Kenneth Thomas

Orthosis versus no orthosis for the treatment of thoracolumbar burst fractures without neurologic injury: a multicenter prospective randomized equivalence trial

BACKGROUND CONTEXT Thoracolumbar burst fractures have good outcomes when treated with early ambulation and orthosis (TLSO). If equally good outcomes could be achieved with early ambulation and no brace, resource utilization would be decreased, especially in developing countries where prolonged bed rest is the default option because bracing is not available or affordable. PURPOSE To determine whether TLSO is equivalent to no orthosis (NO) in the treatment of acute AO Type A3 thoracolumbar burst fractures with respect to their functional outcome at 3 months. STUDY DESIGN A multicentre, randomized, nonblinded equivalence trial involving three Canadian tertiary spine centers. Enrollment began in 2002 and 2-year follow-up was completed in 2011. PATIENT SAMPLE Inclusion criteria included AO-A3 burst fractures between T11 and L3, skeletally mature and older than 60 years, 72 hours from their injury, kyphotic deformity lower than 35°, no neurologic deficit. One hundred ten patients were assessed for eligibility for the study; 14 patients were not recruited because they resided outside the country (3), refused participation (8), or were not consented before independent ambulation (3). OUTCOME MEASURES Roland Morris Disability Questionnaire score (RMDQ) assessed at 3 months postinjury. The equivalence margin was set at δ=5 points. METHODS The NO group was encouraged to ambulate immediately with bending restrictions for 8 weeks. The TLSO group ambulated when the brace was available and weaned from the brace after 8 to 10 weeks. The following competitive grants supported this work: VHHSC Interdisciplinary Research Grant, Zimmer/University of British Columbia Research Fund, and Hip Hip Hooray Research Grant. Aspen Medical provided the TLSOs used in this study. The authors have no financial or personal relationships that could inappropriately influence this work. RESULTS Forty-seven patients were enrolled into the TLSO group and 49 patients into the NO group. Forty-six participants per group were available for the primary outcome. The RMDQ score at 3 months postinjury was 6.8 ± 5.4 (standard deviation [SD]) for the TLSO group and 7.7 ± 6.0 (SD) in the NO group. The 95% confidence interval (-1.5 to 3.2) was within the predetermined margin of equivalence. Six patients required surgical stabilization, five of them before initial discharge. CONCLUSIONS Treating these fractures using early ambulation without a brace avoids the cost and patient deconditioning associated with a brace and complications and costs associated with long-term bed rest if a TLSO or body cast is not available.

Minimally invasive versus open approach for cervical laminoforaminotomy.

BACKGROUND Minimally invasive posterior cervical foraminotomy for radicular symptoms has become more prevalent. The reported experience with microscopic tubular assisted posterior cervical laminoforaminotomy (MTPF) for the treatment of radicular pain is lacking. Tubular assisted techniques have been considered to offer significant benefit, over open procedures, in terms of minimizing tissue damage, operative time, blood loss, analgesic requirements and length of hospital stay. We hypothesized that MTPF reduces post-operative analgesic requirements and length of hospital stay over the traditional open laminoforaminotomy, with no difference in complication rates and, secondly, that MTPF is comparable to endoscopic posterior foraminotomy (EPF). METHODS We conducted a retrospective review of 107 patients who underwent posterior cervical laminoforaminotomy for radicular pain between 1999 and 2009. Patient demographics, intra-operative parameters, length of hospitalization, post-operative analgesic use, complications and short-term neurological outcome were compared between groups. RESULTS Between 1999 and 2009, a total of 107 patients were identified to have undergone a cervical foraminotomy. An open approach was used in 65 patients, while 42 underwent MTPF. Operative time and complications were comparable between groups. Significant differences favoring MTPF were observed in operative blood loss, post-operative analgesic use and length of hospital stay (p<0.001). All results were comparable to previous reports utilizing EPF. CONCLUSIONS MTPF for the treatment of cervical radiculopathy significantly reduces blood loss, post-operative analgesic use and length of hospital stay compared to the standard open approach. Operative time and complication rates were comparable between both techniques, whilst MTPF offered similar results compared to EPF.

Outcome Evaluation of Surgical and Nonsurgical Management of Lumbar Disc Protrusion Causing Radiculopathy

Study Design. Prospective cohort study. Objective. To assess health-related quality of life (HRQOL) following either lumbar discectomy or nonoperative care for lumbar disc protrusion causing radiculopathy (LDPR). Summary of Background Data. Although LDPR is a prevalent disorder, little progress has been made in defining the optimal treatment strategy. Methods. A total of 497 patients (333 in the lumbar discectomy group and 164 in the nonoperative group) were analyzed. Patients completed baseline as well as 6- and 12-month generic (SF-36) and disease-specific (NASS Lumbar Spine Instrument) HRQOL measures. Demographic comparisons between groups, using standard descriptive statistics, were made. Multivariate analysis was used to obtain a regression coefficient for the primary outcome: the neurogenic symptoms score (NSS) from the NASS instrument. Outcome measures were compared between groups and to published normative data. Results. The mean baseline score was lower in the surgical group (30.9 nonoperative, 25.3 surgical), indicative of greater baseline disability. The scores at follow-up were approximately equivalent (44.6 nonoperative, 43.8 surgical). However, neither group returned to an age-matched normative NSS (51.6) within the timeframe of the study. Using regression analysis, the outcome “change in NSS” was not associated with variable “treatment group.” Conclusions. HRQOL after LDPR, as measured in this study by NASS NSS, demonstrated similar improvement in both groups and was not meaningfully associated with the treatment received, within the timeframe of this study. At follow-up, all outcome measures remained lower than population normative scores, suggesting that, irrespective of treatment, an element of disability remained.

Evidence-based recommendations for spine surgery

Lumbar spinal imaging is commonly utilized in the evaluation of low back pain. The rationale for imaging, either plain radiographs, computed tomography (CT), or magnetic resonance imaging (MRI), is primarily based on identifying anatomical sources of pain. Unfortunately, the correlation between findings on imaging and clinical symptoms can be limited. A number of studies have been preformed to elucidate the value of spinal imaging in the setting of acute back pain. The definition of “value”, however, varies from study to study. Investigations have focused separately on diagnostic information, treatment interventions, patient outcomes, or patient satisfaction. Additionally, the inclusion and exclusion criteria for these studies have not been uniform. Specifically the definition of “red flags” for serious disease (fevers, weight loss, neurological deficits, etc.) are subjective and, in some instances, not defined. Nonetheless the clinical question remains: is immediate routine lumbar spine imaging more effective than usual care without imaging in patients with low back pain and no suggestion of “red flags.” Chou et al. used methods of systematic review and meta-analysis to address this question.

Obesity and early reoperation rate after elective lumbar spine surgery: a population-based study

Study design: Population-based retrospective cohort study. Clinical question: Are patients with a body mass index (BMI) of 35 or more who undergo elective lumbar spine surgery at increased risk of post-surgical complications, as evidenced by reoperation within a 3-month period? Methods: The Alberta Health and Wellness Administrative database was queried to identify patients who underwent elective lumbar spine surgery over a 24-month period. This same database was used to classify subjects as obese (BMI ≥35) and non-obese (BMI <35) and to determine who underwent repeated surgical intervention. The rate of reoperation was determined for both the obese and non-obese groups; further analyses were performed to determine whether certain subjects were at increased risk of reoperation. Results: The point estimate for relative risk for requiring reoperation was 1.73 (95% confidence interval, 1.03–2.90) for obese subjects compared with non-obese subjects. The adjusted point estimate shows that deformity correction surgery is predictive for early reoperation while obesity is not. Conclusions: In obese subjects we observed an increased complication rate after elective lumbar spine surgery, as evidenced by reoperation rates within 3 months. When we considered other possible associations with reoperation, in adjusted analysis, deformity surgery was found to be predictive of early reoperation. Final class of evidence-prognosis Study design Prospective Cohort Retrospective Cohort • Case control Case series Methods Patients at similar point in course of treatment • F/U ≥ 85% • Similarity of treatment protocols for patient groups • Patients followed up long enough for outcomes to occur • Control for extraneous risk factors Overall class of evidence III The definiton of the different classes of evidence is available on page 55.

Intrarater and interrater reliability of select clinical tests in patients referred for diagnostic facet joint blocks in the cervical spine

OBJECTIVE To measure the intra- and interrater reliability of select standardized clinical tests used for the assessment of patients with axial neck pain referred for diagnostic facet joint blocks. DESIGN Single-group, repeated-measures study. SETTING Tertiary interventional pain management center. PARTICIPANTS Consecutive patients with persistent neck pain, referred to a tertiary interventional pain management center, were approached to participate. Fifty-six patients consented to participate in the study. INTERVENTIONS Subjects underwent a standardized clinical testing protocol, performed by 2 physiotherapists, before receiving diagnostic facet joint blocks. Subjects were examined twice by 1 assessor for the determination of the intrarater reliability of the testing protocol, and again by a second assessor for determination of interrater reliability. MAIN OUTCOME MEASURES Intraclass correlation coefficients (ICCs), kappa coefficients, and 95% confidence intervals were calculated to determine the intra- and interrater reliability for cervical range of motion (ROM; 6 directions), extension-rotation (ER) test, manual spinal examination (MSE), and palpation for paraspinal tenderness (PST) from C2 through C7. RESULTS For intrarater reliability, kappa coefficients ranged from .51 to .88 for the ER test, MSE, and PST, and ICCs ranged from .91 to .97 for ROM. For interrater reliability, kappa coefficients ranged from .74 to .96 for the ER test, MSE, and PST, and ICCs ranged from .90 to .95 for ROM. CONCLUSIONS The standardized clinical tests exhibited moderate to substantial reliability in patients with axial neck pain referred for diagnostic facet joint blocks. The data justify the incorporation of these tests into a clinical prediction model to screen patients before referral for diagnostic facet blocks.

Reliability of the thoracolumbar injury classification and severity score and comparison with the denis classification for injury to the thoracic and lumbar spine.

Study Design. This study is a series of thoracic and lumbar spine fracture cases to assess the reliability of thoracolumbar injury classification and severity score (TLICS) in simulated clinical scenarios. Objective. To determine the inter- and intraobserver reliability of TLICS compared with the Denis classification system, and to assess differences based on rater characteristics. Summary of Background Data. Thoracolumbar injury severity score and TLICS have been subjected to reliability testing using less robust statistical analysis. Both systems have demonstrated poor to good reliability, with particularly weak agreement on the status of the posterior ligamentous complex. Methods. Fifty-four spine fracture cases were selected from a chart review. These cases were scored on 2 occasions by 11 experts using both TLICS and the Denis classification systems. Reliability was assessed using a generalizability coefficient. The primary outcome was interobserver reliability. Secondary outcomes were intraobserver reliability, difference between orthopedic and neurosurgeons, as well as trainees and consultants, and correlation with treatment recommendations. Results. TLICS demonstrated good interobserver agreement of 0.73 to 0.74. The posterior ligamentous complex component was the least reliable. The Denis classification also demonstrated good reliability between observers, but was least reliable for flexion-distraction injuries. In addition, interobserver reliability between the Denis classification and TLICS morphology subcomponent was strong. TLICS also predicted the need for operative treatment as determined by the experts scoring the injuries. Conclusion. TLICS is a reliable system for assessing fractures of the thoracic and lumbar spine when used by experts. Similar to previous studies, the posterior ligamentous complex subcomponent score was the least reliable component. Reliability assessment using a generalizability coefficient is a robust method for validating fracture classifications.

Does preoperative DVT chemoprophylaxis in spinal surgery affect the incidence of thromboembolic complications and spinal epidural hematomas

Background Deep venous thrombosis (DVT) and pulmonary embolus (PE) remain common surgical complications, often affecting patients without any prior warning. Postoperative spinal epidural hematomas (SEH) may have a devastating impact on a patients recovery from a routine procedure. The effect of preoperative DVT prophylaxis administration on elective spinal patients has not previously been studied. Study Design Retrospective cohort analysis. Objective To correlate the incidence of preoperative DVT prophylaxis administration and the rate of postoperative DVT, PE, and SEH after elective spinal surgery. Summary of Background Data Earlier studies have shown a postoperative DVT rate in elective spinal patients of between 0.3% and 31%, a PE rate of 0.2% to 0.9%, and a SEH rate of approximately 0.1%. Methods About 3870 patient notes, from 2004 to 2008 elective spinal procedures, were reviewed. DVT, PE, and SEH rates were compared between those patients receiving and not receiving preoperative DVT prophylaxis. Results The 36.9% of patients received preoperative DVT prophylaxis, and 19 patients suffered and DVT and/or PE. Nine of these had received preoperative prophylaxis, giving an odds ratio of 0.91. Sixteen patients suffered a SEH, and this gave an odds ratio of 1.33. The SEHs presented with a median postoperative time of 4 days. Conclusions Preoperative DVT prophylaxis does not influence the rate of postoperative DVT or PE among elective spinal patients. It probably does not influence SEH rate, and it is noted that SEH may present quite late, in contrast to currently accepted time courses.

Derivation of a clinical decision guide in the diagnosis of cervical facet joint pain

OBJECTIVE To derive a clinical decision guide (CDG) to identify patients best suited for cervical diagnostic facet joint blocks. DESIGN Prospective cohort study. SETTING Pain management center. PARTICIPANTS Consecutive patients with neck pain (N=125) referred to an interventional pain management center were approached to participate. INTERVENTIONS Subjects underwent a standardized testing protocol, performed by a physiotherapist, prior to receiving diagnostic facet joint blocks. All subjects received the reference standard diagnostic facet joint block protocol, namely controlled medial branch blocks (MBBs). The physicians performing the MBBs were blinded to the local anesthetic used and findings of the clinical tests. MAIN OUTCOME MEASURES Multivariate regression analyses were performed in the derivation of the CDGs. Sensitivity, specificity, positive and negative likelihood ratios, and 95% confidence intervals (CIs) were calculated for the index tests and CDGs. RESULTS A CDG involving the findings of the manual spinal examination (MSE), palpation for segmental tenderness (PST), and extension-rotation (ER) test demonstrated a specificity of 84% (95% CI, 77-90) and a positive likelihood ratio of 4.94 (95% CI, 2.8-8.2). Sensitivity of the PST and MSE were 94% (95% CI, 90-98) and 92% (95% CI, 88-97), respectively. Negative findings on the PST were associated with a negative likelihood ratio of .08 (95% CI, .03-.24). CONCLUSIONS MSE, PST, and ER may be useful tests in identifying patients suitable for diagnostic facet joint blocks. Further research is needed to validate the CDGs prior to their routine use in clinical practice.

Screening of patients suitable for diagnostic cervical facet joint blocks - A role for physiotherapists

The cervical facet joint is a prevalent source of pain in patients with chronic cervical spine pain. Patients with persistent, disabling neck pain, are increasingly being referred for diagnostic facet joint blocks, with the aim of assessing their suitability for interventional procedures such as radiofrequency neurotomy (RFN). A positive response to the block is an indicator of more substantive benefits from RFN. Physiotherapists and medical practitioners are challenged to make appropriate referrals for diagnostic facet joint blocks. This lack of selection contributes to lengthy wait-lists, unnecessary invasive procedures for those who have a negative response and significant costs to the health care system. Physiotherapists use manual examination to identify the facet joint as the primary source of a patients pain but its diagnostic accuracy and reliability is variable. It is reasoned that a combination of findings of a physical, manual and psychological assessment may better indicate that a patient will respond positively or negatively to a diagnostic facet joint block. Clinical prediction guides (CPG) allow practitioners to use the results of the patient history, self-report measures and physical examination toward optimal diagnostic and therapeutic decisions. It is proposed that the development and validation of a CPG may aid in the appropriate selection of patients for this diagnostic procedure.