In Brief Study Design. A cohort study based on the Swedish Spine Register. Objective. To determine the association between body mass index (BMI) and outcome of lumbar spine surgery for spinal stenosis. Summary of Background Data. Several small studies have sought to evaluate the importance of obesity in relation to results after surgery for lumbar spinal stenosis (LSS), but the findings are inconsistent and relatively weak. Methods. All patients who underwent surgery for LSS from January 1, 2006, to June 30, 2008, with a completed 2-year follow-up in the Swedish Spine Register were included. Logistic regression was used to assess the association between BMI and different outcomes. Results. Of the 2633 patients enrolled, 819 (31%) had normal weight, 1208 (46%) were overweight, and 606 (23%) were obese. On average, all 3 BMI groups achieved significant improvements after surgery. A higher BMI, however, was associated with greater odds of dissatisfaction after surgery and inferior results at the 2-year follow-up. After adjusting for differences in baseline characteristics, the obese group demonstrated inferior function and quality of life as measured by the Oswestry Disability Index (ODI) and the EuroQol Group Index (EQ-5D), respectively. At the 2-year follow-up, obese patients had a mean ODI of 33 (95% confidence interval [CI], 31–34) and mean EQ-5D of 0.56 (95% CI, 0.54–0.59) compared with a mean ODI of 25 (95% CI, 24–26) and mean EQ-5D of 0.64 (95% CI, 0.62–0.66) in the normal weight group. When compared with the normal weight patients, the adjusted odds ratio for dissatisfaction was 1.73 in the obese group (95% CI, 1.36–2.19). Differences between the normal weight and overweight groups were modest and therefore could not be considered clinically relevant. Conclusion. Obese patients achieved significant pain reduction, better walking ability, and improved quality of life after surgical treatment of LSS. Nevertheless, obesity was associated with a higher degree of dissatisfaction and poorer outcomes after surgery for LSS. The Swedish Spine Register was used to study the association between body mass index and 2-year follow-up results of surgery for lumbar spinal stenosis. The Oswestry Disability Index and the EuroQol Group Index (EQ-5D) indicated lower quality of life both at baseline and at the follow-up for obese patients. The obese patients were less satisfied with surgery than normal weight patients.
A prospective cohort study that used a Swedish nationwide occupational surveillance program for construction workers (period of registration from 1971 to 1992). In all, 364,467 participants (mean age at baseline 34 yr) were included in the study.To determine whether overweight and obesity are associated with a higher risk of lumbar spinal stenosis (LSS).During recent decades, LSS has become the most common indication for spine surgery, a change that coincides with a higher prevalence of obesity.A diagnosis of LSS was collected through individual linkage to the Swedish National Patient Register through December 31, 2011. Poisson regression models were employed to estimate multivariable-adjusted incidence rate ratios (IRRs) for LSS.At baseline, 65% had normal weight (BMI [body mass index]: 18.5-24.99 kg/m), 29% were overweight (BMI: 25-29.99 kg/m), 5% were obese (BMI ≥30 kg/m), and 2% were underweight (BMI <18.5 kg/m). During 11,190,944 person-years of follow-up, with a mean of 31 years, 2381 participants were diagnosed with LSS. Compared with normal weight individuals, obese workers had an IRR of 2.18 (95% confidence interval, 1.87-2.53) for LSS and overweight workers had an IRR of 1.68 (95% confidence interval, 1.54-1.83). Workers who were underweight halved their risk of LSS (IRR: 0.52, 95% confidence interval, 0.30-0.90).Obese and overweight persons are at a higher risk of developing LSS. Furthermore, our results indicate that obesity might be a novel explanation for the increased number of patients with clinical LSS.3.
Background and purpose Instrumented and non-instrumented methods of fusion have been compared in several studies, but the results are often inconsistent and conflicting. We compared the 2-year results of 3 methods of lumbar fusion when used in degenerative disc disease (DDD), using the Swedish Spine Register (SWESPINE).Methods All patients registered in SWESPINE for surgical treatment of DDD between January 1, 2000 and October 1, 2007 were eligible for the study. Patients who had completed the 2-year follow-up were included in the analysis. The outcomes of 3 methods of surgical fusion were assessed.Results Of 1,310 patients enrolled, 115 had undergone uninstrumented fusion, 620 instrumented posterolateral fusion, and 575 instrumented interbody fusion. Irrespective of the surgical procedure, quality of life (QoL) improved and back pain diminished. Change in QoL and functional disability and return to work was similar in the 3 groups. Patients who had undergone uninstrumented fusion had more back pain than the patients with instrumented interbody fusion at the 2-year follow-up (p = 0.02), although the difference was only 7 visual analog scale (VAS) units (95% CI: 1–13) on a 100-point scale. Moreover, 83% of the patients with uninstrumented fusion used analgesics at the end of follow-up as compared to 68% of the patients who had undergone surgery with one of the 2 instrumented fusion techniques.Interpretation In comparison with instrumented interbody fusion, uninstrumented fusion was associated with higher levels of back pain 2 years after surgery. We found no evidence for differences in QoL between uninstrumented fusion and instrumented interbody fusion.
This was a randomized radiologic biomechanical pilot study in vivo.The objectives of this study was to evaluate if 3-dimensional computed tomography is a feasible tool in motion analyses of the lumbar spine and to study if preservation of segmental midline structures offers less postoperative instability compared with central decompression in patients with lumbar spinal stenosis with degenerative spondylolisthesis.The role of segmental instability after decompression is controversial. Validated techniques for biomechanical evaluation of segmental motion in human live subjects are lacking.In total, 23 patients (mean age, 68 y) with typical symptoms and magnetic resonance imaging findings of spinal stenosis with degenerative spondylolisthesis (>3 mm) in 1 or 2 adjacent lumbar levels from L3 to L5 were included. They were randomized to either laminectomy (LE) or bilateral laminotomy (LT) (preservation of the midline structures). Documentation of segmental motion was made preoperatively and 6 months postoperatively with CT in provoked flexion and extension. Analyses of movements were performed with validated software. The accuracy for this method is 0.6 mm in translation and 1 degree in rotation. Patient-reported outcome measures were collected from the Swespine register preoperatively and 2-year postoperatively.The mean preoperative values for 3D rotation and translation were 6.2 degrees and 1.8 mm. The mean increase in 3D rotation 6 months after surgery was 0.25 degrees after LT and 0.7 degrees after LE (P=0.79) while the mean increase in 3D translation was 0.15 mm after LT and 1.1 mm after LE (P=0.42). Both surgeries demonstrated significant improvement in patient-reported outcome measures 2 years postoperatively.The 3D computed tomography technique proved to be a feasible tool in the evaluation of segmental motion in this group of older patients. There was negligible increase in segmental motion after decompressive surgery. LE with removal of the midline structures did not create a greater instability compared with when these structures were preserved.
Lumbar disc herniation (LDH) is a common indication for lumbar spine surgery. The proportion of patients having a second surgery within 2 years varies in the literature between 0.5% and 24%, with recurrent herniation being the most common cause. Several studies have not found any relevant outcome differences between patients undergoing surgery for primary LDH and patients undergoing reoperation for a recurrent LDH, but these studies have limitations, including small sample size and retrospective design.We (1) compared patient-reported outcomes between patients operated on for primary LDH and patients reoperated on for recurrent LDH within 1 year after index surgery and (2) determined risk factors for worse outcomes.We obtained data from the Swedish National Spine Register, Swespine, where patient-reported outcomes are collected using mailed protocols at 1, 2, 5, and 10 years after surgery. Of the 13,562 patients identified who underwent LDH between January 2000 and May 2011, 13,305 (98%) underwent primary surgery for LDH and 257 (2%) underwent reoperation for a recurrent LDH within the first year. Patient-reported outcomes at 1 to 2 years were available for 8497 patients (63%), 8350 of 13,305 (63%) in the primary LDH group and 147 of 257 (57%) in the recurrent LDH group (p = 0.068). We compared leg and back pain (VAS: 0-100), function (Oswestry Disability Index [ODI]: 0-100), quality of life (EQ-5D: -0.59 to 1.0), patient satisfaction, and global assessment of leg pain between groups. We also analyzed rsik factors for worse global assessment and satisfaction.Mean (95% CI) differences in improvement between groups favoring patients with primary LDH were VAS leg pain 9 (4-14), ODI 6 (3-9), and EQ-5D 0.09 (0.04-0.15). While statistically significant, these effect sizes may be lower than the minimal clinically important differences often referred to. Percentage of satisfied patients was 79% and 58% in the primary and recurrent LDH groups, respectively (p < 0.001), and percentage of patients with no or better leg pain (global assessment) was 74% and 65%, respectively (p = 0.008). Reoperation for recurrent LDH represented the largest independent risk for dissatisfaction; this factor and smoking represented similar risks for less improvement in leg pain.Repeat surgery for a recurrent LDH was performed with good probability for improvement, although not as good as for primary LDH surgery, and patients undergoing repeated surgery were less satisfied. Studies on risk factors for recurrence are warranted.Level II, therapeutic study. See Instructions for Authors for a complete description of levels of evidence.
Pedicle screw loosening is a major safety concern in instrumented spinal surgery due to loosening with potential pseudarthrosis and possible loss of correction requiring revision surgery. Several cadaver studies have compared insertion torque of pedicle screws with resistance to pullout or cyclic loading. In most of these studies, a correlation has been found between these variables. Clinical studies have been made, comparing insertion torque to bone mineral density or radiological signs of screw loosening. There are no clinical studies comparing insertion torque to extraction torque or other biomechanical parameters in vivo. This study was designed to investigate whether the insertion torque of pedicle screws can be used to predict the purchase of the screws.The insertion torque of stainless steel pedicle screws was recorded in eight patients undergoing lumbar fusion surgery with four-screw constructs. Torque gauge manometers were used for the recordings. The implants were removed after one year, and the extraction torque of the screws was recorded.The mean insertion torque was 76 ± 41 Ncm and the mean extraction torque 29 ± 36 Ncm. The r value was 0.591, suggesting that there was a correlation between the insertion and extraction torque. However, the scattergram revealed that the screws could be divided into two groups, six screws with a high correlation between insertion and extraction torque, and 26 screws where no correlation could be demonstrated.In this unique human in-vivo study, the insertion torque could not be used to predict the purchase of lumbar pedicle screws one year after implantation. It could be demonstrated that in vivo insertion torque alone is of minor value to estimate pullout strength, and should be combined with or replaced by more accurate measures.
Loosening of implants is a frequent complication in orthopaedic surgery. The aim of this thesis was to evaluate hydroxyapatite coating of pedicle screws with mechanical and histological methods and to correlate the results with the radiological findings.Hydroxyapatite (HA) coating of pedicle screws was investigated in experimental studies in sheep. Nine sheep were operated on with destabilising laminectomies at L2-L3 and L4-L5 and stabilised with pedicle screw instrumentations, where HA coated and uncoated screws were used in a randomised fashion. After both 6 and 12 weeks of implantation, the HA coated screws demonstrated a higher bone-to-implant contact and a higher amount of bone in the area close to the screw. The pull-out resistance, stiffness and total energy to failure was higher for the HA coated screws after 12 weeks of implantation.HA coating of pedicle screws was examined in two clinical studies. In the first series, the patients were stabilised with pedicle screw instrumentations, where HA coated screws were used in either the upper or lower instrumented level in a randomised fashion. After 10-22 months of implantation, the extraction torque was markedly higher for the HA coated screws. In the second series, instrumentations with uncoated, partly HA coated or fully HA coated screws were used. After 11-16 months implantation, the extraction torques were recorded. There were significant differences between all three groups, with the lowest extraction torques for the uncoated screws and the highest torques for the fully HA coated screws. The frequency of radiolucent zones surrounding the screws was higher for the uncoated screws than for the HA coated screws.Radiographs from both experimental and clinical studies were examined. Screws demonstrating radiolucent zones were compared to screws without zones with respect to pull-out resistance, extraction torque, bone-to-implant contact and amount of bone surrounding the screws. All these variables demonstrated higher values for the screws without radiolucent zones. The frequency of radiolucent zones surrounding uncoated screws in the clinical study was 53%.Conclusions: Radiolucent zones are good predictors of screw loosening. The frequency of radiolucent zones is higher than previously described. Hydroxyapatite coating improves the purchase of pedicle screws and reduces the frequency of screw loosening.
The efficacy of fusion surgery in addition to decompression surgery in patients who have lumbar spinal stenosis, with or without degenerative spondylolisthesis, has not been substantiated in controlled trials.We randomly assigned 247 patients between 50 and 80 years of age who had lumbar spinal stenosis at one or two adjacent vertebral levels to undergo either decompression surgery plus fusion surgery (fusion group) or decompression surgery alone (decompression-alone group). Randomization was stratified according to the presence of preoperative degenerative spondylolisthesis (in 135 patients) or its absence. Outcomes were assessed with the use of patient-reported outcome measures, a 6-minute walk test, and a health economic evaluation. The primary outcome was the score on the Oswestry Disability Index (ODI; which ranges from 0 to 100, with higher scores indicating more severe disability) 2 years after surgery. The primary analysis, which was a per-protocol analysis, did not include the 14 patients who did not receive the assigned treatment and the 5 who were lost to follow-up.There was no significant difference between the groups in the mean score on the ODI at 2 years (27 in the fusion group and 24 in the decompression-alone group, P=0.24) or in the results of the 6-minute walk test (397 m in the fusion group and 405 m in the decompression-alone group, P=0.72). Results were similar between patients with and those without spondylolisthesis. Among the patients who had 5 years of follow-up and were eligible for inclusion in the 5-year analysis, there were no significant differences between the groups in clinical outcomes at 5 years. The mean length of hospitalization was 7.4 days in the fusion group and 4.1 days in the decompression-alone group (P<0.001). Operating time was longer, the amount of bleeding was greater, and surgical costs were higher in the fusion group than in the decompression-alone group. During a mean follow-up of 6.5 years, additional lumbar spine surgery was performed in 22% of the patients in the fusion group and in 21% of those in the decompression-alone group.Among patients with lumbar spinal stenosis, with or without degenerative spondylolisthesis, decompression surgery plus fusion surgery did not result in better clinical outcomes at 2 years and 5 years than did decompression surgery alone. (Funded by an Uppsala institutional Avtal om Läkarutbildning och Forskning [Agreement concerning Cooperation on Medical Education and Research] and others; Swedish Spinal Stenosis Study ClinicalTrials.gov number, NCT01994512.).
Aims We compared decompression alone to decompression with fusion surgery for lumbar spinal stenosis, with or without degenerative spondylolisthesis (DS). The aim was to evaluate if five-year outcomes differed between the groups. The two-year results from the same trial revealed no differences. Methods The Swedish Spinal Stenosis Study was a multicentre randomized controlled trial with recruitment from September 2006 to February 2012. A total of 247 patients with one- or two-level central lumbar spinal stenosis, stratified by the presence of DS, were randomized to decompression alone or decompression with fusion. The five-year Oswestry Disability Index (ODI) was the primary outcome. Secondary outcomes were the EuroQol five-dimension questionnaire (EQ-5D), visual analogue scales for back and leg pain, and patient-reported satisfaction, decreased pain, and increased walking distance. The reoperation rate was recorded. Results Five-year follow-up was completed by 213 (95%) of the eligible patients (mean age 67 years; 155 female (67%)). After five years, ODI was similar irrespective of treatment, with a mean of 25 (SD 18) for decompression alone and 28 (SD 22) for decompression with fusion (p = 0.226). Mean EQ-5D was higher for decompression alone than for fusion (0.69 (SD 0.28) vs 0.59 (SD 0.34); p = 0.027). In the no-DS subset, fewer patients reported decreased leg pain after fusion (58%) than with decompression alone (80%) (relative risk (RR) 0.71 (95% confidence interval (CI) 0.53 to 0.97). The frequency of subsequent spinal surgery was 24% for decompression with fusion and 22% for decompression alone (RR 1.1 (95% CI 0.69 to 1.8)). Conclusion Adding fusion to decompression in spinal stenosis surgery, with or without spondylolisthesis, does not improve the five-year ODI, which is consistent with our two-year report. Three secondary outcomes that did not differ at two years favoured decompression alone at five years. Our results support decompression alone as the preferred method for operating on spinal stenosis. Cite this article: Bone Joint J 2024;106-B(7):705–712.
