Posterior reversible encephalopathy syndrome (PRES) is a clinicoradiological syndrome characterized by headaches, altered mental status, seizures, and visual disturbances. Classic MRI findings include white matter changes of the parieto-occipital regions. This syndrome has been encountered in myriad medical illnesses, including hypertension, preeclampsia/eclampsia, and immunosuppressive conditions. While the pathogenesis of the disorder is unclear, vasoconstriction and hypoperfusion leading to brain ischemia and vasogenic edema have been implicated as potential mechanisms. The authors present, to the best of their knowledge, the first case of PRES following a thoracic spinal surgery-induced dural leak noted on resection of the fifth rib during a thoracotomy for a T4-5 discectomy. Brain MRI revealed large areas of increased FLAIR and T2 hyperintensity in the superior posterior frontal lobes, superior and medial parietal lobes, and bilateral occipital lobes. Following repair of the CSF leak, the patient's symptoms resolved. Spinal surgeons should be alert to the potentially life-threatening condition of PRES, especially in a hypertensive patient who experiences surgery-induced dural leakage. The development of a severe positional headache with neurological signs is a red flag that suggests the presence of PRES. Prompt attention to the diagnosis and treatment of this condition by repairing the dural leak via surgery or expeditious blood patch increases the likelihood of a favorable outcome.

OBJECTIVE:To improve the understanding of relationships among United States Medical Licensing Examination (USMLE Step I), Orthopedic In-Training Examination (OITE), Subjective Clinical Performance Evaluations, and American Board of Orthopedic Surgery Examination Part I (Abos-I) and Part II (Abos-II), which would help residency programs better achieve their educational mission. DESIGN:A 12-year descriptive study of retrospectively collected data. SETTING:One residency program with 47 resident participants. RESULTS:Residents that failed Abos-I and Abos-II had lower program mean OITE year-in-training (YIT) percentile rank scores. The program mean OITE YIT percentile rank score had a moderate relationship with Abos-I (% correct) score (r = 0.68, p < 0.0001) and an insignificant relationship with USMLE Step I (3-digit) score (r = 0.22, p = 0.13). Residents with upper quartile (>or=220) USMLE Step I (3-digit) scores for our program had higher program mean OITE YIT percentile rank scores and Abos-I (% correct) scores than residents with lower quartile scores (or=55) for the program mean OITE YIT percentile rank score had higher Abos-I (% correct) scores than residents who did not. Residents who scored in the lower quartile for the third postgraduate year (PGY-3) program OITE YIT percentile rank score or for the program mean OITE YIT percentile rank score had a 5.2 and 5.8 time greater Abos-I failure risk, respectively. The program PGY-3 OITE YIT percentile rank score was the strongest Abos-I (% correct) score discriminator. Resident Abos-I (% correct), program mean OITE YIT, and program PGY-3 OITE YIT percentile rank scores were the strongest discriminators for Abos-II passage. Residents with a program mean OITE YIT percentile rank score >or=28, program PGY-3 OITE YIT percentile rank score >or=39, and USMLE Step I (3-digit) score >or=207 were more likely to pass Abos-I and II. Residents that had lower quartile USMLE Step I (3-digit) scores for our program had a 2.3 time greater Abos-I failure risk. Program residents with >or=2 below-average subjective clinical performance evaluations had lower Abos-I (% correct) scores but had similar Abos-I and II pass rates. CONCLUSION:Our program uses the USMLE Step I (3-digit) score as a preacceptance estimate of likely supplemental guided mentoring needs. Program mean OITE YIT percentile rank and PGY-3 OITE YIT percentile rank scores help identify educational deficiencies and predict eventual Abos-I and II passage. Subjective clinical performance evaluations provide important supplemental information regarding professionalism, communication, and patient care skills.

Study Design. Prospective longitudinal cohort. Objective. This study evaluated the effect of preoperative Mental Component Summary (MCS), preoperative Physical Component Summary (PCS), preoperative Oswestry Disability Index (ODI), back pain predominance, body mass index (BMI), age, smoking status, and workers’ compensation on health-related quality of life after lumbar fusion. These factors were selected as they are readily available and may influence a surgeon’s decision-making process. Summary of Background Data. Measures of health-related quality of life are increasingly used to evaluate treatment effectiveness. However, their use as a predictive tool to determine which patients will improve has been limited. Methods. The Short Form 36 (SF-36) and ODI were collected before surgery and two years after surgery in 489 patients undergoing lumbar fusion for degenerative disorders. Linear regression modeling was used to determine the effect of preoperative MCS, preoperative PCS, preoperative ODI, back pain predominance, BMI, age, smoking status, and workers’ compensation on the change in ODI and change in SF-36 PCS two years after lumbar fusion. Results. Patients with better preoperative MCS (P = 0.008) and worse preoperative ODI scores (P < 0.0001) achieved greater ODI improvement. Workers’ compensation patients did significantly worse (P = 0.03). Patients with better preoperative MCS (P = 0.0004), better preoperative PCS (P = 0.0155), and worse preoperative ODI scores (P = 0.0210) achieved greater PCS improvement. Those on workers’ compensation had lower changes in PCS, an effect that was nearly significant (P = 0.0644). There were no significant correlations between PCS and ODI improvement and back pain predominance, BMI, age, and smoking status. Attempts at determining threshold values for MCS, PCS, and ODI that are predictive of a patient achieving minimum clinically important difference for PCS and ODI wereunsuccessful. Conclusion. Patients with good preoperative MCS and poor preoperative ODI scores who are not on workers’ compensation are more likely to improve after lumbar fusion. Threshold values for MCS, PCS, and ODI predictive of a patient achieving minimum clinically important difference for PCS and ODI could not be determined.

BACKGROUND CONTEXT: Previous studies have demonstrated poor outcomes in patients receiving workers compensation after lumbar fusion. However, a case-control study where patients are matched for covariates known to affect outcomes after lumbar fusion including baseline clinical outcome measures has not been done.

BACKGROUND CONTEXT: Patients with predominantly back pain have been shown to have worse outcomes following lumbar fusion than patients with some component of leg pain in addition to back pain. Outcomes in patients with predominant arm pain have not been compared to those with predominant neck pain.

BACKGROUND CONTEXT: Health related quality of life (HRQOL) measures after lumbar fusion is gradually becoming more widespread in the literature. Despite the increasing impact of the geriatric population, the availability of geriatric HRQOL after lumbar fusion is limited.

BACKGROUND CONTEXT: Bone Morphogenetic Protein (BMP) is widely used as an ICBG substitute for posterolateral spine fusion (PSF). While this application has been extensively studied in IDE trials and clinical series, the serious complications reported for anterior cervical usage have raised new concerns regarding potentially unidentified risks for PSF as well. As complications are often reported in isolation, without a clear denominator, actual complications rates may be difficult to determine.

Study Design. Randomized clinical trial.Objective. To perform a cost-utility analysis using actual cost data from a randomized clinical trial of patients over 60 years old who underwent posterolateral fusion using either rhBMP-2/ACS or iliac crest bone graft (ICBG).Summary Background Data. Bone morphogenetic protein has been shown to be an effective bone graft substitute for spine fusion. However, a clinical trial-based economic analysis of rhBMP-2/ACS compared with iliac crest bone graft has not been done.Methods. Patients over 60 years old requiring decompression and posterolateral fusion were randomized to rhBMP-2/ACS (n = 50) or ICBG (n = 52). A dedicated hospital coder and research nurse tracked each patient to determine direct costs of inpatient care and all postoperative healthcare encounters up to 2 years after surgery. Preoperative and 2-year-postoperative SF-6D utility scores for each patient were determined. A decision tree was created, which included the probability of complications, need for additional treatments and revision surgery; and the costs associated with initial surgery and treatment for complications and additional treatment for continued spine symptoms; and utility scores.Results. The mean total 2-year cost for care (excluding complication and additional spine treatment costs) was $34,235 in the ICBG group and $36,530 in the rhBMP-2/ACS group. For the entire group, the mean cost to treat a major complication was $10,888, the cost of revision surgery for nonunion was $46,852, and additional treatment for spine-related events was $5892. In the ICBG group, 8 patients had complications; 20 had additional interventions, 5 of whom required revision for nonunion. In the rhBMP-2/ACS group, 6 patients had complications, 10 had additional interventions, and 1 required revision for nonunion. The cost of using rhBMP-2/ACS was $39,967 with a 0.11 mean improvement in SF-6D; and for ICBG the cost was $42,286 with a mean improvement of 0.10 in SF-6D.Conclusion. There are more complications, increased need for additional treatment and revision surgery in patients over 60 years old receiving ICBG compared with rhBMP-2/ACS. This may account for higher costs and lower improvements in utility seen in patients receiving ICBG compared with rhBMP-2/ACS in this study population.

BACKGROUND CONTEXT: Clinical outcomes after lumbar fusion are often presented using one-year rather than two-year results. Studies which reported both one and two year outcomes commonly show a lack of significant difference between one-year and two-year outcomes after lumbar fusion. However, these data are presented as changes in group means, not as changes in individual outcomes.

STUDY DESIGN:Prospective randomized controlled trial of rhBMP-2/ACS (Infuse bone graft) versus iliac crest bone graft (ICBG) for lumbar spine fusion in patients over 60 years of age. OBJECTIVE:To report on clinical, radiographic, and economic outcomes, at 2-year follow-up, in patients treated by posterolateral lumbar fusion with rhBMP-2/ACS versus ICBG. SUMMARY OF BACKGROUND DATA:RhBMP-2/ACS is widely used "off-label" for posterolateral spinal fusion. Despite encouraging initial reports, outstanding issues include the need for evidence regarding safety and efficacy in an older population; and an assessment of cost-effectiveness. METHODS:Patients over 60 years old were randomized to rhBMP-2/ACS (n = 50) or ICBG (n = 52). Oswestry Disability Index, Short Form-36, and numerical rating scales for back and leg pain were determined preoperatively and at 6, 12, and 24 months postoperatively. Fusion was evaluated by fine-cut computed tomography scan 2 years postoperatively by 3 reviewers. All in-patient and subsequent out-patient event costs were recorded by a dedicated hospital coder. RESULTS:Two-year postoperative improvement in Oswestry Disability Index averaged 15.8 in the rhBMP-2/ACS group and 13.0 in the ICBG group. Mean improvement in Short Form-36 physical component score was 6.6 in the rhBMP-2/ACS group and 7.5 in the ICBG group. There were 20 complications in the ICBG group and 8 complications in the rhBMP-2/ACS group (P = 0.014). Sixteen ICBG and 10 rhBMP-2/ACS patients required additional treatment for persistent back or leg symptoms. Two rhBMP-2/ACS patients had revision procedures, 1 for nonunion. Eight patients in the ICBG group had revision procedures, 5 for nonunion. Mean fusion grade on computed tomography scan was significantly (P = 0.030) better in the rhBMP-2/ACS (4.3) compared with the ICBG group (3.8). Mean cost of the initial admission was $36,530 in the rhBMP-2/ACS group and $34,235 in the iliac crest bone graft (ICBG) group. Total cost of care over 2 years was $42,574 for the ICBG group and $40,131 for the rhBMP-2/ACS group. CONCLUSION:RhBMP-2/ACS is a viable ICBG replacement in older patients in terms of safety, clinical efficacy, and cost-effectiveness.

BACKGROUND CONTEXT: Specific and generic measures of Health-related quality of life (HRQOL) such as the SF-36 and Oswestry Disability Index (ODI) are increasingly being used to evaluate effectiveness of treatments such as lumbar fusion for degenerative disorders of the lumbar spine. However, their use as a diagnostic tool to determine which patients will improve has been limited.

BACKGROUND CONTEXT: Bone morphogenetic protein has been shown to be an effective bone graft substitute for various spine fusion procedures. However, a cost-utility analysis of rhBMP-2/ACS compared to the standard of care iliac crest bone graft (ICBG) for posterolateral lumbar fusion has not been done.

This study examined whether sagittal alignment, preexisting adjacent level degeneration, and smoking predispose patients to adjacent segment degeneration following lumbar fusion. Fifty-one patients with adjacent segment degeneration were identified and matched with control patients based on age, sex, level, and date of index surgery. Preexisting adjacent level degeneration and sagittal alignment through the fusion and from L1-S1 were determined before and after initial surgery. Patients with adjacent segment degeneration had significantly less lordosis through the fusion and lumbar spine following their initial surgery. There was no significant difference in the amount of preexisting adjacent level degeneration and smoking between the adjacent segment degeneration and control groups. Fusion of the lumbar spine in abnormal sagittal alignment, with loss of lumbar lordosis, predisposes patients to the development of adjacent segment degeneration. Adjacent segment degeneration does not appear to be just a progression of preexisting degenerative changes at the adjacent level.

BACKGROUND CONTEXT: RhBMP-2/ACS (Infuse Bone Graft) has been widely used “off-label” for posterolateral spinal fusion (PSF). Despite encouraging initial reports, outstanding issues include the need for high quality evidence regarding safety and efficacy in an older patient population. Determination of the appropriate role for rhBMP-2/ACS in PSF also requires an assessment of cost effectiveness.

BACKGROUND CONTEXT: Lumbar spinal fusion is often utilized as a revision procedure in patients who have previously undergone surgery. Little data exists regarding outcomes with revision lumbar fusion, from the patient's perspective. The current study examines patient directed outcomes when lumbar fusion is used as a revision surgery.

BACKGROUND CONTEXT: There is mounting evidence supporting the efficacy of bone morphogenetic protein (BMP) for both anterior interbody and posterolateral lumbar fusion. However, the relative cost of BMP remains an important concern for physicians, hospitals, and payers.PURPOSE: The purpose of this study is to report on the perioperative costs for patients treated with rhBMP-2 as compared with an iliac crest bone graft (ICBG) supplemented with graft extenders.STUDY DESIGN/SETTING: A prospective randomized controlled trial of rhBMP-2/ACS (Infuse Bone Graft; Medtronic Sofamor Danek, Memphis, TN) versus ICBG +/- graft extender for lumbar spine fusion in patients over 60 years old.PATIENT SAMPLE: One hundred two patients over 60 years old who required a posterolateral lumbar spine fusion randomized between receiving rhBMP-2/ACS or ICBG.OUTCOME MEASURES: All health-care costs over the first 3 months after surgery.METHODS: As part of a prospective randomized trial of rhBMP-2/ACS versus ICBG +/- graft extender for lumbar spine fusion, all costs over the first 3 months after surgery were directly recorded by-a dedicated coder funded by Norton Healthcare, Louisville, KY. A dedicated research nurse also followed all patients throughout their hospital stay and posthospitalization recovery to identify any adverse events or additional outpatient medical care.RESULTS: Fifty patients received rhBMP-2/ACS and 52 underwent ICBG harvest. The mean hospital cost for the index admission was $24,736 for the rhBMP-2/ACS group and $21,138 for the ICBG group. Mean inpatient physician costs were $5,082 in the rhBMP-2/ACS group and $5,3 16 in the ICBG group. Costs associated with posthospital rehabilitation averaged $4,906 in the rhBMP-2/ACS group versus $6,820 in the ICBG group. Total payer expenditure for the 3-month perioperative period averaged $33,860 in the rhBMP-2/ACS group and $37,227 in the ICBG group.CONCLUSIONS: The hospital carries the cost burden associated with the utilization of rhBMP-2/ ACS. In contrast, the payer in a Diagnosis-Related Group (DRG) model achieves a net savings, based primarily on the decreased payment for inpatient rehabilitation, but also on decreased hospital reimbursement, physician costs, and other outpatient services. (C) 2008 Elsevier Inc. All rights reserved.

BACKGROUND CONTEXT: Older patients are often advised that their age is a contraindication to lumbar fusion surgery. There is, however, limited available data to support or contradict this assertion. Although prior studies of surgical treatment for lumbar degenerative disease suggest that older patients obtain symptomatic pain relief, an evaluation of fusion outcomes based on modern Health-Related Quality of Life (HRQOL) measures is lacking. PURPOSE: The purpose of this study was to document clinical outcomes based on standardized HRQOL measures in patients over 65 years of age treated by lumbar decompression and fusion surgery. DESIGN/SETTING: This study was a retrospective review of prospectively collected patient reported outcomes data. PATIENT SAMPLE: Ninety-seven consecutive patients over 65 years of age treated by lumbar decompression and fusion between 2000 and 2004 were enrolled in a prospective health status outcomes protocol. Eighty-five patients (88%) had complete data at a minimum 2-year follow-up. OUTCOME MEASURES: Medical Outcomes Study Short Form 36v.2 (SF-36), Oswestry Disability Index (ODI), numeric rating scales (NRS) back and leg pain scores. METHODS: Patients over 65 years of age treated by lumbar fusion were evaluated based on HRQOL measures at a minimum of 2 years postoperatively. Variables including history of prior surgery and occurrence of a perioperative complication were evaluated. A comparison group of patients 50 to 64 years of age was also analyzed. RESULTS: In patients over 65 years old, mean improvement of 6.21 points in SF-36 Physical Composite Score and 5.75 points in SF-36 Mental Composite Score was observed. There was a mean 16.38-point improvement in ODI, 3.08-point improvement in back pain NRS, and 2.65-point improvement in leg pain NRS. SF-36 subscale scores showed improvement for all parameters except general health, where there was a small but statistically significant decline. There was no difference in outcomes at 2 years postoperatively based on the occurrence of a perioperative complication. Patients undergoing a primary lumbar surgical procedure had consistently better outcomes than patients undergoing a revision procedure. CONCLUSIONS: The results of this study support the efficacy of lumbar decompression and fusion in selected patients over 65 years of age. Occurrence of a perioperative complication did not adversely affect clinical outcome. Patients undergoing a revision procedure should be counseled with regard to the more limited benefits seen with revision surgery. (C) 2007 Elsevier Inc. All rights reserved.

The purpose of this study was to develop and validate a classification of indications for fusion in lumbar degenerative disease. Nineteen spine surgeons reviewed a series of 32 case histories and selected the indication for fusion based on an outlined classification system. To determine the degree of interrater variability, K coefficients were calculated (K for all 32 cases, 0.63). Results from this study show the significant difficulty in classifying the indication for fusion in lumbar degenerative disease. The level of the 19 surgeons' agreement regarding surgical indication was only moderate, despite a study design that eliminated controversial issues of patient and procedure selection. To a significant extent, the difficulty in classifying indication for fusion underlines the importance of the process. If we cannot agree on why a specific patient is selected for fusion, it is then impossible to accurately compare outcomes for a given disease process or surgical technique. For this reason, an ongoing effort to refine nomenclature and classification is necessary.

BACKGROUND CONTEXT: Infuse Bone Graft is approved as an ICBG substitute for single-level anterior interbody fusion, but is also used in posterior lumbar fusion cases. Initial reports support the efficacy of Infuse for both posterolateral fusion and TLIF. However, the economic implications of using Infuse instead of ICBG remain a critical unresolved issue.

BACKGROUND CONTEXT:INFUSE has been proven effective in conjunction with threaded cages and bone dowels for single-level anterior lumbar interbody fusion (ALIF). The published experience with posterolateral fusion, although encouraging, utilizes a significantly higher dose and concentration of recombinant human bone morphogenic protein-2 (rhBMP-2) and a different carrier than the commercially available INFUSE.PURPOSE:To present an assessment of fusion rate for posterolateral spine fusion with INFUSE Bone Graft.STUDY DESIGN/SETTING:Retrospective review of patients treated using INFUSE in posterolateral spine fusion in a single institution.PATIENT SAMPLE:91 patients with minimum 2-year follow-up who underwent posterolateral spine fusion using INFUSE as an iliac crest bone graft (ICBG) substitute.OUTCOME MEASURES:Fusion rate based on fine-cut computed tomographic (CT) scans with sagittal and coronal reconstructions.METHODS:Fusion was performed using one large INFUSE kit (12 mg rhBMP-2, 1.5 mg/mL), which was prepared according to the manufacturer's instructions. The INFUSE sponge was wrapped around the local bone or graft extender and placed over the decorticated surfaces in the lateral gutters. Postoperative CT scans with reconstructions were reviewed by two independent orthopedic spine surgeons. CT scans of a comparison group of 35 patients who underwent primary single-level posterolateral fusion with ICBG were also reviewed.RESULTS:The overall group had a mean 4.38 CT fusion grade and a 6.6% nonunion rate. Primary one-level fusion cases (n=48) had a mean 4.42 fusion grade a 4.2% nonunion rate. Primary multilevel fusions (n=27) had a mean 4.65 CT grade and no nonunions detected. Assessment of the 35 primary one-level ICBG control cases demonstrated a mean CT grade of 4.35 and a nonunion rate of 11.4%. In the 16 cases of revision for prior nonunion, mean CT grade was 3.81 and 4 subjects had nonunions. Additional subgroup analysis showed that smokers (n=14) had a mean 4.32 CT grade with no nonunions. Men had a mean 4.04 CT grade and an 11.1% nonunion rate compared with a mean 4.61 CT grade and 3.6% nonunion rate in women. This difference was statistically significant (p=.036). No significant differences in fusion rate were observed based upon the specific graft extender used (p=.200).CONCLUSIONS:Posterolateral spine fusion involves a more difficult healing environment with a limited surface for healing, a gap between transverse processes and the milieu of distractive forces. Historically, only ICBG has been able to overcome these challenges and reliably generate a successful posterolateral lumbar spine fusion. In contrast to prior studies, clinically available INFUSE delivers only 12 mg rhBMP-2 at a concentration of 1.5 mg/mL. Despite the lower dose and concentration of rhBMP-2, this study suggests that fusion success with INFUSE is equivalent to ICBG for posterolateral spine fusion. As with ICBG, development of solid fusion or nonunion is a multifactorial process. The use of INFUSE is not a substitute for proper surgical technique or optimization of patient-related risk factors. Additional studies are needed to determine the incremental benefit of a greater rhBMP-2 dose or use of alternative carriers for posterolateral fusion. Finally, correlation between radiographic findings and clinical outcomes, and a cost-benefit analysis are needed. Despite these issues, this study presents compelling evidence that commercially available INFUSE is an effective ICBG substitute for one- and two-level posterolateral instrumented spine fusion.