Background: The Odom criteria, established in 1958, are a widely used, 4-point rating scale for assessing the clinical outcome after cervical spine surgery. Surprisingly, the Odom criteria have never been validated, to our knowledge. The aim of this study was to investigate the reliability and validity of the Odom criteria for the evaluation of surgical procedures of the cervical spine. Methods: Patients with degenerative cervical spine disease were included in the study and divided into 2 subgroups on the basis of their most predominant symptom: myelopathy or radiculopathy. Reliability was assessed with interrater and test-retest design using quadratic weighted kappa coefficients. Construct validity was assessed by means of hypotheses testing. To evaluate whether the Odom criteria could act as a global perceived effect (GPE) scale, we assessed concurrent validity by comparing area under the curve (AUC) values of receiver operating characteristic (ROC) curves for the set of questionnaires. Results: A total of 110 patients were included in the study; 19 were excluded, leaving 91 in our analysis. Reliability assessments showed κ = 0.77 for overall interrater reliability and κ = 0.93 for overall test-retest reliability. Interrater reliability was κ = 0.81 for the radiculopathy subgroup and κ = 0.68 for the myelopathy subgroup. At least 75% of the hypotheses were met. The AUCs showed similar characteristics between the Odom criteria and GPE scale. Conclusions: The Odom criteria met the predefined criteria for reliability and validity. Therefore, the Odom criteria may be used to assess surgical outcome after a cervical spine procedure, specifically for patients presenting with radicular symptoms. The results of previous studies that have been deemed less trustworthy because of the use of the Odom criteria should be reconsidered.
25 August 2020 in Journal of Bone and Joint Surgery
Background: The effectiveness of surgical interventions for cervical degenerative disorders has been investigated in multiple systematic reviews. Differences in study population (e.g., patients with myelopathy and/or radiculopathy) were often neglected. Therefore, the objective of this study was to investigate the effectiveness of surgical interventions for patients with symptoms of cervical radiculopathy without myelopathy by conducting a systematic review and meta-analysis based on randomized controlled trials (RCTs). Methods: A comprehensive systematic search was conducted in MEDLINE, Embase, and CENTRAL (Cochrane Central Register of Controlled Trials) to identify RCTs that investigated the effectiveness of surgical interventions using an anterior or posterior approach compared with other interventions for patients with pure cervical radiculopathy. Outcomes were success rates (Odom criteria, similar rating scales, or percentage of patients who improved), complication and reoperation rates, work status, disability (Neck Disability Index), and pain (arm and neck). The Cochrane risk-of-bias tool was used to assess the likelihood of the risk of bias. A random-effects model was used. Heterogeneity among study results (I
2
≥ 50% or p < 0.05) was explored by conducting subgroup analyses. Funnel plots were used to assess the likelihood of publication bias. Results: A total of 21 RCTs were included, comprising 1,567 patients. For all outcomes, among all surgical techniques, only 1 pooled estimate showed a significant effect on success rate, which was in favor of anterior cervical discectomy with fusion compared with anterior cervical discectomy without an intervertebral spacer (p = 0.02; risk ratio [RR] = 0.87; 95% confidence interval [CI] = 0.77 to 0.98). Complication rates were higher when autologous bone graft from the iliac crest was used as an intervertebral spacer (p < 0.01; RR = 3.40; 95% CI = 1.56 to 7.43), related to donor-site morbidity. Conclusions: This meta-analysis demonstrated consistent results regarding clinical outcome for pure cervical radiculopathy among all studied interventions. Complication and reoperation rates were also similar, with the exception of higher complication rates in patients in whom autologous bone grafts were used. On the basis of clinical outcome and safety, there is no superior surgical intervention for pure cervical radiculopathy. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
Introduction: Cervical radiculopathy due to discogenic or spondylotic stenosis of the neuroforamen can be surgically treated by an anterior discectomy with fusion (ACDF) or a posterior foraminotomy (FOR). Most surgeons prefer ACDF, although there are indications that FOR is as effective as ACDF, has a lower complication rate and is less expensive. A head-to-head comparison of the 2 surgical techniques in a randomised controlled trial has not yet been performed. The study objectives of the Foraminotomy ACDF Cost-Effectiveness Trial (FACET) study are to compare clinical outcomes, complication rates and cost-effectiveness of FOR to ACDF. Methods and analysis: The FACET study is a prospective randomised controlled trial conducted in 7 medical centres in the Netherlands. The follow-up period is 2 years. The main inclusion criterion is a radiculopathy of the C4, C5, C6 or C7 nerve root, due to a single-level isolated cervical foraminal stenosis caused by a soft disc and/or osteophytic component, requiring operative decompression. A sample size of 308 patients is required to test the hypothesis of clinical non-inferiority of FOR versus ACDF. Primary outcomes are: ‘operative success’, the measured decrease in radiculopathy assessed by the visual analogue scale and ‘patient success’, assessed by the modified Odom's criteria. Secondary outcomes are: Work Ability Index (single-item WAI), quality of life (EuroQol 5 Dimensions 5 level Survey, EQ-5D-5L), Neck Disability Index (NDI) and complications. An economic evaluation will assess cost-effectiveness. In addition, a budget impact analysis will be performed. Ethics and dissemination: Ethical approval was obtained from the Institutional Ethics Committee of the University Medical Center Groningen. Results of this study will be disseminated through national and international papers. The participants and relevant patient support groups will be informed about the results of the study. Trial registration number: NTR5536 , pre-results.
28 March 2022 in Reviews in Endocrine and Metabolic Disorders
Differentiation of pituitary neuroendocrine tumor (PitNET) tissue from surrounding normal tissue during surgery is challenging. A number of fluorescent agents is available for visualization of tissue discrepancy, with the potential of improving total tumor resection. This review evaluates the availability, clinical and technical applicability of the various fluorescent agents within the field of pituitary surgery. According to PRISMA guidelines, a systematic review was performed to identify reports describing results of in vivo application of fluorescent agents. In this review, 15 publications were included. Sodium Fluorescein (FNa) was considered in two studies. The first study reported noticeable fluorescence in adenoma tissue, the second demonstrated the strongest fluorescence in non-functioning pituitary adenomas. 5-Aminolevulinic acid (5-ALA) was investigated in three studies. One study compared laser-based optical biopsy system (OBS) with photo-diagnostic filter (PD) and found that the OBS was able to detect all microadenomas, even when MRI was negative. The second study retrospectively analyzed twelve pituitary adenomas and found only one positive for fluorescence. The third investigated fifteen pituitary adenomas of which one displayed vague fluorescence. Indocyanine green (ICG) was researched in four studies with variable results. Second-Window ICG yielded no significant difference between functioning and non-functioning adenomas in one study, while a second study displayed 4 times higher fluorescence in tumor tissue than in normal tissue. In three studies, OTL38 showed potential in non-functioning pituitary adenomas. At present, evidence for fluorescent agents to benefit total resection of PitNETs is lacking. OTL38 can potentially serve as a selective fluorescent agent in non-functioning pituitary adenomas in the near future.
In recent years, patient-specific spinal drill guides (3DPGs) have gained widespread popularity. Several studies have shown that the accuracy of screw insertion with these guides is superior to that obtained using the freehand insertion technique, but there are no studies that make a comparison with computer-assisted surgery (CAS). The aim of this study was to determine whether the accuracy of insertion of spinal screws using 3DPGs is non-inferior to insertion via CAS. A randomized controlled split-spine study was performed in which 3DPG and CAS were randomly assigned to the left or right sides of the spines of patients undergoing fixation surgery. The 3D measured accuracy of screw insertion was the primary study outcome parameter. Sixty screws inserted in 10 patients who completed the study protocol were used for the non-inferiority analysis. The non-inferiority of 3DPG was demonstrated for entry-point accuracy, as the upper margin of the 95% CI (−1.01 mm–0.49 mm) for the difference between the means did not cross the predetermined non-inferiority margin of 1 mm (p < 0.05). We also demonstrated non-inferiority of 3D angular accuracy (p < 0.05), with a 95% CI for the true difference of −2.30°–1.35°, not crossing the predetermined non-inferiority margin of 3° (p < 0.05). The results of this randomized controlled trial (RCT) showed that 3DPGs provide a non-inferior alternative to CAS in terms of screw insertion accuracy and have considerable potential as a navigational technique in spinal fixation.
Purpose: Symptomatic lumbar spondylolisthesis is usually treated with fusion surgery when conservative methods fail. However, traditional open decompression and fusion involves a large skin incision and muscle detachment. Therefore, minimally invasive techniques have been developed to reduce tissue damage, potentially leading to less postoperative pain and earlier resumption of activities. The purpose of this study was to compare percutaneous versus open pedicle screw placement in patients receiving lumbar midline decompression due to symptomatic lumbar spondylolisthesis focusing on short-term low back pain. Methods: A randomised controlled trial was conducted in 2 Dutch hospital from 2015 to 2020. Participants with spondylolytic or degenerative lumbar spondylolisthesis were randomised into percutaneous pedicle screw placement with a mini-open decompression (mini-open), or conventional open surgery with instrumented fusion (open). The primary outcome measure was short-term low back pain after 2 weeks, measured by a visual analogue scale. Leg pain, disability and quality of life were recorded at 2 and 6 weeks, 3 and 6 months and 1 year. Surgical variables, including complications, were recorded. Analyses were performed in the intention-to-treat population. Results: In total, 169 participants were included and randomised to mini-open (n = 81) or standard open surgery (n = 88). No statistically or clinically significant differences were found between groups in terms of primary or secondary outcomes. Surgery duration, blood loss, hospital stay, and complications were also similar between groups. Conclusions: This study detected no difference in outcome between mini-open compared to open surgery in patients with spondylolisthesis. The hypothetical advantage of reduced short-term low back pain, less blood loss and better clinical outcome could not be confirmed.