Comparative effectiveness research (CER) has impending significance for the field of spine surgery. This article outlines the rationale for comparative effectiveness research and reviews recommended priorities of spinal surgery emphasis. It also examines recent key studies of CER in the spine surgery literature and associated cost-effectiveness studies. It concludes with a discussion of the direction of CER in the spine surgery community.
Kalil G. Abdullah, Edward C. Benzel, and Thomas E. Mroz
Matthew D. Alvin, Daniel Lubelski, Edward C. Benzel, and Thomas E. Mroz
Cervical spondylotic myelopathy (CSM) often can be surgically treated by either ventral or dorsal decompression and fusion. However, there is a lack of high-level evidence on the relative advantages and disadvantages for these treatments of CSM. The authors' goal was to provide a comprehensive review of the relative benefits of ventral versus dorsal fusion in terms of quality of life (QOL) outcomes, complications, and costs. They reviewed 7 studies on CSM published between 2003 and 2013 and summarized the findings for each category. Both procedures have been shown to lead to statistically significant improvement in clinical outcomes for patients. Ventral fusion surgery has been shown to yield better QOL outcomes than dorsal fusion surgery. Complication rates for ventral fusion surgery range from 11% to 13.6%, whereas those for dorsal fusion surgery range from 16.4% to 19%. Larger randomized controlled trials are needed, with particular emphasis on QOL and minimum clinically important differences.
Kene T. Ugokwe, Iain H. Kalfas, Thomas E. Mroz, and Michael P. Steinmetz
Pseudarthrosis and construct failure following single-level anterior cervical discectomy, fusion, and plate placement (ACDFP) rarely occur. Routine postoperative anteroposterior and lateral radiographs may be an inconvenience to patients and expose them to additional and potentially unnecessary radiation. No standard exists to define when patients should obtain radiographs following an ACDFP. The authors hypothesize that routinely obtaining static anteroposterior and lateral radiographs in patients who recently underwent a single-level ACDFP without new axial neck pain or other neurological complaints or symptoms is unwarranted and does not alter the long-term treatment of the patient.
The authors retrospectively reviewed the charts and radiographs of patients who underwent a single-level ACDFP between January 1, 2000, and December 31, 2005. All patients underwent a single-level ACDFP and had routine cervical radiographs obtained at various intervals after surgery.
Twenty-one patients underwent ACDFP at C5–6, 14 patients underwent surgery at C6–7, 11 patients at C4–5, and 7 patients at C3–4. None of the intraoperative radiographs demonstrated malposition of the graft or instrumentation. Based on subjective reporting by the patients, the vast majority (49 of 53) showed improvement in neck and arm pain, and/or neurological dysfunction following surgery. Overall, 5 patients (9%) demonstrated abnormalities on their postoperative radiographs. No patients were returned to the operating room as a result of postoperative radiographic findings. The sensitivity of plain radiographs in this patient series or the percentage of patients with new symptoms that had an abnormality related to the construct on plain radiography was 50%. The specificity of plain radiographs or the percentage of patients who were asymptomatic and had normal radiographs was 94%. The positive predictive value was 25%; that is, there was a 25% chance that patients with symptoms would have a construct abnormality on postoperative radiographs. The negative predictive value was 98%; that is, 98% of patients without symptoms will have normal radiographs.
Pseudarthrosis and construct failure following single-level ACDFP occur rarely, and patients with new symptoms following surgery are as likely to have normal radiographic findings as they are to have abnormalities identified on their postoperative plain radiographs. Routinely obtaining postoperative radiographs at regular intervals in asymptomatic patients following single-level ACDFP does not appear to be warranted.
Eric Z. Herring, Matthew R. Peck, Caroline E. Vonck, Gabriel A. Smith, Thomas E. Mroz, and Michael P. Steinmetz
Spine surgeons in the United States continue to be overwhelmed by an aging population, and patients are waiting weeks to months for appointments. With a finite number of clinic visits per surgeon, analysis of referral sources needs to be explored. In this study, the authors evaluated patient referrals and their yield for surgical volume at a tertiary care center.
This is a retrospective study of new patient visits by the spine surgery group at the Cleveland Clinic Center for Spine Health from 2011 to 2016. Data on all new or consultation visits for 5 identified spinal surgeons at the Center for Spine Health were collected. Patients with an identifiable referral source and who were at least 18 years of age at initial visit were included in this study. Univariate analysis was used to identify demographic differences among referral groups, and then multivariate analysis was used to evaluate those referral groups as significant predictors of surgical yield.
After adjusting for demographic differences across all referrals, multivariate analysis identified physician referrals as more likely (OR 1.48, 95% CI 1.04–2.10, p = 0.0293) to yield a surgical case than self-referrals. General practitioner referrals (OR 0.5616, 95% CI 0.3809–0.8278, p = 0.0036) were identified as less likely to yield surgical cases than referrals from interventionalists (OR 1.5296, p = 0.058) or neurologists (OR 1.7498, 95% CI 1.0057–3.0446, p = 0.0477). Additionally, 2 demographic factors, including distance from home and age, were identified as predictors of surgery. Local patients (OR 1.21, 95% CI 1.13–1.29, p = 0.018) and those 65 years of age or older (OR 0.80, 95% CI 0.72–0.87, p = 0.0023) were both more likely to need surgery after establishing care with a spine surgeon.
In conclusion, referrals from general practitioners and self-referrals are important areas where focused triaging may be necessary. Further research into midlevel providers and nonsurgical spine provider’s role in these referrals for spine pathology is needed. Patients from outside of the state or younger than 65 years could benefit from pre-visit screening as well to optimize a surgeon’s clinic time use and streamline patient care.
Jay M. Levin, Robert D. Winkelman, Joseph E. Tanenbaum, Edward C. Benzel, Thomas E. Mroz, and Michael P. Steinmetz
The Patient Experience of Care, composed of 9 dimensions derived from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey, is being used by the Centers for Medicare & Medicaid Services to adjust hospital reimbursement. Currently, there are minimal data on how scores on the constituent HCAHPS items impact the global dimension of satisfaction, the Overall Hospital Rating (OHR). The purpose of this study was to determine the key drivers of overall patient satisfaction in the setting of inpatient lumbar spine surgery.
Demographic and preoperative patient characteristics were obtained. Patients selecting a top-box score for OHR (a 9 or 10 of 10) were considered to be satisfied with their hospital experience. A baseline multivariable logistic regression model was then developed to analyze the association between patient characteristics and top-box OHR. Then, multivariable logistic regression models adjusting for patient-level covariates were used to determine the association between individual components of the HCAHPS survey and a top-box OHR.
A total of 453 patients undergoing lumbar spine surgery were included, 80.1% of whom selected a top-box OHR. Diminishing overall health status (OR 0.63, 95% CI 0.43–0.91) was negatively associated with top-box OHR. After adjusting for potential confounders, the survey items that were associated with the greatest increased odds of selecting a top-box OHR were: staff always did everything they could to help with pain (OR 12.5, 95% CI 6.6–23.7), and nurses were always respectful (OR 11.0, 95% CI 5.3–22.6).
Patient experience of care is increasingly being used to determine hospital and physician reimbursement. The present study analyzed the key drivers of patient experience among patients undergoing lumbar spine surgery and found several important associations. Patient overall health status was associated with top-box OHR. After adjusting for potential confounders, staff always doing everything they could to help with pain and nurses always being respectful were the strongest predictors of overall satisfaction in this population. These findings highlight opportunities for quality improvement efforts in the spine care setting.
Michael F. Shriver, Valerie Zeer, Vincent J. Alentado, Thomas E. Mroz, Edward C. Benzel, and Michael P. Steinmetz
There are a variety of surgical positions that provide optimal exposure of the dorsal lumbar spine. These include the prone, kneeling, knee-chest, knee-elbow, and lateral decubitus positions. All are positions that facilitate exposure of the spine. Each position, however, is associated with an array of unique complications that result from excessive pressure applied to the torso or extremities. The authors reviewed clinical studies reporting complications that arose from positioning of the patient during dorsal exposures of the lumbar spine.
MEDLINE, Scopus, and Web of Science database searches were performed to find clinical studies reporting complications associated with positioning during lumbar spine surgery. For articles meeting inclusion criteria, the following information was obtained: publication year, study design, sample size, age, operative time, type of surgery, surgical position, frame or table type, complications associated with positioning, time to first observed complication, long-term outcomes, and evidence-based recommendations for complication avoidance.
Of 3898 articles retrieved from MEDLINE, Scopus, and Web of Science, 34 met inclusion criteria. Twenty-four studies reported complications associated with use of the prone position, and 7 studies investigated complications after knee-chest positioning. Complications associated with the knee-elbow, lateral decubitus, and supine positions were each reported by a single study. Vision loss was the most commonly reported complication for both prone and knee-chest positioning. Several other complications were reported, including conjunctival swelling, Ischemic orbital compartment syndrome, nerve palsies, thromboembolic complications, pressure sores, lower extremity compartment syndrome, and shoulder dislocation, highlighting the assortment of possible complications following different surgical positions. For prone-position studies, there was a relationship between increased operation time and position complications. Only 3 prone-position studies reported complications following procedures of less than 120 minutes, 7 studies reported complications following mean operative times of 121–240 minutes, and 9 additional studies reported complications following mean operative times greater than 240 minutes. This relationship was not observed for knee-chest and other surgical positions.
This work presents a systematic review of positioning-related complications following prone, knee-chest, and other positions used for lumbar spine surgery. Numerous evidence-based recommendations for avoidance of these potentially severe complications associated with intraoperative positioning are discussed. This investigation may serve as a framework to educate the surgical team and decrease rates of intraoperative positioning complications.
Haariss Ilyas, Joshua L. Golubovsky, Jingxiao Chen, Robert D. Winkelman, Thomas E. Mroz, and Michael P. Steinmetz
The objective of this study was to evaluate the incidence and risk factors for 90-day readmission and reoperation after elective surgery for lumbar spinal stenosis (LSS).
The authors performed a retrospective consecutive cohort analysis of patients undergoing posterior lumbar decompression with or without fusion for LSS with claudication from January 2014 through December 2015.
Data were collected on 1592 consecutive patients. The mean age at surgery was 67.4 ± 10.1 years and 45% of patients were female. The 90-day reoperation rate was 4.7%, and 69.3% of the reoperations occurred within the first 30 days. The 90-day readmission rate was 7.2%. Multivariable analysis showed that postoperative development of a surgical site infection (SSI; odds ratio [OR] 14.09, 95% confidence interval [CI] 7.86–25.18), acute kidney injury (AKI; OR 6.76, 95% CI 2.39–19.57), and urinary tract infection (UTI; OR 3.96, 95% CI 2.43–6.37), as well as a history of congestive heart failure (CHF; OR 3.03, 95% CI 1.69–5.28), were significant risk factors for readmission within 90 days. Male sex (OR 0.60, 95% CI 0.38–0.92) was associated with decreased odds for readmission. With regards to reoperation, development of SSI (OR 25.06, 95% CI 13.54–46.51), sepsis (OR 7.63, 95% CI 1.52–40.59), UTI (OR 2.54, 95% CI 1.31–4.76), and increased length of stay (LOS; OR 1.25, 95% CI 1.17–1.33) were found to be significant risk factors. A subsequent analysis found that morbid obesity (OR 6.99), history of coronary artery disease (OR 2.263), increased duration of surgery (OR 1.004), and LOS (OR 1.07) were significant risk factors for developing an SSI.
Overall, this study found rates of 4.7% and 7.2% for reoperation and readmission, respectively, within 90 days: 30.7% of the reoperations and 44.7% of the readmissions occurred beyond the first 30 days. A diagnosis of SSI, AKI, UTI, and history of CHF were significant factors for readmission, while male sex was associated with decreased odds for readmission. A diagnosis of SSI, sepsis, UTI, and increased LOS were found to be significant predictors for reoperation. Understanding 90-day complication rates is imperative because there has been increased discussion and healthcare policy extending the global postoperative window to 90 days. Current literature supports a readmission rate of 3%–9% after spine surgery. However, this literature either is limited to a 30-day window or does not stratify between different types of spine surgeries.
Sina Pourtaheri, Akshay Sharma, Jason Savage, Iain Kalfas, Thomas E. Mroz, Edward Benzel, and Michael P. Steinmetz
The flexed posture of the proximal (L1–3) or distal (L4–S1) lumbar spine increases the diameter of the spinal canal and neuroforamina and can relieve symptoms of neurogenic claudication. Distal lumbar flexion can result in pelvic retroversion; therefore, in cases of flexible sagittal imbalance, pelvic retroversion may be compensatory for lumbar stenosis and not solely compensatory for the sagittal imbalance as previously thought. The authors investigate underlying causes for pelvic retroversion in patients with flexible sagittal imbalance.
One hundred thirty-eight patients with sagittal imbalance who underwent a total of 148 fusion procedures of the thoracolumbar spine were identified from a prospective clinical database. Radiographic parameters were obtained from images preoperatively, intraoperatively, and at 6-month and 2-year follow-up. A cohort of 24 patients with flexible sagittal imbalance was identified and individually matched with a control cohort of 23 patients with fixed deformities. Flexible deformities were defined as a 10° change in lumbar lordosis between weight-bearing and non–weight-bearing images. Pelvic retroversion was quantified as the ratio of pelvic tilt (PT) to pelvic incidence (PI).
The average difference between lumbar lordosis on supine MR images and standing radiographs was 15° in the flexible cohort. Sixty-eight percent of the patients in the flexible cohort were diagnosed preoperatively with lumbar stenosis compared with only 22% in the fixed sagittal imbalance cohort (p = 0.0032). There was no difference between the flexible and fixed cohorts with regard to C-2 sagittal vertical axis (SVA) (p = 0.95) or C-7 SVA (p = 0.43). When assessing for postural compensation by pelvic retroversion in the stenotic patients and nonstenotic patients, the PT/PI ratio was found to be significantly greater in the patients with stenosis (p = 0.019).
For flexible sagittal imbalance, preoperative attention should be given to the root cause of the sagittal misalignment, which could be compensation for lumbar stenosis. Pelvic retroversion can be compensatory for both the lumbar stenosis as well as for sagittal imbalance.
Syed K. Mehdi, Vincent J. Alentado, Bryan S. Lee, Thomas E. Mroz, Edward C. Benzel, and Michael P. Steinmetz
Ossification of the posterior longitudinal ligament (OPLL) is a pathological calcification or ossification of the PLL, predominantly occurring in the cervical spine. Although surgery is often necessary for patients with symptomatic neurological deterioration, there remains controversy with regard to the optimal surgical treatment. In this systematic review and meta-analysis, the authors identified differences in complications and outcomes after anterior or posterior decompression and fusion versus after decompression alone for the treatment of cervical myelopathy due to OPLL.
A MEDLINE, SCOPUS, and Web of Science search was performed for studies reporting complications and outcomes after decompression and fusion or after decompression alone for patients with OPLL. A meta-analysis was performed to calculate effect summary mean values, 95% CIs, Q statistics, and I2 values. Forest plots were constructed for each analysis group.
Of the 2630 retrieved articles, 32 met the inclusion criteria. There was no statistically significant difference in the incidence of excellent and good outcomes and of fair and poor outcomes between the decompression and fusion and the decompression-only cohorts. However, the decompression and fusion cohort had a statistically significantly higher recovery rate (63.2% vs 53.9%; p < 0.0001), a higher final Japanese Orthopaedic Association score (14.0 vs 13.5; p < 0.0001), and a lower incidence of OPLL progression (< 1% vs 6.3%; p < 0.0001) compared with the decompression-only cohort. There was no statistically significant difference in the incidence of complications between the 2 cohorts.
This study represents the only comprehensive review of outcomes and complications after decompression and fusion or after decompression alone for OPLL across a heterogeneous group of surgeons and patients. Based on these results, decompression and fusion is a superior surgical technique compared with posterior decompression alone in patients with OPLL. These results indicate that surgical decompression and fusion lead to a faster recovery, improved postoperative neurological functioning, and a lower incidence of OPLL progression compared with posterior decompression only. Furthermore, decompression and fusion did not lead to a greater incidence of complications compared with posterior decompression only.
Michael F. Shriver, Jack J. Xie, Erik Y. Tye, Benjamin P. Rosenbaum, Varun R. Kshettry, Edward C. Benzel, and Thomas E. Mroz
Lumbar microdiscectomy and its various minimally invasive surgical techniques are seeing increasing popularity, but a systematic review of their associated complications has yet to be performed. The authors sought to identify all prospective clinical studies reporting complications associated with lumbar open microdiscectomy, microendoscopic discectomy (MED), and percutaneous microdiscectomy.
The authors conducted MEDLINE, Scopus, Web of Science, and Embase database searches for randomized controlled trials and prospective cohort studies reporting complications associated with open, microendoscopic, or percutaneous lumbar microdiscectomy. Studies with fewer than 10 patients and published before 1990 were excluded. Overall and interstudy median complication rates were calculated for each surgical technique. The authors also performed a meta-analysis of the reported complications to assess statistical significance across the various surgical techniques.
Of 9504 articles retrieved from the databases, 42 met inclusion criteria. Most studies screened were retrospective case series, limiting the number of studies that could be included. A total of 9 complication types were identified in the included studies, and these were analyzed across each of the surgical techniques. The rates of any complication across the included studies were 12.5%, 13.3%, and 10.8% for open, MED, and percutaneous microdiscectomy, respectively. New or worsening neurological deficit arose in 1.3%, 3.0%, and 1.6% of patients, while direct nerve root injury occurred at rates of 2.6%, 0.9%, and 1.1%, respectively. Hematoma was reported at rates of 0.5%, 1.2%, and 0.6%, respectively. Wound complications (infection, dehiscence, orseroma) occurred at rates of 2.1%, 1.2%, and 0.5%, respectively. The rates of recurrent disc complications were 4.4%, 3.1%, and 3.9%, while reoperation was indicated in 7.1%, 3.7%, and 10.2% of operations, respectively. Meta-analysis calculations revealed a statistically significant higher rate of intraoperative nerve root injury following percutaneous procedures relative to MED. No other significant differences were found.
This review highlights complication rates among various microdiscectomy techniques, which likely reflect real-world practice and conceptualization of complications among physicians. This investigation sets the framework for further discussions regarding microdiscectomy options and their associated complications during the informed consent process.