Current treatments of primary sclerosing cholangitis.

Primary Sclerosing Cholangitis (PSC) is a chronic cholestatic disease characterized by hepatic inflammation and obliterative fibrosis, resulting in both intra- and extra-hepatic bile duct strictures. End-stage liver disease and bile duct carcinoma represent frequent complications. Incidence and prevalence of PSC in USA have been recently estimated as 0.9 per 100,000 person-years, and 1-6 per 100,000 person-years, respectively. Major diagnostic criteria include the presence of multifocal strictures, beadings of bile ducts, and compatible biochemical profile, once excluded secondary causes of cholangitis. Since the aetiology of PSC remains poorly defined, medical therapy is currently limited to symptom improvement and prolonged survival. Ursodeoxycholic acid (UDCA), corticosteroids and immunosuppressants have been proposed alone or in combination to improve the clinical outcome. In selected cases, surgical or endoscopic procedures need to be considered. Orthotopic liver transplantation (OLT) is at the moment the only definitive approach although disease relapse has been reported. In this article the state of the art in PSC treatment and future promises in this field are reviewed.

Sacroiliac joint dysfunction: a long-term follow-up study.

Sixty-nine patients with sacroiliac joint dysfunction were prospectively evaluated and treated with a structured physical therapy program. Follow-up clinical outcome was obtained from a patient questionnaire administered by an independent reviewer a minimum of 2 years after treatment. Average patient age was 40 years, and 80% were women. Ninety-five percent rated their result as good or excellent, while 5% believed their outcome was fair or poor. A structured physical therapy program can produce good long-term results in most patients; however, 5% continue to be symptomatic. This small subset may be candidates for more invasive evaluation.

A critical appraisal of the reporting of the National Acute Spinal Cord Injury Studies (II and III) of methylprednisolone in acute spinal cord injury.

From the beginning, the reporting of the results of National Acute Spinal Cord Injury Studies (NASCIS) II and III has been incomplete, leaving clinicians in the spinal cord injury (SCI) community to use or avoid using methylprednisolone in acute SCI on the basis of faith rather than a publicly developed scientific consensus. NASCIS II was initially reported by National Institutes of Health announcements, National Institutes of Health facsimiles to emergency room physicians, and the news media. The subsequent report in the New England Journal of Medicine implied that there was a positive result in the primary efficacy analysis for the entire 487 patient sample. However, this analysis was in fact negative, and the positive result was found only in a secondary analysis of the subgroup of patients who received treatment within 8 hours. In addition, that subgroup apparently had only 62 patients taking methylprednisolone and 67 receiving placebo. The NASCIS II and III reports embody specific choices of statistical methods that have strongly shaped the reporting of results but have not been adequately challenged or or even explained. These studies show statistical artifacts that call their results into question. In NASCIS II, the placebo group treated before 8 hours did poorly, not only when compared with the methylprednisolone group treated before 8 hours but even when compared with the placebo group treated after 8 hours. Thus, the positive result may have been caused by a weakness in the control group rather than any strength of methylprednisolone. In NASCIS III, a randomization imbalance occurred that allocated a disproportionate number of patients with no motor deficit (and therefore no chance for recovery) to the lower dose control group. When this imbalance is controlled for, much of the superiority of the higher dose group seems to disappear. The NASCIS group's decision to admit persons with minor SCIs with minimal or no motor deficit not only enables statistical artifacts it complicates the interpretation of results from the population actually sampled. Perhaps one half of the NASCIS III sample may have had at most a minor deficit. Thus, we do not know whether the results of these studies reflect the severely injured population to which they have been applied. The numbers, tables, and figures in the published reports are scant and are inconsistently defined, making it impossible even for professional statisticians to duplicate the analyses, to guess the effect of changes in assumptions, or to supply the missing parts of the picture. Nonetheless, even 9 years after NASCIS II, the primary data have not been made public. The reporting of the NASCIS studies has fallen far short of the guidelines of the ICH/FDA and of the Evidence-based Medicine Group. Despite the lucrative "off label" markets for methylprednisolone in SCI, no Food and Drug Association indication has been obtained. There has been no public process of validation. These shortcomings have denied physicians the chance to use confidently a drug that many were enthusiastic about and has left them in an intolerably ambiguous position in their therapeutic choices, in their legal exposure, and in their ability to perform further research to help their patients.

Postoperative drains at the donor sites of iliac-crest bone grafts. A prospective, randomized study of morbidity at the donor site in patients who had a traumatic injury of the spine.

A prospective, randomized study was performed to assess the effectiveness of postoperative closed suction drainage. One hundred and twelve consecutive procedures involving autologous iliac-crest bone graft were performed, from December 29, 1992, to July 1, 1993, following a traumatic injury of the spine in 108 patients. Sixty of the sites from which the bone graft had been obtained were drained with a single large Hemovac device. The drains were maintained for two to five days postoperatively. The remaining fifty-two incisions were closed without a drainage device. All patients were evaluated clinically for problems with wound-healing. The incisions were considered to be healed when they had been asymptomatic for one year. Of eleven patients who had problems with wound-healing, six had been managed with a drain and five had not. The findings of this study do not support the routine use of drainage at the donor sites of iliac-crest bone grafts.

Seat-belt use and relation to neurologic injury in motor vehicle crashes.

The relation between seat-belt use and neurologic injury was examined for the 1,352 patients who had spinal injuries as the result of motor vehicle crashes and were subsequently admitted to the Midwest Regional Spinal Cord Injury Center at Northwestern University between 1971 and 1993. Intact lesions were observed in 44% of patients (Frankel level E), complete lesions in 28% (Frankel A), sensory intact lesions in 8% (Frankel B), motor intact lesions in 5% (Frankel C), and functional motor lesions in 14% (Frankel D). Whereas only 14% of the sample were wearing seat belts, 60% of the belted and 41% of the unbelted vehicle occupants had intact lesions. The odds of surviving a motor vehicle crash with an intact injury were greater for patients who were wearing a lap or shoulder belt (odds = 1.57) for women (odds = 0.63) and for patients whose injury occurred more recently (odds = 1.05). The relation between position in the vehicle and extent of injury was strongest for rear passengers: intact lesions were sustained by 73% of belted and 35% of unbelted rear passengers, whereas complete lesions were sustained by 9% of the belted and 21% of the unbelted rear passengers. In conclusion, seat belts appear to be an effective means of decreasing the extent of neurologic deficit in those sustaining spinal injuries caused by motor vehicle crashes. The results of this study support injury-prevention efforts that emphasize lap- and shoulder-belt use.

Adult spondylolisthesis treated with posterolateral lumbar fusion and pedicular instrumentation with AO DC plates.

Attainment of successful lumbar fusion in adults with spondylolisthesis has historically been unpredictable. Recent results and conclusions have been conflicting regarding the role of instrumentation in improving the fusion rate and clinical outcome in this patient population. In a retrospective multicenter clinical study, we assessed the outcome of 42 adults with spondylolisthesis who underwent posterolateral lumbar fusion by using pedicular instrumentation with AO DC plates. No attempt was made to reduce slippage. Follow-up clinical outcome was obtained from a patient questionnaire administered and assessed by an independent reviewer. Fusion status was assessed by anteroposterior, lateral, and oblique radiographs at the most recent follow-up examination. Spondylolisthesis was classified as degenerative in 21 patients and isthmic in 21 patients. Solid fusion was achieved in 32 (76%) patients; pseudoarthrosis occurred in two (5%) patients; the fusion mass was indeterminate in eight (19%) patients. Clinical outcome parameters rated 73% excellent to good and 27% fair to poor. Complications included four infections and two screw breakages. Poor results correlated strongly with cigarette smoking and multiple previous surgeries. In this study, fusion rate and clinical outcome were consistent with previous reports of adult spondylolisthesis. Rates of successful fusion varied according to the type of spondylolisthesis.

Occipitocervical fusion with posterior plate and screw instrumentation. A long-term follow-up study.

STUDY DESIGN: Thirty-two patients at one institution underwent occipitocervical fusions with posterior plate and screw instrumentation. The average follow-up was greater than 4 years (50 months). METHODS: AO plates and screws were used and in more than 50% of the cases, the Magerl transarticular C1-C2 screw technique enhanced the occipitocervical instrumentation. In nine patients, cement was used and thus are excluded in evaluation of fusion results. All 23 patients attained solid fusions. No pseudarthrosis occurred. The average time to fusion was 13 weeks. Halos or traction immobilization was not used postoperatively. The average time of the simple orthosis wear was 11 weeks. Patients were out of bed on an average of the second postoperative day with a range of 1-4 days postoperatively. Reduction of the atlantoaxial joint was required in 10 of the 23 patients. At follow-up, nine remain reduced. RESULTS: In one patient, the atlantodens interval approximated the preoperative distance and radiographs demonstrated one transarticular C1-C2 screw was not placed satisfactorily. The average operative time was 172 minutes, and the average blood loss was 956 cc. The neurologic status of the patients improved or remained the same. No patient deteriorated neurologically. A total of 78 occipital screws were placed. No complications resulted from any of these screws. One intraoperative complication occurred secondary to massive bleeding after a transarticular screw hole was drilled. Bone wax was placed over the drill hole and the bleeding ceased. No postoperative problems occurred in this patient. Most specifically, no central nervous system sequela was evident. CONCLUSIONS: The conclusions from this study are that posterior occipitocervical fusion can be performed very safely with plate and screw instrumentation. An extremely high fusion rate can be expected with minimal complications and minimal postoperative immobilization. This technique, however, is technically demanding.

Posterior instrumentation and fusion for unstable fractures and fracture-dislocations of the thoracic and lumbar spine. A comparative study of three fixation devices in 70 patients.

Acute unstable thoracic and lumbar spine fractures were treated with either Harrington rods and hooks, Luque rods with sublaminar wires, or A-O dynamic compression plates with pedicle screws. The results demonstrated failure of all three techniques to maintain the sagittal plane correction at 12 months' follow-up. Furthermore, in lumbar fractures, Harrington rods did not restore or maintain sagittal plane alignment as well as Luque rods or pedicle screws and plates. Lastly, the pedicle screw fixation system required a shorter segment fusion.

Closed femoral shortening.

Eighteen patients underwent closed intramedullary femoral shortening at a children's teaching hospital. Their average age was 16 years 2 months (range 14-18 years). Clinical and radiographic union was obtained in < or = 3 months in all patients. Shortening averaged 4.4 cm (range 3-5 cm). Complications included one case of acute respiratory distress and three cases of fixation loss. We describe the procedure for closed intramedullary rodding without use of a fracture table and recommend (a) that reaming proceed slowly through an enlarged proximal portal, and (b) that in all cases nails be interlocked both proximally and distally.

Postoperative infections in spinal implants. Classification and analysis--a multicenter study.

A multicenter study was undertaken to analyze postoperative wound infections after posterior spinal instrumentation and fusion. The infection rate of these procedures has been documented in multiple reports. From these results, a classification scheme was developed that can guide therapy and determine the populations at risk. The patients were categorized according to two parameters, the first being the severity or type of infection, and the second being the host response or physiologic classification of the patient. This classification scheme is based on the clinical staging system for adult osteomyelitis developed by Cierny. The severity of infection is divided into three groups. Group 1 is a single-organism infection, either superficial or deep. Group 2 is a multiple-organism, deep infection. Group 3 is multiple organisms with myonecrosis. The host response, likewise, is divided into three classes. Class A is a host with normal systemic defenses, metabolic capabilities, and vascularity. Class B patients demonstrate local or multiple systemic diseases, including cigarette smoking. Class C requires an immunocompromised or severely malnourished host. Our data have demonstrated that single organisms, Group 1, generally can be dealt with by single irrigation and debridement, and closure over suction drainage tubes without the use of an inflow-irrigation system. The Group 2 patients, with multiple organisms and deep infection, required an average of three irrigation debridements. They have a higher percentage of successful closures with closed inflow-outflow suction irrigation systems when compared to simple suction drainage systems without constant inflow irrigation. Multiple-organism infections with myonecrosis, Group 3, are exceedingly difficult to manage, and portend a poor outcome. Patients without normal host defenses, Classes B and C, are at high risk for developing postoperative wound infection. Specifically, this study demonstrated that cigarette smoking may be a significant risk factor.

Posterior fixation of thoracic and lumbar spine fractures using DC plates and pedicle screws.

A prospective investigation of internal fixation of acute thoracic and lumbar spine fractures using pedicle screws and dynamic compression plates was performed. This article details the results of 23 patients who were followed for an average of 20 months. The indications for the procedure were an unstable fracture--dislocation below the eighth thoracic vertebra or low lumbar fractures that would be difficult to treat with conventional spinal implants. The patients were divided into three groups based on the fracture pattern and the level of the fracture. Group I consisted of fracture--dislocation injuries at the thoracic level and thoracolumbar junction. Group II patients sustained lumbar fracture--dislocations, and Group III contained lumbar burst fractures. Sagittal and coronal angles as well as anterior and posterior vertebral body height were measured at the injury level preoperatively, postoperatively, and at 3-month intervals. Statistical analysis of these angles demonstrated that Group I and III patients had significant correction of their relative kyphotic deformity after surgery; however, there were no differences in kyphotic angle at the 3-month interval. Despite this eventual return to preoperative angles, all patients except one developed solid fusion. There was no increase in neurologic deficit. One patient developed an asymptomatic pseudarthrosis demonstrated by breakage of both plates through unfilled screw holes at the motion segment. Other complications included one wound infection, one case of arachnoiditis after an intradural bone fragment was excised, and one dural tear created by a Kirschner wire, which did not result in a neurologic deficit or a cerebrospinal fluid leak.(ABSTRACT TRUNCATED AT 250 WORDS)