The Nerve Root Sedimentation Sign in transverse magnetic resonance imaging has been shown to discriminate well between selected patients with and without lumbar spinal stenosis (LSS), but the performance of this new test, when used in a broad patient population, is not yet known (Barz et al. 2010). We conducted a retrospective study of consecutive patients with suspected LSS from 2004–2006, before the sign had been described, to assess its association with health outcomes. Based on clinical and radiological diagnostics, patients had been treated with decompression surgery or conservative treatment (physical therapy, oral pain medication). Changes in the Oswestry Disability Index (ODI) from baseline to 24 month follow-up were compared between Sedimentation Sign positives and negatives in both treatment arms. Of the 146 included patients (52% female, mean age 59 yrs), 71 underwent surgery. Baseline ODI in this treatment arm was 52%, the sign was positive in 44 patients (mean ODI improvement 25 points) and negative in 27 (ODI improvement 24), with no significant difference between groups. In the 75 patients of the conservative treatment arm, baseline ODI was 44%, the sign was negative in 45 (ODI improvement 17), and positive in 30 (ODI improvement 5). Here a positive sign was associated with a smaller ODI improvement compared with sign negatives (t-test, p=0.003). This study allowed an unbiased clinical validation of the Sedimentation Sign by avoiding it influencing treatment selection. In the conservative treatment arm a positive sign identifies a group of patients who are less likely to benefit. In these cases, surgery might be effective; however, this needs confirmation in prospective studies.
Most people experience low back pain (LBP) at least once in their lifetime. A minority goes on to develop persistent LBP causing significant socioeconomic costs. Aim of this study was to identify factors that influence the progression of acute to persistent LBP at an early stage (Hilfiker et al. 2007). Prospective inception cohort study of patients attending a health practitioner for their first episode of acute LBP or recurrent LBP after a pain free period of at least six months. Patients were assessed at baseline addressing occupational and psychological factors as well as pain, disability, quality of life and physical activity, and followed up over six months. Baseline and follow-up questionnaires were based on the recommendations of the Multinational Musculoskeletal Inception Cohort Study (MMICS) Statement (Pincus et al. 2008). Variables were combined to the three indices ‘working condition’, ‘depression and maladaptive cognitions’ and ‘pain and quality of life’. The index ‘depression and maladaptive cognitions’ comprising of depression, somatisation, a resigned attitude towards the job, fear-avoidance, catastrophizing and negative expectations on return to work was found to be a significant baseline predictor for persistent LBP up to six months (OR 5.1; 95%CI 1.04–25.1). The diagnostic accuracy of the predictor model had a sensitivity of 0.54 and a specificity of 0.90. Positive likelihood ratio was moderate with 5.3, negative likelihood ratio 0.5. Overall predictive accuracy of the model was 81%. The area under the curve in receiver operating characteristic (ROC) analysis of the index was 0.78 (CI95% 0.65–0.92), demonstrating a satisfactory quality of discrimination. Psychological factors in patients with acute LBP in a primary care setting correlated with a progression to persistent LBP up to six months. The benefit of including factors such as ‘depression and maladaptive cognition’ in screening tools is that these factors can be addressed in primary and secondary prevention.
Posterior lumbar fusion is a frequently performed procedure in spinal surgery. High percentages of good and excellent results are indicated by physicians. On the other hand patient-based outcomes are reported. Little is known about the correlations of these two assessment types. We aimed at their comparison. The analysis included 1013 patients with degenerative spinal disease or spondylolisthesis from an international spine registry, treated with posterior lumbar fusion. All patients were pre/postop assessed by physician-based McNab criteria (‘excellent’, ‘good’, ‘fair’, ‘poor’). Of these patients, 210 (mean age 61 years; 57% females) were in addition assessed by patient-based Oswestry Disability Index (ODI). The remaining 803 patients (mean age 59 years; 56% females) were assessed by patient-based Core Outcome Measure Index (COMI), including Visual Analogue Scale (VAS) for back and leg pain as well as verbal self-rating (‘helped a lot’, ‘helped’, ‘helped only little’, ‘didn’t help’, ‘made things worse’). McNab criteria were compared to the Minimal Clinically Important Difference (MCID) in ODI (12.8), in VAS back (1.2) and leg pain (1.6). We investigated the correlations between McNab criteria and these patient-based outcomes. In the ‘excellent’ group as rated by physicians, the proposed MCID was reached in 83% of patients for ODI, in 69% for VAS back and in 83% for VAS leg pain. All patients said the treatment had ‘helped’ or ‘helped a lot’. In the ‘good’ group 56% (ODI), 66% (back pain) and 86% (leg pain) reached the MCID. 96% of patients perceived the treatment as positive. In the ‘fair’ group 37% (ODI), 55% (back pain) and 63% (leg pain) reached the MCID. 49% had positive treatment considerations. The ‘poor’ group revealed 30% (ODI), 35% (back pain) and 44% (leg pain) of patients with reached MCID. Only 15% rated the treatment as positive. The Spearman correlation coefficients between McNab criteria on the one hand and ODI, back and leg pain as well as patients’ verbal self-rating on the other hand were 0.57, 0.37, 0.36 and 0.46 respectively. The comparison of physician and patient-based outcomes showed the highest correlations between McNab criteria and ODI, somewhat weaker correlations with patients’ self-rating and the weakest correlations with back and leg pain. Based on these findings, physicians’ evaluation of patient outcomes can be considered a valuable part of patient assessment, corresponding very well with patients’ perceptions of success or failure of spinal surgery.
Physician administered McNab criteria “excellent, good, fair and poor” were compared to ODI, VAS back- and leg pain and to the patients answer describing the outcome of the operation with the following options: helped a lot, helped, helped only little, didn’t help and made things worse. Then the concept of minimum clinically important difference (MCID) was applied
In the “good” group 86% (MCID: 51.7%) of patients improved regarding ODI, 81% (MCID: 65,7%) regarding back and 93% (MCID: 89.4%) regarding leg pain. 99% of patients said that the treatment helped a lot, helped or helped only little. 65% (MCID: 40%) of patients in the “fair” group had improved ODIs. Even in this group 88% of patients perceived the treatment as helping a lot, helping or helping only little. Moreover in the “poor” group had 60% (MCID: 40%) of patients improved ODIs, 55% (MCID: 40%) alleviated back and 36% (MCID: 30%) reduced leg pain. But only 30% of patient stated that the treatment helped or helped only little. Spearman correlation coefficients for ODI, VAS back, VAS leg and patient’s verbal statement on overall outcome were 0.42, 0.18, 0.27 and 0.53.
As an example of benchmarking in spinal surgery using Spine Tango, we extracted data on dural tears, one of the most frequent types of complications in posterior spinal fusion. Little is known about their predictors. This study examined which factors predict the occurrence of dural tears in posterior spinal fusion. Prospective consecutive documentation of hospital based interventions with an evidence level 2++. Between May 2005 and November 2006 data of 3437 patients were documented in the registry. Nine hundred and twenty nine patients, who had been treated with posterior spinal fusion after opening of the spinal canal, were included in this study. Dural tears being the most frequent type of complications in the registry were chosen as dependent outcome variable. Multiple linear regression with stepwise elimination was performed on potential predictor-variables of the occurrence of dural tears. Benchmarking compared the performance of single hospitals with international peers. Median age was 62.7 years (min 12.5, max 90.5 yrs) with a female to male ratio of 2:1. In 18 of 929 cases a dural tear occurred. Hospital (p=0.02) and number of segments of fusion (p=0.018) were found to be predictors of the occurrence of dural tears in posterior spinal fusion. Number of fusions per hospital (min 25, max 526) and academic status of hospital had no influence on the rate of dural tears. Fusions of four and more segments showed an increase of the rate of dural tears by a factor of three compared to fusions of less than four segments. There was no significant difference between fusions of one segment and fusions of two or three segments (1.3 vs. 1.9%) as well as between fusions of four or five segments and fusions of more than five segments (4.6 vs. 4.2%). Differences between hospitals remained when benchmarking dural tears with case mix. Predictors of dural tears in posterior spinal fusion are
hospital and number of segments of fusion. In fusions of four and more segments a threefold higher risk of dural tears in comparison to fusions of less than four segments should be taken into consideration.
Posterior lumbar fusion is one of the most frequent procedures in spinal surgery. This study examined which factors predict physician-based outcomes in posterior lumbar fusion within the international spine registry Spine Tango. This study used prospective consecutive hospital based documentation. Between May 2005 and October 2007 720 patients had been treated with posterior lumbar fusion for degenerative disease or spondylolisthesis. McNab criteria as commonly used physician-based outcomes were chosen as dependent outcome variable. We dichotomised the original McNab criteria combining “excellent” with “good” to “good”, and “fair” with “poor” to “poor”. Multivariate logistic regression was performed on following potential predictor-variables: age, gender, main pathology, number of previous spinal surgeries, number of spinal segments of posterior fusion, operation time, surgeon credentials, follow-up interval. Median age was 63 years (range 13–90 yrs) with a female to male ratio of 6.3:3.7. Number of previous spinal surgeries (p<
0.001) and follow-up interval (p<
0.001) were found to be predictors of the dichotomised McNab criteria. Patients without previous spinal surgery showed the highest ratio of “good” to “poor” outcome (80.5%:19.5%). This ratio was almost consistently decreasing with the number of previous spinal surgeries to 40%:60% in patients with more than five previous surgeries. At six and twelve-weeks follow-up outcomes were significantly better than after one year, without significant differences between other follow-up intervals. Other examined co-variables showed no influence on the outcomes. Predictors of physician-based outcomes in posterior lumbar fusion are “number of previous spinal surgeries” and “follow-up interval”. In patients with more than five previous spinal surgeries a higher likelihood of “poor” outcomes should be taken into consideration. A too positive outcome may occur at six or twelve-week’s follow-up.
hospital and number of segments of fusion. In fusions of four and more segments a threefold higher risk of dural tears in comparison to fusions of less than four segments should be taken into consideration. A subgroup analysis on the predictor-variable hospital should be performed assessing further covariates. However, this goes beyond the possibilities of documentation in this international spine registry.
The area of the dural sac and neuroforamina was examined with MRI for the narrowest spinal segment. ODI and VAS were used for clinical assessment.
SPINE TANGO is the first International Spine Register. While it has now been fully operational for five years, no results of its collected data have been presented yet. The Swedish Spine Register has already shown that a National Spine Register can generate valid and meaningful data. Here we present data from the first three versions of SPINE TANGO. From 2002 until 2006 about 6000 datasets were submitted by 25 hospitals worldwide. Descriptive analysis was performed for demographic, surgery, and follow-up data comparing all three versions of SPINE TANGO. Over the course of its existence the SPINE TANGO data base showed a rise in median patient age from 52.3 years to 58.6 years and an increasing percentage of degenerative disease as main pathology from 60.1% to 71.4 %. Posterior decompression was the most frequent surgical measure. About one third of all patients had follow-ups. Rehabilitation was arranged more frequently, especially home-based and outpatient rehabilitation. The complication rate was decreasing below 10%. The feasibility of data analysis from the International Spine Register SPINE TANGO could be demonstrated performing descriptive analysis with an evidence level III. In the near future, the meanwhile established SPINE TANGO version 3 with patient based data will make outcome evaluation possible. This will enable us to present more comprehensive analyses of SPINE TANGO and to make the data base even more beneficial for the whole spine community. In parallel to the International Spine Register SPINE TANGO, a National Spine Register in New Zealand could be set up – comparable to NZOA’s National Joint Register.
Methods: We conducted a two-arm matched pairs case-control study assessing the influence of patient characteristics sex, age, weight, BMI, diagnosis, and activity level (Charnley classification) on the odds for mechanical socket loosening. The cemented and uncemented fixation mode was analyzed separately. Results: 299 cases and 986 controls were included in the cemented study arm and 510 cases and 3000 controls in the uncemented arm. Women had reduced loosening odds for the cemented (OR=0.59, p=0.0024) and uncemented (OR=0.63, p=0.0001) fixation compared to men (OR=1). Each additional year the intervention was postponed reduced the loosening odds by about 2 % for cemented (OR=0.98, p=0.017) and uncemented (OR=0.98, p=0.0002) sockets. In cemented sockets the weight group of 73–82 kg had lower loosening odds (OR=0.63, p=0.017) than the lighter (OR>
0.92) and heavier (OR>
1.1) weight groups. There were no significant effects of weight in the uncemented group. In contrast, obese patients (BMI>
30) with uncemented sockets displayed elevated loosening odds (OR=1.41, p=0.034) compared to an insignificant effect in the cemented arm. Osteonecrosis was the only main pathology revealing elevated loosening odds (OR=1.27, p=0.049) but only in cemented sockets. The Charnley classification as an indirect proxy of activity revealed changing and insignificant effects. Conclusions: Female sex and a delayed intervention have similarly protective effects on the odds for cemented and uncemented socket loosening. Whilst a certain body weight range has a significantly protective effect in cemented sockets the more important finding is the significantly increased risk for uncemented socket loosening in obese patients. Patients with osteonecrosis are the only etiologic group at a significantly increase risk for socket loosening, but only with a cemented fixation. The Charnley classification as a surrogate for activity level had no influence on loosening risks in either socket fixation mode. Level of Evidence: Level III (case-control study)
Patients after ALIF and PLF had an even complication rate (5/39 vs. 26/296, p = 0,41). The types of complications in the ALIF group were less severe (sensory and motoric disturbance vs. implant failure and implant malposition). All five patients needing reintervention belonged to the PLF group. Three quarters of all patients underwent rehabilitation. The proportion of patients with outpatient rehabilitation was higher in the ALIF group (14/39 vs. 50/296 patients, p = 0,05).