John J. Knightly

Minimally invasive versus open fusion for Grade I degenerative lumbar spondylolisthesis: analysis of the Quality Outcomes Database

OBJECTIVE Lumbar spondylolisthesis is a degenerative condition that can be surgically treated with either open or minimally invasive decompression and instrumented fusion. Minimally invasive surgery (MIS) approaches may shorten recovery, reduce blood loss, and minimize soft-tissue damage with resultant reduced postoperative pain and disability. METHODS The authors queried the national, multicenter Quality Outcomes Database (QOD) registry for patients undergoing posterior lumbar fusion between July 2014 and December 2015 for Grade I degenerative spondylolisthesis. The authors recorded baseline and 12-month patient-reported outcomes (PROs), including Oswestry Disability Index (ODI), EQ-5D, numeric rating scale (NRS)-back pain (NRS-BP), NRS-leg pain (NRS-LP), and satisfaction (North American Spine Society satisfaction questionnaire). Multivariable regression models were fitted for hospital length of stay (LOS), 12-month PROs, and 90-day return to work, after adjusting for an array of preoperative and surgical variables. RESULTS A total of 345 patients (open surgery, n = 254; MIS, n = 91) from 11 participating sites were identified in the QOD. The follow-up rate at 12 months was 84% (83.5% [open surgery]; 85% [MIS]). Overall, baseline patient demographics, comorbidities, and clinical characteristics were similarly distributed between the cohorts. Two hundred fifty seven patients underwent 1-level fusion (open surgery, n = 181; MIS, n = 76), and 88 patients underwent 2-level fusion (open surgery, n = 73; MIS, n = 15). Patients in both groups reported significant improvement in all primary outcomes (all p < 0.001). MIS was associated with a significantly lower mean intraoperative estimated blood loss and slightly longer operative times in both 1- and 2-level fusion subgroups. Although the LOS was shorter for MIS 1-level cases, this was not significantly different. No difference was detected with regard to the 12-month PROs between the 1-level MIS versus the 1-level open surgical groups. However, change in functional outcome scores for patients undergoing 2-level fusion was notably larger in the MIS cohort for ODI (-27 vs -16, p = 0.1), EQ-5D (0.27 vs 0.15, p = 0.08), and NRS-BP (-3.5 vs -2.7, p = 0.41); statistical significance was shown only for changes in NRS-LP scores (-4.9 vs -2.8, p = 0.02). On risk-adjusted analysis for 1-level fusion, open versus minimally invasive approach was not significant for 12-month PROs, LOS, and 90-day return to work. CONCLUSIONS Significant improvement was found in terms of all functional outcomes in patients undergoing open or MIS fusion for lumbar spondylolisthesis. No difference was detected between the 2 techniques for 1-level fusion in terms of patient-reported outcomes, LOS, and 90-day return to work. However, patients undergoing 2-level MIS fusion reported significantly better improvement in NRS-LP at 12 months than patients undergoing 2-level open surgery. Longer follow-up is needed to provide further insight into the comparative effectiveness of the 2 procedures.

Back pain improvement after decompression without fusion or stabilization in patients with lumbar spinal stenosis and clinically significant preoperative back pain

OBJECTIVE The relief of leg symptoms by surgical decompression for lumbar stenosis is well supported by the literature. Less is known about the effect on back pain. Some surgeons believe that the relief of back pain should not be an expected outcome of decompression and that substantial back pain may be a contraindication to decompression only; therefore, stabilization may be recommended for patients with substantial preoperative back pain even in the absence of well-accepted indications for stabilization such as spondylolisthesis, scoliosis, or sagittal malalignment. The purpose of this study is to determine if patients with lumbar stenosis and substantial back pain-in the absence of spondylolisthesis, scoliosis, or sagittal malalignment-can obtain significant improvement after decompression without fusion or stabilization. METHODS Analysis of the National Neurosurgery Quality and Outcomes Database (N2QOD) identified 726 patients with lumbar stenosis (without spondylolisthesis or scoliosis) and a baseline back pain score ≥ 5 of 10 who underwent surgical decompression only. No patient was reported to have significant spondylolisthesis, scoliosis, or sagittal malalignment. Standard demographic and surgical variables were collected, as well as patient outcomes including back and leg pain scores, Oswestry Disability Index (ODI), and EuroQoL 5D (EQ-5D) at baseline and 3 and 12 months postoperatively. RESULTS The mean age of the cohort was 65.6 years, and 407 (56%) patients were male. The mean body mass index was 30.2 kg/m2, and 40% of patients had 2-level decompression, 29% had 3-level decompression, 24% had 1-level decompression, and 6% had 4-level decompression. The mean estimated blood loss was 130 ml. The mean operative time was 100.85 minutes. The vast majority of discharges (88%) were routine home discharges. At 3 and 12 months postoperatively, there were significant improvements from baseline for back pain (7.62 to 3.19 to 3.66), leg pain (7.23 to 2.85 to 3.07), EQ-5D (0.55 to 0.76 to 0.75), and ODI (49.11 to 27.20 to 26.38). CONCLUSIONS Through the 1st postoperative year, patients with lumbar stenosis-without spondylolisthesis, scoliosis, or sagittal malalignment-and clinically significant back pain improved after decompression-only surgery.

Effect of patients’ functional status on satisfaction with outcomes 12 months after elective spine surgery for lumbar degenerative disease

BACKGROUND Comprehensive assessment of quality of care includes patient-reported outcomes, safety of care delivered, and patient satisfaction. The impact of the patient-reported Oswestry Disability Index (ODI) scores at baseline and 12 months on satisfaction with outcomes following spine surgery is not well documented. PURPOSE This study aimed to determine the impact of patient disability (ODI) scores at baseline and 12 months on satisfaction with outcomes following surgery. STUDY DESIGN Analysis of prospectively collected longitudinal web-based multicenter data. PATIENT SAMPLE Patients undergoing elective surgery for degenerative lumbar disease were entered into a prospective multicenter registry. OUTCOME MEASURES Primary outcome measures were ODI, North American Spine Society satisfaction (NASS) questionnaire. METHODS Baseline and 12-month ODI scores were recorded. Satisfaction at 12 months after surgery was measured using NASS questionnaire. Multivariable proportional odds logistic regression analysis was conducted to determine the impact of baseline and 12-month ODI on satisfaction with outcomes. RESULTS Of the total 5,443 patients, 64% (n=3,460) were satisfied at a level where surgery met their expectations (NASS level 1) at 12 months after surgery. After adjusting for all baseline and surgery-specific variables, the 12-month ODI score had the highest impact (Wald χ2=1,555, 86% of the total χ2) on achieving satisfaction with outcomes compared with baseline ODI scores (Wald χ2=93, 5% of the total χ2). The level of satisfaction decreases with increasing 12-month ODI score. Greater change in ODI is required to achieve a better satisfaction level when the patient starts with a higher baseline ODI score. CONCLUSION Absolute 12-month ODI following surgery had a significant association on satisfaction with outcomes 12 months after surgery. Patients with higher baseline ODI required a larger change in ODI score to achieve satisfaction. No single measure can be used as a sole yardstick to measure quality of care after spine surgery. Satisfaction may be used in conjunction with baseline and 12-month ODI scores to provide an assessment of the quality of spine surgery provided in a patient centric fashion.

Risk factors for 30-day reoperation and 3-month readmission: analysis from the Quality and Outcomes Database lumbar spine registry

OBJECTIVE The aim of this paper was to use a prospective, longitudinal, multicenter outcome registry of patients undergoing surgery for lumbar degenerative disease in order to assess the incidence and factors associated with 30-day reoperation and 90-day readmission. METHODS Prospectively collected data from 9853 patients from the Quality and Outcomes Database (QOD; formerly known as the N2QOD [National Neurosurgery Quality and Outcomes Database]) lumbar spine registry were retrospectively analyzed. Multivariate binomial regression analysis was performed to identify factors associated with 30-day reoperation and 90-day readmission after surgery for lumbar degenerative disease. A subgroup analysis of Medicare patients stratified by age (< 65 and ≥ 65 years old) was also performed. Continuous variables were compared using unpaired t-tests, and proportions were compared using Fishers exact test. RESULTS There was a 2% reoperation rate within 30 days. Multivariate analysis revealed prolonged operative time during the index case as the only independent factor associated with 30-day reoperation. Other factors such as preoperative diagnosis, body mass index (BMI), American Society of Anesthesiologists (ASA) class, diabetes, and use of spinal implants were not associated with reoperations within 30 days. Medicare patients < 65 years had a 30-day reoperation rate of 3.7%, whereas those ≥ 65 years had a 30-day reoperation rate of 2.2% (p = 0.026). Medicare beneficiaries younger than 65 years undergoing reoperation within 30 days were more likely to be women (p = 0.009), have a higher BMI (p = 0.008), and have higher rates of depression (p < 0.0001). The 90-day readmission rate was 6.3%. Multivariate analysis demonstrated that higher ASA class (OR 1.46 per class, 95% CI 1.25-1.70) and history of depression (OR 1.27, 95% CI 1.04-1.54) were factors associated with 90-day readmission. Medicare beneficiaries had a higher rate of 90-day readmissions compared with those who had private insurance (OR 1.43, 95% CI 1.17-1.76). Medicare patients < 65 years of age were more likely to be readmitted within 90 days after their index surgery compared with those ≥ 65 years (10.8% vs 7.7%, p = 0.017). Medicare patients < 65 years of age had a significantly higher BMI (p = 0.001) and higher rates of depression (p < 0.0001). CONCLUSIONS In this analysis of a large prospective, multicenter registry of patients undergoing lumbar degenerative surgery, multivariate analysis revealed that prolonged operative time was associated with 30-day reoperation. The authors found that factors associated with 90-day readmission included higher ASA class and a history of depression. The 90-day readmission rates were higher for Medicare beneficiaries than for those who had private insurance. Medicare patients < 65 years of age were more likely to undergo reoperation within 30 days and to be readmitted within 90 days after their index surgery.

Comparison of Outcomes Following Anterior vs Posterior Fusion Surgery for Patients With Degenerative Cervical Myelopathy: An Analysis From Quality Outcomes Database

BACKGROUND The choice of anterior vs posterior approach for degenerative cervical myelopathy that spans multiple segments remains controversial. OBJECTIVE To compare the outcomes following the 2 approaches using multicenter prospectively collected data. METHODS Quality Outcomes Database (QOD) for patients undergoing surgery for 3 to 5 level degenerative cervical myelopathy was analyzed. The anterior group (anterior cervical discectomy [ACDF] or corpectomy [ACCF] with fusion) was compared with posterior cervical fusion. Outcomes included: patient reported outcomes (PROs): neck disability index (NDI), numeric rating scale (NRS) of neck pain and arm pain, EQ-5D, modified Japanese Orthopedic Association score for myelopathy (mJOA), and NASS satisfaction questionnaire; hospital length of stay (LOS), 90-d readmission, and return to work (RTW). Multivariable regression models were fitted for outcomes. RESULTS Of total 245 patients analyzed, 163 patients underwent anterior surgery (ACDF-116, ACCF-47) and 82 underwent posterior surgery. Patients undergoing an anterior approach had lower odds of having higher LOS (P < .001, odds ratio 0.16, 95% confidence interval 0.08-0.30). The 12-mo NDI, EQ-5D, NRS, mJOA, and satisfaction scores as well as 90-d readmission and RTW did not differ significantly between anterior and posterior groups. CONCLUSION Patients undergoing anterior approaches for 3 to 5 level degenerative cervical myelopathy had shorter hospital LOS compared to those undergoing posterior decompression and fusion. Also, patients in both groups exhibited similar long-term PROs, readmission, and RTW rates. Further investigations are needed to compare the differences in longer term reoperation rates and functional outcomes before the clinical superiority of one approach over the other can be established.

Development of a Predictive Score for Discharge Disposition After Lumbar Fusion Using the Quality Outcomes Database

BACKGROUND Lumbar fusion remains the treatment of choice for many degenerative pathologies. Healthcare costs related to the procedure are a concern, and postdischarge needs often contribute to greater expenditure. The Quality Outcomes Database (QOD) is a prospective, multicenter clinical registry designed to analyze outcomes after neurosurgical procedures. OBJECTIVE To create a simple scoring system to predict discharge needs after lumbar fusion. METHODS Institutional QOD data from 2 high-volume neurosurgical centers were collected retrospectively. Univariate and multivariable logistic regression analyses were used to identify factors for our model. A receiver operating characteristic curve was used to set cutoff scores for patients likely to discharge home without ongoing services and those likely to require additional services/alternative placement after discharge. RESULTS Two hundred seventeen patients were included. Five variables-osteoporosis, predominant preoperative symptom, need for assistive ambulation device, American Society of Anesthesiologist grade, and age-were included in our final scoring system. Patients with higher scores are less likely to need additional services. In patients with high scores (8-10), our scale correctly predicted discharge needs in 88.7% of cases. In patients with low scores (0-5), our scale predicted discharge needs (additional home services/alternative placement) in 75% of cases. For our final instrument, the area under the receiver operating characteristic curve was 0.809 (95% confidence interval 0.720-0.897). CONCLUSION We present a simple scoring system to assist in predicting postdischarge needs for patients undergoing lumbar fusion for degenerative disease. Further validation studies are needed to assess the generalizability of our scale.