The utilization of orthotic devices for lumbar degenerative disease has been justified from both a prognostic and therapeutic perspective. As a prognostic tool, bracing is applied prior to surgery to determine if immobilization of the spine leads to symptomatic relief and thus justify the performance of a fusion. Since bracing does not eliminate motion, the validity of this assumption is questionable. Only one low-level study has investigated the predictive value of bracing prior to surgery. No correlation between response to bracing and fusion outcome was observed; therefore a trial of preoperative bracing is not recommended. Based on low-level evidence, the use of bracing is not recommended for the prevention of low-back pain in a general working population, since the incidence of low-back pain and impact on productivity were not reduced. However, in laborers with a history of back pain, a positive impact on lost workdays was observed when bracing was applied. Bracing is recommended as an option for treatment of subacute low-back pain, as several higher-level studies have demonstrated an improvement in pain scores and function. The use of bracing following instrumented posterolateral fusion, however, is not recommended, since equivalent outcomes have been demonstrated with or without the application of a brace.
Andrew T. Dailey, Zoher Ghogawala, Tanvir F. Choudhri, William C. Watters III, Daniel K. Resnick, Alok Sharan, Jason C. Eck, Praveen V. Mummaneni, Jeffrey C. Wang, Michael W. Groff, Sanjay S. Dhall and Michael G. Kaiser
Alok Sharan, Michael W. Groff, Andrew T. Dailey, Zoher Ghogawala, Daniel K. Resnick, William C. Watters III, Praveen V. Mummaneni, Tanvir F. Choudhri, Jason C. Eck, Jeffrey C. Wang, Sanjay S. Dhall and Michael G. Kaiser
Intraoperative monitoring (IOM) is commonly used during lumbar fusion surgery for the prevention of nerve root injury. Justification for its use stems from the belief that IOM can prevent nerve root injury during the placement of pedicle screws. A thorough literature review was conducted to determine if the use of IOM could prevent nerve root injury during the placement of instrumentation in lumbar or lumbosacral fusion. There is no evidence to date that IOM can prevent injury to the nerve roots. There is limited evidence that a threshold below 5 mA from direct stimulation of the screw can indicate a medial pedicle breach by the screw. Unfortunately, once a nerve root injury has taken place, changing the direction of the screw does not alter the outcome. The recommendations formulated in the original guideline effort are neither supported nor refuted with the evidence obtained with the current studies.
Michael G. Kaiser, Michael W. Groff, William C. Watters III, Zoher Ghogawala, Praveen V. Mummaneni, Andrew T. Dailey, Tanvir F. Choudhri, Jason C. Eck, Alok Sharan, Jeffrey C. Wang, Sanjay S. Dhall and Daniel K. Resnick
In an attempt to enhance the potential to achieve a solid arthrodesis and avoid the morbidity of harvesting autologous iliac crest bone (AICB) for a lumbar fusion, numerous alternatives have been investigated. The use of these fusion adjuncts has become routine despite a lack of convincing evidence demonstrating a benefit to justify added costs or potential harm. Potential alternatives to AICB include locally harvested autograft, calcium-phosphate salts, demineralized bone matrix (DBM), and the family of bone morphogenetic proteins (BMPs). In particular, no option has created greater controversy than the BMPs. A significant increase in the number of publications, particularly with respect to the BMPs, has taken place since the release of the original guidelines. Both DBM and the calciumphosphate salts have demonstrated efficacy as a graft extender or as a substitute for AICB when combined with local autograft. The use of recombinant human BMP-2 (rhBMP-2) as a substitute for AICB, when performing an interbody lumbar fusion, is considered an option since similar outcomes have been observed; however, the potential for heterotopic bone formation is a concern. The use of rhBMP-2, when combined with calcium phosphates, as a substitute for AICB, or as an extender, when used with local autograft or AICB, is also considered an option as similar fusion rates and clinical outcomes have been observed. Surgeons electing to use BMPs should be aware of a growing body of literature demonstrating unique complications associated with the use of BMPs.
Michael G. Kaiser, Jason C. Eck, Michael W. Groff, Zoher Ghogawala, William C. Watters III, Andrew T. Dailey, Daniel K. Resnick, Tanvir F. Choudhri, Alok Sharan, Jeffrey C. Wang, Sanjay S. Dhall and Praveen V. Mummaneni
The relationship between the formation of a solid arthrodesis and electrical and electromagnetic energy is well established; most of the information on the topic, however, pertains to the healing of long bone fractures. The use of both invasive and noninvasive means to supply this energy and supplement spinal fusions has been investigated. Three forms of electrical stimulation are routinely used: direct current stimulation (DCS), pulsed electromagnetic field stimulation (PEMFS), and capacitive coupled electrical stimulation (CCES). Only DCS requires the placement of electrodes within the fusion substrate and is inserted at the time of surgery. Since publication of the original guidelines, few studies have investigated the use of bone growth stimulators. Based on the current review, no conflict with the previous recommendations was generated. The use of DCS is recommended as an option for patients younger than 60 years of age, since a positive effect on fusion has been observed. The same, however, cannot be stated for patients over 60, because DCS did not appear to have an impact on fusion rates in this population. No study was reviewed that investigated the use of CCES or the routine use of PEMFS. A single low-level study demonstrated a positive impact of PEMFS on patients undergoing revision surgery for pseudarthrosis, but this single study is insufficient to recommend for or against the use of PEMFS in this patient population.
Zoher Ghogawala, Daniel K. Resnick, William C. Watters III, Praveen V. Mummaneni, Andrew T. Dailey, Tanvir F. Choudhri, Jason C. Eck, Alok Sharan, Michael W. Groff, Jeffrey C. Wang, Sanjay S. Dhall and Michael G. Kaiser
Assessment of functional patient-reported outcome following lumbar spinal fusion continues to be essential for comparing the effectiveness of different treatments for patients presenting with degenerative disease of the lumbar spine. When assessing functional outcome in patients being treated with lumbar spinal fusion, a reliable, valid, and responsive outcomes instrument such as the Oswestry Disability Index should be used. The SF-36 and the SF-12 have emerged as dominant measures of general health-related quality of life. Research has established the minimum clinically important difference for major functional outcomes measures, and this should be considered when assessing clinical outcome. The results of recent studies suggest that a patient's pretreatment psychological state is a major independent variable that affects the ability to detect change in functional outcome.
Zoher Ghogawala, Robert G. Whitmore, William C. Watters III, Alok Sharan, Praveen V. Mummaneni, Andrew T. Dailey, Tanvir F. Choudhri, Jason C. Eck, Michael W. Groff, Jeffrey C. Wang, Daniel K. Resnick, Sanjay S. Dhall and Michael G. Kaiser
A comprehensive economic analysis generally involves the calculation of indirect and direct health costs from a societal perspective as opposed to simply reporting costs from a hospital or payer perspective. Hospital charges for a surgical procedure must be converted to cost data when performing a cost-effectiveness analysis. Once cost data has been calculated, quality-adjusted life year data from a surgical treatment are calculated by using a preference-based health-related quality-of-life instrument such as the EQ-5D. A recent cost-utility analysis from a single study has demonstrated the long-term (over an 8-year time period) benefits of circumferential fusions over stand-alone posterolateral fusions. In addition, economic analysis from a single study has found that lumbar fusion for selected patients with low-back pain can be recommended from an economic perspective. Recent economic analysis, from a single study, finds that femoral ring allograft might be more cost-effective compared with a specific titanium cage when performing an anterior lumbar interbody fusion plus posterolateral fusion.
Tanvir F. Choudhri, Praveen V. Mummaneni, Sanjay S. Dhall, Jason C. Eck, Michael W. Groff, Zoher Ghogawala, William C. Watters III, Andrew T. Dailey, Daniel K. Resnick, Alok Sharan, Jeffrey C. Wang and Michael G. Kaiser
The ability to identify a successful arthrodesis is an essential element in the management of patients undergoing lumbar fusion procedures. The hypothetical gold standard of intraoperative exploration to identify, under direct observation, a solid arthrodesis is an impractical alternative. Therefore, radiographic assessment remains the most viable instrument to evaluate for a successful arthrodesis. Static radiographs, particularly in the presence of instrumentation, are not recommended. In the absence of spinal instrumentation, lack of motion on flexion-extension radiographs is highly suggestive of a successful fusion; however, motion observed at the treated levels does not necessarily predict pseudarthrosis. The degree of motion on dynamic views that would distinguish between a successful arthrodesis and pseudarthrosis has not been clearly defined. Computed tomography with fine-cut axial images and multiplanar views is recommended and appears to be the most sensitive for assessing fusion following instrumented posterolateral and anterior lumbar interbody fusions. For suspected symptomatic pseudarthrosis, a combination of techniques including static and dynamic radiographs as well as CT images is recommended as an option. Lack of facet fusion is considered to be more suggestive of a pseudarthrosis compared with absence of bridging posterolateral bone. Studies exploring additional noninvasive modalities of fusion assessment have demonstrated either poor potential, such as with 99mTc bone scans, or provide insufficient information to formulate a definitive recommendation.
Sanjay S. Dhall, Tanvir F. Choudhri, Jason C. Eck, Michael W. Groff, Zoher Ghogawala, William C. Watters III, Andrew T. Dailey, Daniel K. Resnick, Alok Sharan, Praveen V. Mummaneni, Jeffrey C. Wang and Michael G. Kaiser
In an effort to diminish pain or progressive instability, due to either the pathological process or as a result of surgical decompression, one of the primary goals of a fusion procedure is to achieve a solid arthrodesis. Assuming that pain and disability result from lost mechanical integrity of the spine, the objective of a fusion across an unstable segment is to eliminate pathological motion and improve clinical outcome. However, conclusive evidence of this correlation, between successful fusion and clinical outcome, remains elusive, and thus the necessity of documenting successful arthrodesis through radiographic analysis remains debatable. Although a definitive cause and effect relationship has not been demonstrated, there is moderate evidence that demonstrates a positive association between radiographic presence of fusion and improved clinical outcome. Due to this growing body of literature, it is recommended that strategies intended to enhance the potential for radiographic fusion are considered when performing a lumbar arthrodesis for degenerative spine disease.
Jason C. Eck, Alok Sharan, Daniel K. Resnick, William C. Watters III, Zoher Ghogawala, Andrew T. Dailey, Praveen V. Mummaneni, Michael W. Groff, Jeffrey C. Wang, Tanvir F. Choudhri, Sanjay S. Dhall and Michael G. Kaiser
Identifying the etiology of pain for patients suffering from chronic low-back pain remains problematic. Noninvasive imaging modalities, used in isolation, have not consistently provided sufficient evidence to support performance of a lumbar fusion. Provocative testing has been used as an adjunct in this assessment, either alone or in combination with other modalities, to enhance the diagnostic capabilities when evaluating patients with low-back pain. There have been a limited number of studies investigating this topic since the publication of the original guidelines. Based primarily on retrospective studies, discography, as a stand-alone test, is not recommended to formulate treatment strategies for patients with low-back pain. A single randomized cohort study demonstrated an improved potential of discoblock over discography as a predictor of success following lumbar fusion. It is therefore recommended that discoblock be considered as a diagnostic option. There is a possibility, based on a matched cohort study, that an association exists between progression of degenerative disc disease and the performance of a provocative discogram. It is therefore recommended that patients be counseled regarding this potential development prior to undergoing discography.
Jason C. Eck, Alok Sharan, Zoher Ghogawala, Daniel K. Resnick, William C. Watters III, Praveen V. Mummaneni, Andrew T. Dailey, Tanvir F. Choudhri, Michael W. Groff, Jeffrey C. Wang, Sanjay S. Dhall and Michael G. Kaiser
Establishing an appropriate treatment strategy for patients presenting with low-back pain, in the absence of stenosis or spondylolisthesis, remains a controversial subject. Inherent to this situation is often an inability to adequately identify the source of low-back pain to justify various treatment recommendations, such as lumbar fusion. The current evidence does not identify a single best treatment alternative for these patients. Based on a number of prospective, randomized trials, comparable outcomes, for patients presenting with 1- or 2-level degenerative disc disease, have been demonstrated following either lumbar fusion or a comprehensive rehabilitation program with a cognitive element. Limited access to such comprehensive rehabilitative programs may prove problematic when pursuing this alternative. For patients whose pain is refractory to conservative care, lumbar fusion is recommended. Limitations of these studies preclude the ability to present the most robust recommendation in support of lumbar fusion. A number of lesser-quality studies, primarily case series, also support the use of lumbar fusion in this patient population.