Appropriateness and Quality of Composite Endpoint Use and Reporting in Spine Surgery: A Systematic Review.

BACKGROUND: A composite endpoint (CEP) is a measure comprising 2 or more separate component outcomes. The use of these constructs is increasing. We sought to conduct a systematic review on the usage, quality of reporting, and appropriate use of CEPs in spine surgery research. METHODS: A systematic review was conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. Articles reporting randomized controlled trials of a spine surgery intervention using a CEP as a primary outcome were included. We assessed the quality of CEP reporting, appropriateness of CEP use, and correspondence between CEP treatment effect and component outcome treatment effect in the included trials. RESULTS: Of 2,321 initial titles, 43 citations were included for analysis, which reported on 20 unique trials. All trials reported the CEP construct well. In 85% of trials, the CEP design was driven by US Food and Drug Administration guidance. In the majority of trials, the reporting of CEP results did not adhere to published recommendations: 43% of tests that reported statistically significant results on component outcomes were not statistically significant when adjusted for multiple testing. 67% of trials did not meet appropriateness criteria for CEP use. In addition, CEP treatment effect tended to be 6% higher than the median treatment effect for component outcomes. CONCLUSION: Given that CEP analysis was not appropriate for the majority of spine surgery trials and the inherent challenges in the reporting and interpretation of CEP analysis, CEP use should not be mandated by regulatory bodies in spine surgery trials. LEVEL OF EVIDENCE: Level I. See Instructions for Authors for a complete description of levels of evidence.

Incidence and Recurrence of Deep Spine Surgical Site Infections: A Systematic Review and Meta-analysis.

STUDY DESIGN: Systematic review and meta-analysis. OBJECTIVE: To determine a pooled incidence rate for deep surgical site infection (SSI) and compare available evidence for deep SSI management among instrumented spinal fusions. SUMMARY OF BACKGROUND DATA: Deep SSI is a common complication of instrumented spinal surgery associated with patient morbidity, poorer long-term outcomes, and higher health care costs. MATERIALS AND METHODS: We systematically searched Medline and Embase and included studies with an adult patient population undergoing posterior instrumented spinal fusion of the thoracic, lumbar, or sacral spine, with a reported outcome of deep SSI. The primary outcome was the incidence of deep SSI. Secondary outcomes included persistent deep SSI after initial debridement, mean number of debridements, and microbiology. The subsequent meta-analysis combined outcomes for surgical site infection using a random-effects model and quantified heterogeneity using the χ 2 test and the I2 statistic. In addition, a qualitative analysis of management strategies was reported. RESULTS: Of 9087 potentially eligible studies, we included 54 studies (37 comparative and 17 noncomparative). The pooled SSI incidence rate was 1.5% (95% CI, 1.1%-1.9%) based on 209,347 index procedures. Up to 25% of patients (95% CI, 16.8%-35.3%), had a persistent infection. These patients require an average of 1.4 (range: 0.8-1.9) additional debridements. Infecting organisms were commonly gram-positive, and among them, staphylococcus aureus was the most frequent (46%). Qualitative analysis suggests implant retention, especially for early deep SSI management. Evidence was limited for other management strategies. CONCLUSIONS: The pooled incidence rate of deep SSI post-thoracolumbar spinal surgery is 1.5%. The rate of recurrence and repeat debridement is at least 12%, up to 25%. Persistent infection is a significant risk, highlighting the need for standardized treatment protocols. Our review further demonstrates heterogeneity in management strategies. Large-scale prospective studies are needed to develop better evidence around deep SSI incidence and management in the instrumented thoracolumbar adult spinal fusion population.

Is the modified Ponseti method effective in treating atypical and complex clubfoot? A systematic review.

PURPOSE: In 2006, Ponseti modified the standard technique to treat cases of "atypical" and "complex" clubfoot. To determine the outcomes of Ponseti's modified method to treat complex idiopathic clubfoot patients, we asked the following: (1) What is the deformity correction success rate? (2) What is the relapse rate after the correction? (3) What is the incidence of complications? MATERIALS AND METHODS: We performed a systematic review by searching the EMBASE, MEDLINE, Cochrane Library, and Web of Science databases from inception to March 1, 2021. All studies on idiopathic, complex, and atypical clubfoot that assessed Ponseti's modified technique were included. Of 699 identified articles, ten met the inclusion criteria. The mean index for non-randomized studies score for the included studies was 11.8 ± 1.7. RESULTS: Early detection of the deformity and modifying the standard protocol, as described by Ponseti, resulted in a high rate of success. Initial correction occurred in all children, with a mean ankle dorsiflexion of 15°. Relapse occurred often ranging between 10.5 and 55%. The incidence of complications associated with the modified Ponseti method ranged from 6 to 30%. CONCLUSIONS: Studies using the modified Ponseti technique have shown high initial correction rates and a smaller number of relapses. However, studies with prospective designs and long-term follow-up are required to conclude whether these observations are due to properly performing the modified method or if higher rates of relapse increase with further follow-up.

Research activities and critical appraisal skills among Saudi orthopedic residents.

BACKGROUND: Medical research is a central part of any residency training. In view of the new Saudi orthopedic committee promotion regulation that mandates each resident to participate in a research project, the challenges that stand in the way of completion of substantial research within surgical residency must be investigated. The aim of this study was to assess the practice, attitudes, perception, and limitations associated with research among residents in the Saudi orthopedic program in the central region. METHODS: A cross-sectional study was conducted between June and July 2020 using an online-based survey. The total number of study participants was 128 orthopedic residents out of the 191 residents enrolled in the central region program. Data were analyzed, and descriptive statistics in the form of frequency and percentage were determined, analytical tests were performed with P < 0.05 being statistically significant. RESULTS: Most residents (95 %) participated in a research project during residency. Most projects (53.10 %) were case reports followed by retrospective studies (48.40 %). The majority (79.70 %) did not attend a research methods course during residency. Experience in research differed significantly (P < 0.05) by age, residency year, and center. The mean involvement score was significantly higher among males at 3 (± 1) than among females at 2 (± 0) (P < 0.001). Only 40.60 % have access to orthopedic journals, and the same percentage (40.60 %) knew how to Critique original articles. There was a statistically significant difference in the accessibility score according to the training center. Lack of faculty support and mentorship were the main barriers to medical research at 62.50 and 39.10 %, respectively. A total of 68.80 % reported that funding was not available through their institutes. CONCLUSIONS: In Saudi Arabia, the level of meaningful clinical research and publications by orthopedic residents is still low. The results of this study should be taken into consideration before the implementation of the new promotion criteria in the centers under the umbrella of Saudi orthopedic committee.

One-Year Mortality Rates Following Fracture of the Femoral Neck Treated With Hip Arthroplasty in an Aging Saudi Population: A Trauma Center Experience.

INTRODUCTION: Femoral neck fracture is a common problem in elderly patients, and it is managed with either total hip arthroplasty or hemiarthroplasty with very good outcomes. However, the reported 1-year mortality rate is as high as 33%. MATERIAL AND METHODS: This study was a retrospective cohort study. The electronic patient records were searched for all physiologically old patients with displaced femoral neck fractures that were managed with either hemiarthroplasty or total hip arthroplasty. The primary aim of this study was to estimate morbidity and mortality rates at 30 days and 1 year. The secondary outcome was to determine major complications and factors influencing mortality. RESULTS: From January 2017 to December 2018, a total of 99 patients were included in the study. Of those, 57 were female patients. The mortality rate was 15.2%. The significant predictors of death included the age at the time of surgery, readmission within 30 days of initial admission, acute renal impairment, and the need for preoperative medical intervention. Patients treated with total hip arthroplasty had lower mortality rates than those treated with hemiarthroplasty (P = .017). DISCUSSION: To the best of our knowledge, this is the first study conducted in Saudi Arabia to report detailed perioperative-related complications and outcomes following neck of femur fractures. The results of our study confirm the persistently high morbidity and mortality associated with this patient group. CONCLUSION: Efforts should be aimed at optimizing preoperative medical management, which is vital to ensure early identification of medically unfit patients.