Management of degenerative spondylolisthesis: development of appropriate use criteria.

BACKGROUND CONTEXT: Outcomes of treatment in care of patients with spinal disorders are directly related to patient selection and treatment indications. However, for many disorders, there is absence of consensus for precise indications. With the increasing emphasis on quality and value in spine care, it is essential that treatment recommendations and decisions are optimized. PURPOSE: The purpose of the North American Spine Society Appropriate Use Criteria was to determine the appropriate (ie reasonable) multidisciplinary treatment recommendations for patients with degenerative spondylolisthesis across a spectrum of more common clinical scenarios. STUDY DESIGN: A Modified Delphi process was used. METHODS: The methodology was based on the Appropriate Use Criteria development process established by the Research AND Development Corporation. The topic of degenerative spondylolisthesis was selected by the committee, key modifiers determined, and consensus reached on standard definitions. A literature search and evidence analysis were completed by one work group simultaneously as scenarios were written, reviewed, and finalized by another work group. A separate multidisciplinary rating group was assembled. Based on the literature, provider experience, and group discussion, each scenario was scored on a nine-point scale on two separate occasions, once without discussion and then a second time following discussion based on the initial responses. The median rating for each scenario was then used to determine if indications were rarely appropriate (1 - 3), uncertain (4-6), or appropriate (7-9). Consensus was not mandatory. RESULTS: There were 131 discrete scenarios. These addressed questions on bone grafting, imaging, mechanical instability, radiculopathy with or without neurological deficits, obesity, and yellow flags consisting of psychosocial and medical comorbidities. For most of these, appropriateness was established for physical therapy, injections, and various forms of surgical intervention. The diagnosis of spondylolisthesis should be determined by an upright x-ray. Scenarios pertaining to bone grafting suggested that patients should quit smoking prior to surgery, and that use of BMP should be reserved for patients who had risk factors for non-union. Across all clinical scenarios, physical therapy (PT) had an adjusted mean of 7.66, epidural steroid injections 5.76, and surgery 4.52. Physical therapy was appropriate in most scenarios, and most appropriate in patients with back pain and no neurological deficits. Epidural steroid injections were most appropriate in patients with radiculopathy. Surgery was generally more appropriate for patients with neurological deficits, higher disability scores, and dynamic spondylolisthesis. Mechanical back pain and presence of yellow flags tended to be less appropriate, and obesity in general had relatively little influence on decision making. Decompression alone was more strongly considered in the presence of static versus dynamic spondylolisthesis. On average, posterior fusion with or without interbody fusion was similarly appropriate, and generally more appropriate than stand-alone interbody fusion which was in turn more appropriate than interspinous spacers. CONCLUSIONS: Multidisciplinary appropriate treatment criteria were generated based on the Research AND Development methodology. While there were consistent and significant differences between surgeons and non-surgeons, these differences were generally very small. This document provides comprehensive evidence-based recommendations for evaluation and treatment of degenerative spondylolisthesis. The document in its entirety will be found on the North American Spine Society website (https://www.spine.org/Research-Clinical-Care/Quality-Improvement/Appropriate-Use-Criteria).

Ghost and guest authors: you can't always trust who you read.

Clinicians and educators rely on the published medical information. They trust that original research and narrative or systematic reviews are reliable and the authorship is transparent, but this is not always the case. Disclosure of conflicts of interest by authors is required by most journals, disclosure will not detect ghost or guest authorship. Ghosting or guesting is of more than academic interests because it can directly or indirectly affect patient care. Therefore it is important for readers to be aware of this issue, and to be alert to suggestions that particular works may be at increased risk for ghost or guest authors. It is important to take a proactive stance against these practices. Industry, universities, research centers, and professional medical associations should be clear and unequivocal in condeming these practices. Processes need to be in place to investigate and, if need be, deal with violations. Clearly, we must all participate in this endeavor for professional, ethical, and most importantly, best patient care reasons.

Characterization of a first thoracic rib ligament: anatomy and possible clinical relevance.

STUDY DESIGN: Cadaver dissection and measurement. OBJECTIVE: To describe a previously undocumented intracostal ligament that limits the potential space through which the T1 ventral ramus passes before joining the C8 ventral ramus. SUMMARY OF BACKGROUND DATA: Preclavicular entrapment of the T1 ventral ramus can lead to radiculopathy, neurogenic thoracic outlet syndrome, or both, the so called "double crush" phenomenon. The usual sites of entrapment include the neural foramen, the interscalene interval, an aberrant cervical rib, the first rib itself, or an apical thoracic mass. METHODS: A total of 42 shoulders from 21 embalmed cadavers (13 male, 8 female) were dissected. The presence of the ligament was noted and its anatomic characteristics were measured with digital calipers by 3 independent investigators. Means, ranges, and standard deviations were calculated. RESULTS: The average ligament length was 31.0 mm (SD, 4.3). The ligament was trapezoidal in shape, and wider anteriorly. The mean anterior width was 7.1 mm (SD, 3.8), midsubstance width 3.6 mm (SD, 1.5), and posterior width 3.5 mm (SD, 1.3). The mean thickness was 0.5 mm (SD, 0.3), and the maximal opening through which the T1 nerve passed between the first rib and the ligament was 6.3 mm (SD, 1.6). The ligament was present on at least one side in 81% of individuals (67% of shoulders): 52% bilateral and 29% unilateral. CONCLUSION: This previously undescribed ligament is a robust structure, present on at least one side in over 80% of the individuals studied. When present, the ligament creates a narrow interval between the ligament and the first rib that the T1 ventral ramus traverses before crossing the first rib superiorly and contributing to the inferior trunk of the brachial plexus. Although the actual clinical significance has not been demonstrated, this ligament may represent another entrapment site for the T1 ventral ramus.

Static versus dynamic plating for multilevel anterior cervical discectomy and fusion.

BACKGROUND CONTEXT: Dynamic anterior plates have been popularized to promote cervical spine fusion by allowing controlled settling, thereby promoting load sharing across the construct. To date these proposed benefits have been largely theoretical and there are no studies confirming any benefits over more traditional static plates. PURPOSE: To compare the clinical and radiographic outcomes of patients undergoing an instrumented multilevel anterior cervical discectomy and fusion (ACDF) with either a static or dynamic plate design. STUDY DESIGN: A retrospective clinical and radiographic study. PATIENT SAMPLE: From 1997 to 2002, 52 patients with either radiculopathy or myelopathy underwent two- or three-level ACDF with either static or dynamic plate fixation. OUTCOME MEASURES: Functional outcome, fusion status, radiographic measurements. METHODS: A statically locked plating system was used in 21 patients, and a dynamic plating system was used in 31 patients. Functional outcome, fusion status, plate migration, settling, and adjacent-level disc space impingement were evaluated. RESULTS: Clinical outcome was found to be similar between the statically and dynamically plated groups. Eighty-four percent of patients in both groups experienced good or excellent results at final follow-up. We observed a higher rate of nonunion in patients treated with a dynamic plate (16% [5 of 31]) compared with a rate of 5% (1 of 21) in those patients treated with a static plate (p=.05). Settling of the construct and plate migration was similar between the study groups at all time points. CONCLUSIONS: This study failed to confirm our hypothesis that a dynamic plate (that allows angular motion between the screws and plate) confers any clinical or radiographic advantage over earlier design static plates. A higher rate of nonunion was actually seen in the dynamically plated patients; however, clinical results were similar between the two groups.

A prospective, randomized, double-blind study evaluating the efficacy of postoperative continuous local anesthetic infusion at the iliac crest bone graft site after spinal arthrodesis.

STUDY DESIGN: Parallel design, prospective, double-blind, randomized, controlled trial composed of two independent groups treated with a continuous infusion catheter (saline vs. Marcaine) placed into the iliac crest bone graft (ICBG) site. OBJECTIVE: To determine the effects of postoperative continuous local anesthetic agent infusion at the ICBG harvest site in reducing pain, narcotic demand and usage, and improving early postoperative function after spinal fusion. SUMMARY OF BACKGROUND DATA: Harvesting iliac crest bone has been shown to be a source of pain and morbidity. Long-term patient complaints may be more closely associated with the procurement of the iliac crest graft rather than the primary surgical site. METHODS: Thirty-seven patients were enrolled in a prospective, randomized, double-blind parallel-designed study after informed consent and IRB approval was obtained. Twenty-eight patients had ICBG harvested for lumbar arthrodesis and nine for cervical arthrodesis. During spinal arthrodesis surgery, patients were randomly assigned to receive 96 mL (2 mL/hr x 48 hours) of either normal saline (control group, n = 22) or 0.5% Marcaine (treatment group, n = 15) delivered via a continuous infusion catheter placed at the ICBG harvest site. All patients received Dilaudid PCA after surgery. Pain scores, narcotic use/frequency, activity level, and length of stay (LOS) were recorded. Physicians, patients, nursing staff, and statisticians were blinded to the treatment. RESULTS: Mean patient age was 60 years and similar between groups. Narcotic dosage, demand frequency, and mean VAS pain score were significantly less in the treatment (Marcaine) group at 24 and 48 hours (P < 0.05). The average LOS was 4.1 days with no difference between Marcaine or control groups. No complications were attributed to the infusion-catheter system. CONCLUSIONS: Continuous infusion of 0.5% Marcaine at the ICBG harvest site reduced postoperative parenteral narcotic usage by 50% and decreased overall pain scores. No complications were attributed to the infusion-catheter system. The use of continuous local anesthetic infusion at the iliac crest may help in alleviating acute graft-related pain, hastening patient recovery and improving short-term satisfaction.

Lumbar arthrodesis for degenerative conditions.

There is significant disagreement among spine surgeons regarding the optimal technique of arthrodesis for treatment of degenerative disorders of the lumbar spine. Degenerative conditions of the lumbar spine include degenerative disk "disease," post-decompression degeneration, degenerative spondylolisthesis, junctional degeneration, spondylolis, and low-grade lytic spondylolisthesis. Although it is impossible to develop strict evidence-based criteria for the selection of one surgical approach over another, some generalizations are possible based on empiric process, anecdotal experience, and published surgical series. Patient selection, cessation of nicotine use, and use of autologous bone graft are factors that influence clinical outcome after lumbar arthrodesis.

The role of repeated end-range/pain response assessment in the management of symptomatic lumbar discs.

BACKGROUND CONTEXT: The selection of appropriate patients for lumbar disc surgery is a challenging task involving a highly variable, multifactorial decision process complicated by a lack of reliable, validated clinical signs and imaging findings. Recently, multiple studies have demonstrated the reliability and diagnostic utility of a standardized form of spinal assessment using repeated end-range test movements while monitoring patterns of pain response (McKenzie assessment). PURPOSE: It is the aim of this article to evaluate the utility of this assessment system and its literature support in the selection of candidates for surgery for disc-related pain. STUDY DESIGN AND METHODS: A literature review. RESULTS: Most patients under consideration for lumbar disc surgery, when examined using this form of dynamic mechanical spinal evaluation, based on patients' patterns of pain response to standardized repeated end-range lumbar test movements and positions, fall into one of three subgroups: 1) a reversible condition, 2) an irreversible condition or 3) an unaffected condition. Reversible conditions in acute to chronic low back and/or leg pain are recoverable, often rapidly so, using nonoperative self-care dictated by the patient's assessment findings. The elicitation of pain "centralization," an improvement (favorable change) in pain location in response to repetitive end-range testing, typically occurring with only one direction of test movement(s), predicts a high likelihood of successful response to conservative care, even in the presence of neurologic deficits. Irreversible conditions are characterized by symptom aggravation by all directions of testing, including the absence of the centralization response, predicting a poor response to nonsurgical care. In those whose pain is unaffected with similar testing, evidence indicates the pain is likely nondiscogenic. A dynamic disc model has been described as a possible model for these varying pain responses. Insight into annular integrity of symptomatic discs is also provided using this repeated end-range/pain response (McKenzie) assessment. CONCLUSIONS: As described, the literature supports the use of a repeated end-range/pain response assessment (dynamic mechanical evaluation) in obtaining diagnostic and therapeutic information in patients with low back and leg pain. This may contribute to improving the selection process of surgical patients.

Treatment of chronic discogenic low back pain with intradiskal electrothermal therapy.

The treatment of chronic, nonradicular, discogenic low back pain remains controversial. The posterior anulus fibrosus appears to be a potential site of origin of the pain, which is mediated by nociceptors in the inner layers of the anulus. Diagnosis requires a thorough history, physical examination, and imaging protocol; provocative diskography is key. Nonsurgical treatment options have been limited to physical therapy and pharmacotherapy. Success rates of spinal fusion range from 39% to 96%. Reported therapeutic success rates of intradiskal electrothermal therapy, a possible intermediate treatment, range from 60% to 80%. Despite this apparent therapeutic effect, however, a more precise quantification of clinical benefits remains to be proved in randomized prospective trials.

Spinal cord stimulation for chronic pain of spinal origin: a valuable long-term solution.

STUDY DESIGN: A literature review was conducted. OBJECTIVE: To review the indications and efficacy of spinal cord stimulation, particularly in reference to chronic pain of spinal origin. SUMMARY OF BACKGROUND DATA: The first spinal cord stimulation was implanted by Shealy in 1967 via a subarachnoid route. Early systems were plagued with a high rate of complications and technical problems. With the evolving technology, especially the advent of multichannel programmable systems and more precise epidural placement, the ability of spinal cord stimulation to treat various pain syndromes improved. This article reviews the literature on spinal cord stimulation from 1967 to the present. METHODS: The literature is reviewed, with a particular focus on recent studies investigating the efficacy of spinal cord stimulation for low back pain. RESULTS: Most studies are limited by the same flaws, namely, retrospective study design. At this writing, the few published randomized prospective studies have suggested that spinal cord stimulation may be superior to repeat surgery. Complication rates have declined to approximately 8%, and reoperation is necessary in approximately 4% of patients. When current percutaneous techniques are used, a lead migration rate lower than 3% may be achieved. For certain topographies, laminotomy leads may be superior, particularly with regard to low back pain. CONCLUSIONS: The ultimate efficacy of spinal cord stimulation remains to be determined, primarily because of limitations associated with the published literature. However, on the basis of the current evidence, it may represent a valuable treatment option, particularly for patients with chronic pain of predominantly neuropathic origin and topographical distribution involving the extremities. The potential treatment of other pain topographies and etiologies by spinal cord stimulation continues to be studied.

Intradiscal electrothermal therapy used to manage chronic discogenic low back pain: new directions and interventions.

STUDY DESIGN: Retrospective literature review. OBJECTIVES: To review the data on the clinical efficacy of intradiscal electrothermal annuloplasty found at this writing in the peer-reviewed literature to date, to discuss the methodologic strengths and flaws of the studies, to discuss the pitfalls of clinical study designs, to emphasize the need for prospective randomized studies and for increased basic science investigation. SUMMARY OF BACKGROUND DATA: Studies published or presented at peer-reviewed societies concerning the clinical efficacy of intradiscal electrothermal annuloplasty are reviewed, including background studies on deafferentation and application of thermal energy to alter biomechanical and structural properties. A proposal for future investigations is presented. METHODS: Background data from intracapsular annuloplasty highlighting the safety and efficacy of intradiscal electrothermal annuloplasty are presented. Current studies on this procedure, including those in the National Registry are reviewed. All the studies share a common study design: prospective cohort with historical or noninterventional groups used as controls. The patients reviewed are similar. All have nonradicular low back pain of at least 3 months duration, failed conservative care, normal neurologic examination, and MRI showing only nondegenerative disc disease and positive concordant discography. All the patients underwent intradiscal electrothermal annuloplasty lesion at one or two levels according to standard protocols. Follow-up evaluation was performed at various intervals up to 2 years. All the studies used data from a visual analog scale, with most using the Short Form 36 (SF-36) as outcome instruments. RESULTS: The reported follow-up periods for the studies ranged from 6 months to 2 years. Three published studies, one with a 6-month follow-up period and two with a 1-year follow-up period, were published in the peer-reviewed literature. Two recent reports presented to the North American Spine Society were reviewed: a study of patients on a manufacturer-sponsored registry with a 1-year follow-up period and a multicenter prospective cohort study of 75 patients in an intent-to-treat group, with a 1-year follow-up period. Using the 7-point criteria of Deyo et al, all the studies suggested a positive effect of treatment, with a decrease in visual analog scale ratings and improvement in SF-36 scales, particularly those for physical function and bodily pain. CONCLUSIONS: The studies published so far suggest that the pain resulting from lumbar disc disease may be diminished by intradiscal electrothermal annuloplasty. All these studies project a positive therapeutic effect. However, all the studies suffer from the same methodologic flaws. A prospective cohort design or a nonrandomized prospective design is used with a biased control. The scientific validity of various study designs is discussed, and a randomized prospective study is recommended. Additionally, more investigation into the basic science of the action of intradiscal electrothermal annuloplasty is required.