National trends in revision spinal fusion in the USA: patient characteristics and complications.

Using the United States Nationwide Inpatient Sample, we identified national trends in revision spinal fusion along with a comprehensive comparison of comorbidities, inpatient complications and surgical factors of revision spinal fusion compared to primary spinal fusion. In 2009, there were 410 158 primary spinal fusion discharges and 22 128 revision spinal fusion discharges. Between 2002 and 2009, primary fusion increased at a higher rate compared with revision fusion (56.4% vs 51.0%; p < 0.001). In 2009, the mean length of stay and hospital charges were higher for revision fusion discharges than for primary fusion discharges (4.2 days vs 3.8 days, p < 0.001; USD $91 909 vs. $87 161, p < 0.001). In 2009, recombinant human bone morphogenetic protein (BMP) was used more in revision fusion than in primary fusion (39.6% vs 27.6%, p < 0.001), whereas interbody devices were used less in revision fusion (41.8% vs 56.6%, p < 0.001). In the multivariable logistic regression model for all spinal fusions, depression (odds ratio (OR) 1.53, p < 0.001), psychotic disorders (OR 1.49, p < 0.001), deficiency anaemias (OR 1.35, p < 0.001) and smoking (OR 1.10, p = 0.006) had a greater chance of occurrence in revision spinal fusion discharges than in primary fusion discharges, adjusting for other variables. In terms of complications, after adjusting for all significant comorbidities, this study found that dural tears (OR 1.41; p < 0.001) and surgical site infections (OR 3.40; p < 0.001) had a greater chance of occurrence in revision spinal fusion discharges than in primary fusion discharges (p < 0.001). A p-value < 0.01 was considered significant in all final analyses.

Dose-dependent toxicity of a commercially available demineralized bone matrix material.

STUDY DESIGN: A relative risk assessment was performed to determine the safety of three commercially available Grafton demineralized bone matrix quantities used in athymic rats. OBJECTIVE: To evaluate the possible dose-dependent adverse effects of a commercially available demineralized bone matrix containing glycerol. SUMMARY OF BACKGROUND DATA: Commercially available Grafton demineralized bone matrix contains glycerol. The toxic effects of glycerol leading to acute renal failure have been documented. The toxicity of this glycerol-containing substance in higher doses has not been reported. METHODS: Three doses of Grafton putty were implanted in the upper hind limb muscles of athymic nude rats. The rats were observed for adverse effects and early death. Histologic studies were performed. RESULTS: All eight of the rats implanted with the highest dose of Grafton putty (0.008 mL/g) died, five of them within 12 hours of implantation and three in 48 to 72 hours. One rat with the intermediate dose (0.004 mL/g) died within 12 hours of implantation. By 72 hours after implantation, three of the six rats (50%) with the intermediate dose had died. All six of the rats receiving the lowest dose (0.002cc/g) survived. The median lethal dose of Grafton putty in athymic rats was estimated to be 0.00469 mL/g body weight. Histologic analysis of the animals that received the high dose showed acute tubular necrosis, probably secondary to rhabdomyolysis. CONCLUSIONS: In athymic rats, large amounts of Grafton putty lead to death in a dose-dependent manner. Because the median lethal doses of Grafton putty (0.00469 mL/g) and glycerol (0.00442 mL/g) are comparable, a potential source of toxicity is the glycerol contained in the material. The results of this study suggest that high doses have the potential to cause acute renal failure. The authors suggest that clinical usage of Grafton putty in humans should be limited to no more than 2 mL/kg body weight of this material.

Increased fusion rates with cervical plating for three-level anterior cervical discectomy and fusion.

STUDY DESIGN: A retrospective review of all patients surgically treated by a single surgeon with a three-level anterior cervical discectomy and fusion with and without anterior plate fixation. OBJECTIVES: To compare the clinical and radiographic success of anterior three-level discectomy and fusion performed with and without anterior cervical plate fixation. SUMMARY OF BACKGROUND DATA: Previous studies of multilevel cervical discectomies and fusions have shown fusion rates to decrease as the number of surgical levels increases. Anterior cervical plate stabilization can provide more stability and may increase fusion rates for multilevel fusions. METHODS: Over a 7-year period, 59 patients were treated surgically with a three-level anterior cervical discectomy and fusion by the senior author. Forty patients had cervical plates, whereas 19 had fusions with no plates. These patients were observed for an average of 3.2 years. Clinical and radiographic follow-up data were obtained. RESULTS: Of the 59 patients, 14 had a pseudarthrosis (7 in each group). The pseudarthrosis rates were 18% (7 of 40) for patients with plating and 37% (7 of 19) for patients with no plating. Although the nonunion rate for unplated fusions was double that of plated fusions, this difference was not statistically significant. There was no statistically significant correlation between pseudarthrosis and gender, age, level of surgery, history of tobacco use, or previous anterior surgery. The fusion rates were improved with the use of a cervical plate. Inferior clinical results were demonstrated in patients with a pseudarthrosis, regardless of the use of a cervical plate. CONCLUSIONS: The addition of plate fixation for three-level anterior cervical discectomy and fusion is a safe procedure and does not result in higher complication rates. In this study, the pseudarthrosis rate was lower for patients with a cervical plate. However, this difference was not statistically significant. Patients treated with cervical plating had overall better results when compared with those of patients treated without cervical plates. Although the use of cervical plates decreased the pseudarthrosis rate, a three-level procedure is still associated with a high nonunion rate, and other strategies to increase fusion rates should be explored.

The effect of cervical plating on single-level anterior cervical discectomy and fusion.

The use of anterior plates for single-level cervical fusions is controversial. Previous studies that evaluated single and multiple-level fusions have shown increased and decreased fusion rates when cervical plates are used. The purpose of this study was to compare the clinical and radiographic success of single-level discectomy performed with and without anterior cervical plate fixation. During a 6-year period, 80 patients were surgically treated with a single-level anterior cervical discectomy. Forty-four patients had cervical plates, whereas 36 had fusions without plates (average follow-up, 2.3 years). The pseudarthrosis rates were 4.5% (2 of 44) for patients with plating and 8.3% (3 of 36) without plating. This difference was not significant (p = 0.653). There was no correlation of pseudarthrosis with sex, age, level of surgery, history of tobacco use, or the presence of previous anterior surgery. The amount of graft collapse for patients with plating was 0.75 mm compared with 1.5 mm for those without a plate (p = 0.026). The amount of kyphotic deformity of the fused segment was 1.2 degrees with plating compared with 1.9 degrees for patients without plating (p = 0.079). Ninety-one percent of the patients with plating had good or excellent results compared with 88% in the group without cervical plates, based on Odom's criteria. The addition of plate fixation for single-level anterior cervical discectomy and fusion is safe and not associated with a significant increase in complication rates. The pseudarthrosis rates are not significantly different when a cervical plate is used.

Intraoperative dermatomal evoked potential monitoring fails to predict outcome from lumbar decompression surgery.

STUDY DESIGN: Thirty-three patients with single-level, unilateral lumbosacral radiculopathy underwent micro-decompression and intraoperative dermatomal evoked potential monitoring. Side-to-side latency asymmetry was calculated. A criteria for "abnormal" was defined. Intraoperative dermatomal evoked potentials were obtained before and after decompression. The changes were correlated with clinical outcome at the 3-month follow-up examination. OBJECTIVES: To determine whether intraoperative dermatomal evoked potential latency asymmetry confirms nerve root compression and whether an improvement of latency asymmetry after decompression predicts a good clinical outcome. SUMMARY OF BACKGROUND DATA: Intraoperative dermatomal evoked potential has been proposed as a test to assess the adequacy of nerve root decompression. Initial reports suggested improvement of dermatomal evoked potential amplitude and latency after decompression. The clinical efficacy is controversial because of its technical difficulty and inherent variation. METHODS: Cervical recording was chosen to reduce the effects of anesthesia. The asymptomatic nerve root was used as a control. Quality of the tracings was determined by evoked potentials-to-noise amplitude ratio. Clinical outcome was based on patient's pain relief and satisfaction. RESULTS: Tracings of acceptable quality were obtained at baseline in 57.6% (19 of 33) of patients. A side-to-side latency asymmetry > 5% was defined as abnormal. Before decompression, 68.4% (13 of 19) of patients had an abnormal dermatomal evoked potential. After decompression, latency asymmetry returned to normal in every patient. Clinical outcome was good or excellent in 13 patients, fair in four patients, and poor in two patients. Dermatomal evoked potential latency improvements were not related to variation in clinical outcome. CONCLUSIONS: Intraoperative dermatomal evoked potential monitoring is technically demanding. Finding reproducible potentials is difficult. More research is necessary before general use of dermatomal evoked potentials for monitoring nerve root decompression.

Experimental spinal fusion with recombinant human bone morphogenetic protein-2 without decortication of osseous elements.

STUDY DESIGN: L4-L5 intertransverse process fusions were produced with 58 micrograms, 230 micrograms, or 920 micrograms of recombinant human bone morphogenetic protein-2 in 20 dogs. Eleven had traditional decortication of posterior elements before insertion of the implant. Nine were left undecorticated. All animals were evaluated 3 months after surgery. OBJECTIVES: To determine whether decortication is a prerequisite for successful fusion in the presence of osteoinductive proteins such as bone morphogenetic protein-2. SUMMARY OF BACKGROUND DATA: Recombinant osteoinductive proteins can induce de novo bone in ectopic soft-tissue sites in the absence of bone marrow elements. Traditional methods for achieving spinal fusion rely on exposure of bone marrow through decortication to facilitate osteogenesis. It is hypothesized that the presence of an implanted osteoinductive protein obviates the need for exposure and release of host inductive factors. METHODS: Recombinant human bone morphogenetic protein-2-induced intertransverse process fusions were performed with and without decortication. Fusion sites were evaluated by computed tomography imaging, high-resolution radiography, manual testing, mechanical testing, and histologic analysis. RESULTS: One hundred percent of decorticated spines and 89% of undecorticated spines were clinically fused by 3 months. Ninety-one percent of decorticated spines and 78% of undecorticated specimens exhibited bilateral transverse process osseous bridging. The only spines that failed to achieve solid bilateral arthrodesis were in the lowest dose group. With the higher two doses, there was histologic evidence of osseous continuity between the fusion mass and undecorticated transverse processes. CONCLUSIONS: There were no statistical differences in clinical and radiographic fusion rates between decorticated and undecorticated sites. With higher doses of recombinant human bone morphoganetic protein-2, there was little histologic distinction between fusions in decorticated versus undecorticated spines.

Effective doses of recombinant human bone morphogenetic protein-2 in experimental spinal fusion.

STUDY DESIGN: Nineteen dogs underwent L4-L5 intertransverse process fusions with either 58 micrograms, 115 micrograms, 230 micrograms, 460 micrograms, or 920 micrograms of recombinant human bone morphogenetic protein-2 carried by a polylactic acid polymer. A previous study (12 dogs) compared 2300 micrograms of recombinant human bone morphogenetic protein-2, autogenous iliac bone, and carrier alone in this model. All fusions subsequently were compared. OBJECTIVES: To characterize the dose-response relationship of recombinant human bone morphogenetic protein-2 in a spinal fusion model. SUMMARY OF BACKGROUND DATA: Recombinant osteoinductive morphogens, such as recombinant human bone morphogenetic protein-2, are effective in vertebrate diaphyseal defect and spinal fusion models. It is hypothesized that the quality of spinal fusion produced with recombinant human bone morphogenetic protein-2, above a threshold dose, does not change with increasing amounts of inductive protein. METHODS: After decortication of the posterior elements, the designated implants were placed along the intertransverse process space bilaterally. The fusion sites were evaluated after 3 months by computed tomography imaging, high-resolution radiography, manual testing, mechanical testing, and histologic analysis. RESULTS: As in the study using 2300 micrograms of recombinant human bone morphogenetic protein-2, implantation of 58-920 micrograms of recombinant human bone morphogenetic protein-2 successfully resulted in intertransverse process fusion in the dog by 3 months. This had not occurred in animals containing autograft or carrier alone. The cross-sectional area of the fusion mass and mechanical stiffness of the L4-L5 intersegment were not dose-dependent. Histologic findings varied but were not related to rhBMP-2 dose. Inflammatory reaction to the composite implant was proportional inversely to the volume of the fusion mass. CONCLUSIONS: No mechanical, radiographic, or histologic differences in the quality of intertransverse process fusion resulted from a 40-fold variation in dose of recombinant human bone morphogenetic protein-2.

Distractive properties of a threaded interbody fusion device. An in vivo model.

STUDY DESIGN: Twenty sheep underwent anterior lumbar interbody fusions with either a threaded titanium interbody fusion device (cage, n = 8), autogenous iliac crest dowel graft (autograft, n = 6), or interbody decortication only (sham, n = 6). Two sheep had misplaced cages and were excluded. Sheep were killed after 6 months. OBJECTIVES: To determine whether this model is useful for examining the distractive and fixation properties of interbody fusion cages. SUMMARY OF BACKGROUND DATA: Interbody fusion cages are used in anterior lumbar interbody fusion procedures to provide immediate intersegmental fixation and to distract and preserve interbody height. The process of physiologic anchorage by bone ingrowth into such devices is under investigation. METHODS: Sheep were radiographed immediately after surgery and 2, 4, and 6 months after surgery. Interbody distraction and angulation were measured with a digital photo image analyzer at each time point. After the sheep were killed, stiffness to flexion, extension, and lateral bending moments were measured. Twelve untreated cadaver spines were also tested for comparison. RESULTS: After surgery, interbody distraction successfully occurred in cage and autograft-implanted sites. Loss of interbody height ensued, however, in all groups during the first 2 months. Percentage loss of height was lowest in cage sites. By 6 months, only cage sites remained distracted beyond normal. Fusions in all groups were stiffer than untreated spines. Autograft sites were stiffer than cage sites to lateral bending. Sham sites were stiffer than cage and autograft sites to flexion, but this likely resulted from complete intervertebral collapse. CONCLUSION: Despite early subsidence, interbody fusion cages successfully distracted and preserved interbody spaces. This model is useful for investigating methods of improving distraction and stabilization.

Evaluation of rhBMP-2 with an OPLA carrier in a canine posterolateral (transverse process) spinal fusion model.

STUDY DESIGN: Posterolateral L4-L5 transverse process fusions were done on 14 adult beagles. Six were implanted with recombinant human bone morphogenetic protein-2 carried by open-cell polylactic acid polymer delivery vehicle. Six received autogenous iliac bone graft. Two received carrier alone. Eleven were killed 3 months after implantation. One in each group was maintained for 8 months. OBJECTIVES: To compare recombinant human bone morphogenetic protein-2 and open-cell polylactic acid polymer with autogenous iliac bone for inducing transverse process fusion in the canine by 3 months and to determine whether transverse process decortication and implantation of carrier alone causes spontaneous transverse process fusion in the canine. SUMMARY OF BACKGROUND DATA: Recombinant human bone morphogenetic proteins have healed segmental long bone defects in several models. They have induced interlaminar and facet fusions in canines. Interlaminar and facet fusions have occurred after sham decortications in canines. Recombinant human bone morphogenetic protein-2 has not been evaluated for transverse process fusion in canines. Transverse process fusion is a preferred clinical method for achieving posterior lumbar fusion. METHODS: Fusion sites were evaluated by serial computed tomography scans. After the dogs were killed, explanted spines were subjected to manual testing, mechanical testing, high resolution radiography, and histologic analysis. RESULTS: One hundred percent of recombinant human bone morphogenetic protein-2-implanted sites had solid transverse process fusion by 3 months according to all measures. No autografted sites were fused at this interval. Osseous bridging of posterolateral gutters occurred in the recombinant human bone morphogenetic protein-2-implanted sites after 2 months, the earliest radiographic measure. None of the carrier-only sites showed bone formation. CONCLUSIONS: Recombinant bone morphogenetic protein-2 carried by open-cell polyactic acid polymer is superior to autogenous iliac bone for producing radiographically and mechanically solid transverse process fusions in canines by 3 months. Spontaneous transverse process fusion does not occur in canines after decortication and open-cell polylactic acid polymer implantation.

Somatosensory evoked potential spinal cord monitoring reduces neurologic deficits after scoliosis surgery: results of a large multicenter survey.

Neurologic deficits were compared to somatosensory evoked potential (SEP) spinal cord monitoring in a survey of spinal orthopedic surgeons. Experienced SEP spinal cord monitoring teams had fewer than one-half as many neurologic deficits per 100 cases compared to teams with relatively little monitoring experience. Experienced SEP monitoring teams also had fewer neurologic deficits than were seen in previous surveys of this group. Definite neurologic deficits, despite stable SEPs (false negative monitoring), occurred during surgery in only 0.063% of patients. Factors independently associated with fewer neurologic deficits also included the surgeon's years of experience in orthopedic surgery and the use of the wake-up test. Other technical survey results are also presented here. These results confirm the clinical efficacy of experienced SEP spinal cord monitoring for prevention of neurologic deficits during spinal surgery such as for scoliosis.

Hyponatremia and syndrome of inappropriate antidiuretic hormone secretion in adult spinal surgery.

STUDY DESIGN: Patients undergoing spinal surgery were monitored for sodium balance, fluid type, and volume input and output during surgery and for the first 3 postoperative days. OBJECTIVE: To prospectively document the true incidence of the syndrome of inappropriate antidiuretic hormone secretion and hyponatremia, and identify risk and protective factors for the development of the syndrome of inappropriate antidiuretic hormone secretion after spinal surgery. METHODS: Data on medical history, surgical procedure, estimated blood loss, and volumes and types of intraoperative and postoperative fluids were collected on 116 consecutive spinal surgery patients during March to July 1992. RESULTS: One hundred one spinal operations in 96 patients were evaluated. There were 48 males and 48 females, with a mean age of 52 years (range, 16 to 90 years). Hyponatremia developed in 45 (44.6%) patients. The etiology of hyponatremia was the syndrome of inappropriate antidiuretic hormone secretion in seven patients (6.9%), hypovolemia in 19 patients (18%), and other causes in six patients. CONCLUSIONS: Spine patients are at risk for hyponatremia and the syndrome of inappropriate antidiuretic hormone secretion. The incidence of the syndrome of inappropriate antidiuretic hormone secretion was 6.9%. Serum sodium should be monitored postoperatively. Patients who undergo a revision operation have an approximately two to four times greater risk of being affected by the syndrome of inappropriate antidiuretic hormone secretion than those who have primary surgery.

Optoelectronic evaluation of trunk deformity in scoliosis.

In this study, truncal deformity in patients with scoliosis was evaluated by circumferential scanning using an optoelectronic device (Optronic Torsograph, Anima Corp., Tokyo, Japan). This device generates cross-sectional skin surface topography at 10 axial levels to provide a three-dimensional representation of truncal shape. Ninety-three patients with suspected idiopathic scoliosis were evaluated with conventional Cobb measurements, and their parameters were computed using the device's measurements. The geometric cross-sectional indexes correlated poorly with the Cobb angle and were highly variable during repeated measurements. The optoelectronic device's angle, a measure of centroid curvature, correlated highly with the Cobb angle for primary spinal curves. The highest correlation was observed in thoracolumbar curves. This optoelectronic device has clinical relevance as a method for further scoliosis screening and monitoring the progression of spinal curvature in a patient.

Vitamin C intake and mortality among a sample of the United States population.

We examined the relation between vitamin C intake and mortality in the First National Health and Nutrition Examination Survey (NHANES I) Epidemiologic Follow-up Study cohort. This cohort is based on a representative sample of 11,348 noninstitutionalized U.S. adults age 25-74 years who were nutritionally examined during 1971-1974 and followed up for mortality (1,809 deaths) through 1984, a median of 10 years. An index of vitamin C intake has been formed from detailed dietary measurements and use of vitamin supplements. The relation of the standardized mortality ratio (SMR) for all causes of death to increasing vitamin C intake is strongly inverse for males and weakly inverse for females. Among those with the highest vitamin C intake, males have an SMR (95% confidence interval) of 0.65 (0.52-0.80) for all causes, 0.78 (0.50-1.17) for all cancers, and 0.58 (0.41-0.78) for all cardiovascular diseases; females have an SMR of 0.90 (0.74-1.09) for all causes, 0.86 (0.55-1.27) for all cancers, and 0.75 (0.55-0.99) for all cardiovascular diseases. Comparisons are made relative to all U.S. whites, for whom the SMR is defined to be 1.00. There is no clear relation for individual cancer sites, except possibly an inverse relation for esophagus and stomach cancer among males. The relation with all causes of death among males remains after adjustment for age, sex, and 10 potentially confounding variables (including cigarette smoking, education, race, and disease history).

Spinal cord monitoring. Results of the Scoliosis Research Society and the European Spinal Deformity Society survey.

The Scoliosis Research Society (SRS) and the European Spinal Deformity Society (ESDS) membership was surveyed regarding the use of intraoperative monitoring of somatosensory evoked potentials in spinal surgery. A total of 242 people responded, with 188 using intraoperative monitoring. A second survey was distributed detailing the technical aspects of monitoring, of which 71 were returned. A total of 342 neurologic deficits were reported to have occurred with monitoring in place. Two hundred forty-six (72%) were accurately detected, and 96 (28%) were not detected by sensory cord evoked potentials (SCEP). There were 1,003 false-positive cases reported. The incidence of false-negative cases was related to those not monitoring both latency and amplitude, to using fewer recording electrodes, and with those surgeons doing more kyphosis corrections.

Ethnic variations in the prevalence of smoking among registered nurses.

A survey of smoking behavior was conducted on 1,569 registered nurses in six unrelated acute care hospitals in Los Angeles in 1984-1985. Smoking prevalence, higher than for other health professionals but lower than for women in the United States or in other recently surveyed samples of nurses, was closely linked to the ethnicity and the age distribution of the nurses surveyed. Patterns for black and white nurses, who account for the majority of nurses nationally, were similar to those found in other recent studies of registered nurses. Among Asian nurses, however, prevalence was lower, age of initiation was higher, and the mean number of cigarettes smoked daily was lower than for other nurses. Smoking prevalence for younger nurses was lower than for other nurses, and these nurses were more likely to report themselves as never having smoked. Smoking patterns among nurses remain a significant public health concern.

Evaluation of a worksite self-help smoking cessation program for registered nurses.

Cigarette smoking among nurses remains a public health concern despite a recent decline in current smoking prevalence. We recruited 149 registered nurses into a no-cost, targeted, self-help smoking cessation program supplemented by a supportive worksite environmental module. The study was designed to expand understanding of nurses' smoking and to measure program effectiveness. Follow-ups were conducted at one, six and 12 months post-intervention to assess self-reported smoking status (92% objectively validated) and predictors of cessation. Point prevalence abstinence at these time points (22.5%, 21.5% and 19.5%), continuous abstinence (12.7%), and an ever-quit rate of 57% (i.e., quit for at least 48 hours), compare favorably to population quit rates and to rates reported for other self-help programs. Logistic regression analyses were utilized to identify predictors of short-term cessation [time before needing a cigarette, concern regarding the health hazards of smoking, working in a critical care setting, use of targeted weight manual] and long-term cessation [dosage (inverse relationship), use of standard American Lung Association maintenance manual, working with dying patients, and M.D.s' opposition to upgrading nursing service (inverse relationship)].

The relationship between vitamin C intake, general health practices, and mortality in Alameda County, California.

To evaluate the relation between vitamin C intake and mortality, a prospective follow-up study was carried out among 3,119 noninstitutionalized adult residents of Alameda County, California who had completed a detailed lifestyle questionnaire around the beginning of 1974. During 10 years of follow-up, 276 deaths have been identified. The questionnaire information and mortality data indicate that this sample is fairly representative of the county population and similar to the United States population. There is no important relation between the estimated 1974 vitamin C intake at levels above and below 250 mg per day and subsequent mortality from cancer, circulatory disease, all other causes, or all causes combined. However, there is an inverse relation between combinations of several health habits and total mortality. The health habits include never smoking cigarettes, regular physical activity, moderate or no use of alcohol, 7-8 hours of sleep per day, and maintaining proper weight. The conclusions with regard to vitamin C are limited by the crudeness with which the dietary intake has been estimated and changes in intake over time. Nevertheless, these results are not consistent with any substantial relation between vitamin C intake and subsequent mortality.