Alok Sharan

Mitigating Adverse Event Reporting Bias in Spine Surgery

BACKGROUND Recent articles in the lay press and literature have raised concerns about the ability to report honest adverse event data from industry-sponsored spine surgery studies. To address this, clinical trials may utilize an independent Clinical Events Committee (CEC) to review adverse events and readjudicate the severity and relatedness accordingly. We are aware of no prior study that has quantified either the degree to which investigator bias is present in adverse event reporting or the effect that an independent CEC has on mitigating this potential bias. METHODS The coflex Investigational Device Exemption study is a prospective randomized controlled trial comparing coflex (Paradigm Spine) stabilization with lumbar spinal fusion to treat spinal stenosis and spondylolisthesis. Investigators classified the severity of adverse events (mild, moderate, or severe) and their relationship to the surgery and device (unrelated, unlikely, possibly, probably, or definitely). An independent CEC, composed of three spine surgeons without affiliation to the study sponsor, reviewed and reclassified all adverse event reports submitted by the investigators. RESULTS The CEC reclassified the level of severity, relation to the surgery, and/or relation to the device in 394 (37.3%) of 1055 reported adverse events. The proportion of adverse events that underwent reclassification was similar in the coflex and fusion groups (37.9% compared with 36.0%, p = 0.56). The CEC was 5.3 (95% confidence interval [CI], 2.6 to 10.7) times more likely to upgrade than downgrade the adverse event. The CEC was 7.3 (95% CI, 5.1 to 10.6) times more likely to upgrade than downgrade the relationship to the surgery and 11.6 (95% CI, 7.5 to 18.8) times more likely to upgrade than downgrade the relationship to the device. The status of the investigators financial interest in the company had little effect on the reclassification of adverse events. CONCLUSIONS Thirty-seven percent of adverse events were reclassified by the CEC; the large majority of the reclassifications were an upgrade in the level of severity or a designation of greater relatedness to the surgery or device. CLINICAL RELEVANCE An independent CEC can identify and mitigate potential inherent investigator bias and facilitate an accurate assessment of the safety profile of an investigational device, and a CEC should be considered a requisite component of future clinical trials.

Cognitive Reserve and Postoperative Delirium in Older Adults

To examine the role of cognitive reserve in reducing delirium incidence and severity in older adults undergoing surgery.

Thoracoscopic anterior instrumented fusion for adolescent idiopathic scoliosis with emphasis on the sagittal plane

BACKGROUND CONTEXT Anterior fusion through an open thoracotomy restores kyphosis more reliably than posterior techniques in patients with thoracic adolescent idiopathic scoliosis (AIS). Video-assisted thoracoscopic spinal fusion and instrumentation (VATS) minimizes the morbidity, from soft tissue and muscle dissection that accompanies traditional open thoracotomy. To our knowledge, there has not been a comprehensive analysis of VATS with respect to radiographic and clinical outcomes in the sagittal plane. PURPOSE To measure the radiographic and clinical outcomes after VATS with emphasis on the sagittal plane. STUDY DESIGN/SETTING A retrospective, radiographic review of 26 consecutive patients with Lenke type-I AIS who underwent VATS. METHODS Radiographs of 26 consecutive patients with Lenke type-I AIS curves operated by a single surgeon were retrospectively reviewed after VATS. Sagittal and coronal parameters were compared with reported data for open anterior and posterior procedures. RESULTS There was an increase in kyphosis from baseline to final follow-up by 6.6 degrees (25%) from T2 to T12 (p<.0001), 8.7 degrees (50%) from T5 to T12 (p<.0001), and 8 degrees (54%) in the instrumented segment (p<.0001). Junctional kyphosis did not occur. No differences were detected in sagittal measurements between the first postoperative erect and the final radiographs. Patients experienced significant improvements from baseline to 2 years in Scoliosis Research Society-22 Health-Related Quality-of-Life Outcome Questionnaire scores (p<.0001). CONCLUSIONS Video-assisted thoracoscopic spinal fusion and instrumentation, in agreement with results reported for open anterior instrumentation, reliably restores or increases thoracic kyphosis while preserving junctional alignment in thoracic AIS.

Extensive ossification of the ligamentum flavum treated with triple stage decompression: a case report

BACKGROUND CONTEXT Concurrent ossification of the ligamentum flavum (OLF) in the cervical, thoracic, and lumbar spine is a rare occurrence often associated with rheumatologic abnormalities. Although the pathology may be asymptomatic and discovered incidentally on routine imaging, compression of the cord and surrounding nerve roots can produce myelopathic or radiculopathic symptoms that are best treated with surgical decompression. There is limited evidence to support the use of single versus multistage decompression for tandem ossification at multiple levels, although several factors including duration of symptoms have been associated with a worse prognosis. PURPOSE To describe the presence of extensive symptomatic tandem OLF with concurrent ossification of the posterior longitudinal ligament (PLL) and its treatment using multistage decompression. STUDY DESIGN Case report and literature review. METHODS The authors describe a case of a 35-year-old woman with OLF extending from the cervical to lumbar spine and tandem ossification of the cervical PLL. Her initial presentation was significant for symptoms consistent with thoracic myelopathy in the absence of radiculopathic findings, and initial imaging also demonstrated disc herniation at L4-L5 and L5-S1. RESULTS The patient was first treated with a thoracic laminectomy and fusion from T7 to T11, given her back pain and thoracic myelopathy. Persistence of myelopathic symptoms necessitated further surgical intervention with a posterior cervical decompression and fusion from C3 to T1. Finally, after the appearance of radiculopathic findings, she underwent a microscopic L4-L5 laminectomy with improvements in her symptoms and ambulation. CONCLUSIONS Symptomatic OLF in non-East Asian population is a rare occurrence. Its etiology is likely multifactorial, involving both biomechanical and genetic factors. Although early detection and management are necessary, multistage decompression can be an effective intervention for extensive multilevel ossification.

The role of accountable care organizations in delivering value

The goal of Accountable Care Organizations is to improve patient outcomes while maximizing the value of the services provided. This will be achieved through the use of performance and quality measures that facilitate efficient, cost-effective, evidence-based care. By creating a network connecting primary care physicians, specialists, rehabilitation facilities and hospitals, patient care should be maximized while at the same time delivering appropriate value for those services provided. The Medicare Shared Savings Program will financially reward ACOs that meet performance standards while at the same time lowering costs. The orthopaedic surgeon can only benefit by understanding how to participate in and negotiate the complexities of these organizations.

The Science of Quality Improvement

The manufacturing industry has supplied many quality-improvement methodologies that have been successfully utilized in health-care delivery, such as Plan-Do-Study-Act (PDSA) cycles, Total Quality Management, Six Sigma, and Lean.Many tools of quality improvement, such as PDSA cycles and DMAIC (Design-Measure-Analyze-Improve-Control) of the Six Sigma method, are similar to the scientific method that is familiar to clinicians.Correct identification of the sources and types of process variation within a system is paramount for process improvement.Reduction in process variation via standardization and reinforcement of process protocols leads to improved process outcomes.Quality-improvement projects should define a clear governance structure to maintain project timeliness and completion.

Destructive T10 vertebral lesion leads to diagnosis of metastatic ovarian cancer.

► Ovarian cancer presents as thoracic vertebral lesion in the absence of gross abdominal disease ► Bilateral salpingo-oophorectomy with surgical resection of vertebral lesion leaves patient with no clinical evidence of disease ► Ovarian cancer can present as vertebral metastases in the absence of pelvic or abdominal metastatic disease.

The Science of Health-Care Delivery.

As the health-care system evolves toward delivering greater value for the patient, orthopaedic surgeons are continually being challenged to manage the health of a population. The traditional focus of scientific inquiry within orthopaedics has been at the individual patient level. The science of health-care delivery is an evolving field that is aimed at bringing rigorous inquiry into determining the proper organizational design that can deliver high-quality and low-cost care for a population. This article provides an overview of basic concepts involved in systems and organizational theory relevant to orthopaedic surgery.

Minimally Invasive Stereotactic Separation Surgery for Resection of Metastatic Spine Lesion: A Feasibility Study

Introduction The current treatment of spinal metastasis consists of algorithms combining reconstructive surgical and radiation modalities. Recently, the concept of separation surgery followed by adjuvant stereotactic radiosurgery (SRS) was shown to be a safe and effective treatment to achieve long-term local tumor control. We examined the possibility of a minimally invasive approach to separation surgery first in a cadaveric feasibility study and then in a patient cohort with spinal metastasis in conjunction with intraoperative computer-assisted navigation. Methods A cadaveric study using standard minimally invasive access systems examined the feasibility of spinal cord decompression in the thoracic and lumbar spine. Subsequently, 10 patients (7 males and 3 females) with spinal metastasis underwent minimally invasive separation surgery (MISS) and percutaneous pedicle screw fixation using intraoperative navigation or standard fluoroscopy. The O-arm three-dimensional imaging with stereotactic navigation was used intraoperatively to localize and guide the resection of the metastatic spinal tumors. All patients were at least 3/5 strength in the lower extremities preoperatively. Pre- and postoperative CT scan and CT myelography were used to evaluate the degree of decompression. Endpoints included neurological function, operative time, estimated blood loss, incision length, hospital stay duration, and complications. Results The cadaveric study demonstrated a proof of principle with a wide decompression of the spinal cord. For the operative cases, the postoperative imaging demonstrated excellent separation that meets the requirements for safe SRS. All patients remained at/or improved their neurological baseline with excellent pain control. One patient incurred a perioperative complication (pulmonary embolism). The mean estimated blood loss was 290 mL. The mean incision length was 4.9 cm. The operative time mean was 5.2 hours and the mean length of stay was 7.5 days. Conclusion MISS for spinal metastasis allows for a circumferential decompression of the spinal cord and safe postoperative SRS. In addition, we demonstrated the efficacy of intraoperative navigation in guiding the resection. Future prospective enrollment of patients can help to determine which patients would be ideal candidates for MISS and if the smaller incision and an enduring faster healing process can allow a faster start of radiation and chemotherapy.

Cystic Angiomatosis: A Rare Cause of Thoracic Radiculopathy

Thoracic radiculopathy is a rare condition that is most frequently attributed to thoracic disc disease and diabetes mellitus. It typically presents as pain, paresthesias, dysesthesias, and loss of sensation in a dermatomal distribution across the chest, thorax, and/or abdomen. Neoplasms, skeletal deformities (e.g., scoliosis, kyphosis, and compression fractures), and other skeletal and extraskeletal diseases encompass some of the numerous disease etiologies1-4. Cystic angiomatosis (CA), a disease characterized by cystic skeletal lesions with or without extraskeletal involvement, represents an even rarer cause of thoracic radiculopathy. CA is histologically described as cystic lesions of hemangiomatous, lymphangiomatous, or mixed origin. It typically presents in the first three decades of life4-6 with no sex preference7, and has an estimated incidence rate of between 0.1 and 1.0 in 1,000,0008. It most frequently presents with skeletal and extraskeletal lesions, but it also may present with isolated skeletal lesions5,9,10. The skull, ribs, vertebrae (cervical vertebrae most frequently)7, pelvis, femora, and humeri10,11 are the skeletal structures that are most commonly involved. The spleen, liver, kidneys, pleurae, and lungs represent the most commonly affected extraskeletal structures5,9,12. Skeletal lesions are most commonly located within the medullary cavity; however, cortical involvement has been noted13. CA tends to be diagnosed in asymptomatic individuals after routine radiographs reveal diffuse cystic skeletal lesions. Symptomatic patients may present with bone pain with or without pathological fractures, localized swelling and tenderness, dyspnea, hemoptysis, ascites, and even organ failure. While the lesions may spontaneously remit, patients are at risk for permanent deformity, loss of function, and even death—especially in patients with splenic14,15 or pleural involvement12,16 or infected angiomatic lesions11. …