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Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLI | Pages 60 - 60
1 Sep 2012
Melloh M Barz T Staub L Lord S Merk H Theis J
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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.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 562 - 562
1 Oct 2010
Barz T Lange J Melloh M Merk H Rieger P Theis J
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Introduction: Lumbar spinal stenosis (LSS) is diagnosed by a history of claudication, clinical investigation, treadmill test, and cross sectional area (CSA) in MRI or CT. Because commonly used radiological findings not always correlate with clinical symptoms, additional parameters with high specificity and sensitivity are needed.

Methods: Prospective study of dorsal lumbar nerve root sedimentation in MRI scans in supine position of 2 groups of 100 consecutive patients each between 01/2007 – 12/2007. Patients in group 1 had non-specific low back pain (LBP), no claudication, and a CSA above 120 mm2 (LBP group); patients in group 2 showed claudication with or without LBP and a CSA below 80 mm2 (LSS group). We excluded patients with a previous spine surgery. In addition to the sedimentation sign, in both groups VAS, ODI, and walking distance in the treadmill test were measured.

Results: The sedimentation sign was positive in 94 patients in the LSS group but in no patient in the LBP group, showing a specificity of 100%, a sensitivity of 94%, and an accuracy of 97%. There was no difference between segmental levels L1 – L5. Walking distance in the LSS group was shorter than in the LBP group (67 m vs. > 1000 m; p< 0.001). There were no significant differences between both groups regarding VAS and ODI.

Conclusion: In patients without LSS during MRI in supine position lumbar nerve roots sediment due to gravity to the dorsal part of the dural sac leading to a positive sedimentation sign. This sedimentation is not observed in patients with LSS. Therefore, a negative sedimentation sign is a predictor of LSS in patients without prior spine surgery with a high specificity and sensitivity. Level S1 and below were excluded in our study because nerve roots S1 and S2 leave the dural sac in a ventral position inhibiting sedimentation to the dorsal part of the dural sac. The sedimentation sign is a reliable additional diagnostic parameter in patients with LSS.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_II | Pages 345 - 345
1 May 2010
Melloh M Staub L Aghayev E Barz T Theis J Roeder C
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Background: context: Length of hospital stay (LOS) varies widely within patients with posterior spinal fusion. So far there is little evidence on its co-variates.

Purpose: This study examined which co-variates influence LOS in posterior spinal fusion. Study design: Prospective consecutive documentation of hospital based interventions in the international spine registry Spine Tango. Patient sample: Between 05/2005 and 11/2006 data of 3437 patients were documented in the registry. 790 patients with degenerative spinal disease (614) or spondylolisthesis (176), who had been treated with posterior decompression and spinal fusion, were included in this study. Median age was 62.8 yrs (min 13.2 yrs, max 89.8 yrs) with a female to male ratio of 2:1. Median LOS was 11 days (IQR 8–14 d). Outcome measures: LOS was chosen as dependent outcome variable.

Methods: Multiple linear regression was performed on following independent variables: age, gender, main pathology, number of spinal segments of posterior fusion, level of fusion, number of previous spinal surgeries, operation time, clinic (number of fusions, academic status), surgeon credentials, type of fusion (sole fusion, fusion + instrumentation, fusion + instrumentation + cage).

Results: Clinic (p< 0.0001) was found to be a highly significant co-variate for LOS (min 7 d, max 14 d). Number of fusions per clinic (min 25, max 434) and academic status of clinic had no influence on LOS. Further significant covariates were surgeon credentials (surgeons in training: 8.5 d, specialised spine surgeons: 11 d, orthopaedic or neurosurgeons: 12 d; p=0.001), number of spinal segments of posterior fusion (1 segment: 10 d, 2–3 segments: 12 d, 4–5 segments: 12.5 d, > 5 segments: 15 d; p=0.002), and age group (< 50 yrs: 9 d, 50–59 yrs: 11 d, 60–69 yrs: 12 d, ≥70 yrs: 13 d; p=0.01). Borderline significance was found for gender (women: 12 d, men: 10 d; p=0.05). All other variables showed no influence on LOS.

Conclusion: Co-variates of LOS of patients with posterior spinal fusion are clinic, independent of number of spinal surgeries per clinic and academic status of clinic, surgeon credentials, number of segments of fusion, age group, and gender. A short LOS in surgeries performed by surgeons in training is explained by a smaller number of segments of fusions in these procedures. A subgroup analysis on the co-variate clinic should be performed assessing further explanatory variables. However, this goes beyond the possibilities of documentation in a spine registry.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 219 - 219
1 Mar 2010
Melloh M Roeder C Zweig T Barz T Theis J
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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.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 218 - 218
1 Mar 2010
Melloh M Aghayev E Zweig T Barz T Theis J
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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.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_III | Pages 439 - 439
1 Sep 2009
Melloh M Staub L Zweig T Barz T Reiger P Theis J Roeder C
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Introduction: With a life of over five years, Spine Tango can be considered the first truly International Spine Registry. The Swedish Spine Registry has already shown the feasibility of a registry on a national level. But, there is a need for an international spine registry allowing a benchmarking on an international level. Here we demonstrate the genesis of questionnaire development, the constantly increasing activity, and limitations of the International Spine Registry Spine Tango.

Methods: From 2002 until 2007 about 9000 datasets were submitted by 28 hospitals in nine countries worldwide. Three different generations of Spine Tango questionnaires were used for documentation.

Results: To cope with varying international administrative issues and legal requirements of data anonymisation, national Spine Tango modules are necessary. Four national Spine Tango modules are in operation to date, another three modules are in the process of roll-out. Considering all these participants, Spine Tango will soon expand to include data from 52 hospitals in 18 countries. One-fourth of these hospitals are University Hospitals, which are destined to take the lead in the Spine Tango registry as opinion leading hospitals. Although the number of participants is steadily growing, no country is yet represented with a sufficient number of hospitals. Indisputably, a marketing concept is needed. An acquisition of new centres via national spine societies seems an obvious strategic approach. Further limitations of Spine Tango include the low number and short duration of follow-ups and the lack of sufficiently detailed patient based data on subgroup level.

Discussion: Spine Tango has achieved a firm position as international spine registry and with its increasing acceptance it is also gaining importance. The strengths of Spine Tango include a potentially very large network, the participation of a specialized international society and an academic partner with expertise and extensive experience in registry implementation. Data analysis from Spine Tango is possible but complicated by the incompatibility of generations one and two with the more recent generation three. Consequently findings cannot yet be generalized to any specific country or patient population. Nevertheless, the potential benefits of the project for the whole spine community become increasingly visible. In the near future, the established Spine Tango version three with standardised patient based data will make outcome evaluations possible. In parallel to the International Spine Registry Spine Tango, a National Spine Registry in Australia could be set up – comparable to AOA’s National Joint Replacement Registry.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_III | Pages 440 - 440
1 Sep 2009
Melloh M Staub L Aghayev E Zweig T Barz T Reiger P Theis J Roeder C
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Introduction: As an example of possibilities of 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.

Methods: Prospective consecutive documentation of hospital based interventions with an evidence level 2++. Between 05/2005 and 11/2006 data of 3437 patients were documented in the registry. 929 patients, who had been treated with posterior spinal fusion after opening of the spinal canal, were included in this study. Median age was 62.7 yrs (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. Dural tears being the most frequent type of complications in the registry were chosen as dependent outcome variable (3–6). 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.

Results: 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 lesions with case mix.

Discussion: The feasibility of data analysis and benchmarking from the International Spine Registry Spine Tango could be demonstrated. 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. 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.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_III | Pages 431 - 431
1 Sep 2009
Melloh M Barz T Reiger P Staub L Aghayev E Roeder C Zweig T Theis J
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Introduction: Lumbar spinal stenosis is a frequent indication for spinal surgery. The predictive quality of treadmill testing and MRI for diagnostic verification is not yet clearly defined. The aim of our study was to assess correlations between treadmill testing and MRI findings in the lumbar spine.

Methods: Patients with lumbar spinal stenosis who had been admitted for surgical treatment by means of decompression with or without stabilisation were prospectively examined. We included patients with lumbar spinal stenosis as defined by clinical symptoms like low back and/or leg pain, which increased when walking, and by the area of the dural sac examined by MRI. We excluded patients with clinically manifest peripheral arterial disease, polyneuropathy or musculoskeletal impairments compromising the ability to walk. Treadmill tests were performed using the standardized testing protocoll by Deen at a speed of 0.5 m/sec without inclination. After the onset of symptoms (pain, weakness or dysaesthesia), each patient decided when to end the test.

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.

Results: 25 patients were included with a median age of 67 years (Interquartile range IQR 60–72 yrs). In the narrowest spinal segment the median area of the dural sac was 91mm2 (IQR 67–135 mm2). The median ODI was 66 percent (IQR 64–72 percent). The median walking distance in the treadmill test was 70 m (IQR 30–130 m). The distance reached in the treadmill test correlated with the area of the dural sac (Spearman’s rho=0.53) and ODI (rho=0.51), but not with the area of the neuroforamina and VAS.

Discussion: The treadmill test helps objectifying pre- and postsurgical clinical complaints and verifying a lumbar spinal stenosis by creating a situation of dynamic strain. Moreover, the treadmill test lets the patient experience his own physical limits and enables the examiner to attain a replicable postoperative assessment. The distance reached in the treadmill test predicts the grade of stenosis in MRI but has a limited diagnostic importance for the level of clinical symptoms in lumbar spinal stenosis.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 345 - 345
1 May 2009
Melloh M Staub L Roeder C Barz T Theis J
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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.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 109 - 109
1 Mar 2009
Barz T Melloh M Merk H Staub L Knöfler F
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Background context: Surgical treatment of lumbar spinal stenosis is one of the most frequent procedures in spinal surgery. Nevertheless, the predictive quality of instruments like treadmill test and MRI has not yet been clearly defined for the lumbar spinal stenosis.

Purpose: Objective of this study was to verify correlations between treadmill test and MRI findings in the narrowest spinal segment.

Methods: In a prospective study (EBM-level 3) 25 patients with inpatient treatment for lumbar spinal stenosis were investigated between 01/2005 and 06/2005. Exclusion criteria were a reduced walking capacity for other reasons (e.g. gonarthrosis). Treadmill tests were performed following the protocol by Deen. Patients estimated their maximum walking distance before performing the tests. Area of the dural sac, area of the neuroforamina and disc height at the dorsal margin were examined by MRI for the narrowest spinal segment. VAS and ODI were used as clinical assessment instruments.

Outcome Measures: The median age of patients was 67 yrs (IQR 58–73 yrs) with 44 % females. The median distance reached in the treadmill test was 70 m (IQR 30–135 m), the median estimated maximum walking distance 200 m (IQR 100–300 m). In the narrowest spinal segment the median area of the dural sac was 91 mm2 (IQR 65–143 mm2), the median area of the neuroforamina 43 mm2 (IQR 36–51 mm2) and the median disc height 1,4 mm (IQR 0,9–2,5 mm). The median VAS was 7 (IQR 6,5–8) and the median ODI 33 (IQR 32–37).

Results: The distance reached in the treadmill test correlated with the maximum walking distance estimated by the patients (Spearman’s rho=0,62, p=0,001), area of the dural sac (rho=0,54, p=0,006) and disc height (rho=0,45, p=0,03), but not with area of the neuroforamina and VAS. VAS correlated with the disc height (rho=−0,6, p=0,002), but with no other MRI findings.

Conclusions: The distance reached in the treadmill test and MRI findings in the narrowest spinal segment predict the level of clinical symptoms. Possible reasons for the slightly limited predictive quality of MRI findings are that this study did not regard the time of development of the stenosis, that effects of multilevel stenosis were not considered, and that MRI findings in lying position without lordosis might differ from findings in standing position. However, the treadmill test is a valid and highly practicable pre-surgery diagnostic instrument in lumbar spinal stenosis.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 147 - 147
1 Mar 2009
Melloh M Staub L Roeder C Sommer S Rieger P Barz T
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Introduction: Lumbar fusion is one of the most frequently recommended treatments in spinal surgery, whereas ALIF and PLF are discussed controversially. This prospective and consecutive study examined if complications and rehabilitation differed between patients with a degenerated lumbar spine, who had been treated with ALIF or PLF.

Methods: Between 04/2002 and 12/2005 clinical data of 39 patients, who were treated with ALIF, and of 296 patients, who received PLF, were submitted to the European Spine Register SSE Spine Tango. Complications and rehabilitation process were documented after a median follow-up time of 9 weeks (IQR 8–24 weeks). Analysis was performed with non-parametric tests. The study corresponds with an EBM-level 3.

Results: The median age of patients with ALIF was 56 years (IQR 37-66 yrs) vs. 64 yrs in the PLF group (IQR 54–72 yrs) with a male to female ratio 10:29 vs. 108:188.

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).

Conclusions: Patients with degenerative lumbar spine disease have a less severe type of complications after ALIF than after PLF, whereas the complication rate is even. Concerning the higher proportion of patients with outpatient rehabilitation in the ALIF group, one has to consider their lower age compared with patients in the PLF group. Except for the severeness of complications and the proportion of outpatient rehabilitation one cannot conclude an advantage of either of the two surgical methods.