Gary Ghiselli

An evidence-based clinical guideline for the diagnosis and treatment of cervical radiculopathy from degenerative disorders

Abstract Background context The North American Spine Society (NASS) Evidence-Based Clinical Guideline on the Diagnosis and Treatment of Cervical Radiculopathy from Degenerative Disorders provides evidence-based recommendations on key clinical questions concerning the diagnosis and treatment of cervical radiculopathy from degenerative disorders. The guideline addresses these questions based on the highest quality clinical literature available on this subject as of May 2009. The guideline’s recommendations assist the practitioner in delivering optimum efficacious treatment of and functional recovery from this common disorder. Purpose Provide an evidence-based educational tool to assist spine care providers in improving quality and efficiency of care delivered to patients with cervical radiculopathy from degenerative disorders. Study design Systematic review and evidence-based clinical guideline. Methods This report is from the Cervical Radiculopathy from Degenerative Disorders Work Group of the NASS’ Evidence-Based Clinical Guideline Development Committee. The work group consisted of multidisciplinary spine care specialists trained in the principles of evidence-based analysis. Each member of the group formatted a series of clinical questions to be addressed by the group. The final questions agreed on by the group are the subjects of this report. A literature search addressing each question using a specific search protocol was performed on English language references found in MEDLINE, EMBASE (Drugs and Pharmacology), and four additional evidence-based databases. The relevant literature was then independently rated by a minimum of three reviewers using the NASS-adopted standardized levels of evidence. An evidentiary table was created for each of the questions. Final recommendations to answer each clinical question were arrived at via work group discussion, and grades were assigned to the recommendations using standardized grades of recommendation. In the absence of Levels I to IV evidence, work group consensus statements have been developed using a modified nominal group technique, and these statements are clearly identified as such in the guideline. Results Eighteen clinical questions were formulated, addressing issues of natural history, diagnosis, and treatment of cervical radiculopathy from degenerative disorders. The answers are summarized in this article. The respective recommendations were graded by the strength of the supporting literature, which was stratified by levels of evidence. Conclusions A clinical guideline for cervical radiculopathy from degenerative disorders has been created using the techniques of evidence-based medicine and best available evidence to aid both practitioners and patients involved with the care of this condition. The entire guideline document, including the evidentiary tables, suggestions for future research, and all references, is available electronically at the NASS Web site ( www.spine.org ) and will remain updated on a timely schedule.

An evidence-based clinical guideline for the diagnosis and treatment of degenerative lumbar spondylolisthesis†

BACKGROUND CONTEXT The objective of the North American Spine Society (NASS) evidence-based clinical guideline on the diagnosis and treatment of degenerative lumbar spondylolisthesis is to provide evidence-based recommendations on key clinical questions concerning the diagnosis and treatment of degenerative lumbar spondylolisthesis. The guideline is intended to address these questions based on the highest quality clinical literature available on this subject as of January 2007. The goal of the guideline recommendations is to assist the practitioner in delivering optimum, efficacious treatment of and functional recovery from this common disorder. PURPOSE To provide an evidence-based, educational tool to assist spine care providers in improving the quality and efficiency of care delivered to patients with degenerative lumbar spondylolisthesis. STUDY DESIGN Systematic review and evidence-based clinical guideline. METHODS This report is from the Degenerative Lumbar Spondylolisthesis Work Group of the NASS Evidence-Based Clinical Guideline Development Committee. The work group was comprised of multidisciplinary spine care specialists, all of whom were trained in the principles of evidence-based analysis. Each member participated in the development of a series of clinical questions to be addressed by the group. The final questions agreed on by the group are the subject of this report. A literature search addressing each question and using a specific search protocol was performed on English language references found in MEDLINE, EMBASE (Drugs and Pharmacology) and four additional, evidence-based, databases. The relevant literature was then independently rated by at least three reviewers using the NASS-adopted standardized levels of evidence. An evidentiary table was created for each of the questions. Final grades of recommendation for the answer to each clinical question were arrived at via face-to-face meetings among members of the work group using standardized grades of recommendation. When Level I-IV evidence was insufficient to support a recommendation to answer a specific clinical question, expert consensus was arrived at by the work group through the modified nominal group technique and is clearly identified as such in the guideline. RESULTS Nineteen clinical questions were formulated, addressing issues of prognosis, diagnosis, and treatment of degenerative lumbar spondylolisthesis. The answers to these 19 clinical questions are summarized in this document. The respective recommendations were graded by the strength of the supporting literature that was stratified by levels of evidence. CONCLUSIONS A clinical guideline for degenerative lumbar spondylolisthesis has been created using the techniques of evidence-based medicine and using the best available evidence as a tool to aid practitioners involved with the care of this condition. The entire guideline document, including the evidentiary tables, suggestions for future research, and all references, is available electronically at the NASS Web site (www.spine.org) and will remain updated on a timely schedule.

L5-S1 segment survivorship and clinical outcome analysis after L4-L5 isolated fusion

Study Design. A retrospective investigation of the L5–S1 motion segment after an isolated L4–L5 posterior lumbar fusion Objective. To determine the survivorship of the L5–S1 segment in patients undergoing L4–L5 fusion and to identify the correlation between radiographic degeneration and clinical outcome at this level. Summary of Background Data. There is current controversy regarding future degeneration of the L5–S1 segment following single-segment fusion at L4–L5. There are no long-term studies that look at L5–S1 after L4–L5 fusion to assess the rate of degeneration at this adjacent segment and the functional clinical outcome of the patient. Methods. Thirty-two consecutive patients (average age 56.4 years, range 27–77 years) having isolated L4–L5 posterior spinal fusion for instability or stenosis by a single surgeon were included in this study. There were 25 females and 7 males with an average follow-up of 7.3 years (range 2.3–12.4 years). A survivorship analysis was performed to determine the degeneration at the adjacent L5–S1 segment. Radiographs were analyzed for arthritic degeneration at that level. At the time of the L4–L5 index procedure, the L5–S1 disc spaces were graded on a 4-point scale for degeneration. Questionnaires were submitted by mail, and telephone interviews were conducted by one of the authors to determine the current level of patient function. Results. Of the total 32 patients assessed, 31 (97%) had no evidence of symptomatic degeneration at L5–S1 requiring additional decompression or fusion. One patient had clinical symptoms that required a foraminotomy and laminotomy at L5–S1, but none of the patients required any further fusion. Although there was a trend of progression of the arthritic grade at L5–S1 from preoperative to postoperative examination, there was no correlation between preoperative arthritic grade versus further degeneration. The discs showed progression of degeneration from an average score of 2.28 before surgery to a score of 2.49 after surgery at the last follow-up. Conclusion. There appears to be no need to routinely include the L5–S1 segment when performing a posterior lumbar fusion for patients with instability or stenosis at L4–L5 if no symptoms are attributed to the lumbosacral level. At an average of 7.3 years, there was neither increased symptomatic disc degeneration nor symptoms necessitating the need for an L5–S1 fusion.

A Prospective Multicenter Trial of Excimer Laser Phototherapeutic Keratectomy for Corneal Vision Los

PURPOSE The 193-nm argon fluoride excimer laser can remove corneal scars and smooth corneal irregularities, obviating corneal transplantation. We conducted a prospective multicenter trial of excimer laser phototherapeutic keratectomy for corneal vision loss as a basis for Food and Drug Administration premarket approval. METHODS We treated 232 eyes of 211 patients with corneal vision loss. All had corneal pathology in the anterior 100 microns of the stroma. Mean postoperative follow-up was 10 +/- 8 months. The primary outcome variable was change in best spectacle-corrected visual acuity. RESULTS At postoperative month 12, best spectacle-corrected visual acuity improved in 46 (45%) of 103 eyes and worsened in nine (9%) of 103 eyes by 2 or more Snellen lines. Best spectacle-corrected visual acuity improved by a mean of 1.6 +/- 2.8 Snellen lines (95% confidence interval, 1.1 to 2.1 lines). Every postoperative visit confirmed statistically significant improvement of mean best spectacle-corrected acuity. At month 12, treated eyes had a mean hyperopic shift in refraction of 0.87 diopter and a mean reduction in astigmatism of 0.36 diopter. Treatment appeared most effective in eyes with hereditary corneal dystrophies, Salzmanns nodular degeneration, and corneal scars, and least effective in eyes with calcific band keratopathy. Complications included recurrence of underlying pathology, corneal graft rejection, and bacterial keratitis. CONCLUSIONS Argon fluoride excimer laser phototherapeutic keratectomy is effective, with relatively few complications, for treating vision loss from corneal opacification or irregularity. Efficacy, however, varies widely depending upon individual eyes and underlying diagnoses.

On-the-field evaluation of an athlete with a head or neck injury

Head and cervical spine sports-related injuries are intimately associated. The on-field evaluation and management of the athlete with these injuries is of paramount importance to stabilize the athlete and prevent further injury. Clinicians need to be aware of the differential diagnoses and consider each possibility based on the mechanism of injury. Although recognition of head and cervical spine injuries has resulted in significant reductions of catastrophic neurological injuries, especially in the cervical spine, further advances to decrease the incidence and long-term sequelae of head and neck injuries are needed. The first step is education of the athlete and the individuals involved in the care of that athlete.

Prospective analysis of imaging prediction of pseudarthrosis after anterior cervical discectomy and fusion: computed tomography versus flexion-extension motion analysis with intraoperative correlation.

Study Design. A prospective comparison of quantitative motion analyzed (QMA) flexion/extension radiographs versus computed tomography (CT) as an analytical predictor of cervical pseudarthrosis. Intraoperative confirmation of the fusion was performed. Objective. To prospectively compare motion analyzed flexion/extension radiographs to CT to predict pseudarthroses. Define motion thresholds on flexion/extension radiographs to define pseudarthroses. Summary of Background Data. Assessment of postoperative fusion success is an important factor in assessing success after anterior cervical spine fusion. Gross intervertebral motion can be used as a measure; however, the current “gold standard” for determining fusion status is a CT to assess bridging bone. Defining the amount of intervertebral motion at the fusion site has been previously addressed and definitions have varied widely. Methods. Data were analyzed at 47 fusion segments. Intervertebral motion at the fusion site was measured from flexion/extension radiographs taken at least 1 year after the cervical spine fusion. Motion was quantified from digitized radiographs by an independent researcher using proprietary quantitative motion analysis (QMA) software. CT scans on all patients were analyzed for fusion status by a neuroradiologist. Those patients determined to have a symptomatic pseudarthrosis were revised and intraoperative motion at the facet joints was documented. Correlation between intraoperative findings, CT and QMA was performed. Results. Using greater than 4° of measured motion on flexion/extension radiographs resulted in a Spearman correlation P-value of 0.096 (95% confidence interval: −0.06 to 0.66). Using greater than 1° of motion, the Spearman correlation P < 0.0001 (95% CI: 0.54–0.90). The positive predictive value (PPV) using 4° of motion as the criterion was 100%, indicating a high specificity. The negative predictive value (NPV) was 52%, indicating a low sensitivity. Using greater than 1° of motion, the PPV was 100% and the NPV was 73%. Findings from CT showed an identical PPV and NPV to assessments made using greater than 1° of rotation. Specificity and positive predictive value were 100% for all criteria. Using a lack of bridging on CT or more than 1° of intervertebral motion during flexion/extension increased the sensitivity to 85% and the negative predictive value to 85%. Conclusion. A threshold level of 4° of motion is commonly used to identify a pseudarthrosis. Our prospective study suggests that this value has a high PPV, but a low specificity and would miss many of the pseudarthroses that have angular motion less than 4° (sensitivity 23%). By lowering the threshold for angular motion to 1°, the sensitivity improves to 77%. CT scan has been touted as the gold standard, and it has a high positive predictive value of 100%. However, its NPV was slightly lower than using 1° of motion on QMA analyzed flexion-extension films (73% vs. 79%). In conclusion, although CT scan has long been regarded as the gold standard for determining a pseudarthrosis in the cervical spine, the interpretation is subjective and vulnerable to both type I and type II errors. Analysis of motion using Quantitative Motion Analysis is seemingly less subjective than CT and in our prospective study was more predictive of an operatively confirmed pseudarthrosis.

ANALYSIS OF REIMBURSEMENT DECISIONS: THE EXAMPLE OF LUMBAR DISC ARTHROPLASTY

Approval by the Food and Drug Administration (FDA) is the first step in introducing new technology into clinical practice. Increasingly, an equally large hurdle is obtaining reimbursement authorization. A review of the coverage decisions from the Center for Medicare and Medicaid Services (CMS) for Charite and the Blue Cross and Blue Shield Technology Evaluation Center (BCBS-TEC) for Charite and ProDisc was performed. A fundamental concern in the reports was the level of evidence available for the baseline control procedure of spinal fusion. There was criticism of the lack of randomized controlled trials for disc arthroplasty (only two). Concerns about the RCT’s themselves. ● Non inferiority of the designs vs. superiority (Charite with a d 0.15 i.e. 95% confidence interval could allow a 15% worse result compared to BAK and still meet non-inferiority criteria. For ProDisc d 0.125 i.e. would allow 12.5% worse result compared to circumferential fusion. FDA requested 10% for non-inferiority). ● Neither of the clinical trials reaching the predicted rate of success used to design the clinical trials (Charite 70% success predicted, actual 57.1%, ProDisc 85% success predicted, actual 63.5%). ● Number of patients classified as a success who were still on narcotic pain medication ● Number of patients excluded from analysis presumably secondary to missing data (Charite 25.3% fusions, 14.1% arthroplasty, ProDisc 11% fusions, 7.5% arthroplasty). ● Whether a procedure with a 57.1% (Charite) and 63.5% (ProDisc) composite success rate is truly a good intervention that positively affects “net health outcomes”. Conclusions; Most spine physicians will not invest the time or effort to perform an in-depth analysis of the coverage decision documents for disc arthroplasty. The issues raised give us important insight into the criteria used in the decision making process and has implications for the design and execution of future trials. I N T E R N A T I O N A L S O C I E T Y F O R T H E S T U D Y O F L U M B A R S P I N E