9 results on '"Prashant S. Kelkar"'
Search Results
2. The effect of ketorolac on posterior minimally invasive transforaminal lumbar interbody fusion: an interim analysis from a randomized, double-blinded, placebo-controlled trial
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Gustavo Anton, Jacob Jasinski, Evan Lytle, Dejan Slavnic, Ammar Alsalahi, Diana Sigler, Daniel A Carr, Doris Tong, Elise Yoon, Robert W McCabe, Prashant S. Kelkar, Michael H Lawless, Karl Kado, Ascher Kaufmann, Boyd Richards, Chad F Claus, Lucas Garmo, Peter Bono, Clifford Houseman, and Teck M Soo
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Adult ,Visual analogue scale ,medicine.medical_treatment ,Context (language use) ,Placebo ,Lumbar ,Medicine ,Humans ,Minimally Invasive Surgical Procedures ,Orthopedics and Sports Medicine ,Prospective Studies ,Retrospective Studies ,Lumbar Vertebrae ,business.industry ,Interim analysis ,Oswestry Disability Index ,Ketorolac ,Spinal Fusion ,Treatment Outcome ,Spinal fusion ,Anesthesia ,Surgery ,Neurology (clinical) ,business ,medicine.drug - Abstract
Postoperative pain control following posterior lumbar fusion continues to be challenging and often requires high doses of opioids for pain relief. The use of ketorolac in spinal fusion is limited due to the risk of pseudarthrosis. However, recent literature suggests it may not affect fusion rates with short-term use and low doses.We sought to demonstrate noninferiority regarding fusion rates in patients who received ketorolac after undergoing minimally invasive (MIS) posterior lumbar interbody fusion. Additionally, we sought to demonstrate ketorolac's opioid-sparing effect on analgesia in the immediate postoperative period.This is a prospective, randomized, double-blinded, placebo-controlled trial. We are reporting our interim analysis.Adults with degenerative spinal conditions eligible to undergo a one to three-level MIS transforaminal lumbar interbody fusion (TLIF).Six-month and 1-year radiographic fusion as determined by Suk criteria, postoperative opioid consumption as measured by intravenous milligram morphine equivalent, length of stay, and drug-related complications. Self-reported and functional measures include validated visual analog scale, short-form 12, and Oswestry Disability Index.A double-blinded, randomized placebo-controlled, noninferiority trial of patients undergoing 1- to 3-level MIS TLIF was performed with bone morphogenetic protein (BMP). Patients were randomized to receive a 48-hour scheduled treatment of either intravenous ketorolac (15 mg every 6 hours) or saline in addition to a standardized pain regimen. The primary outcome was fusion. Secondary outcomes included 48-hour and total postoperative opioid use demonstrated as milligram morphine equivalence, pain scores, length of stay (LOS), and quality-of-life outcomes. Univariate analyses were performed. The present study provides results from a planned interim analysis.Two hundred and forty-six patients were analyzed per protocol. Patient characteristics were comparable between the groups. There was no significant difference in 1-year fusion rates between the two treatments (p=.53). The difference in proportion of solid fusion between the ketorolac and placebo groups did not reach inferiority (p=.072, 95% confidence interval, -.07 to .21). There was a significant reduction in total/48-hour mean opioid consumption (p.001) and LOS (p=.001) for the ketorolac group while demonstrating equivalent mean pain scores in 48 hours postoperative (p=.20). There was no significant difference in rates of perioperative complications.Short-term use of low-dose ketorolac in patients who have undergone MIS TLIF with BMP demonstrated noninferior fusion rates. Ketorolac safely demonstrated a significant reduction in postoperative opioid use and LOS while maintaining equivalent postoperative pain control.
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- 2021
3. The effect of ketorolac on posterior minimally invasive lumbar spinal fusion: an interim analysis from a randomized, double-blinded, placebo-controlled trial
- Author
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Dejan Slavnic, Teck M Soo, Jacob Jasinski, Ammar Alsalahi, Lucas Garmo, Boyd Richards, Evan Lytle, Chad F Claus, Clifford Houseman, Peter Bono, Robert W McCabe, Prashant S. Kelkar, Karl Kado, Doris Tong, Elise Yoon, Daniel A Carr, Michael H Lawless, Gustavo Anton, Ascher Kaufmann, and Diana Sigler
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Visual analogue scale ,business.industry ,medicine.medical_treatment ,Placebo-controlled study ,Interim analysis ,Placebo ,Oswestry Disability Index ,Ketorolac ,Lumbar ,Spinal fusion ,Anesthesia ,medicine ,Surgery ,Orthopedics and Sports Medicine ,Neurology (clinical) ,business ,medicine.drug - Abstract
BACKGROUND CONTEXT Postoperative pain control following posterior lumbar fusion continues to be challenging and often requires high doses of opioids for pain relief. The use of ketorolac in spinal fusion is limited due to the risk of pseudarthrosis. However, recent literature suggests it may not affect fusion rates with short-term use and low doses. PURPOSE We sought to demonstrate non-inferiority regarding fusion rates in patients who received ketorolac after undergoing minimally invasive (MIS) posterior lumbar fusions. Additionally, we sought to demonstrate ketorolac's opioid-sparing effect on analgesia in the immediate postoperative period. STUDY DESIGN/SETTING This is a prospective, randomized, double-blinded, placebo-controlled trial. We are reporting our interim analysis. PATIENT SAMPLE Adults with degenerative spinal conditions eligible to undergo a 1- to 3-level minimally invasive lumbar spinal fusion. OUTCOME MEASURES Six-month and 1-year radiographic fusion as determined by Suk criteria, postoperative opioid consumption as measured by intravenous milligram morphine equivalent (MME), length of stay (LOS), and drug-related complications. Self-reported and functional measures include validated visual analog scale (VAS), short-form 12 (SF-12), and Oswestry Disability Index (ODI). METHODS A double-blinded, randomized placebo-controlled, non-inferiority trial of patients undergoing 1- to 3-level minimally invasive (MIS) transforaminal lumbar interbody fusion (TLIF) was performed. Patients were randomized to receive a 48-hour scheduled treatment of either intravenous ketorolac (15mg every 6 hours) or saline in addition to a standardized pain regimen. The primary outcome was fusion. Secondary outcomes included 48-hour and total postoperative opioid use demonstrated as MME, pain scores, LOS, and quality-of-life (QoL) outcomes. Univariate and multivariate analyses were performed. The present study provides results from a planned interim analysis. RESULTS Two hundred and forty-six patients were analyzed per protocol. Patient characteristics were comparable between the groups. There was no significant difference in 1-year fusion rates between the two treatments (p=.53). The difference in proportion for solid fusion between the ketorolac and placebo groups did not reach inferiority (.072, 95% CI, -.07-.21). There was a significant reduction in total/48-hour mean opioid consumption (p CONCLUSION Short-term use of low-dose ketorolac in patients who have undergone MIS lumbar fusion demonstrated favorable results suggesting non-inferior fusion rates. Ketorolac safely demonstrated a significant reduction in postoperative opioid use and LOS while maintaining equivalent postoperative pain control. FDA DEVICE/DRUG STATUS Not applicable.
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- 2021
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4. Biomechanical Evaluation of the Pedicle Screw Insertion Depth Effect on Screw Stability Under Cyclic Loading and Subsequent Pullout
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Laura E. Buckenmeyer, Vijay K. Goel, Prashant S. Kelkar, Constantine K. Demetropoulos, Teck M Soo, Ata M. Kiapour, and Kristophe J. Karami
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Adult ,Male ,musculoskeletal diseases ,medicine.medical_treatment ,In Vitro Techniques ,Random Allocation ,Lumbar ,Pedicle Screws ,Cadaver ,Tensile Strength ,Ultimate tensile strength ,Humans ,Medicine ,Orthopedics and Sports Medicine ,Pedicle screw ,Reduction (orthopedic surgery) ,Aged ,Fixation (histology) ,Orthodontics ,Lumbar Vertebrae ,business.industry ,Stiffness ,Anatomy ,Middle Aged ,equipment and supplies ,musculoskeletal system ,Biomechanical Phenomena ,Spinal Fusion ,surgical procedures, operative ,Spinal fusion ,Osteoporosis ,Female ,Surgery ,Stress, Mechanical ,Neurology (clinical) ,medicine.symptom ,business - Abstract
STUDY DESIGN A biomechanical ex vivo study of the human lumbar spine. OBJECTIVE To evaluate the effects of transpedicular screw insertion depth on overall screw stability and pullout strength following cyclic loading in the osteoporotic lumbar spine. SUMMARY OF BACKGROUND DATA Although much is known about the clinical outcomes of spinal fusion, questions remain in our understanding of the biomechanical strength of lumbar pedicle screw fixation as it relates to screw sizing and placement. Biomechanical analyses examining ideal pedicle screw depth with current pedicle screw technology are limited. In the osteoporotic spine, optimized pedicle screw insertion depth may improve construct strength, decreasing the risk of loosening or pullout. METHODS A total of 100 pedicles from 10 osteoporotic lumbar spines were randomly instrumented with pedicle screws in mid-body, pericortical, and bicortical depths. Instrumented specimens underwent cyclic loading (5000 cycles of ±2 N m pure flexion moment) and subsequent pullout. Screw loosening, failure loads, and energy absorption were calculated. RESULTS Cyclic loading significantly (P
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- 2015
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5. Resolution of Diminished Olfactory Sensation After Treatment of Bilateral Ophthalmic Segment Aneurysms With Flow Diversion
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John P. Deveikis, Mark R. Harrigan, Bradford A. Woodworth, Beverly C. Walters, Mohamad R. Chaaban, and Prashant S. Kelkar
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Adult ,medicine.medical_specialty ,medicine.medical_treatment ,Anosmia ,Gadolinium ,Olfaction ,Neuropsychological Tests ,Imaging, Three-Dimensional ,Aneurysm ,Hyposmia ,medicine.artery ,medicine ,Humans ,cardiovascular diseases ,Embolization ,medicine.diagnostic_test ,business.industry ,Endovascular Procedures ,Intracranial Aneurysm ,Olfactory Pathways ,Olfactory Perception ,medicine.disease ,Embolization, Therapeutic ,Magnetic Resonance Imaging ,Cerebral Angiography ,Frontal Lobe ,Surgery ,Treatment Outcome ,Angiography ,Agnosia ,Female ,Neurology (clinical) ,Internal carotid artery ,medicine.symptom ,Tomography, X-Ray Computed ,business ,Carotid Artery, Internal ,Follow-Up Studies ,Olfactory tract - Abstract
BACKGROUND AND IMPORTANCE Olfactory tract dysfunction due to an unruptured intracranial aneurysm is rare. We present a case in which a patient with impaired olfaction related to bilateral internal carotid artery aneurysms experienced subjective and quantitative objective improvement of olfactory sensation after treatment of ophthalmic segment aneurysms with flow diversion. CLINICAL PRESENTATION A 44-year-old woman presented with hyposmia and bilateral ophthalmic segment internal carotid artery aneurysms. The symptom of hyposmia, worsening over a period of several months, was suspected to be due to mass effect from bilateral unruptured ophthalmic segment aneurysms pressing on the olfactory tracts. Each aneurysm was treated with a Pipeline embolization device (PED). Follow-up angiography at 5 months showed occlusion of both aneurysms. The patient experienced subjective improvement in olfaction and complete objective resolution of her hyposmia as measured by the validated University of Pennsylvania Smell Identification Test (UPSIT). CONCLUSION Intracranial aneurysms causing dysfunction of olfactory sensation due to mass effect upon the olfactory tract can be successfully treated with flow diversion. Flow diversion should be considered as one of the treatment options for patients with cranial nerve dysfunction due to unruptured intracranial aneurysms.
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- 2014
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6. Malignant Peripheral Nerve Sheath Tumor of the Vestibulocochlear Nerve and Brainstem
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Daniel R Pieper, Dennis I. Bojrab, Inga S. Grills, Kristophe J. Karami, Michael P Verdon, and Prashant S. Kelkar
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Vestibulocochlear Nerve Diseases ,Pathology ,medicine.medical_specialty ,medicine.medical_treatment ,Malignant peripheral nerve sheath tumor ,Nerve Sheath Neoplasms ,Radiosurgery ,Vestibulocochlear nerve ,Young Adult ,medicine ,Humans ,Cranial Nerve Neoplasms ,Neurofibromatosis ,business.industry ,medicine.disease ,Combined Modality Therapy ,Radiation therapy ,Female ,Surgery ,Neurology (clinical) ,Neoplasm Recurrence, Local ,business ,Nerve sheath neoplasm ,Brain Stem ,Cranial Nerve Neoplasm - Abstract
BACKGROUND AND IMPORTANCE: Malignant peripheral nerve sheath tumors are the most common malignant mesenchymal tumors of soft tissues, but they are very rare when found to arise from a cranial nerve and when not in association with neurofibromatosis. These tumors are highly malignant and carry a poor prognosis with survival usually less than 6 months. CLINICAL PRESENTATION: The authors report the case of a 23-year-old female with no history of phakomatoses, previous irradiation, or known genetic disorders, who presented with a malignant peripheral nerve sheath tumor of the vestibulocochlear nerve and brainstem. Multiple staged skull base approaches were carried out with maximal possible resection. Adjunctive therapies including standard radiation therapy, intensity-modulated radiation therapy, and stereotactic gamma knife radiosurgery were used with an ultimate patient survival of 27 months. CONCLUSION: To our knowledge, this is the first report describing a patient with a malignant peripheral nerve sheath tumor of the vestibulocochlear nerve and brainstem treated with staged surgical approaches in conjunction with multiple forms of radiotherapy and having a significant survival of more than 2 years.
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- 2011
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7. The effect of ketorolac on posterior thoracolumbar spinal fusions: a prospective double-blinded randomised placebo-controlled trial protocol
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Doris Tong, Matthew Bahoura, Chad F Claus, Teck M Soo, Evan Lytle, Clifford Houseman, Dominick Lago, Peter Bono, Michael H Lawless, Boyd Richards, Diana Sigler, Amarpal Dosanjh, Prashant S. Kelkar, and Dejan Slavnic
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medicine.medical_treatment ,Placebo-controlled study ,ketorolac ,Placebo ,pseudoarthrosis ,03 medical and health sciences ,0302 clinical medicine ,Lumbar ,Double-Blind Method ,Protocol ,medicine ,non-steroidal anti-inflammatory drugs ,Humans ,Multicenter Studies as Topic ,Prospective Studies ,030212 general & internal medicine ,Adverse effect ,lumbar ,Pain Measurement ,Randomized Controlled Trials as Topic ,Pain, Postoperative ,business.industry ,Anti-Inflammatory Agents, Non-Steroidal ,opioids ,General Medicine ,Length of Stay ,Institutional review board ,Ketorolac ,Spinal Fusion ,Treatment Outcome ,Opioid ,Anesthesia ,Spinal fusion ,Surgery ,business ,030217 neurology & neurosurgery ,medicine.drug - Abstract
IntroductionKetorolac has been shown to provide quality postoperative pain control and decrease opioid requirement with minimal side effects following spinal surgery. However, the literature addressing its use in spinal fusions is highly variable in both its effectiveness and complications, such as pseudarthrosis. Recent literature postulates that ketorolac may not affect fusion rates and large randomised controlled trials are needed to demonstrate ketorolac as a safe and effective adjuvant treatment to opioids for postoperative pain control.Methods and analysisThis is a multihospital, prospective, double-blinded, randomised placebo-controlled trial. Data concerning fusion rates, postoperative opioid use, pain scores, length of stay will be recorded with the aim of demonstrating that the use of ketorolac does not decrease thoracolumbar spinal fusion rates while identifying possible adverse events related to short-term minimal effective dose compared with placebo. Additionally, this investigation aims to demonstrate a decrease in postoperative opioid use demonstrated by a decrease in morphine equivalence while showing equivalent postoperative pain control and decrease the average length of stay.Ethics and disseminationEthical approval was obtained at all participating hospitals by the institutional review board. The results of this study will be submitted for publication in peer-reviewed journals.Trial registration numberNCT03278691.
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- 2019
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8. Infection risk in neurointervention and cerebral angiography
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Mark R. Harrigan, Prashant S. Kelkar, Beverly C. Walters, and J. Brett Fleming
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Adult ,Male ,Methicillin-Resistant Staphylococcus aureus ,Risk ,medicine.medical_specialty ,Lung Neoplasms ,medicine.drug_class ,medicine.medical_treatment ,Antibiotics ,Context (language use) ,medicine.disease_cause ,Infections ,Neurosurgical Procedures ,law.invention ,Randomized controlled trial ,law ,medicine ,Humans ,Surgical Wound Infection ,Embolization ,Antibiotic prophylaxis ,Carcinoma, Small Cell ,Retrospective Studies ,medicine.diagnostic_test ,business.industry ,Retrospective cohort study ,Antibiotic Prophylaxis ,Middle Aged ,Subarachnoid Hemorrhage ,Methicillin-resistant Staphylococcus aureus ,Embolization, Therapeutic ,Surgery ,Cerebral Angiography ,Femoral Artery ,Debridement ,Sample Size ,Female ,Neurology (clinical) ,business ,Immunosuppressive Agents ,Cerebral angiography - Abstract
Background The risk of infection with cerebral angiography and neurointerventional procedures has not been defined. Likewise, although the use of routine prophylactic antibiotics has been advocated by some neurointerventionalists, the utility of prophylactic antibiotics in this setting has not been determined. Objective To determine the rate of infection associated with neuroangiographic procedures in a clinical setting in which prophylactic antibiotics are not routinely given. Methods All cerebral angiograms and neurointerventional procedures done by a single neurointerventionalist over a recent 7-year period were retrospectively reviewed. Patients with infections directly attributable to the procedure were identified. A sample size calculation was done to determine the necessary size of a randomized, controlled trial aimed at determining whether prophylactic antibiotics can lower the rate of infection. Results Among a total of 2918 cerebral angiograms and neurointerventional procedures done without prophylactic antibiotics, there were 3 infections (0.1%) attributable to the procedure. All infections were localized femoral artery infections with no systemic complications. One infection occurred in a patient who was immunosuppressed because of treatment for cancer. Two of the patients required surgical debridement; all were treated with intravenous antibiotics with resolution of all infections. There were no central nervous system infections and no deaths associated with the infections. Conclusion These data suggest that the overall risk of infection associated with most neuroangiographic procedures is very low. Prophylactic antibiotic use may be a reasonable option for selected patients but is probably unnecessary for standard use in the context of meticulous care during procedures.
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- 2012
9. Article Commentary: 'Spinal Myeloid Sarcoma ‘Chloroma’ Presenting as Cervical Radiculopathy: Case Report'
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Johnny B. Delashaw, Amitoz S. Manhas, and Prashant S. Kelkar
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medicine.medical_specialty ,Neck pain ,business.industry ,medicine.medical_treatment ,Arthrodesis ,Kyphosis ,Laminectomy ,Debulking ,medicine.disease ,Surgery ,Dissection ,medicine ,Myeloid sarcoma ,Orthopedics and Sports Medicine ,Neurology (clinical) ,Differential diagnosis ,medicine.symptom ,business - Abstract
The authors report on their unique experience with a patient harboring a cervical spinal myeloid sarcoma presenting with cervical radiculopathy and neck pain. The authors succinctly present a rare clinical presentation of cervical radiculopathy and neck pain in an otherwise healthy 43-year-old man. Their diagnostic workup revealed a posterior extradural extramedullary epidural and soft tissue cervical mass spanning the cervicothoracic junction. Multidisciplinary treatment was followed with surgical debulking and biopsy, followed by diagnosis of the primary myeloproliferative neoplasm by bone biopsy. The patient received adjuvant chemoradiation. Follow-up visual analog scale scores were all improved, and his preoperative symptoms resolved. In addition, he showed local control of the soft tissue and epidural cervical disease on follow-up imaging. In the operative intervention, the authors chose a midline approach with laminectomy and decompression of the epidural tumor without posterior stabilization. Their follow-up imaging showed no evidence of destabilization or kyphosis. This approach is reasonable and appropriate for posterior midline epidural disease. Care must be taken, as is known, to minimize the soft tissue dissection and facet violation during laminectomy to prevent deformity. An argument may be made to perform an instrumented arthrodesis given the fact that the lesion and laminectomy spanned the cervicothoracic junction and that there was no known primary at the time, making it difficult to prognosticate the overall expected length of survival, which others have shown can influence the aggressiveness of surgical management.1 Though this is not an unreported presentation, it is a rare pathology2 3; the previously published literature does support the same treatment paradigm that was undertaken for this patient. Surgical decompression with adjuvant chemoradiation has been the standard used by other practitioners.3 4 In summary, the authors effectively share their case report of cervical spinal myeloid sarcoma presenting with radiculopathy. The case outlines their treatment and highlights the insidious course this pathology took in a patient who otherwise appeared healthy. Tumors of any variety should always be kept in the differential diagnosis when evaluating patients with neurologic symptoms.
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- 2015
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