Jonathan N Grauer

Yale University, New Haven, Connecticut, United States

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Publications (222)418.57 Total impact

  • Andre M. Samuel · Jonathan N. Grauer · Jeffrey A. Rihn · Joseph T. Labrum ·

    Journal of Spinal Disorders & Techniques 12/2015; 28(10):349-351. DOI:10.1097/BSD.0000000000000338 · 2.20 Impact Factor
  • Andre M. Samuel · Vinay K. Rathi · Jonathan N. Grauer · Joseph S. Ross ·
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    ABSTRACT: Background: The FDA approves novel, high-risk medical devices through the premarket approval (PMA) process based on clinical evidence supporting device safety and effectiveness. Devices subsequently may undergo postmarket modifications that are approved via one of several PMA supplement review tracks, usually without additional supporting clinical data. While orthopaedic devices cleared via the less rigorous 510(k) pathway have been studied previously, devices cleared through the PMA pathway and those receiving postmarket PMA supplements warrant further investigation. Questions/purposes: We asked: What are (1) the types of original orthopaedic devices receiving FDA PMA approval, (2) the number and rate of postmarket device changes approved per device, (3) the types of PMA supplement review tracks used, (4) the types of device changes approved via the various review tracks, and (5) the number of device recalls and market withdrawals that have occurred for these devices? Methods: All original PMA-approved orthopaedic devices between January 1982 and December 2014 were identified in the publically available FDA PMA database. The number of postmarket device changes approved, the PMA supplement review track used, the types of postmarket changes, and any FDA recalls for each device were assessed. Results: Seventy original orthopaedic devices were approved via the FDA PMA pathway between 1982 and 2014. These devices included 34 peripheral joint implants or prostheses, 18 spinal implants or prostheses, and 18 other devices or materials. These devices underwent a median 6.5 postmarket changes during their lifespan or 1.0 changes per device-year (interquartile range, 0.4-1.9). The rate of new postmarket device changes approved per active device, increased from less than 0.5 device changes per year in 1983 to just fewer than three device changes per year in 2014, or an increase of 0.05 device changes per device per year in linear regression analysis (95% CI, 0.04-0.07). Among the 765 total postmarket changes, 172 (22%) altered device design or components. The majority of the design changes were reviewed via either the real-time review track (n = 98; 57%), intended for minor design changes, or the 180-day review track (n = 71; 41%), intended for major design changes. Finally, a total of 12 devices had FDA recalls at some point during their lifespan, two being for hip prostheses with high revision rates. Conclusions: Relatively few orthopaedic devices undergo the FDA PMA process before reaching the market. Orthopaedic surgeons should be aware that high-risk medical devices cleared via the FDA's PMA pathway do undergo considerable postmarket device modification after reaching the market, with potential for design "drift," ie, shifting away from the initially tested and approved device designs. Clinical relevance: As the ultimate end-users of these devices, orthopaedic surgeons should be aware that even among high-risk medical devices approved via the FDA's PMA pathway, considerable postmarket device modification occurs. Continued postmarket device monitoring will be essential to limit patient safety risks.
    Clinical Orthopaedics and Related Research 11/2015; DOI:10.1007/s11999-015-4634-x · 2.77 Impact Factor
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    ABSTRACT: Background: Quality improvement in orthopaedic surgery has received increasing attention; however, there is insufficient information available about the perioperative safety of many common pediatric orthopaedic procedures. This study aimed to characterize the incidence of adverse events in a national pediatric patient sample to understand the risk profiles of common pediatric orthopaedic procedures, and to identify patients and operations that are associated with increased rates of adverse outcomes. Methods: A retrospective cohort study was conducted using the prospectively collected American College of Surgeons National Surgical Quality Improvement Program (NSQIP) Pediatric database. Pediatric patients who underwent 29 different orthopaedic procedures were identified in the 2012 NSQIP Pediatric database. The occurrence of any adverse event, infection, return to the operating room, and readmission within 30 days, were reported for each procedure. Multivariate regression was then used to identify the association of patient and operative characteristics with the occurrence of each adverse outcome. Results: A total of 8975 pediatric patients were identified. Supracondylar humerus fracture fixation was the most common procedure performed in this sample (2274 patients or 25.57% of all procedures), followed by posterior spinal fusion (1894 patients or 21.10% of all procedures). Adverse events occurred in 352 patients (3.92% of all patients). Four deaths were noted (0.04% of all patients), which only occurred in patients with nonidiopathic scoliosis undergoing spinal fusion. Infections occurred in 143 patients (1.59%), and 197 patients (2.19%) were readmitted within 30 days. Multiple patient characteristics and procedures were found to be associated with each adverse outcome studied. Conclusions: Spinal fusion, multiaxial external fixation, and fasciotomy were procedures associated with increased rates of adverse outcomes within 30 days. Patients with obesity, ASA class ≥3, and impaired cognitive status also had increased rates of adverse outcomes. The results from this study of a large, national sample of pediatric orthopaedic patients are important for benchmarking and highlight areas for quality improvement. Level of evidence: Level III-Prognostic.
    Journal of pediatric orthopedics 11/2015; DOI:10.1097/BPO.0000000000000683 · 1.47 Impact Factor
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    ABSTRACT: Background context: Multiple methods are used to measure proximal junctional angle (PJA) and diagnose proximal junctional kyphosis (PJK) after fusion for adolescent idiopathic scoliosis (AIS), however there is no gold standard. Previous studies using the three most common measurement methods, UIV (upper instrumented vertebra) +1, UIV+2, and UIV to T2, have minimized the difficulty in obtaining these measurements, and often exclude patients for which measurements cannot be recorded. Purpose: The purpose of this study is to assess the technical feasibility of measuring PJA and PJK in a series of AIS patients who have undergone posterior instrumented fusion and to assess the variability in results depending on the measurement technique utilized. Study design/setting: Retrospective cohort study. Patient sample: 460 radiographs from 98 patients with AIS who underwent posterior spinal fusion at a single institution from 2006 through 2012. Outcome measures: The outcomes for this study were the ability to obtain a PJA measurement for each method, the ability to diagnose PJK, and the inter- and intra-rater reliability of these measurements. Methods: PJA was determined by measuring the sagittal Cobb angle on preoperative and postoperative lateral upright films using the three most common methods (UIV+1, UIV+2, and UIV to T2). The ability to obtain a PJA measurement, the ability to assess PJK, and the total number of patients with a PJK diagnosis were tabulated for each method based on established definitions. Intra- and inter-rater reliability of each measurement method were assessed using intraclass correlation coefficients (ICCs). Results: A total of 460 radiographs from 98 patients were evaluated. The average number of radiographs per patient was 5.3 ± 1.7 (mean ± standard deviation), with an average follow-up of 2.1 years (780 ± 562 days). A PJA measurement was only readable on 13-18% of preoperative films and 31-49% of postoperative films (range based on measurement technique). Only 12-31% of films were able to be assessed for PJK based on established definitions. The rate of PJK diagnosis ranged from 1% to 29%. Of these diagnoses, 21-100% disappeared on at least one subsequent film for the given patient. ICC ranges for intra-rater and inter-rater reliability were 0.730-0.799 and 0.794-0.836, respectively. Conclusions: This study suggests significant limitations of the three most common methods of measuring and diagnosing PJK. The results of studies using these methods can be significantly affected based on the exclusion of patients for whom measurements cannot be made and choice of measurement technique.
    The spine journal: official journal of the North American Spine Society 11/2015; DOI:10.1016/j.spinee.2015.10.040 · 2.43 Impact Factor

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    ABSTRACT: Objective: To determine (1) the incidence of delayed surgical treatment, (2) risk factors associated with delayed surgical intervention, (3) inpatient adverse events and discharge disposition, and (4) the association of delayed surgery with inpatient adverse events. Design: Retrospective cohort study SETTING:: 2011 and 2012 National Trauma Data Bank PATIENTS/PARTICIPANTS:: All adult patients less than 50 years of age with femoral neck fractures INTERVENTION:: Not applicable MAIN OUTCOME MEASURES:: (1) Time to surgical intervention after inpatient admission (2) Odds ratio for delayed surgery (later than 24 hours after admission) (3) Incidence of inpatient adverse events and discharge disposition (3) Rates of inpatient adverse events and discharge disposition (4) Odds ratio for occurrence of serious adverse events, minor adverse events, and any adverse events. Results: Of a total of 1,361 patients, 67.8% of patients underwent surgery within 24 hours of presentation. In multivariate analysis (controlling for patient and injury characteristics), Charlson Comorbidity Index of 3+ compared to Charlson Comorbidity Index of 0; odds ratio [OR]: 3.62), pelvic fracture (OR: 2.01), and treatment at an ACS level I trauma center (compared to levels II - IV; OR: 1.56) were associated with delayed surgery. The overall rate of mortality and inpatient adverse events was 0.2% and 12.1%, respectively. Delayed surgery was independently associated with increased occurrence of serious adverse events, minor adverse events, and any adverse events. Conclusions: While majority of non-elderly patients with femoral neck fractures underwent surgery within the first 24 hours of admission and had good outcomes in the short-term, certain subpopulations have higher risk of delayed surgery. As delayed surgery is associated with worse outcomes short-term and long-term outcomes, efforts should focus on expediting care of these patients. Level of evidence: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.
    Journal of orthopaedic trauma 10/2015; DOI:10.1097/BOT.0000000000000456 · 1.80 Impact Factor

  • Spine 10/2015; 15(10):S173-S174. DOI:10.1016/j.spinee.2015.07.209 · 2.30 Impact Factor
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    ABSTRACT: Background: The use of large national databases for clinical research has increased recently in the field of trauma care as they allow study of rare events without the logistical difficulties of a prospective study. However, many of these databases use administrative billing codes, such as International Classification of Disease-9th Rev. (ICD-9) codes, to identify preexisting patient comorbidities. While the accuracy of these billing codes for research purposes has previously been called into question, this has not been studied in a trauma population. Methods: All patients with proximal tibia fractures in the 2011 and 2012 American College of Surgeons' National Trauma Data Bank were reviewed. Rates of 12 individual comorbidities in this population were computed using both ICD-9 diagnosis codes and also National Trauma Data Bank chart-abstracted variables. The sensitivity was computed for ICD-9 coding of each comorbidity taking chart-abstracted data elements as criterion standard. With the use of multivariate logistic regression, controlling for age and Injury Severity Score (ISS), the odds ratio for mortality was computed for each comorbidity, using both ICD-9 diagnoses and chart-abstracted diagnoses. Results: A total of 32,441 patients with proximal tibia fractures were identified. The sensitivities of ICD-9 billing codes for the comorbidities analyzed ranged from 18.8% for previous myocardial infarction to 2.4% for alcoholism. In individual multivariate analyses of each comorbidity, there was a change in the statistical significance of the odds ratio for mortality for 6 of 12 comorbidities analyzed. Conclusion: Researchers and those evaluating research in the field of trauma should carefully consider the accuracy of data elements in future studies, especially ICD-9-coded comorbidity diagnoses.
    09/2015; 79(4):622-630. DOI:10.1097/TA.0000000000000805
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    ABSTRACT: Background: It is not known which adverse events occur more commonly following revision than following primary total joint arthroplasty. Methods: Patients undergoing total hip arthroplasty (THA) or total knee arthroplasty (TKA) during 2011 to 2013 as part of the America College of Surgeons National Surgical Quality Improvement Program were identified. Rates of adverse events were compared between patients undergoing primary and patients undergoing revision procedures with adjustments for demographic and comorbidity characteristics. Results: In total, 48307 THA patients and 70605 TKA patients met inclusion criteria. Of the THA patients, 43247 (89.5%) underwent primary procedures, while 5060 (10.5%) underwent revision procedures. Of the TKA patients, 65694 (93.0%) underwent primary procedures, while 4911 (7.0%) underwent revision procedures. Patients undergoing revision procedures had higher rates of systemic sepsis (for THA, 0.3% vs 0.1%, adjusted relative risk [RR], 3.5; 95% confidence interval [CI], 1.7-7.0; P < .001; for TKA, 0.3% vs 0.1%, adjusted RR, 3.0; 95% CI, 1.7-5.2, P < .001), deep incisional surgical site infection (for THA, 1.3% vs 0.3%, adjusted RR, 4.3; 95% CI, 3.2-5.8, P < .001; for TKA, 0.7 vs 0.2%, RR, 4.0; 95% CI, 2.7-5.9, P < .001), and organ/space infection (for THA, 1.8% vs 0.2%, RR, 7.4; 95% CI, 5.4-10.0, P < .001; for TKA, 1.1% vs 0.1%, adjusted RR, 7.5; 95% CI, 5.4-10.6, P < .001). Patients undergoing revision procedures did not have higher rates of pulmonary embolism or deep vein thrombosis (P ≥ .05 for each). Conclusions: Public reporting of adverse events should be interpreted in the context of the differences between primary and revision procedures, and reimbursement systems should reflect the greater amount of postoperative care that patients undergoing revision procedures require.
    The Journal of arthroplasty 09/2015; DOI:10.1016/j.arth.2015.09.033 · 2.67 Impact Factor
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    ABSTRACT: OBJECT Surgery for subdural hematoma (SDH) is a commonly performed neurosurgical procedure. This study identifies patient characteristics associated with adverse outcomes and prolonged length of stay (LOS) in patients who underwent surgical treatment for SDH. METHODS All patients in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) who were treated via craniotomy or craniectomy for SDH between 2005 and 2012 were identified. Patient demographics, comorbidities, and 30-day outcomes were described. Multivariate regression was used to identify predictors of adverse events. RESULTS A total of 746 surgical procedures performed for SDH were identified and analyzed. Patients undergoing this procedure were 64% male with an average age (± SD) of 70.9 ± 14.1 years. The most common individual adverse events were death (17%) and intubation for more than 48 hours (19%). In total, 34% experienced a serious adverse event other than death, 8% of patients returned to the operating room (OR), and the average hospital LOS was 9.8 ± 9.9 days. In multivariate analysis, reduced mortality was associated with age less than 60 years (relative risk [RR] = 0.47, p = 0.017). Increased mortality was associated with gangrene (RR = 3.5, p = 0.044), ascites (RR = 3.00, p = 0.006), American Society of Anesthesiologists (ASA) Class 4 or higher (RR = 2.34, p = 0.002), coma (RR = 2.25, p < 0.001), and bleeding disorders (RR = 1.87, p = 0.003). Return to the OR was associated with pneumonia (RR = 3.86, p = 0.044), male sex (RR = 1.85, p = 0.015), and delirium (RR = 1.75, p = 0.016). Serious adverse events were associated with ventilator dependence preoperatively (RR = 1.86, p < 0.001), dialysis (RR = 1.44, p = 0.028), delirium (RR = 1.40, p = 0.005), ASA Class 4 or higher (RR = 1.36, p = 0.035), and male sex (RR = 1.29, p = 0.037). Similarly, LOS was increased in ventilator dependent patients by 1.56-fold (p = 0.002), in patients with ASA Class 4 or higher by 1.30-fold (p = 0.006), and in delirious patients by 1.29-fold (p = 0.008). CONCLUSIONS Adverse outcomes are common after surgery for SDH. In this study, 18% of the patients died within 30 days of surgery. Factors associated with adverse outcomes were identified. Patients and families should be counseled about the serious risks of morbidity and death associated with acute traumatic SDH requiring surgery.
    Journal of Neurosurgery 08/2015; DOI:10.3171/2015.2.JNS142721 · 3.74 Impact Factor
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    ABSTRACT: Magnetic resonance imaging (MRI) is often used in the evaluation of degenerative conditions of the cervical spine. However, the agreement of interpreting and reporting varying degenerative findings on cervical MRI has not been well assessed. To compare the inter-rater and intra-rater agreement of MRI findings between common degenerative findings of the cervical spine. Retrospective diagnostic study. Forty-eight patients who underwent routine cervical spine MRI at our institution between January 2011 and June 2012. Reviewers evaluated each MRI study at each vertebral level for disc hydration, disc space height, central stenosis, foraminal stenosis, endplate changes, spondylolithesis, and cord signal change. A panel of two orthopaedic spine surgeons and four musculoskeletal radiologists independently reviewed 48 sets of T2-weighted axial and sagittal MRI sequences for a series of pre-selected criteria, and their findings were compared with those of the other panelists to determine inter-rater agreement. Each panelist also re-reviewed the first ten studies to determine intra-rater agreement. Absolute inter-rater and intra-rater agreements were then calculated and compared for different findings. A modified analysis ignored disagreements between the least severe grades of findings in order to determine the inter-rater and intra-rater agreements of the most clinically important severity grades. There were no sources of funding or conflicts of interest related to this study. Absolute inter-rater agreement ranged from 54.6% to 95.0%. Disc hydration (54.6%), central stenosis (72.7%), and foraminal stenosis (73.1%) demonstrated the lowest inter-rater agreement, while spondylolisthesis (95.0%) and cord signal change (92.9%) demonstrated the highest agreement. The modified analysis found better inter-rater agreement, ranging from 80.9%-95.0%. Absolute intra-rater agreement ranged from 74.2% to 94.7%. The modified analysis again found better agreement, ranging from 85.0%-94.7%. As would be expected, overall intra-rater agreement (81.6%, 95% C.I., 78.9%-84.3%) was higher than inter-rater agreement (75.7%, 95% C.I., 74.4%-77.0%). The clinical specialty of the reviewer had no significant impact on inter- or intra-rater agreement. MRI findings play an important role in the management of patients with cervical spine conditions. For this reason, consistent descriptions of these findings are essential and physicians should be aware of the relative reliability of these findings. This systematic study developed standardized grading criteria and nomenclature for common clinically significant MRI findings in the cervical spine. Even in this optimized research setting, we found significant ranges in agreement across these MRI findings. In the clinical setting inter- and intra-rater agreements may be lower and the range of agreements between findings may be greater. Physicians should be aware of inconsistencies inherent in the interpretation of cervical MRI findings and should be aware that some findings demonstrate lower agreement than others. Copyright © 2015. Published by Elsevier Inc.
    The spine journal: official journal of the North American Spine Society 08/2015; DOI:10.1016/j.spinee.2015.08.026 · 2.43 Impact Factor
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    ABSTRACT: Retrospective cohort study. To determine the incidence and risk factors for short-term morbidity following posterior spinal fusion (PSF) for neuromuscular scoliosis (NMS). NMS is a challenging spinal deformity for which PSF is often recommended. There is a lack of information on risk factors for short-term adverse outcomes after PSF for NMS. Patients who underwent PSF for NMS during 2012 and 2013 were identified from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) Pediatric database. Patient characteristics were tested for association with adverse events, infectious complications, extended length of stay (LOS), and readmission using multivariate regression. Of the 940 NMS patients identified, 133 (14.1%) had an adverse event and 99 (10.5%) had a severe adverse event. American Society of Anesthesiologists (ASA) classification ≥3 was found to be the only independent risk factor for any adverse event (relative risk [RR] 2.2, p = 0.012) and severe adverse events (RR 2.5, p = 0.008). Infectious complications were associated with body mass index (BMI)-for-age ≥95 percentile (RR 2.8, p = 0.005), ASA classification ≥3 (RR 5.9, p = 0.003), and instrumentation to the pelvis (RR 1.8, p = 0.039).A total of 254 patients (27%) spent longer than a week in the hospital postoperatively, and ASA classification ≥3 (RR 2.3, p<0.001), preoperative seizure disorder (RR 1.4, p = 0.002), previous cardiac surgery (RR 1.6, p = 0.004), operative time ≥470 minutes (RR 1.8, p<0.001), and ≥13 levels instrumented (RR 1.9, p = 0.001) were associated with extended LOS.Seventy-six patients (8.1%) were readmitted, and BMI-for-age ≥ 95 percentile (RR 1.8, p = 0.033) was the only risk factor found for readmission. The identified factors associated with poor short-term outcomes after PSF for NMS can be used as benchmark data, be useful for optimizing patient care, and can inform future studies in these patients.
    Spine 08/2015; 15(10). DOI:10.1097/BRS.0000000000001093 · 2.30 Impact Factor

  • Orthopaedic Surgery 08/2015; 7(3):281-5. DOI:10.1111/os.12187
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    ABSTRACT: We conducted a study to characterize the risk factors for extended length of stay (LOS) and readmission after primary total shoulder arthroplasty (TSA). Patients who were 60 years or older and underwent TSA between 2011 and 2012 were identified from the American College of Surgeons National Surgical Quality Improvement Program database. Bivariate and multivariate analyses were used to test patient characteristics for association with extended LOS and readmission within 30 days. Extended LOS was defined as LOS of more than 3 days (90th percentile LOS). Of the 1505 TSA patients identified, 49 (3.3%) were readmitted. Multivariate analysis revealed that extended LOS was independently associated with age 70 years or older and history of diabetes. Readmission was independently associated with history of heart disease and history of hypertension. The identified risk factors may be useful for preoperative discussions, surgical decision-making, and postoperative planning for THA patients.
    American journal of orthopedics (Belle Mead, N.J.) 08/2015; 44(8):E268-71.

Publication Stats

3k Citations
418.57 Total Impact Points


  • 1998-2015
    • Yale University
      • Department of Orthopaedics and Rehabilitation
      New Haven, Connecticut, United States
  • 1997-2015
    • Yale-New Haven Hospital
      New Haven, Connecticut, United States
  • 2012
    • Duke University
      Durham, North Carolina, United States
  • 2011
    • Columbia University
      New York, New York, United States
  • 2009
    • Kansas City VA Medical Center
      Kansas City, Missouri, United States
  • 2008
    • University of New Haven
      New Haven, Connecticut, United States
  • 2003-2007
    • Thomas Jefferson University
      • • Rothman Institute
      • • Department of Orthopaedic Surgery
      Philadelphia, Pennsylvania, United States
  • 2006
    • University of Pittsburgh
      • Department of Orthopaedic Surgery
      Pittsburgh, Pennsylvania, United States
  • 2003-2005
    • Rothman Institute
      Philadelphia, Pennsylvania, United States
  • 2004
    • Boston University
      • Division of Orthopaedic Surgery
      Boston, Massachusetts, United States
    • Keio University
      • Department of Orthopedic Surgery
      Edo, Tōkyō, Japan