Clinical outcomes and safety assessment in elderly patients undergoing decompressive laminectomy for lumbar spinal stenosis: a prospective study

<p>Abstract</p> <p>Background</p> <p>To assess safety, risk factors and clinical outcomes in elderly patients with spinal stenosis after decompressive laminectomy.</p> <p>Methods</p> <p>A prospective cohort of patients 70 years and older with spinal stenosis undergoing conventional laminectomy without fusion (n = 101) were consecutively enrolled from regular clinical practice and reassessed at 3 and 12 months. Primary outcome was change in health related quality of life measured (HRQL) with EuroQol-5 D (EQ-5D). Secondary outcomes were safety assessment, changes in Oswestry disability index (ODI), Visual Analogue Scale (EQ-VAS) score for self reported health, VAS score for leg and back pain and patient satisfaction. We used regression analyses to evaluate risk factors for less improvement.</p> <p>Results</p> <p>The mean EQ-5 D total score were 0.32, 0.63 and 0.60 at baseline, 3 months and 12 months respectively, and represents a statistically significant (P < 0.001) improvement. Effect size was > 0.8. Mean ODI score at baseline was 44.2, at 3 months 25.6 and at 27.9. This represents an improvement for all post-operative scores. A total of 18 (18.0%) complications were registered with 6 (6.0%) classified as major, including one perioperative death. Patients stating that the surgery had been beneficial at 3 months was 82 (89.1%) and at 12 months 73 (86.9%). The only predictor found was patients with longer duration of leg pain had less improvement in ODI (P < 0.001). Increased age or having complications did not predict a worse outcome in any of the outcome variables.</p> <p>Conclusions</p> <p>Properly selected patients of 70 years and older can expect a clinical meaningful improvement of HRQL, functional status and pain after open laminectomy without fusion. The treatment seems to be safe. However, patients with longstanding leg-pain prior to operation are less likely to improve one year after surgery.</p

Clinical outcomes after surgery for cervical radiculopathy performed in public and private hospitals : a nationwide relative effectiveness study

Aims - The number of patients undergoing surgery for degenerative cervical radiculopathy has increased. In many countries, public hospitals have limited capacity. This has resulted in long waiting times for elective treatment and a need for supplementary private healthcare. It is uncertain whether the management of patients and the outcome of treatment are equivalent in public and private hospitals. The aim of this study was to compare the management and patient-reported outcomes among patients who underwent surgery for degenerative cervical radiculopathy in public and private hospitals in Norway, and to assess whether the effectiveness of the treatment was equivalent. Methods - This was a comparative study using prospectively collected data from the Norwegian Registry for Spine Surgery. A total of 4,750 consecutive patients who underwent surgery for degenerative cervical radiculopathy and were followed for 12 months were included. Case-mix adjustment between those managed in public and private hospitals was performed using propensity score matching. The primary outcome measure was the change in the Neck Disability Index (NDI) between baseline and 12 months postoperatively. A mean difference in improvement of the NDI score between public and private hospitals of ≤ 15 points was considered equivalent. Secondary outcome measures were a numerical rating scale for neck and arm pain and the EuroQol five-dimension three-level health questionnaire. The duration of surgery, length of hospital stay, and complications were also recorded. Results - The mean improvement from baseline to 12 months postoperatively of patients who underwent surgery in public and private hospitals was equivalent, both in the unmatched cohort (mean NDI difference between groups 3.9 points (95% confidence interval (CI) 2.2 to 5.6); p Conclusion - The clinical effectiveness of surgery for degenerative cervical radiculopathy performed in public and private hospitals was equivalent 12 months after surgery

Prospects of returning to work after lumbar spine surgery for patients considering disability pension: A nationwide study based on data from the Norwegian Registry for Spine Surgery

Objectives To assess the odds for not returning to work (non-RTW) 1 year after treatment among patients who had applied for or were planning to apply for disability pension (DP-applicant) prior to an operation for degenerative disorders of the lumbar spine. Methods This population-based cohort study from the Norwegian Registry for Spine surgery included 26 688 cases operated for degenerative disorders of the lumbar spine from 2009 to 2020. The primary outcome was RTW (yes/no). Secondary patient-reported outcome measures (PROMs) were the Oswestry Disability Index, Numeric Rating Scales for back and leg pain, EuroQoL five-dimension and the Global Perceived Effect Scale. Logistic regression analysis was used to investigate associations between being a DP-applicant prior to surgery (exposure), possible confounders (modifiers) at baseline and RTW 12 months after surgery (outcome). Results The RTW ratio for DP-applicants was 23.1% (having applied: 26.5%, planning to apply 21.1%), compared with 78.6% among non-applicants. All secondary PROMs were more favourable among nonapplicants. After adjusting for all significant confounders (low expectations and pessimism related to working capability, not feeling wanted by the employer and physically demanding work), DP-applicants with under 12 months preoperative sick leave had 3.8 (95% CI 1.8 to 8.0) higher odds than non-applicants for non-RTW 12 months after surgery. The subgroup having applied for disability pension had the strongest impact on this association. Conclusion Less than a quarter of the DP-applicants returned to work 12 months after surgery. This association remained strong, also when adjusted for the confounders as well as other covariates related RTW

A nationwide study of patients operated for cervical degenerative disorders in public and private hospitals

During the last decades, there has been an increase in the rate of surgery for degenerative disorders of the cervical spine and in the use of supplementary private health insurance. Still, there is limited knowledge about the diferences in characteristics of patients operated in public and private hospitals. Therefore, we aimed at comparing sociodemographic-, clinical- and patient management data on patients operated for degenerative cervical radiculopathy and degenerative cervical myelopathy in public and private hospitals in Norway. This was a cross-sectional study on patients in the Norwegian Registry for Spine Surgery operated for degenerative cervical radiculopathy and degenerative cervical myelopathy between January 2012 and December 2020. At admission for surgery, we assessed disability by the following patient reported outcome measures (PROMs): neck disability index (NDI), EuroQol-5D (EQ-5D) and numerical rating scales for neck pain (NRS-NP) and arm pain (NRS-AP). Among 9161 patients, 7344 (80.2%) procedures were performed in public hospitals and 1817 (19.8%) in private hospitals. Mean age was 52.1 years in public hospitals and 49.7 years in private hospitals (P< 0.001). More women were operated in public hospitals (47.9%) than in private hospitals (31.6%) (P< 0.001). A larger proportion of patients in private hospitals had high education (≥4 years of college or university) (42.9% vs 35.6%, P< 0.001). Patients in public hospitals had worse disease-specifc health problems than those in private hospitals: unadjusted NDI mean diference was 5.2 (95% CI 4.4 – 6.0; P< 0.001) and adjusted NDI mean diference was 3.4 (95% CI 2.5 – 4.2; P< 0.001), and they also had longer duration of symptoms (P< 0.001). Duration of surgery (mean diference 29 minutes, 95% CI 27.1 – 30.7; P< 0.001) and length of hospital stay (mean diference 2 days, 95% CI 2.3 – 2.4; P< 0.001) were longer in public hospitals. In conclusion, patients operated for degenerative cervical spine in private hospitals were healthier, younger, better educated and more often men. They also had less and shorter duration of symptoms and seemed to be managed more efciently. Our fndings indicate that access to cervical spine surgery in private hospitals could be skewed in favour of patients with higher socioeconomic status

Comparison of the SF6D, the EQ5D, and the oswestry disability index in patients with chronic low back pain and degenerative disc disease

Background The need for cost effectiveness analyses in randomized controlled trials that compare treatment options is increasing. The selection of the optimal utility measure is important, and a central question is whether the two most commonly used indexes - the EuroQuol 5D (EQ5D) and the Short Form 6D (SF6D) – can be used interchangeably. The aim of the present study was to compare change scores of the EQ5D and SF6D utility indexes in terms of some important measurement properties. The psychometric properties of the two utility indexes were compared to a disease-specific instrument, the Oswestry Disability Index (ODI), in the setting of a randomized controlled trial for degenerative disc disease. Methods In a randomized controlled multicentre trial, 172 patients who had experienced low back pain for an average of 6 years were randomized to either treatment with an intensive back rehabilitation program or surgery to insert disc prostheses. Patients filled out the ODI, EQ5D, and SF-36 at baseline and two-year follow up. The utility indexes was compared with respect to measurement error, structural validity, criterion validity, responsiveness, and interpretability according to the COSMIN taxonomy. Results At follow up, 113 patients had change score values for all three instruments. The SF6D had better similarity with the disease-specific instrument (ODI) regarding sensitivity, specificity, and responsiveness. Measurement error was lower for the SF6D (0.056) compared to the EQ5D (0.155). The minimal important change score value was 0.031 for SF6D and 0.173 for EQ5D. The minimal detectable change score value at a 95% confidence level were 0.157 for SF6D and 0.429 for EQ5D, and the difference in mean change score values (SD) between them was 0.23 (0.29) and so exceeded the clinical significant change score value for both instruments. Analysis of psychometric properties indicated that the indexes are unidimensional when considered separately, but that they do not exactly measure the same underlying construct. Conclusions This study indicates that the difference in important measurement properties between EQ5D and SF6D is too large to consider them interchangeable. Since the similarity with the “gold standard” (the disease-specific instrument) was quite different, this could indicate that the choice of index should be determined by the diagnosis

Non-respondents do not bias outcome assessment after cervical spine surgery: a multicenter observational study from the Norwegian registry for spine surgery (NORspine)

Background - The Norwegian registry for spine surgery (NORspine) is a national clinical quality registry which has recorded more than 10,000 operations for degenerative conditions of the cervical spine since 2012. Registries are large observational cohorts, at risk for attrition bias. We therefore aimed to examine whether clinical outcomes differed between respondents and non-respondents to standardized questionnaire-based 12-month follow-up. Methods - All eight public and private providers of cervical spine surgery in Norway report to NORspine. We included 334 consecutive patients who were registered with surgical treatment of degenerative conditions in the cervical spine in 2018 and did a retrospective analysis of prospectively collected register data and data on non-respondents’ outcomes collected by telephone interviews. The primary outcome measure was patient-reported change in arm pain assessed with the numeric rating scale (NRS). Secondary outcome measures were change in neck pain assessed with the NRS, change in health-related quality of life assessed with EuroQol 5 Dimensions (EQ-5D), and patients’ perceived benefit of the operation assessed by the Global Perceived Effect (GPE) scale. Results - At baseline, there were few and small differences between the 238 (71.3%) respondents and the 96 (28.7%) non-respondents. We reached 76 (79.2%) non-respondents by telephone, and 63 (65.6%) consented to an interview. There was no statistically significant difference between groups in change in NRS score for arm pain (3.26 (95% CI 2.84 to 3.69) points for respondents and 2.77 (1.92 to 3.63) points for telephone interviewees) or any of the secondary outcome measures. Conclusions - The results indicate that patients lost to follow-up were missing at random. Analyses of outcomes based on data from respondents can be considered representative for the complete register cohort, if patient characteristics associated with attrition are controlled for

Effect of caudal epidural steroid or saline injection in chronic lumbar radiculopathy: multicentre, blinded, randomised controlled trial

Objective To assess the efficacy of caudal epidural steroid or saline injection in chronic lumbar radiculopathy in the short (6 weeks), intermediate (12 weeks), and long term (52 weeks). Design Multicentre, blinded, randomised controlled trial. Setting Outpatient multidisciplinary back clinics of five Norwegian hospitals. Participants Between October 2005 and February 2009, 461 patients assessed for inclusion (presenting with lumbar radiculopathy >12 weeks). 328 patients excluded for cauda equina syndrome, severe paresis, severe pain, previous spinal injection or surgery, deformity, pregnancy, ongoing breast feeding, warfarin therapy, ongoing treatment with non-steroidal anti-inflammatory drugs, body mass index >30, poorly controlled psychiatric conditions with possible secondary gain, and severe comorbidity. Interventions Subcutaneous sham injections of 2 mL 0.9% saline, caudal epidural injections of 30 mL 0.9% saline, and caudal epidural injections of 40 mg triamcinolone acetonide in 29 mL 0.9% saline. Participants received two injections with a two week interval. Main outcome measures Primary: Oswestry disability index scores. Secondary: European quality of life measure, visual analogue scale scores for low back pain and for leg pain. Results Power calculations required the inclusion of 41 patients per group. We did not allocate 17 of 133 eligible patients because their symptoms improved before randomisation. All groups improved after the interventions, but we found no statistical or clinical differences between the groups over time. For the sham group (n=40), estimated change in the Oswestry disability index from the adjusted baseline value was −4.7 (95% confidence intervals −0.6 to −8.8) at 6 weeks, −11.4 (−6.3 to −14.5) at 12 weeks, and −14.3 (−10.0 to −18.7) at 52 weeks. For the epidural saline intervention group (n=39) compared with the sham group, differences in primary outcome were −0.5 (−6.3 to 5.4) at 6 weeks, 1.4 (−4.5 to 7.2) at 12 weeks, and −1.9 (−8.0 to 4.3) at 52 weeks; for the epidural steroid group (n=37), corresponding differences were −2.9 (−8.7 to 3.0), 4.0 (−1.9 to 9.9), and 1.9 (−4.2 to 8.0). Analysis adjusted for duration of leg pain, back pain, and sick leave did not change this trend. Conclusions Caudal epidural steroid or saline injections are not recommended for chronic lumbar radiculopathy

The Risk of Getting Worse: Predictors of Deterioration After Decompressive Surgery for Lumbar Spinal Stenosis: A Multicenter Observational Study

ObjectiveTo investigate the frequency and predictors of deterioration after decompressive surgery for single and 2-level lumbar spinal stenosis.MethodsProspectively collected data were retrieved from the Norwegian Registry for Spine Surgery. Clinically significant deterioration was defined as an 8-point increase in Oswestry disability index (ODI) between baseline and 12 months' follow-up.ResultsThere were 2181 patients enrolled in the study. Of 1735 patients with complete 12 months follow-up, 151 (8.7%) patients reported deterioration. The following variables were significantly associated with deterioration at 12 months' follow-up; decreasing age (odds ratio [OR] 1.02, 95% confidence interval [95% CI] 1.00–1.04, P = 0.046), tobacco smoking (OR 2.10, 95% CI 1.42–3.22, P = 0.000), American Society of Anesthesiologists grade ≥3 (OR 1.80, 95% CI 1.07–2.94, P = 0.025), decreasing preoperative ODI (OR 1.05, 95% CI 1.02–1.07, P = 0.000), previous surgery at the same level (OR 2.00, 95% CI 1.18–3.27, P = 0.009), and previous surgery at other lumbar levels (OR 2.10, 95% CI 1.19–3.53, P = 0.009).ConclusionsOverall risk of clinically significant deterioration in patient-reported pain and disability after decompressive surgery for lumbar spinal stenosis is approximately 9%. Predictors for deterioration are decreasing age, current tobacco smoking, American Society of Anesthesiologists grade ≥3, decreasing preoperative ODI, and previous surgery at same or different lumbar level. We suggest that these predictors should be emphasized and discussed with the patients before surgery