Should polytrauma patients with unstable spinal column injuries who are neurologically intact be operated on within 24 hours to optimize patient and nonpatient outcomes?
The patient with multiple trauma presents a unique challenge, even more so when combined with an unstable spinal fracture. The dilemma revolves around appropriately prioritizing the treatment of the various injuries into a safe and effective paradigm that allows for surgical stabilization of the spine. Factors that may delay the stabilization of a traumatic spinal column injury include delayed transport time from the accident site or outlying hospital, unavailability of a qualified trauma team familiar with the identification of spinal trauma,1 lack of medical and surgical resources capable of shortening resuscitation time to prevent any secondary morbidity, and the lack of a highly experienced spine surgery team.2
Once the patient is stable, the question of the timing of the surgery has become the subject of much controversy. Most of the debate has centered on the relative merits of early versus late surgery and its effect on neurologic recovery.3–8 Although preserving neurologic function is of paramount importance, there are no published clinical studies in humans that definitively prove that early surgical stabilization is effective in improving neurologic function.8–10 In terms of non-neurologic outcome parameters, Thomas et al in his analysis of the literature comparing operative versus nonoperative treatment of thoracolumbar burst fractures in neurologically intact patients concluded that there is a low level of evidence supporting early surgery.11 This and other studies have shown there are few strong evidentiary clinical studies that have sufficient data to unequivocally support the efficacy of early surgery for the treatment of spinal injuries. Future studies using methodologies consisting of adequately powered, prospective, randomized designs with patient-reported outcomes collected by multicenter study groups may be superior.11,12
There are other outcome parameters in the treatment of spinal trauma that have been substantially affected by early versus late surgical stabilization. These parameters are more amenable to analysis because they are easier to track and quantify. In addition, these parameters do not require the protracted follow-up that patient-reported health-related quality of life instruments require and are relatively immune to study bias. Previous studies have shown that early surgery allows for more rapid mobilization, a significant reduction of the incidence of pressure ulcers and pulmonary complications,5 a decreased length of stay in the intensive care unit (ICU), a decreased duration of ventilator support, a decreased stay in the hospital, a substantial decrease in hospitalization costs, and facilitation of earlier transfer to rehabilitation.3,7,10,13 The purpose of this review is to evaluate the effect of early versus late surgical stabilization after a spinal column injury on factors other than neurologic recovery.
Materials and Methods
This is a systematic review of the medical literature that sought to answer the following 2 research questions:
- What are the benefits of early versus late surgery?
- Are there disadvantages to early surgery?
Between January 1990 and July 2009, a computer-aided search using the keywords Spine or Spinal, Trauma, Spinal Cord Injury, and Surgery was performed that included MEDLINE, EMBASE, HealthSTAR, Cumulative Index to Nursing & Allied Health Literature, Cochrane Database of Systematic Reviews, ACP Journal Club, Database of Abstracts of Reviews of Effects, Cochrane Central Register of Controlled Trials, PsycINFO, and PsychLit. Articles dealing only with neurologic improvement that did not mention other non-neurologic factors that were affected by early surgery were excluded. The authors selected and assessed the studies to be included in the analysis. An unblinded assessment of the quality of the study was done using the Grades of Recommendation, Assessment, Development and Evaluation approach to rank each article for its relevance to the topic.14–18
The initial search included 90 articles. After review, 28 articles that included information on factors that were directly affected by early versus late surgery were identified and graded by the authors (Table 1). Twelve articles directly comparing 2 cohorts that had early or late surgery were identified.4,6–9,19,20,21–24 Two articles used the same database and only data from the more recent article was included in the analysis.6,7 The majority of the studies used 72 hours as the delineation between early and late surgery.4,6–9,19,20,23,24 There were 3 articles that used 24 hours to separate early versus late surgery.9,21,22 The outcome parameters available and evaluated in each of the 11 articles are summarized in Table 2.
Fusion and instrumentation to restore stability to the spine after a major injury are a widely accepted treatment technique. In their review of 132 studies evaluating the safety of surgical intervention in 5748 patients undergoing surgical stabilization for spinal fractures, Verlaan et al concluded that surgical treatment is generally safe, has acceptable risks, has generally better functional outcomes, and provides effective treatment of spinal fractures.25 However, certain authors have disputed this concept by encouraging nonoperative bracing and Rotabed treatment in an effort to avoid the high risk of complications (infection rate = 10% in operative patients in this series) associated with surgery in polytrauma patients.26 However, the timing of surgery, whether early or late, continues to be controversial, especially as major traumatic spinal injury is usually associated with severe polytrauma. The timing of the surgical treatment of spinal trauma has traditionally been divided into either early treatment (less than 72 hours) or late treatment (greater than 72 hours).20 The origin of this time cut-off is most likely based on well-controlled animal studies that showed that early surgical treatment of acute spinal cord injury (SCI) had favorable results in terms of neurologic recovery.27 Unfortunately, there is no definitive evidence in human clinical trials that supports the efficacy of early surgical intervention in improving neurologic outcomes. A single study on cervical fractures showed no benefit after early surgery.8 Another study on thoracic fractures showed a nonsignificant trend toward improved neurologic recovery in the early surgery group.9
When neurologic recovery is excluded from the decision-making process of when to operate after a major injury to the spinal column, certain injury parameters have been shown to be significantly affected by the timing of surgery (Table 2). All of the studies evaluated, consistently demonstrated shorter hospital and intensive care unit length of stays, fewer days on mechanical ventilation, and lower pulmonary complications in patients who are treated with early spine decompression and stabilization. However, the results addressing morbidity and mortality rates are more variable. There are many potential confounding factors that can preclude early stabilization. These potential confounding factors include the presence of significant associated injuries, patient baseline medical comorbidities, and operating room or surgeon scheduling conflicts. Rarely are these factors identified in the body of a retrospective review. In our review of the included studies, there was only 1 randomized study8 and 1 study that were quasi-randomized.9
Three studies that included an analysis of cost data demonstrated lower costs in patients undergoing early stabilization compared with their late stabilization cohorts. Although health care costs alone should not determine the timing of surgical intervention, if no additional risks are identified by early intervention, the cost factor can no longer be ignored.
Well-designed, Level 1 prospective randomized clinical trials to evaluate the timing of surgery for spinal trauma are difficult to execute due to various uncontrollable factors. Hospital resource issues (operating room availability, ICU beds, equipment needs, C-arm availability, spinal cord monitoring), and lack of appropriate support personnel may lead to delayed surgery. On the patient side, similar to the issues discussed with comparing morbidity and mortality rates, a prospective study would need to control for variables such as the presence of associated life-threatening injuries, specific trauma to the chest, and associated patient comorbidities. There are also complex ethical questions of delaying surgical intervention for subjects randomized to the late surgery group. These hurdles are in addition to the difficulty of obtaining adequate informed consent in the acute trauma setting.
There are only 2 prospective, randomized studies that evaluate the effect of early versus late surgery on patient outcomes and neurologic recovery.8,9 A study of Vacarro et al8 included patients with cervical SCI with no other trauma or concurrent illness that would preclude early surgery. Subjects were randomized to either an early or late surgery group (early ≤72 hours, late >72 hours). No significant difference in neurologic outcomes between the 2 groups was seen. No significant differences were seen in the length of hospital stay, length of stay in the intensive care unit, or length of stay at a rehabilitation facility.
A more recent quasi-randomized prospective study9 of 27 spinal fractures reported on the results of early surgery in 12 patients (≤8 hours) and late surgery in 15 patients (3–15 days). The patients in this study had isolated thoracolumbar SCIs, such that any patient with concurrent polytrauma was excluded from the study. The study showed that subjects who underwent early surgery had better neurologic outcomes, shorter hospital stays, shorter intensive care unit stays, and lower complication rates. However, this study included only a small number of patients and excluded polytrauma patients. Although the exclusion of polytrauma patients was necessary in the study design to eliminate confounders that could lead to delays in surgery and to produce comparable groups; this exclusion limits the generalizability of the results of these 2 studies. In addition, because the primary focus of these 2 prospective studies is neurologic outcomes, their evidence supporting the benefit of early surgery on non-neurologic outcomes is weak.
The majority of recent evidence supporting early stabilization for spinal trauma has come from retrospective analyses of several large trauma databases.4,6 Analyzing the data of 1.3 million cases from the National Trauma Data Bank, Kerwin et al studied 2 matched cohorts comprising of 497 patients who underwent early spinal fixation (≤72 hours) and 374 patients who underwent late spinal fixation (>72 hours). Although the details on the matching of these 2 cohorts were not available from the published article, the 2 groups had similar demographics, injury patterns, injury severity score (ISS), and Glasgow Coma Scale (GCS) scores. They found a significantly lower complication rate in the early surgical intervention in patients when compared to the later group (P < 0.0001). The mortality rates were noted to be comparable.3 Infections were the most common complication in both groups and included pneumonia, urinary tract infections, and wound infections (Early = 44.4% vs. Late = 41.1%). The study also confirmed previous publications that identified that patients who underwent early surgery had significantly shorter lengths of stay in both the intensive care unit (P < 0.001) and the overall hospital stay (P < 0.001) when compared to the late surgery group. A pattern of stratification was also noted with the thoracic injuries followed by the cervical injuries showing the most improvement of the recovery parameters. There was also a 20% reduction of costs in the early group when compared to the late group (P = 0.03). Although this is a retrospective study, the large sample size and matched cohorts provide strong evidence supporting early surgery for improvement of non-neurologic outcome parameters.4
Mirza et al23 looked at patients who had cervical SCIs with ISS less than 30 and found that patients undergoing early surgery had significantly greater improvement in neurologic outcome as well as shorter hospital stays. This finding was also seen in study by Levi et al21 with subgroup of patients with cervical SCI treated urgently (≤24).
There are 3 studies that specifically looked at the effect of the timing of surgery as it relates to the severity of the injuries associated with the trauma to the spine. Schinkel and Anastasiadis6 retrospectively evaluated the German Trauma Registry and identified patients with severe thoracic spine fractures of which 156 patients had early surgery (≤72 hours) and 49 had late surgery (>72 hours). The patients in this study suffered much more severe injuries with a mean with ISS of 30.1, and 95% had significant associated thoracic trauma. Similar to other studies, the authors showed that patients who underwent early stabilization had shorter ICU stays (P = 0.001), shorter hospital stays (P = 0.048), less days on a mechanical ventilator (P = 0.02), and lower mortality rates. When a subgroup analysis was performed, stratifying for ISS, the authors report that the most severely injured patients (ISS >38) benefited the most from early surgery.
Chipman et al19evaluated the effect of ISS on outcomes in patients undergoing early or late surgery by stratifying their patients into high ISS (ISS ≥15) and low ISS (ISS <15) groups. The authors retrospectively reviewed 146 patients from a trauma registry who underwent surgery for thoracolumbar spinal column injuries to validate the hypothesis that early surgery (≤72 hours) was safe and resulted in fewer complications. The study showed patients undergoing early surgery in both the high ISS and low ISS groups had significantly shorter hospital stays (P < 0.001). However, differences in complication rates and ICU stays were seen only in the high ISS group, with patients undergoing early surgery having less complications (P = 0.03) and shorter ICU stays (P = 0.003). This finding that patients with high ISS scores benefits most from early surgery is similar to the findings of Schinkel and Anastasiadis.6
McLain and Benson22 reviewed patients who required segmental instrumentation for spinal fractures who had ISS scores greater than 26 and evaluated the effect of urgent (≤24 hours) and early surgery (between 24 and 72 hours). Their data showed no difference in the rate of complications or mortality between the 2 groups. Although their numbers were small, a larger proportion of patients in the urgently treated group had neurologic improvement compared with the early surgery group.
The study by McHenry et al5 used a different study design, by looking at multiple factors and performing a logistic regression analysis to determine risk factors for respiratory failure after operative stabilization of thoracic and lumbar fractures. Their analysis identified the factors of age greater than 35, ISS >25; Glasgow Coma Scale ≤12, blunt chest injury, and surgical stabilization performed 2 days after injury as predictive of respiratory failure.
The difficulties in designing and performing a well-designed study to evaluate the optimum timing of surgical stabilization of patients with spinal column injuries is well-understood. Therefore, majority of the available data in the literature has been extracted from retrospective comparisons of patients undergoing early versus late stabilization from large databases. The evidence supporting early versus late surgery in the polytrauma patient with spinal trauma is low and very low quality for non-neurologic patient and nonpatient process outcomes. Despite the low quality, there are consistent favorable trends in the literature and when combined with the principles of the benefits of early surgery in the polytrauma patient, the consensus opinion among the spine trauma study group was for a strong recommendation for early surgery (less than 24 hours). These benefits include shorter hospital stays, shorter intensive care unit stays, less days on mechanical ventilation, and lower pulmonary complications. This effect is more evident in patients who have more severe injuries as measured by ISS. This benefit is seen in both, spinal cord injured and noncord-injured patients. There is also some evidence that early stabilization does not increase the complication rates compared with late surgery. Finally, even though there is low quality evidence supporting early surgery for non-neurologic outcomes there does not appear to be any deleterious effect on patients.
- There is strong evidence within the literature that early surgical stabilization consistently leads to shorter hospital stays, shorter intensive care unit stays, less days on mechanical ventilation, and lower pulmonary complications.
- This effect is more evident in patients who have more severe injuries as measured by ISS.
- This benefit is seen in both spinal cord injured and noncord-injured patients.
- There is also some evidence that early stabilization does not increase the complication rates compared with late surgery.
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