Dural sac cross-sectional area and morphological grade show significant associations with patient-rated outcome of surgery for lumbar central spinal stenosis.

PURPOSE: Lumbar central spinal stenosis (LSS) is one of the most common reasons for spine surgery in the elderly patient. Magnetic resonance imaging (MRI) represents the gold standard for the assessment of LSS and can be used to obtain quantitative measures of the dural sac cross-sectional area (DCSA) or qualitative measures (morphological grades A-D) of the rootlet/cerebrospinal fluid ratio. This study investigated the intercorrelation between these two MRI evaluation methods and explored their respective relationships with the patient baseline clinical status and outcome 12 months after surgery. METHODS: This was a retrospective analysis of prospectively collected data from 157 patients (88 male, 69 female; age 72 ± 7 years) who were undergoing first-time surgery for LSS. Patients with foraminal or isolated lateral stenosis were excluded. The Core Outcome Measures Index (COMI) was completed before and 12 months after surgery. Preoperative T2 axial MRIs were blinded and independently evaluated for DCSA and morphological grade. Spearman rank correlation coefficients described the relationship between the two MRI measures of stenosis severity and between each of these and the COMI baseline and change-scores (pre to 12 months' postop). Multiple logistic regression analysis (controlling for baseline COMI, age, gender, number of operated levels, health insurance status) was used to analyse the influence of stenosis severity on the achievement of the minimum clinically important change (MCIC) score for COMI and on global treatment outcome (GTO). RESULTS: There was a correlation of ρ = -0.69 (p < 0.001) between DCSA and morphological grade. There was no significant correlation between COMI baseline scores and either DCSA or morphological grades (p > 0.85). However, logistic regression revealed significant (p < 0.05) associations between stenosis ratings and 12-month outcome, whereby patients with more severe stenosis (as measured using either of the methods) benefited more from the surgery. Patients with a DCSA <75 mm2 or morphological grade D had a 4-13-fold greater odds of achieving the MCIC for COMI or a "good" GTO, compared with patients in the least severe categories of stenosis. CONCLUSIONS: Postoperative outcome was clearly related to the degree of preoperative radiological LSS. The two MRI methods appeared to deliver similar information, as given by the relatively strong correlation between them and their comparable performance in relation to baseline and 12-month outcomes. However, the qualitative morphological grading can be performed in an instant, without measurement tools, and does not deliver less clinically useful information than the more complex and time-consuming measures; as such, it may represent the preferred method in the clinical routine for assessing the extent of radiological stenosis and the likelihood of a positive outcome after decompression.

A novel use of the Spine Tango registry to evaluate selection bias in patient recruitment into clinical studies: an analysis of patients participating in the Lumbar Spinal Stenosis Outcome Study (LSOS).

PURPOSE: Patients enrolled in clinical studies typically represent a sub-set of all who are eligible, and selection bias may compromise the generalizability of the findings. Using Registry data, we evaluated whether surgical patients recruited by one of the referring centres into the Lumbar Spinal Stenosis Outcome Study (LSOS; a large-scale, multicentre prospective observational study to determine the probability of clinical benefit after surgery) differed in any significant way from those who were eligible but not enrolled. METHODS: Data were extracted for all patients with lumbar spinal stenosis registered in our in-house database (interfaced to Eurospine's Spine Tango Registry) from 2011 to 2013. Patient records and imaging were evaluated in relation to the admission criteria for LSOS to identify those who would have been eligible for participation but were not enrolled (non-LSOS). The Tango surgery data and Core Outcome Measures Index (COMI) data at baseline and 3 and 12 months after surgery were analysed to evaluate the factors associated with LSOS enrolment or not. RESULTS: 514 potentially eligible patients were identified, of which 94 (18%) were enrolled into LSOS (range 2-48% for the 6 spine surgeons involved in recruiting patients) and 420 (82%) were not; the vast majority of the latter were due to non-referral to the study by the surgeon, with only 5% actually refusing participation. There was no significant difference in gender, age, BMI, smoking status, or ASA score between the two groups (p ≥ 0.18). Baseline COMI was significantly (p = 0.002) worse in the non-LSOS group (7.4 ± 1.9) than the LSOS group (6.7 ± 1.9). There were no significant group differences in any Tango surgery parameters (additional spine patholothegies, operation time, blood loss, complications, etc.) although significantly more patients in the non-LSOS group had a fusion procedure (38 vs 18% in LSOS; p = 0.0004). Postoperatively, neither the COMI nor its subdomain scores differed significantly between the groups (p > 0.05). Multiple logistic regression revealed that worse baseline COMI (p = 0.021), surgeon (p = 0.003), and having fusion (p = 0.014) predicted non-enrolment in LSOS. CONCLUSION: A high proportion of eligible patients were not enrolled in the study. Non-enrolment was explained in part by the specific surgeon, worse baseline COMI status, and having a fusion. The findings may reflect a tendency of the referring surgeon not to overburden more disabled patients and those undergoing more extensive surgery with the commitments of a study. Beyond these factors, non-enrolment appeared to be somewhat arbitrary, and was likely related to surgeon forgetfulness, time constraints, and administrative errors. Researchers should be aware of potential selection bias in their clinical studies, measure it (where possible) and discuss its implications for the interpretation of the study's findings.