Searched for: person:goldsj04
Total Joint Replacement of the Lumbar Spine: 12-Month Pain and Functional Outcomes From an Investigational Device Exemption Clinical Trial
Nunley, Pierce D; Sielatycki, J Alex; Humphreys, S Craig; Hodges, Scott D; Block, Jon E; Coric, Domagoj; Goldstein, Jeffrey A
BACKGROUND:Lumbar fusion eliminates motion at the operative level and is associated with altered load transfer and adjacent segment degeneration. Total joint replacement (TJR) of the lumbar spine is a motion segment reconstruction procedure performed via a bilateral transforaminal approach that allows direct neural decompression and replacement of both disc and facet function. This prospective investigational device exemption clinical trial compared TJR with a concurrent, propensity-score-weighted real-world evidence cohort treated with either instrumented transforaminal lumbar interbody fusion (TLIF) or posterior lumbar interbody spine fusion (PLIF). METHODS:. RESULTS:= 0.04). CONCLUSIONS:Substantial decreases in back impairment and pain severity were realized in both study groups. However, longitudinal improvement in ODI significantly favored patients treated with TJR. CLINICAL RELEVANCE/CONCLUSIONS:Lumbar TJR combines decompression with motion preservation in a single procedure, potentially offering an alternative to fusion in selected patients. The advantage of utilizing a standard posterior operative approach with TJR is that it allows for direct decompression of the neural elements prior to implant placement. LEVEL OF EVIDENCE/METHODS:2b.
PMID: 41120216
ISSN: 2211-4599 
CID: 5956832 
24-month patient-reported outcomes for a novel lumbar total joint replacement
Sivaganesan, Ahilan; Koscielski, Marissa; Kabani, Ashmal Sami; Sielatycki, J Alex; Goldstein, Jeffrey; Riesgraf, Brady; Humphreys, Craig; Hodges, Scott
BACKGROUND/UNASSIGNED:Lumbar fusion remains a prevalent treatment for degenerative conditions; however, its limitations have sparked interest in alternative motion-sparing procedures. Our study evaluates 24-month postoperative patient-reported outcomes from an OUS pilot clinical study on a novel lumbar total joint replacement (TJR) for degenerative conditions. METHODS/UNASSIGNED:Data was collected from 63 patients, of which 56 patients fulfilled the inclusion criteria. Self-reported measures collected for this study are Oswestry Disability Index (ODI), Numeric Rating Scale (NRS), Minimal Symptom State (MSS), Minimal Clinical Important Difference (MCID), Substantial Clinical Benefit (SCB). This retrospective analysis of prospective, IRB-approved collected data reports 24 month patient-reported outcomes on a cohort receiving lumbar TJR. The cohort includes skeletally mature individuals who underwent lumbar TJR at 1-3 Lumbar levels (L1-S1) between 2008 and 2019. Conservative treatment was mandatory for at least 3 months unless facing a neurologic emergency or intractable pain. Descriptive analysis was performed for continuous variables and frequencies were calculated for categorical variables. RESULTS/UNASSIGNED:63 patients were treated with lumbar TJR and electively participated in data collection after 12 months. 56 patients, with age ranging from 19 to 82 years, and 93 levels were treated with lumbar TJR at 1-3 lumbar levels and had complete follow-up data at 12 and 24 m. No device-related adverse events were reported during the 12-to-24-month follow-up window. At 24 months, patients exhibited sustained clinical improvement in back pain, leg pain, and disability scores, similar to the 12-month observations. An overall improvement in Minimal Clinically Important Difference (MCID) was also noted. CONCLUSIONS/UNASSIGNED:Our study shows consistent improvement in PROs, indicating the clinical improvement of lumbar TJR at both the 12-month and 24-month follow-up points, compared to baseline. Acknowledging limitations, including the lack of comparative data with standard of care, these findings suggest that TJR may be a treatment option for indicated lumbar degenerative pathologies.
PMCID:12284549
PMID: 40704167
ISSN: 2666-5484 
CID: 5901762 
Three-Dimensional Fluoroscopic System to Assess Robotically Placed Pedicle Screws: Should We Confirm Robotic Pedicle Screw Placement With Advanced Imaging?
Lebovic, Jordan; Trudeau, Maxwell; Charalambous, Lefko T; Venkat, Nitya; Gallina, Jason; Goldstein, Jeffrey A
STUDY DESIGN/METHODS:Retrospective cohort study. OBJECTIVE:The purpose of this study is to determine the utility of advanced imaging to confirm the placement of robotic pedicle screws. SUMMARY OF BACKGROUND DATA/BACKGROUND:With increasing robotic adoption, certain institutions and surgeons have developed protocols for obtaining 3D intraoperative imaging after robotic pedicle screw placement to ensure proper hardware placement. No studies have assessed the utility of these protocols relative to the potential risks of increased radiation exposure and operative time. The purpose of this study is to determine if we should be obtaining advanced imaging to confirm the placement of robotic pedicle screws. METHODS:This is a single institution retrospective cohort study of patients from May 2022 to July 2023 who underwent lumbar spinal fusion by a high-volume orthopedic spine surgeon at a level 1 metropolitan hospital. All cases used combined robotics and navigation systems for pedicle screw placement and intraoperative 3D imaging for evaluation of screw position. Pedicle screw accuracy was assessed using the Gertzbein and Robbins system (GRS). Acceptable pedicle screw position was defined as GRS A or B. RESULTS:Seventy patients with 354 robotically placed pedicle screws were assessed with intraoperative 3D fluoroscopy. All pedicle screws were placed in either a GRS type A or type B position. Three hundred forty-seven were placed in a GRS A classification (99.2%, 351/354), and 3 were placed in a GRS B classification (0.08% 3/354). No patients had screw-related complications. The average radiation dosage of 3D imaging was 289.7±164.6 mGy. CONCLUSION/CONCLUSIONS:The robotic system places pedicle screws accurately without 3D intraoperative imaging. Given the increased radiation and operative time associated with 3D imaging protocols 3D imaging scans should only be obtained in cases with heightened clinical concern. LEVEL OF EVIDENCE/METHODS:Level IV.
PMID: 39480015
ISSN: 2380-0194 
CID: 5747242 
Total Joint Replacement of the Lumbar Spine: The Future of Motion Preservation
Goldstein, Jeffrey A; Nunley, Pierce D; Sivaganesan, Ahilan; Alex Sielatycki, J; Jorgensen, Anton Y; Khachatryan, Armen; Humphreys, S Craig; Block, Jon E; Hodges, Scott D; Nel, Louis J; Coric, Domagoj
PMID: 40154997
ISSN: 2211-4599 
CID: 5817782 
Proficiency Development and Learning Curve in Robot-Assisted Spine Surgery Using the ExcelsiusGPS® System: Experience From a Single Institution
Shi, Chen; Tong, Yixuan; Harris, Liam; Owusu-Sarpong, Stephane; Goldstein, Jeffrey
STUDY DESIGN/METHODS:system at a single institution. METHODS:A total of 95 patients (541 screws) who underwent RASS between 2021 and 2022 were included. Variables including operative time, robot registration time, screw placement time, fluoroscopy utilization, and complications were analyzed. Statistical analysis was performed using descriptive statistics and two-sample t-tests. RESULTS:The average operative time significantly decreased after the first 14 cases, indicating a learning curve. However, no significant improvement was observed in robot registration time. Notably, screw placement time significantly improved after approximately 13 cases. When controlling for the number of levels fused, the trends remained consistent. CONCLUSIONS:system and demonstrated rapid proficiency development. Our findings highlight the relatively quick learning curve of 1 RASS system.
PMID: 38635306
ISSN: 2192-5682 
CID: 5734592 
In Scheuermann's kyphosis, a proximal UIV and postop kyphosis value close to patients' PI decreases the risk of PJK
Sarwahi, Vishal; Hasan, Sayyida; Galina, Jesse; Atlas, Aaron; Fakhoury, Jordan; Wendolowski, Stephen; Goldstein, Jeffrey; Dowling, Thomas J; Molloy, Sean; Yu, Haiming; Khoyratty, Sara; Lo, Yungtai; Amaral, Terry; Lui, Darren F
PURPOSE:Prevalence of proximal junctional kyphosis (PJK) in Scheuermann's kyphosis (SK) varies between 24 and 40%. Multiple factors have been implicated, including kyphosis overcorrection, failure to include proximal end vertebra, and implant choice. This study aimed to determine the goal correction parameters based upon patients' pelvic incidence, and UIV to decrease PJK in Scheuermann's kyphosis. METHODS:X-ray and chart review of SK patients operated with all pedicle screw (PS), hybrid fixation (HF), and anterior/posterior fusions with hybrid fixation (AP). T1/T2 were grouped together as proximal fusion groups compared to T3 and distal groups. RESULTS:96 total patients: PS (n = 41), HF (n = 24), and AP (n = 31). Overall, at early postop 12 (12.5%) patients had PJK. At final follow-up, 33 (34.4%) had PJK. There was no significant difference between groups at early postop (p = 0.86) or final follow-up (p = 0.67). When correcting kyphosis-PI to > - 10.0° and UIV was chosen to be T1 or T2, PJK developed in 6.1% of patients at final follow-up; when fusing to T1/T2 but with kyphosis-PI < - 10.0°, 38.9% of patients developed PJK. With kyphosis-PI > - 10.0° and UIV at T3 or below, 37.0% of patients developed PJK at final follow-up. When fusing to T3 or below but failing to correct kyphosis-PI to > - 10.0°, 77.8% of patients developed PJK. CONCLUSION:Selecting proximal UIV and avoiding kyphosis-PI mismatch can significantly decrease the prevalence of PJK rather than surgical technique or implant choice. Surgeons treating SK should, therefore, aim to correct kyphosis closer to the patient's pelvic incidence and choose T2/T1 as UIV.
PMID: 35389165
ISSN: 2212-1358 
CID: 5675762 
57. Staged vs same-day circumferential thoracolumbar spine surgery [Meeting Abstract]
Lim, P; Bono, J; Deveza, L; Protopsaltis, T S; Goldstein, J A
BACKGROUND CONTEXT: Complexity and potential risk to the patient in the perioperative period have led to circumferential spine fusion surgery often being performed in a staged fashion, whether in the same admission or split admission. There is no established protocol or clear evidence that this is beneficial to the patient. Previous studies of this topic have tended to favor same-day surgery to staged surgery with decreased blood loss, length of stay and cost. Multiple factors can potentially contribute to morbidity for these patients, including multiple insults activating inflammatory response and repeated exposures to anesthetics. PURPOSE: To determine if there is a difference in complication profile between staged vs same-day circumferential, multi-approach thoracolumbar spine surgery. STUDY DESIGN/SETTING: A retrospective single-center cohort assessment for adult patients undergoing multiple approach thoracolumbar fusion surgery from January 2012 to December 2021 in an academic center. PATIENT SAMPLE: All patients who underwent anterior or lateral approaches for the purpose of disc preparation and fusion and subsequently had a posterior approach for screws were included. The same-day group had both parts performed under the same anesthetic vs the staged group who had separate anesthetics on separate days in a planned fashion OUTCOME MEASURES: Primary outcome: complication rate at 90 days. 
Secondary Outcomes: complication profile - readmission, reoperation, DVT/PE, Ileus, delayed extubation, infection. Surgical characteristics - length of stay, operative time, estimated blood loss, transfusion rates. Demographic characteristics -ages, sex, BMI, diabetes, smoking habits. 
METHOD(S): A retrospective single-center cohort assessment for adult patients undergoing multiple approach thoracolumbar fusion surgery from January 2012 to December 2021. Patients who underwent anterior or lateral approaches for the purpose of disc preparation and fusion and subsequently had a posterior approach for screws were included. The same-day group had both parts performed under the same anesthetic vs the staged group who had separate anesthetics on separate days in a planned fashion. Statistical comparison of demographic data (ages, sex, BMI, diabetes, smoking habits), complication rates (readmission, reoperation, DVT/PE, Ileus, delayed extubation, infection) and surgical characteristics (operative time, length of stay, estimated blood loss, transfusion rates) was made between the two groups. 
RESULT(S): A total of 1039 patients (918 same-day vs 121 staged) underwent circumferential thoracolumbar spine surgery from 2012 to 2021. The groups differed slightly in demographics with the staged group being slightly older (56.7 yrs same-day vs 59.6 yrs staged, p < 0.05) and had a higher incidence of smoking (6.6% same-day vs 22.3% staged, p < 0.001). The average time between stages was 2.5 days (SD 2.15). The total operative time was significantly longer in the staged group (354 min same-day vs 523 min staged, p < 0.001). The overall complication rate was not significantly different between the two groups (22.0% same-day vs 29.8% staged, p=0.748). Analysis of specific complications demonstrated an increase in DVT/PE (1.4% same-day vs 11.6% staged, p < 0.001) and postoperative ileus (4.2% same-day vs 15.7% staged, p < 0.001) in the staged group. The length of hospital admission was longer in the staged group (4.6 days same-day vs 7.7 days staged, p < 0.0001). 
CONCLUSION(S): Staging circumferential surgery did not demonstrate statistical increase in complications at 90 days. However, review of specific postoperative complications including DVT/PE and postoperative ileus demonstrated significant increase in the staged group compared to the same-day group. The staged patients had a significantly longer hospital stay and their total surgery time was significantly longer. These would ultimately contribute heavily to hospital costs. There were potential limitations in the comparison of the groups with the staged patients being older and more likely to smoke. The study group recommends considering if staging the surgery is required as it can lead to increase in DVT/PE and postoperative ileus with prolonged stay in hospital. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright 
EMBASE:2019804055
ISSN: 1878-1632 
CID: 5510752 
Intrathecal Fentanyl With a Myofascial Plane Block in Open Lumbar Surgeries: A Case Series
Metcalf, Tyler; Sielatycki, J Alex; Schatzman, Nathan; Devin, Clinton J; Goldstein, Jeffrey A; Hodges, Scott Dean
BACKGROUND:Acute postoperative pain control after lumbar surgery is imperative to minimizing long-term narcotic use and associated adverse sequela. The safety of intrathecal morphine for postoperative pain management in spine surgery has been investigated; however, to date, no studies have investigated the safety of intrathecal fentanyl with a myofascial plane (MP) block in lumbar procedures. OBJECTIVE:To assess the safety profile of intrathecal fentanyl with a MP block administered during lumbar surgery and the subsequent utilization of postoperative intravenous opioids. METHODS:An intraoperative intrathecal injection of fentanyl and a MP block was administered in 40 patients undergoing open lumbar reconstructive surgery. The procedure performed was an open decompression with lumbar total joint reconstruction at 1 to 3 lumbar levels. Postoperative complications including urinary retention, respiratory depression, and need for IV opioid use were recorded. RESULTS:Postoperatively, none of the study patients required IV opioid medication for supplemental pain control. Thirty-six patients (85%) were discharged same day or before 23 hours postoperatively. No intrathecal fentanyl-related perioperative complications were noted. None of the 40 listed patients experienced urinary retention or delayed respiratory depression. One patient (2%) experienced orthostatic hypotension at postoperative day 1, which resolved on discontinuation of oral oxycodone. CONCLUSION/CONCLUSIONS:Intrathecal fentanyl and MP block may be a safe option for perioperative pain control and may reduce the need for supplemental intravenous opioids without increased risk of respiratory depression, urinary retention, or other side effects. Further studies are necessary to compare the efficacy of intrathecal fentanyl with other analgesia techniques.
PMID: 35867079
ISSN: 2332-4260 
CID: 5276032 
Personal Interventions for Reducing Exposure and Risk for Outdoor Air Pollution: An Official American Thoracic Society Workshop Report
Laumbach, Robert J; Cromar, Kevin R; Adamkiewicz, Gary; Carlsten, Christopher; Charpin, Denis; Chan, Wanyu R; de Nazelle, Audrey; Forastiere, Francesco; Goldstein, Jeffrey; Gumy, Sophie; Hallman, William K; Jerrett, Michael; Kipen, Howard M; Pirozzi, Cheryl S; Polivka, Barbara J; Radbel, Jared; Shaffer, Ronald E; Sin, Don D; Viegi, Giovanni
Poor air quality affects the health and wellbeing of large populations around the globe. Although source controls are the most effective approaches for improving air quality and reducing health risks, individuals can also take actions to reduce their personal exposure by staying indoors, reducing physical activity, altering modes of transportation, filtering indoor air, and using respirators and other types of face masks. A synthesis of available evidence on the efficacy, effectiveness, and potential adverse effects or unintended consequences of personal interventions for air pollution is needed by clinicians to assist patients and the public in making informed decisions about use of these interventions. To address this need, the American Thoracic Society convened a workshop in May of 2018 to bring together a multidisciplinary group of international experts to review the current state of knowledge about personal interventions for air pollution and important considerations when helping patients and the general public to make decisions about how best to protect themselves. From these discussions, recommendations were made regarding when, where, how, and for whom to consider personal interventions. In addition to the efficacy and safety of the various interventions, the committee considered evidence regarding the identification of patients at greatest risk, the reliability of air quality indices, the communication challenges, and the ethical and equity considerations that arise when discussing personal interventions to reduce exposure and risk from outdoor air pollution.
PMID: 34468284
ISSN: 2325-6621 
CID: 4998432 
Placental Pathology in COVID-19
Shanes, Elisheva D; Mithal, Leena B; Otero, Sebastian; Azad, Hooman A; Miller, Emily S; Goldstein, Jeffery A
OBJECTIVES:To describe histopathologic findings in the placentas of women with coronavirus disease 2019 (COVID-19) during pregnancy. METHODS:Pregnant women with COVID-19 delivering between March 18, 2020, and May 5, 2020, were identified. Placentas were examined and compared to historical controls and women with placental evaluation for a history of melanoma. RESULTS:Sixteen placentas from patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were examined (15 with live birth in the third trimester, 1 delivered in the second trimester after intrauterine fetal demise). Compared to controls, third trimester placentas were significantly more likely to show at least one feature of maternal vascular malperfusion (MVM), particularly abnormal or injured maternal vessels, and intervillous thrombi. Rates of acute and chronic inflammation were not increased.The placenta from the patient with intrauterine fetal demise showed villous edema and a retroplacental hematoma. CONCLUSIONS:Relative to controls, COVID-19 placentas show increased prevalence of decidual arteriopathy and other features of MVM, a pattern of placental injury reflecting abnormalities in oxygenation within the intervillous space associated with adverse perinatal outcomes. Only 1 COVID-19 patient was hypertensive despite the association of MVM with hypertensive disorders and preeclampsia. These changes may reflect a systemic inflammatory or hypercoagulable state influencing placental physiology.
PMID: 32441303
ISSN: 1943-7722 
CID: 4831462