Endoscopic sleeve gastroplasty as an early tool against obesity: a multicenter international study on an overweight population.

BACKGROUND AND AIMS: Endoscopic sleeve gastroplasty (ESG) is an effective, minimally invasive gastric remodeling procedure to treat mild and moderate obesity. Early adoption of ESG may be desirable to try to halt progression of obesity, but there are few data on its efficacy and safety for overweight patients. METHODS: This was a multicenter, international, analytical case series. Six U.S., 1 Brazilian, 1 Mexican, and 1 Indian center were included. Overweight patients according to local practice undergoing ESG were considered eligible for the study. The end points were percent total weight loss (%TWL), body mass index (BMI) reduction, rate of BMI normalization, and rate of adverse events. RESULTS: One hundred eighty-nine patients with a mean age of 42.6 ± 14.1 years and a mean BMI of 27.79 ± 1.17 kg/m2 were included. All procedures were successfully accomplished, and there were 3 intraprocedural adverse events (1.5%). The mean %TWL was 12.28% ± 3.21%, 15.03% ± 5.30%, 15.27% ± 5.28%, and 14.91% ± 5.62% at 6, 12, 24, and 36 months, respectively. At 12 and 24 months, 76% and 86% of patients achieved normal BMI, with a mean BMI reduction of 4.13 ± 1.46 kg/m2 and 4.25 ± 1.58 kg/m2. There was no difference in mean %TWL in the first quartile versus the fourth quartile of BMI in any of the time points. However, the BMI normalization rate was statistically higher in the first group at 6 and 12 months (6 months, 100% vs 48.5% [P < .01]; 12 months, 86.2% vs 50% [P < .01]; 24 months, 84.6% vs 76.1% [P = .47]; 36 months, 86.3% vs 66.6% [P = .26]). CONCLUSIONS: ESG is safe and effective in treating overweight patients with high BMI normalization rates. It could help halt or delay the progression to obesity.

Evidence-based treatment of Achilles tendon rupture.

The treatment of Achilles tendon rupture has recently seen a shift toward non-operative management, as supported by the literature, yet many surgeons continue to treat these injuries operatively. The evidence clearly supports non-operative management of these injuries except for Achilles insertional tears and for certain patient groups, such as athletic patients, for whom further research is warranted. This nonadherence to evidence-based treatment may be explained by patient preference, surgeon subspecialty, surgeon era of practice or other variables. Further research to understand the reasons behind this nonadherence would help to promote conformity in the surgical community across all specialties and adherence to evidence-based approaches.

Prophylaxis for preventing venous thromboembolism in knee arthroscopy and soft tissue reconstruction: consensus statements from an international panel of experts.

PURPOSE: There is a lack of consensus regarding need for Venous Thrombo Embolism (VTE) prophylaxis following arthroscopic knee surgery and open soft tissue knee reconstruction. Clear cut guidelines like ones for trauma surgery and arthroplasty do not exist and the published literature is limited to case reports with a few society guidelines. Given this lack of consensus, we conducted a modified Delphi questionnaire of international experts to provide recommendations on this topic. METHODS: The consensus statements were generated using an anonymised 3 round modified Delphi questionnaire, sent to an international panel of 38 knee surgeons, with an 80% agreement being set as the limit for consensus. The responses were analysed using descriptive statistics with measures like mode, median and box plots. Feedback was provided to all panelists based on responses from the previous rounds to help generate the consensus. RESULTS: Six consensus statements were generated after the three rounds of Delphi. Patient factors, prolonged surgery duration and family history of thrombogenic events emerged as the main points to be taken into consideration for prophylaxis. CONCLUSION: It was established through this study, that there exists a select group of patients undergoing arthroscopic surgery that justify the usage of VTE prophylaxis. The expert responses to most of the questions in different scenarios favoured usage of VTE prophylaxis based on patient factors like advanced age, past history of VTE, smoking, oral contraceptive use etc. LEVEL OF EVIDENCE: Level V.

Local antibiotics in primary hip and knee arthroplasty: a systematic review and meta-analysis.

BACKGROUND: Infection is a truly devastating complication of total joint arthroplasty, causing most patients to undergo a revision surgery, and to bear significant psychological and financial burden. The purpose of this study is to systematically evaluate the literature to determine the efficacy and complication profile of local antibiotic application in primary total joint arthroplasty. METHODS: All studies of primary total joint arthroplasty which assessed local antibiotics in any form other than antibiotic-impregnated cement as an intervention were included. Studies that reported at least one outcome related to infection and were available in full text in English were eligible for inclusion. Studies which included both primary and revision cases but did not report the stratified data for each type of surgery and studies on fracture populations were excluded. RESULTS: A total of 9 studies involving 3,714 cases were included. The pooled deep infection rate was 1.6% in the intervention groups and 3.5% in the control groups. Meta-analysis revealed a RR of 0.53 (95%CI: 0.35-0.79, p = 0.002) with no heterogeneity (I2 = 0%) for infection in the intervention groups. Meta-analysis revealed a non-significant reduction in superficial infection rates in the intervention groups; however, there was a significant increase in aseptic wound complications in the intervention groups. CONCLUSION: Local antibiotic application results in a moderate reduction in deep infection rates in primary total joint arthroplasty, with no significant impact on superficial infection rates. However, local antibiotic application may be associated with a moderate increase in aseptic wound complications.

Posterior-Based Approaches to Open Reduction Internal Fixation of Bimalleolar and Trimalleolar Fractures: A Systematic Review and Meta-analysis.

Although there is growing evidence supporting posterior-based surgical approaches to open reduction internal fixation (ORIF) of malleolar fractures, the lateral approach still remains the standard of care for this injury. The purpose of this review was to integrate the results of several studies investigating outcomes following posterior-based approaches to the ORIF of malleolar fractures. The literature search was undertaken using PubMed, the Cochrane Library, and Embase. Crude event rates for fracture healing and postoperative complications were calculated. When possible, meta-analyses were conducted to estimate the relative risk of these outcomes between patients treated by posterior-based approaches versus other approaches to ORIF of malleolar fractures. Twenty-two studies were eligible, and 4 studies were included in the meta-analyses. The healing rate was 100% in all patients, regardless of the surgical approach. Overall, 1.26% of patients developed an infection, 0.63% required reoperation, 1.13% experienced aseptic loosening, 5.53% experienced pain after treatment, and 2.52% experienced symptomatic hardware. No malunion or heterotopic ossification was reported in any study. Among patients treated with a posterior-based approach, the most frequently reported complication was infection (2.50%), with lower rates of reoperation and postoperative pain. Patients with trimalleolar fractures experienced slightly poorer outcomes. Patients treated by posterior-based approaches had a significantly increased risk of infection (p = .010) relative to those treated by the lateral approach; patients treated by the lateral approach had a significantly increased risk of pain after surgery (p = .004) and symptomatic hardware (p = .007). This study brought together evidence that posterior-based surgical approaches and non-posterior-based approaches to ORIF are effective in healing malleolar fractures, with significant differences in specific postoperative complications that need to be further explored.

A scoping review of intimate partner violence educational programs for health care professionals.

Multiple intimate partner violence (IPV) educational programs have been developed for health care professionals (HCPs); however, program content and effectiveness vary substantially. The purpose of this scoping review was to identify and synthesize the literature evaluating IPV education programs for HCPs to identify key areas for potential evidence-based recommendations and focus future research priorities. We conducted a systematic literature search using broad eligibility criteria to identify studies published between January 2000 and July 2015 that evaluated the effectiveness of IPV education programs in health care settings. All potentially eligible references were screened independently by two reviewers. Data extraction was completed independently by two reviewers for all eligible studies. Descriptive statistics were used to summarize all data. We identified 65 eligible studies, 55% of which reported positive program effectiveness. Effective programs often reported the use of online training components, delivery by an IPV educator/expert or physician/surgeon, the inclusion of a treatment protocol and resources for patients and HCPs, and included more than five training sessions lasting no more than one hours each. Our results demonstrate that IPV educational programs are heterogeneous and that a wide variety of methodologies have been used to evaluate their effectiveness.

Effect of sleeve gastrectomy bariatric surgery-induced weight loss on serum AMH levels in reproductive aged women.

OBJECTIVE: This study aims to evaluate the change in serum anti-Mullerian hormone (AMH) levels in patients with morbid obesity undergoing bariatric surgery for weight loss. MATERIAL AND METHODS: In this prospective observational study, 75 patients of reproductive age (20-35 years) undergoing bariatric surgery for morbid obesity were followed up after six months to determine the changes in weight, Body Mass Index (BMI), menstrual pattern and serum AMH. The results were further studied on basis of pre operative classification of patients in polycystic ovary syndrome (PCOS) and non-PCOS group. RESULT: The serum AMH levels were statistically higher in patients of PCOS group pre operatively and at the end of six months in comparison to non-PCOS patients. The AMH values reduced post operatively in both groups significantly so much in the values though not significant statistically. Non-PCOS patients had lower AMH values pre operatively and showed a trend towards reducing ovarian reserve after six months. The overall change in AMH values in both groups was statistically significant as was the normalization of menstrual irregularity. CONCLUSION: Morbidly obese patients with PCOS appear to benefit from bariatric surgery both in terms of regularization of menstrual function and normalization of serum AMH values.

Arthroscopy Up to Date: Hip Femoroacetabular Impingement.

PURPOSE: To provide a comprehensive review and summary of the research published in Arthroscopy: The Journal of Arthroscopic and Related Surgery and The American Journal of Sports Medicine (AJSM) related to hip arthroscopy for femoroacetabular impingement (FAI). METHODS: A comprehensive review was conducted in duplicate of Arthroscopy and AJSM from February 2012 to February 2015 for all articles related to FAI, and a quality assessment was completed for all included studies. Clinical outcomes were dichotomized into short-term (<6 months) and midterm (<24 months) outcomes, and values were pooled when possible. RESULTS: We identified 60 studies in Arthroscopy and 44 studies in AJSM, primarily from North America (78.8%), that predominantly assessed clinical outcomes after arthroscopic hip surgery (46.1%). Seventy-one percent of Arthroscopy studies and 20.5% of AJSM studies were Level IV evidence. The modified Harris Hip Score (mHHS) was used by 81.5% of included studies. Pooled weighted mean mHHS values after arthroscopic surgery for FAI showed improvements at the midterm from 60.5 points (range, 56.6 to 83.6 points) to 80.5 points (range, 72.1 to 98.0 points) out of a possible 100 points. Pooled weighted outcomes for labral repair showed mean mHHS improvements from 63.8 points (range, 62.5 to 69.0 points) preoperatively to 86.9 points (range, 85.5 to 89.9 points) up to 24 months postoperatively. CONCLUSIONS: This comprehensive review of research published in Arthroscopy and AJSM over the past 3 years identified a number of key findings. Arthroscopic intervention results in improvements in functional outcomes at both the short-term and midterm for patients with symptomatic FAI in the absence of significant existing degenerative changes. Labral repair may result in improvements over labral debridement. The most commonly used outcome score was the mHHS for objective assessment of surgical success. There is a need for continued focus on improvement of methodologic quality and reporting of research pertaining to FAI. LEVEL OF EVIDENCE: Level IV, systematic review of Level IV studies.

Media coverage of violence against women in India: a systematic study of a high profile rape case.

BACKGROUND: On December 16, 2012 a 23 year old female was gang-raped on a bus in Delhi. We systematically reviewed professional online media sources used to inform the timing, breadth of coverage, opinions and consistency in the depiction of events surrounding the gang-rape. METHODS: We searched two news databases (LexisNexis Academic and Factivia) and individual newspapers for English-language published media reports covering the gang-rape. Two reviewers screened the media reports and extracted data regarding the time, location and content of each report. Results were summarized qualitatively. RESULTS: We identified 534 published media reports. Of these, 351 met our eligibility criteria. Based on a time chart, the total number of reports published increased steadily through December, but plateaued to a steady rate of articles per day by the first week of January. Content analysis revealed significant discrepancies between various media reports. From the 57 articles which discussed opinions about the victim, 56% applauded her bravery, 40% discussed outrage over the events and 11% discussed cases of victim-blaming. CONCLUSIONS: The global media response of the December 16th gang-rape in India resulted in highly inconsistent depiction of the events. These findings suggest that although the spread of information through media is fast, it has major limitations.

Intrawound vancomycin to prevent infections after spine surgery: a systematic review and meta-analysis.

PURPOSE: Post-operative spine surgical site infections are associated with substantial morbidity, mortality, and economic burden. Intrawound vancomycin may prevent infections after spine surgery, but recent studies have reported conflicting results. The objectives of this systematic review and meta-analysis were to determine: (1) In patients undergoing spine surgery, does the application of intrawound vancomycin lead to reduced rates of post-operative surgical site infections? (2) Are there differences in the estimates of effect between observational studies and randomized trials? (3) What adverse events are reported in the literature? METHODS: All published comparative studies of intrawound vancomycin in spine surgery were included. Two reviewers independently screened eligible articles and assessed study quality. Observational studies and randomized trials were pooled separately using a random-effects model. RESULTS: Eight observational studies and one randomized controlled trial met the inclusion criteria. Across observational studies, the odds of infection with intrawound vancomycin was 0.19 times the odds of infection without intrawound vancomycin (95 % CI 0.08-0.47, p = 0.0003, I (2) = 52 %). The single randomized controlled trial produced a conflicting result (OR 0.96, 95 % CI 0.34-2.66, p = 0.93). There were no adverse events attributable to intrawound vancomycin. The quality of the evidence was low or very low. CONCLUSIONS: There is a lack of high-quality evidence to inform the use of intrawound vancomycin in spine surgery. Surgeons should be cautious before widely adopting this intervention and should be vigilant in monitoring for adverse effects. Further investigation with additional randomized controlled trials is justified.

Arthroscopic surgery for degenerative tears of the meniscus: a systematic review and meta-analysis.

BACKGROUND: Arthroscopic surgery for degenerative meniscal tears is a commonly performed procedure, yet the role of conservative treatment for these patients is unclear. This systematic review and meta-analysis evaluates the efficacy of arthroscopic meniscal débridement in patients with knee pain in the setting of mild or no concurrent osteoarthritis of the knee in comparison with nonoperative or sham treatments. METHODS: We searched MEDLINE, Embase and the Cochrane databases for randomized controlled trials (RCTs) published from 1946 to Jan. 20, 2014. Two reviewers independently screened all titles and abstracts for eligibility. We assessed risk of bias for all included studies and pooled outcomes using a random-effects model. Outcomes (i.e., function and pain relief) were dichotomized to short-term (< 6 mo) and long-term (< 2 yr) data. RESULTS: Seven RCTs (n = 805 patients) were included in this review. The pooled treatment effect of arthroscopic surgery did not show a significant or minimally important difference (MID) between treatment arms for long-term functional outcomes (standardized mean difference [SMD] 0.07, 95% confidence interval [CI] -0.10 to 0.23). Short-term functional outcomes between groups were significant but did not exceed the threshold for MID (SMD 0.25, 95% CI 0.02 to 0.48). Arthroscopic surgery did not result in a significant improvement in pain scores in the short term (mean difference [MD] 0.20, 95% CI -0.67 to 0.26) or in the long term (MD -0.06, 95% CI -0.28 to 0.15). Statistical heterogeneity was low to moderate for the outcomes. INTERPRETATION: There is moderate evidence to suggest that there is no benefit to arthroscopic meniscal débridement for degenerative meniscal tears in comparison with nonoperative or sham treatments in middle-aged patients with mild or no concomitant osteoarthritis. A trial of nonoperative management should be the first-line treatment for such patients.

Surgical management of internal snapping hip syndrome: a systematic review evaluating open and arthroscopic approaches.

PURPOSE: This systematic review explored reported outcomes addressing internal snapping hip as well as comparing outcomes between open and arthroscopic management of internal snapping hip syndrome. METHODS: Two databases (Embase and Medline) were screened for clinical studies involving the surgical management of internal snapping hip syndrome. Two reviewers conducted a full-text review of eligible studies and the references of these studies. Inclusion and exclusion criteria were applied to the searched studies, and a quality assessment was completed for included studies. RESULTS: We identified 11 eligible studies involving 248 patients. The mean age of the participants was 26.5 years (range, 14 to 62 years). The 2 most commonly reported standardized outcome measures were the modified Harris Hip Score (27%) and the Western Ontario and McMaster Universities Osteoarthritis Index (18%). Six studies (54%) presented return to the same level of competition or activities of daily living as an outcome. Among patients undergoing arthroscopic management for this condition, postoperative improvements in the modified Harris Hip Score and Western Ontario and McMaster Universities Osteoarthritis Index score were greater in the studies involving transection at the lesser trochanter compared with the transcapsular technique. Standardized outcome measures were not reported among patients undergoing open procedures. Resolution of snapping was seen in 100% of patients who underwent arthroscopic release and 77% of open procedure patients. Complication rates were higher in patients undergoing an open procedure (21%) compared with an arthroscopic procedure (2.3%). CONCLUSIONS: This review shows a decreased failure rate, fewer complications, and decreased postoperative pain with arthroscopic management of internal snapping hip syndrome in comparison with open management. However, given the lack of high-quality evidence or direct comparison data, these results should be interpreted with caution. This review also highlights the need for the development of a standardized outcome tool for consistent reporting of clinical outcomes. LEVEL OF EVIDENCE: Level IV, systematic review of Level IV studies.

Consistency of reported outcomes after arthroscopic management of femoroacetabular impingement.

PURPOSE: The purpose of this systematic review is to evaluate the consistency of the reporting of clinical and radiographic outcomes after arthroscopic management of femoroacetabular impingement (FAI). METHODS: Two databases (Medline and EMBASE) were screened for clinical studies involving the arthroscopic management of FAI. A full-text review of eligible studies was conducted, and the references were searched. Inclusion and exclusion criteria were applied to the searched studies, and a quality assessment was completed for included studies. RESULTS: We identified 29 eligible studies involving 2,816 patients. There was a lack of consensus with regard to reported outcomes (clinical and radiographic) after arthroscopic treatment of FAI. Clinical outcomes reported include the Harris Hip Score (45%) and the Non-Arthritic Hip Scale (28%), range of motion (34%), pain scores (24%), and patient satisfaction (28%). The most commonly reported radiographic outcomes included the alpha angle (38%), head-neck offset (14%), and degenerative changes (21%). CONCLUSIONS: There is significant variation in reported clinical and radiographic outcomes after arthroscopic treatment of FAI. This study highlights the need for consistent outcome reporting after arthroscopic FAI surgery. LEVEL OF EVIDENCE: Level IV, systematic review of Level II, III, and IV studies.

The Role of Hyaluronic Acid for Soft Tissue Indications: A Systematic Review and Meta-Analysis.

CONTEXT: Soft tissue injuries are often treated with injectables such as corticosteroids and platelet-rich plasma (PRP) to reduce inflammation and promote healing. There is increasing evidence examining the use of hyaluronic acid (HA) for the management of soft tissue injuries. OBJECTIVE: To evaluate the treatment effect and role of HA for available soft tissue indications. DATA SOURCES: A search of PubMed, MEDLINE, EMBASE, and CENTRAL from the inception date of each database through February 24, 2021, was conducted for all randomized controlled trials (RCTs) involving the use of HA for soft tissue indications. Two reviewers independently screened articles for eligibility and extracted data from included studies for analysis. We assessed risk of bias for all included studies and pooled outcomes using a fixed-effects model. Outcomes (ie, function and pain relief) were categorized to short-term (<6 weeks, 6-12 weeks) and mid-term (>12 weeks) data. We present effect estimates as mean differences (MDs) and standardized mean differences (SMDs) and present the estimate of effect of HA for available indications in relation to available comparators. STUDY DESIGN: Meta-analysis of RCTs. LEVEL OF EVIDENCE: Level 1. RESULTS: Of the 6930 articles screened, 19 RCTs (n = 1629 patients) were eligible and included in this review. HA was evaluated across a variety of soft tissue indications including rotator cuff disease, elbow pain, ankle sprains, Achilles tendinopathy, patellar tendinopathy, and trigger finger. Of the 19 RCTs, 11 were placebo-controlled and 9 used active comparators (PRP, cortisone, prolotherapy, or extracorporeal shockwave therapy). The pooled treatment effect of HA across most soft indications against placebo and active comparators demonstrated benefit in short-term pain <6 weeks (MD visual analogue scale [VAS] 2.48, 95% CI 2.31-2.65) and 6 to 12 weeks (MD VAS 2.03, 95% CI 1.86-2.20). Mid-term pain relief also favored HA over comparators across indications >12 weeks from administration (MD VAS 3.57, 95% CI 3.35-3.78). High heterogeneity was present with rotator cuff (10 trials, I2 = 94%), and elbow tendinopathy (2 trials, I2 = 99%). We identified uncertain benefit for trigger finger (2 trials, I2 = 67%). Heterogeneity for ankle sprains, patellar tendinopathy and Achilles tendinopathy could not be assessed as they only had 1 trial each. CONCLUSION: This systematic review and meta-analysis support HA's efficacy in the treatment of a variety of soft tissue indications. Understanding the relative effects of HA to other injectable modalities requires additional, large trials.

Quadratus lumborum block for postoperative pain management in patients undergoing total hip arthroplasty: a systematic review and meta-analysis.

BACKGROUND: The use of quadratus lumborum nerve blocks (QLB) for pain control following elective total hip arthroplasty (THA) has increased substantially in recent years. The objective of this systematic review and meta-analysis was to compare outcomes from randomised controlled trials (RCTs) utilising QLBs following elective THA. METHODS: MEDLINE, EMBASE, and Cochrane databases were searched for RCTs perioperative QLBs for THA. Quantitative synthesis was conducted for pain scores, opioid consumption and adverse events. RESULTS: A total of 7 RCTs with 429 patients undergoing THA were included. No differences in pain scores were demonstrated between QLBs and control interventions. Subgroup analysis demonstrated no differences between QLBs and sham procedures or active comparators. No differences in postoperative opioid consumption between QLB and control interventions was found. In trials reporting adverse events, they were rare and similar between groups. Overall, the certainty of the evidence was graded as low or very low. CONCLUSIONS: The current literature suggests that a QLB for THA does not reduce pain or opioid consumption compared to sham or active comparators.

A pragmatic randomized trial evaluating pre-operative aqueous antiseptic skin solutions in open fractures (Aqueous-PREP): statistical analysis plan.

BACKGROUND: Approximately 1 in 10 patients with a surgically treated open fracture will develop a surgical site infection. The Aqueous-PREP trial will investigate the effect of 10% povidone-iodine versus 4% chlorhexidine in aqueous antiseptic solutions in reducing infections after open fracture surgery. The study protocol was published in April 2020. METHODS AND DESIGN: The Aqueous-PREP trial is a pragmatic, multicenter, open-label, randomized multiple period cluster crossover trial. Each participating cluster is randomly assigned in a 1:1 ratio to provide 1 of the 2 study interventions on all eligible patients during a study period. The intervention periods are 2 months in length. After completing a 2-month period, the participating cluster crosses over to the alternative intervention. We plan to enroll a minimum of 1540 patients at 14 sites. RESULTS: The primary outcome is surgical site infection guided by the Centers for Disease Control and Prevention's National Healthcare Safety Network reporting criteria (2017). All participants' surgical site infection surveillance period will end 30 days after definitive fracture management surgery for superficial infections and 90 days after definitive fracture management surgery for deep incisional or organ/space infections [1]. The secondary outcome is an unplanned fracture-related reoperation within 12 months of the fracture. CONCLUSION: This manuscript serves as the formal statistical analysis plan (version 1.0) for the Aqueous-PREP trial. The statistical analysis plan was completed on February 28, 2022.

Comparison of Prophylactic Intravenous Antibiotic Regimens After Endoprosthetic Reconstruction for Lower Extremity Bone Tumors: A Randomized Clinical Trial.

IMPORTANCE: The use of perioperative, prophylactic, intravenous antibiotics is standard practice to reduce the risk of surgical site infection after oncologic resection and complex endoprosthetic reconstruction for lower extremity bone tumors. However, evidence guiding the duration of prophylactic treatment remains limited. OBJECTIVE: To assess the effect of a 5-day regimen of postoperative, prophylactic, intravenous antibiotics compared with a 1-day regimen on the rate of surgical site infections within 1 year after surgery. DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical superiority trial was performed at 48 clinical sites in 12 countries from January 1, 2013, to October 29, 2019. The trial included patients with a primary bone tumor or a soft tissue sarcoma that had invaded the femur or tibia or oligometastatic bone disease of the femur or tibia with expected survival of at least 1 year who required surgical management by excision and endoprosthetic reconstruction. A total of 611 patients were enrolled, and 7 were excluded for ineligibility. INTERVENTIONS: A 1- or 5-day regimen of postoperative prophylactic intravenous cephalosporin (cefazolin or cefuroxime) that began within 8 hours after skin closure and was administered every 8 hours thereafter. Those randomized to the 1-day regimen received identical saline doses every 8 hours for the remaining 4 days; patients, care providers, and outcomes assessors were blinded to treatment regimen. MAIN OUTCOMES AND MEASURES: The primary outcome in this superiority trial was a surgical site infection (superficial incisional, deep incisional, or organ space) classified according to the criteria established by the Centers for Disease Control and Prevention within 1 year after surgery. Secondary outcomes included antibiotic-related complications, unplanned additional operations, oncologic and functional outcomes, and mortality. RESULTS: Of the 604 patients included in the final analysis (mean [SD] age, 41.2 [21.9] years; 361 [59.8%] male; 114 [18.9%] Asian, 43 [7.1%] Black, 34 [5.6%] Hispanic, 15 [2.5%] Indigenous, 384 [63.8%] White, and 12 [2.0%] other), 293 were randomized to a 5-day regimen and 311 to a 1-day regimen. A surgical site infection occurred in 44 patients (15.0%) allocated to the 5-day regimen and in 52 patients (16.7%) allocated to the 1-day regimen (hazard ratio, 0.93; 95% CI, 0.62-1.40; P = .73). Antibiotic-related complications occurred in 15 patients (5.1%) in the 5-day regimen and in 5 patients (1.6%) allocated to the 1-day regimen (hazard ratio, 3.24; 95% CI, 1.17-8.98; P = .02). Other secondary outcomes did not differ significantly between treatment groups. CONCLUSIONS AND RELEVANCE: This randomized clinical trial did not confirm the superiority of a 5-day regimen of postoperative intravenous antibiotics over a 1-day regimen in preventing surgical site infections after surgery for lower extremity bone tumors that required an endoprosthesis. The 5-day regimen group had significantly more antibiotic-related complications. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01479283.

Plate fixation or intramedullary fixation of humeral shaft fractures.

BACKGROUND: The optimal approach to operative treatment of humeral shaft fractures remains debatable. Previously published trials have been limited in size and have been inconclusive regarding important patient outcome variables following treatment with either intramedullary nails or plates. We conducted a meta-analysis of available trials comparing treatment of humeral shaft fractures. METHODS: We performed a literature search from 1967 to November 2007 in the main medical search engines and selected 4 randomized trials that compared nails and plates in patients with humeral shaft fractures and that reported on complications due to surgery. We statistically pooled patient data using standard meta-analytic approaches. Our primary outcome was the total complication rate, comprised of all complications listed in the articles included. Secondary outcomes included non-union, infection, nerve palsy, and reoperation rate. Methodology was assessed using the CLEAR NPT. RESULTS: When pooling the data of the 4 trials (n = 203 patients), we did not find a statistically significant difference between implants in the rate of total complications, non-union, infection, nerve-palsy, or the need for reoperation. The studies included were small and had methodological limitations. CONCLUSIONS: Our meta-analysis suggests stastistically insignificant differences between plates and nails in the treatment of humeral shaft fractures. Small sample sizes, study heterogeneity, and methodological limitations argue strongly for a definitive, large trial. We recommend that this trial should be a randomized controlled trial with appropriate allocation of patients and blinding of patients and care providers and outcome assessors, and that it should include patient-important outcomes.