains disputed with meta-analyses and societal clinical guidelines drawing disparate conclusions. The American Academy of Orthopaedic Surgeons (AAOS) recently published a best-evidence systematic review and concluded that available data did not support the routine use of HA for knee OA. The purpose of the current article is to highlight issues that confound interpretation of metaanalyses on HA for knee OA, to provide realistic estimates of the true efficacy of HA injections in knee OA, and to provide commentary on the methods and conclusions from the AAOS systematic review. In general, the clinical benefit of HA is underestimated using conventional meta-analytic techniques. When accounting for differential control group effects in HA studies, it can be reasonably concluded that HA injections may be beneficial to an appreciable number of patients with knee OA. In addition, the systematic review methodology used by AAOS was questionable due to exclusion of numerous relevant studies and inclusion of studies that used HAs not approved for use in the US, both of which underestimated the true efficacy of HA injections. Overall, the efficacy of HA injections for knee OA is likely better than previously reported. Future clinical trials and meta-analyses should account for differential control group effects in order to avoid the continued confusion surrounding HA injection efficacy. [ABSTRACT FROM AUTHOR]