The data project: a shared approach between stakeholders of the healthcare system in definition of a therapeutic algorithm for inflammatory arthritis.

Rheumatic musculoskeletal diseases or RMD [rheumatoid arthritis (RA) and spondyloarthritis (SpA)] are systemic inflammatory diseases for which there are no biomarkers capable of predicting treatments with a higher likelihood of response in naive patients. In addition, the expiration of the anti-TNF blocking drugs' patents has resulted in the availability of anti-TNF biosimilar drugs with the same efficacy and safety than originators but at significantly reduced prices. To guarantee a personalized therapeutic approach to RMD treatment, a board of rheumatologists and stakeholders from the Campania region, Italy, developed a clinically applicable arthritis therapeutic algorithm to guide rheumatologists (DATA project). The general methodology relied on a Delphi technique forecast to produce a set of statements that summarized the experts' consensus. Selected clinical scenarios were discussed in light of the available evidence, and there were two rounds of voting on the therapeutic approaches. Separate discussions were held regarding rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. The decision-making factors for each disease were clinical presentation, demographics, and comorbidities. In this paper, we describe a virtuous process between rheumatologists and healthcare system stakeholders that resulted in the development of a shared therapeutic algorithm for RMD patients naive to bDMARDs.

Decreasing spine implant costs and inter-physician cost variation: the impact of programme of cost containment on implant expenditure in spinal surgery.

The demand for spinal surgery and its costs have both risen over the past decade. In 2008 the aggregate hospital bill for surgical care of all spinal procedures was reported to be $33.9 billion. One key driver of rising costs is spinal implants. In 2011 our institution implemented a cost containment programme for spinal implants which was designed to reduce the prices of individual spinal implants and to reduce the inter-surgeon variation in implant costs. Between February 2012 and January 2013, our spinal surgeons performed 1493 spinal procedures using implants from eight different vendors. By applying market analysis and implant cost data from the previous year, we established references prices for each individual type of spinal implant, regardless of vendor, who were required to meet these unit prices. We found that despite the complexity of spinal surgery and the initial reluctance of vendors to reduce prices, significant savings were made to the medical centre.

Spinal cord injury models: a review.

BACKGROUND: Animal spinal cord injury (SCI) models have proved invaluable in better understanding the mechanisms involved in traumatic SCI and evaluating the effectiveness of experimental therapeutic interventions. Over the past 25 years, substantial gains have been made in developing consistent, reproducible and reliable animal SCI models. STUDY DESIGN: Review. OBJECTIVE: The objective of this review was to consolidate current knowledge on SCI models and introduce newer paradigms that are currently being developed. RESULTS: SCI models are categorized based on the mechanism of injury into contusion, compression, distraction, dislocation, transection or chemical models. Contusion devices inflict a transient, acute injury to the spinal cord using a weight-drop technique, electromagnetic impactor or air pressure. Compression devices compress the cord at specific force and duration to cause SCI. Distraction SCI devices inflict graded injury by controlled stretching of the cord. Mechanical displacement of the vertebrae is utilized to produce dislocation-type SCI. Surgical transection of the cord, partial or complete, is particularly useful in regenerative medicine. Finally, chemically induced SCI replicates select components of the secondary injury cascade. Although rodents remain the most commonly used species and are best suited for preliminary SCI studies, large animal and nonhuman primate experiments better approximate human SCI. CONCLUSION: All SCI models aim to replicate SCI in humans as closely as possible. Given the recent improvements in commonly used models and development of newer paradigms, much progress is anticipated in the coming years.

Intrahepatic cholestatic jaundice related to administration of ranitidine. A case report with histologic and ultramicroscopic study.

Ranitidine may cause liver injuries ranging from transient, subclinical serum transaminases increase every 100-1,000 treated patients to cholestatic hepatitis in less than 1/100,000. Other H2-receptor antagonists are more dangerous: 11 toxic hepatitis cases have been reported as adverse effect after 1 year of marketed ebrotidine. A 75-year-old male with ischemic cardiopathy history was started on an 8 days treatment of oral ranitidine due to pirosis, without any other changes of therapy; 48 h after drug withdrawal, light-coloured stools, dark urine and icteric scleras developed. On hospital admission, 10 days later, physical examination showed slight hepatomegaly and severe jaundice with skin excoriations followed by serum mixed bilirubin further increase and aminotransferases activities mild rise. Total bilirubin peaked at 381.33 mmol/l (5.1-17.1) and progressively returned to normal, after discharge home, in 3 months and now, 1 year later, there is no sign of liver disease. Ultrasonographic biliary anomalies and the most frequent causes of liver damage were excluded. Liver biopsy confirmed ranitidine as the most likely cause of liver toxicity since histological and ultramicroscopical study revealed a drug-induced picture. We report a rare case of intrahepatic cholestasis jaundice related to ranitidine, a widely used drug. Diagnosis would need an ethically unacceptable rechallange test.

Spinal infections. Diagnosis and treatment.

Spinal infections encompass a broad spectrum of pathology. Any element of the spine, the vertebrae, disks, surrounding soft tissues, potential spaces, or the cord itself may be involved solely, or more commonly, in combination. Staphylococcus aureus is the organism most frequently found, with Gram negative bacteria often cited in association with infections of the urinary tract and in intravenous drug abusers. Early diagnosis and treatment are essential for optimal outcomes. In some cases, the only necessary treatment consists of parenteral antibiotics and immobilization. However, certain instances require operative intervention. The goals of treatment for any infection of the spine are: early diagnosis with identification of the offending organism, preservation of neurological function or cessation of progressive neurologic deficit, and complete eradication of the infection with a pain-free, stable spine.

Use of epidural steroids after discectomy may predispose to infection.

STUDY DESIGN: This is a report of three cases of epidural abscess occurring after use of intraoperative epidural methylprednisolone in 31 patients who had undergone lumbar microdiscectomy. The possible role of epidural steroids in the cause of these abscesses is discussed, and a review the literature concerning its value is provided. OBJECTIVE: To evaluate experiences with the efficacy and safety of perioperative methylprednisolone. SUMMARY OF BACKGROUND DATA: No previous study has described a high infection rate with the use of epidural methylprednisolone. The literature supporting epidural steroids is equivocal, and reports supporting their perioperative use are scant. METHODS: In an 8-month period, 31 patients received 1 mL (40 mg) epidural methylprednisolone at the conclusion of microdiscectomy. Therapy was discontinued after an increased postoperative deep infection rate was noted. Results in these patients were compared with those in more than 400 others who did not receive intraoperative steroids during a 7-year period. RESULTS: In the steroid group, three epidural abscesses were encountered. There were no deep infections in the nonsteroid group. CONCLUSION: The use of perioperative epidural methylprednisolone in the currently reported cases was associated with three incidences of infection. A prospective study is needed to examine its use.

Contemporary management of spinal osteomyelitis.

OBJECTIVE: We review the results of treatment of a series of patients with spinal osteomyelitis, to formulate a systematic and comprehensive approach to the management of this disease in light of recent technical and conceptual advances in imaging, spinal biomechanics, and internal fixation. METHODS: We retrospectively reviewed the records for 57 consecutive patients with pyogenic spinal osteomyelitis who were treated between June 1987 and June 1995. Pain and weakness were the most common presenting symptoms. The mean duration of symptoms at the time of diagnosis was 10.6 weeks. Surgical indications included the presence or development of motor deficits with epidural compression and/or localized kyphotic deformities or the failure of medical therapy. RESULTS: Thirty-three patients underwent surgery as their initial treatment. Six additional patients experienced medical therapy failure and received subsequent surgical treatment. Seventeen patients were treated using an anterior approach only, 13 were treated using a posterior approach only, and 9 were treated using a combined anterior and posterior approach. After a minimal follow-up period of 24 months, 93% of the surgically treated patients showed neurological improvement or were neurologically intact, with a mean 16-degree decrease in localized kyphotic deformities and with solid bony fusion and resolution of pain for all patients. CONCLUSION: Early surgical decompression results in rapid improvement of neurological deficits, decreases in kyphotic deformities, and stabilization with bony fusion. The presence of active infection does not preclude the use of internal fixation. Nonsurgical management is indicated for patients with minimal or no neurological deficits and the absence of significant localized kyphotic deformities. However, 25% of patients who were initially treated nonsurgically experienced medical therapy failure and underwent surgical treatment.

Semirigid instrumentation in the management of lumbar spinal conditions combined with circumferential fusion. A multicenter study.

STUDY DESIGN: Patients with the diagnosis of degenerative disc conditions or spondylolisthesis undergoing circumferential fusion with posterior pedicle screw fixation using a semirigid rod were reviewed. OBJECTIVES: To determine the effectiveness of this approach in achieving a spinal fusion and satisfactory clinical outcome, and to determine the complications associated with the procedure. SUMMARY OF BACKGROUND DATA: The use of instrumentation to stabilize the lumbar motion segments and thereby enhance the fusion rate has been proposed in a number of studies. Semirigid fixation was believed to be effective in achieving these objectives without concern for stress-shielding, which was suggested by some authors using rigid fixation systems. METHODS: Patients who required spinal fusion with anterior and posterior approaches because of specific lumbar pathology or previous surgeries were selected. The surgery consisted of an anterior interbody fusion using allograft, followed by a posterolateral fusion and pedicle screw fixation. Fusion was determined by continuity of trabecular bridging, and outcomes were determined by pain reduction and return to previous levels of activity. Fusion was considered solid if the two posterolateral areas were fused (Zones one and two), if the anterior interbody area was fused (Zone three), or if all three zones were fused. Complications were documented during and after surgery. RESULTS: Sixty-two percent of patients had previous surgery with 25% of these patients having a diagnosis of pseudarthrosis. Fifty-five percent of patients had two or more levels fused, and 43% were heavy smokers. Ninety-seven percent of patients had successful fusions. Pain was significantly reduced on a pain analogue scale from 7.1 to 2.1 in the back and from 5.8 to 1.5 in the leg (p < 0.006 and 0.0001, respectively). Fifty-nine percent of patients returned to their previous level of activity, and 18% returned to lighter work or job retraining, for a total of 77% returning to the same or lighter levels of activity. Complications included metal failure, 4.9%; neurologic deficit, 1.2%; deep infection, 1.2%; deep venous thrombosis, 4.9%; and vascular injury, 2.4%. Fatal pulmonary embolus occurred in one patient. CONCLUSION: This technique produces a satisfactory fusion rate (97%) and a good clinical outcome based on pain reduction and return to a satisfactory level of activity (77%). It is associated with few, but significant, complications that compare well with other reported series in a difficult group of patients. This procedure should be reserved for patients who are considered to be at high risk for not achieving spinal fusion.

Microdiskectomy for lumbar disk herniation: a review of 100 cases.

One hundred patients who underwent microlumbar diskectomy over 5 years were retrospectively reviewed. L4-5 and L5-S1 were compared to determine whether a patient's post-surgical outcome is related to the level where a herniation has occurred. Overall results included 70 excellent, 19 good, 2 fair, and 9 poor. Statistical analysis showed that neither the level involved, length of follow-up, nor degree of manual labor predicted outcome. Older patients and females tended to fare worse, but the trends were not significant. Three recurrent herniations occurred, 1 in the L4-L5 group and 2 in the L5-S1 group. No variable predicted recurrence.

Open discectomy as treatment for herniated nucleus pulposus of the lumbar spine.

Open discectomy is the "gold standard" for operative intervention in patients with herniated lumbar discs whose conservative treatment has failed. Over 60 years the indications for surgery and the expected success rates have been clearly elucidated. The specific patient selection and determination of surgical procedures continues to evolve. Recurrent herniations occur at a low rate, and serious complications are rare.

Modern management of spinal tuberculosis.

The resurgence of pulmonary tuberculosis in the United States has been paralleled by a concomitant rise in tuberculosis of the spine (Pott's disease). The appearance of drug-resistant strains of tuberculosis, infection in large numbers of immunocompromised hosts, newer imaging modalities, and the development of more effective spinal reconstruction techniques have raised important issues regarding the management of Pott's disease. In spite of this, there has been little published recently on the modern management of Pott's disease in developed countries. We report our experience with the management of 20 patients with Pott's disease in the past 5 years, 16 of whom were admitted during the last 18 months of this retrospective study. The mean patient age was 49 years. Sixteen (80%) were men. Nineteen (95%) had a positive tuberculin skin test, and 13 (65%) had pulmonary tuberculosis. Symptoms consisted of spinal pain, weakness, sensory complaints, and flank mass in order of decreasing frequency. Ten patients were neurologically intact; the remainder had motor deficits of variable severity. The thoracic spine was involved in 13 patients, the lumbar spine was involved in 4, the cervical spine was involved in 2, and the thoracolumbar spine was involved in 1. Spinal deformity was present in 11 patients, spinal epidural compression was present in 13, and a paraspinal mass was present in 18. Operative indications included motor deficits, spinal deformity, nondiagnostic computer tomographic-guided needle biopsy, and noncompliance with, or lack of, response to medical therapy. Eleven patients underwent operations. Six patients had vertebrectomy and bone grafting with posterior instrumentation when indicated; three had laminectomy, debridement, and abscess drainage; one had laminectomy and posterior instrumentation; and one had paraspinal abscess drainage. Two patients have died; the remainder have been monitored for at least 1 year and are neurologically improved or normal without residual infection. The average angulation decreased from 31 to 24 degrees by the follow-up examination. In selected patients, early operative treatment with instrumentation, when indicated, minimizes neurological deterioration and spinal deformity, allows early ambulation, and results in excellent neurological outcome.

Posterior plates in the management of cervical instability: long-term results in 44 patients.

Although posterior plates are increasingly used to manage cervical spinal instability, long-term follow-up evaluation of patients with a critical analysis of efficacy and complications has not been reported. The authors have retrospectively analyzed the outcome in 44 consecutive patients (37 males and seven females, age range 16 to 80 years) treated with posterior cervical plates. The indications for instrumentation were instability due to trauma in 42 cases, tumor in one, and infection in one. In four patients the follow-up period was limited to 3, 5, 11, and 16 months. Two patients died of chronic medical problems 4 and 9 months after treatment. The remaining 38 patients were followed from 2 to 6 years (mean 46 months). One motion segment was stabilized in 23 patients using two-hole plates; two motion segments were stabilized in the other 21 patients using three-hole plates. In the majority of patients (37 cases), supplemental bone grafting was not used. Patients were immobilized postoperatively in a Philadelphia collar. Solid arthrodesis was achieved in 39 (93%) of 42 patients. Three patients required revision of the cervical plating: in one patient with a C-5 burst fracture, two-hole plates were applied at C5-6 and progressive kyphosis mandated anterior fusion; the second patient required posterior wiring due to screw pull-out resulting from a technical error in screw insertion; the third patient, who refused to wear an orthosis postoperatively, also developed screw pull-out. In two patients who went on to spinal fusion, there was an increase in sagittal kyphosis (6 degrees and 8 degrees) without clinical sequelae. Screw loosening was noted in five patients, involving eight (3.8%) of the 210 lateral mass screws; this complication resulted in instrumentation failure or increased kyphosis in three cases. There were two superficial infections. This analysis indicates that posterior cervical plating is highly effective; at long-term follow-up review the cervical spine was successfully stabilized in 93% of cases. Plate failure was related to faulty screw placement, failure to include sufficient motion segments, and noncompliance with postoperative orthoses. Halo vest immobilization was unnecessary and supplemental bone grafting was generally not required for recent trauma.

A new method of thoracic and lumbar body replacement for spinal tumors: technical note.

Anterior decompressive procedures have gained more widespread usage in the treatment of anterior compressive lesions of the spinal cord due to neoplasms. Alternative methods of vertebral body replacement that use a modified silastic tube placed into adjacent vertebral segments and filled with methyl methacrylate cement are described. The technique is reserved for patients with limited longevity as the result of the malignant nature of their disease process.

Late infection of spinal instrumentation by hematogenous seeding.

Six cases of late spinal infection following instrumentation are described. In all cases, there was a delay of at least 10 months between surgery and the clinical development of sepsis. In 5 of the 6 cases, a distant focus of infection could be identified. Two patients had active intravenous drug usage, two patients were paraplegic with neurogenic bladders, and one patient had an episode of pyelonephritis secondary to renal calculi two months prior to presentation. In no instance was there any preceding breakdown of overlying skin. This previously unreported phenomenon is an extremely rare but major complication of spinal surgery.

Occipitocervical fusion with a five-millimeter malleable rod and segmental fixation.

Although occipitocervical fusion is frequently used for instability of the upper cervical spine and the occipitocervical articulation, most currently used techniques have one or more of the following disadvantages: the necessity for sublaminar wires, the use of occipital screws, a fixed angle of instrumentation, or the necessity for routine postoperative halo immobilization. Moreover, many reported techniques are associated with a high rate of nonunion or instrumentation failure. We present our experience with a technically simple method of obtaining rigid occipitocervical arthrodesis using a 5-mm malleable rod that is fixed to the skull by a pair of wires passed through four suboccipital burr holes. Segmental spinal fixation is achieved with Wisconsin interspinous wires and is occasionally supplemented with sublaminar wires. Supplemental autogenous bone graft is used in all cases. A cervical collar is routinely used for postoperative immobilization. The results of treatment were retrospectively reviewed in 16 patients with an average age of 49.4 years (range, 9-69). Mean follow-up was 24 months (range, 12-36 mo). The indication for fusion was instability of the occiput-C1-C2 complex as a result of Chiari malformation, rheumatoid disease, skull base tumor resection, basilar invagination, ankylosing spondylitis, Down's syndrome, cervical laminectomy, and trauma. The average number of levels fused was 5.4 (range, O-C3 to O-T3). Successful occipitocervical arthrodesis was achieved in all but one of the surviving patients. The single patient with a pseudarthrosis was successfully managed with supplemental bone grafting and halo immobilization. There were two deaths from medical complications in chronically ill patients. Other complications included one postoperative instrumentation loosening, one myocardial infarction, and one superficial occipital decubitus. In conclusion, rodding and segmental interspinous wiring is an effective, technically simple method of obtaining rigid occipitocervical fixation, which obviates the need for bulky orthoses.

A systematic approach to spinal reconstruction after anterior decompression for neoplastic disease of the thoracic and lumbar spine.

The anterior approach to the thoracic and lumbar spine for neoplastic disease is now a well-accepted procedure, with results, for the most part, superior to those achieved with laminectomy. However, the specific indications for anterior decompression and the selection of reconstruction techniques based on the location and extent of bony destruction have received surprisingly little attention. The authors report their experience with the operative management of 33 patients with benign and malignant tumors of the thoracic and lumbar spine, using the anterior transthoracic or retroperitoneal approach. The role of stabilization and the relative indications for anterior or posterior instrumentation are emphasized. The mean age of patients was 58 years. Twenty-three patients were male. Five patients had benign tumors, and the remainder had a variety of metastatic lesions. Twenty-nine patients had lower extremity motor deficits, although 25 were ambulatory preoperatively. Thirty-seven noncontiguous resections were performed in 33 patients. In 13 patients, the resected vertebral body was replaced with acrylic or bone without instrumentation; in 18, the acrylic was supplemented with anterior instrumentation; and in 6, both anterior and posterior instrumentation were used. Above T11, vertebral reconstruction techniques were used to restore stability after decompression. Between T11 and L4, anterior instrumentation was used to supplement vertebral reconstruction in all patients. Supplemental posterior instrumentation was used for three-column involvement. Motor function was stabilized or improved in 94% of patients, and 88% of patients were ambulatory postoperatively. Of 28 patients with malignant disease, 23 died after a mean survival of 10.2 months (range, 2-51 mo) and 5 are alive a mean of 34.4 months since their operation.(ABSTRACT TRUNCATED AT 250 WORDS)

Pullout strength comparison of two methods of orienting screw insertion in the lateral masses of the bovine cervical spine.

We undertook a biomechanical study to compare the pullout strength of 3.5-mm AO screws placed in two different orientations within the bovine cervical spine. The first set of screws were oriented obliquely and passed through the lateral mass, as recommended by the AO group. The orientation of the second set was anterior to posterior through the lateral mass, as recommended by Roy-Camille. All screw holes were drilled and tapped by a spinal surgeon experienced with both techniques. Pullout force was measured on an Instron materials testing machine using a self-centering screw-holding chuck and loading rate of 0.833 mm/sec. Although the bone strength in the Roy-Camille orientation was greater (46.7 N/mm versus 36.1 N/mm, p < 0.05), the overall mean pullout force for the AO orientation was greater (607 N versus 471 N, p < 0.025) due to the longer length of bone available for screw purchase (17.0 mm versus 10.3 mm).

Using tissue expanders in spinal surgery for deficient soft tissue or postirradiation cases.

Prior irradiation and scarring can complicate wound closure following spinal surgery. Implanted tissue expanders were used six times in four patients to aid skin closure. Three patients had prior irradiation for cancer, and one had myelomeningocele. The average interval between placement and removal of the expanders was 46 days. Two late failures occurred because of prominent hardware. These expanders may provide adequate myocutaneous covers following spinal surgery in difficult cases.

Luque instrumentation in degenerative conditions of the lumbar spine.

The authors report on the experience obtained in using L-rods and sublaminar wires in obtaining lower lumbar fusions of three or more levels in degenerative diseases of the lumbar spine. A successful fusion was obtained in 86% of the patients. The technique, while offering a satisfactory method of fusion, does violate the spinal canal with sublaminar wires with potential for neurologic injury. Specifically, the passage of sacral wires should be avoided.