Predictors of surgical, general and follow-up complications in lumbar spinal stenosis relative to patient age as emerged from the Spine Tango Registry

Published opinions regarding the outcomes and complications in older patients have a broad spectrum and there is a disagreement whether surgery in older patients entails a higher risk. Therefore this study examines the risk of surgery for lumbar spinal stenosis relative to age in the pooled data set of the Spine Tango registry.

Hospital for joint diseases participates in international spine registry Spine Tango after successful pilot study

Spine Tango is currently the only international spine registry in existence. It was developed under the auspices of Eurospine, the Spine Society of Europe, and is hosted at the University of Bern, Switzerland. The HJD Spine Center successfully tested Spine Tango during a 3-month pilot study and has since expanded documentation activities to more surgeons. Workflow integration and dedicated research staff are key factors for such an endeavor. Participation enables benchmarking against national and international peers and outcome research and quality assurance of surgical and non-surgical treatments.

The international spine registry SPINE TANGO: status quo and first results

With an official life time of over 5 years, Spine Tango can meanwhile be considered the first international spine registry. In this paper we present an overview of frequency statistics of Spine Tango for demonstrating the genesis of questionnaire development and the constantly increasing activity in the registry. Results from two exemplar studies serve for showing concepts of data analysis applied to a spine registry. Between 2002 and 2006, about 6,000 datasets were submitted by 25 centres. Descriptive analyses were performed for demographic, surgical and follow-up data of three generations of the Spine Tango surgery and follow-up forms. The two exemplar studies used multiple linear regression models to identify potential predictor variables for the occurrence of dura lesions in posterior spinal fusion, and to evaluate which covariates influenced the length of hospital stay. Over the study period there was a rise in median patient age from 52.3 to 58.6 years in the Spine Tango data pool and an increasing percentage of degenerative diseases as main pathology from 59.9 to 71.4%. Posterior decompression was the most frequent surgical measure. About one-third of all patients had documented follow-ups. The complication rate remained below 10%. The exemplar studies identified "centre of intervention" and "number of segments of fusion" as predictors of the occurrence of dura lesions in posterior spinal fusion surgery. Length of hospital stay among patients with posterior fusion was significantly influenced by "centre of intervention", "surgeon credentials", "number of segments of fusion", "age group" and "sex". Data analysis from Spine Tango is possible but complicated by the incompatibility of questionnaire generations 1 and 2 with the more recent generation 3. Although descriptive and also analytic studies at evidence level 2++ can be performed, findings cannot yet be generalised to any specific country or patient population. Current limitations of Spine Tango include the low number and short duration of follow-ups and the lack of sufficiently detailed patient data on subgroup levels. Although the number of participants is steadily growing, no country is yet represented with a sufficient number of hospitals. Nevertheless, the benefits of the project for the whole spine community become increasingly visible.

How to Tango: a manual for implementing Spine Tango

The generic approach of the Spine Tango documentation system, which uses web-based technologies, is a necessity for reaching a maximum number of participants. This, in turn, reduces the potential for customising the Tango according to the individual needs of each user. However, a number of possibilities still exist for tailoring the data collection processes to the user's own hospital workflow. One can choose between a purely paper-based set-up (with in-house scanning, data punching or mailing of forms to the data centre at the University of Bern) and completely paper-free online data entry. Many users work in a hybrid mode with online entry of surgical data and paper-based recording of the patients' perspectives using the Core Outcome Measures Index (COMI) questionnaires. Preoperatively, patients can complete their questionnaires in the outpatient clinic at the time of taking the decision about surgery or simply at the time of hospitalisation. Postoperative administration of patient data can involve questionnaire completion in the outpatient clinic, the handing over the forms at the time of discharge for their mailing back to the hospital later, sending out of questionnaires by post with a stamped addressed envelope for their return or, in exceptional circumstances, conducting telephone interviews. Eurospine encourages documentation of patient-based information before the hospitalisation period and surgeon-based information both before and during hospitalisation; both patient and surgeon data should be acquired for at least one follow-up, at a minimum of three to six months after surgery. In addition, all complications that occur after discharge, and their consequences should be recorded.

Benchmarking with Spine Tango: potentials and pitfalls

The newly released online statistics function of Spine Tango allows comparison of own data against the aggregated results of the data pool that all other participants generate. This comparison can be considered a very simple way of benchmarking, which means that the quality of what one organization does is compared with other similar organizations. The goal is to make changes towards better practice if benchmarking shows inferior results compared with the pool. There are, however, pitfalls in this simplified way of comparing data that can result in confounding. This means that important influential factors can make results appear better or worse than they are in reality and these factors can only be identified and neutralized in a multiple regression analysis performed by a statistical expert. Comparing input variables, confounding is less of a problem than comparing outcome variables. Therefore, the potentials and limitations of automated online comparisons need to be considered when interpreting the results of the benchmarking procedure.

Patient outcomes after laminotomy, hemilaminectomy, laminectomy and laminectomy with instrumented fusion for spinal canal stenosis: a propensity score-based study from the Spine Tango registry.

PURPOSE To compare patient outcomes and complication rates after different decompression techniques or instrumented fusion (IF) in lumbar spinal stenosis (LSS). METHODS The multicentre study was based on Spine Tango data. Inclusion criteria were LSS with a posterior decompression and pre- and postoperative COMI assessment between 3 and 24 months. 1,176 cases were assigned to four groups: (1) laminotomy (n = 642), (2) hemilaminectomy (n = 196), (3) laminectomy (n = 230) and (4) laminectomy combined with an IF (n = 108). Clinical outcomes were achievement of minimum relevant change in COMI back and leg pain and COMI score (2.2 points), surgical and general complications, measures taken due to complications, and reintervention on the index level based on patient information. The inverse propensity score weighting method was used for adjustment. RESULTS Laminotomy, hemilaminectomy and laminectomy were significantly less beneficial than laminectomy in combination with IF regarding leg pain (ORs with 95% CI 0.52, 0.34-0.81; 0.25, 0.15-0.41; 0.44, 0.27-0.72, respectively) and COMI score improvement (ORs with 95% CI 0.51, 0.33-0.81; 0.30, 0.18-0.51; 0.48, 0.29-0.79, respectively). However, the sole decompressions caused significantly fewer surgical (ORs with 95% CI 0.42, 0.26-0.69; 0.33, 0.17-0.63; 0.39, 0.21-0.71, respectively) and general complications (ORs with 95% CI 0.11, 0.04-0.29; 0.03, 0.003-0.41; 0.25, 0.09-0.71, respectively) than laminectomy in combination with IF. Accordingly, the likelihood of required measures was also significantly lower after laminotomy (OR 0.28, 95% CI 0.17-0.46), hemilaminectomy (OR 0.28, 95% CI 0.15-0.53) and after laminectomy (OR 0.39, 95% CI 0.22-0.68) in comparison with laminectomy with IF. The likelihood of a reintervention was not significantly different between the treatment groups. DISCUSSION As already demonstrated in the literature, decompression in patients with LSS is a very effective treatment. Despite better patient outcomes after laminectomy in combination with IF, caution is advised due to higher rates of surgical and general complications and consequent required measures. Based on the current study, laminotomy or laminectomy, rather than hemilaminectomy, is recommendable for minimum relevant pain relief.

Total disc arthroplasty versus anterior cervical interbody fusion: use of the Spine Tango registry to supplement the evidence from randomized control trials.

BACKGROUND CONTEXT Several randomized controlled trials (RCTs) have compared patient outcomes of anterior (cervical) interbody fusion (AIF) with those of total disc arthroplasty (TDA). Because RCTs have known limitations with regard to their external validity, the comparative effectiveness of the two therapies in daily practice remains unknown. PURPOSE This study aimed to compare patient-reported outcomes after TDA versus AIF based on data from an international spine registry. STUDY DESIGN AND SETTING A retrospective analysis of registry data was carried out. PATIENT SAMPLE Inclusion criteria were degenerative disc or disc herniation of the cervical spine treated by single-level TDA or AIF, no previous surgery, and a Core Outcome Measures Index (COMI) completed at baseline and at least 3 months' follow-up. Overall, 987 patients were identified. OUTCOME MEASURES Neck and arm pain relief and COMI score improvement were the outcome measures. METHODS Three separate analyses were performed to compare TDA and AIF surgical outcomes: (1) mimicking an RCT setting, with admission criteria typical of those in published RCTs, a 1:1 matched analysis was carried out in 739 patients; (2) an analysis was performed on 248 patients outside the classic RCT spectrum, that is, with one or more typical RCT exclusion criteria; (3) a subgroup analysis of all patients with additional follow-up longer than 2 years (n=149). RESULTS Matching resulted in 190 pairs with an average follow-up of 17 months that had no residual significant differences for any patient characteristics. Small but statistically significant differences in outcome were observed in favor of TDA, which are potentially clinically relevant. Subgroup analyses of atypical patients and of patients with longer-term follow-up showed no significant differences in outcome between the treatments. CONCLUSIONS The results of this observational study were in accordance with those of the published RCTs, suggesting substantial pain reduction both after AIF and TDA, with slightly greater benefit after arthroplasty. The analysis of atypical patients suggested that, in patients outside the spectrum of clinical trials, both surgical interventions appeared to work to a similar extent to that shown for the cohort in the matched study. Also, in the longer-term perspective, both therapies resulted in similar benefits to the patients.