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1.
Artigo em Inglês | MEDLINE | ID: mdl-38949248

RESUMO

STUDY DESIGN: An observational registry-based study. OBJECTIVE: We investigated the long-term patterns of sick leave among patients undergoing surgery for lumbar disk herniation using two nationwide databases to study the achievement of post-surgery return to work (RTW). SUMMARY OF BACKGROUND DATA: The ability to RTW is increasingly recognized as an essential outcome measure for spine surgery. METHODS: The study included 13,698 patients aged 18 to 60 on sick leave undergoing surgery for lumbar disk herniation from January 2007 through January 2019. Data from the Norwegian Registry for Spine Surgery (NORspine) and the Norwegian Labour and Welfare Administration (NAV) were linked. Certified sick leave around the time of surgery was assessed. The patients were further categorized according to the length of pre-surgery sick leave, and the rate of sustainable RTW for the different groups was compared using survival analysis. The association between successful surgical outcomes, defined by a 30% improvement in Oswestry Disability Index score, and achievement of sustainable RTW was analyzed using a logistic regression model. RESULTS: Two years after surgery, 76% of the patients had returned to work. Shorter pre-surgery sick leave was associated with a higher proportion and rate of achieved sustainable RTW: Among patients with sick leave of less than 30 days, a total of 99% achieved sustainable RTW (median 46 d); only 40% of patients with longer-lasting work assessment allowance achieved the same goal within two years. Successful surgical outcomes were associated with sustainable RTW for all patient groups, but the impact of surgical success on RTW declined as sick leave extended beyond 180 days. CONCLUSION: Most patients had returned to work two years after lumbar disk herniation surgery. Shorter pre-surgery sick leave was associated with achieving faster and more sustainable RTW. Successful surgical outcomes had less impact on patients with extended sick leave. LEVEL OF EVIDENCE: III.

2.
Artigo em Inglês | MEDLINE | ID: mdl-38857371

RESUMO

STUDY DESIGN: Observational cohort study (secondary analysis of two randomized trials). OBJECTIVE: To investigate whether function, disability, pain and quality of life before surgery and patient-reported outcome as well as complication and reoperation rates up to two years after surgery differ between lumbar spinal stenosis patients with and without spondylolisthesis. SUMMARY OF BACKGROUND DATA: Lumbar spinal stenosis is a degenerative condition of the spine, which appears with or without degenerative spondylolisthesis often presenting similar signs and symptoms. METHOD: This study is a secondary analysis of two randomized trials on patients with lumbar spinal stenosis with and without spondylolisthesis conducted at 16 public Norwegian hospitals. Disability, function, back pain, leg pain, quality of life, complication and reoperation rates up to two years after surgery were compared between the two cohorts. RESULTS: A total of 704 patients were included in this study, 267 patients with spondylolisthesis (median age 67.0 years [IQR 61.0-72.0]; 68.7% female) and 437 patients without spondylolisthesis (median age 68.0 years IQR 62.0-73.0]; 52.9% female). In the linear mixed model analysis there were no significant differences in disability, function, back pain, leg pain and quality of life scores between the two cohorts of patient with and without spondylolisthesis before surgery or at two years follow-up. The complication rate was 22.9% in patients with spondylolisthesis and 12.1% in patients without spondylolisthesis (P<0.001). There were no significant differences in reoperation rates. CONCLUSION: In patients with lumbar spinal stenosis the symptom burden before surgery and the clinical outcome up to two years after surgery were similar independently of a concomitant spondylolisthesis.

3.
Plast Reconstr Surg Glob Open ; 12(5): e5837, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38798940

RESUMO

Acute cervical osteomyelitis due to an epidural abscess and pyogenic spondylodiscitis in an immunosuppressed patient with progressive myelopathy is a challenge for the reconstructive surgeon. This report presents our novel approach to treat such a condition in a 56-year-old patient in whom antibiotic treatment and decompression of the medulla by laminectomy of C4-C6 failed. Under general anesthesia, debridement of all infected tissue, including anterior corpectomy of C4-C6, was performed. Simultaneously, a free vascularized fibula graft (FVFG) was harvested, adapted to the bone defect, and anastomosed to the superior thyroid artery and external jugular vein. The graft was stabilized with an anterior plate. A scheduled posterior stabilization was performed 1 week later. Staphylococcus aureus was cultured from bone samples and was treated with antibiotics. The postoperative course was uncomplicated besides a dorsal midline defect 6 weeks postoperatively that was closed with a sensate midline-based perforator flap. Five years on, the patient is infection free, and regular control computed tomography and magnetic resonance imaging scan images show progressive fusion and hypertrophy of the fibula to C3/C7 vertebrae. An FVFG combined with posterior stabilization could be a promising primary salvage procedure in cases with progressive myelopathy caused by acute cervical osteomyelitis due to spinal infection. The FVFG contributes to blood circulation, delivery of antibiotics, and an immunological response to the infected wound bed and can stimulate rapid fusion and hypertrophy over time.

7.
Neurosurgery ; 2024 Feb 07.
Artigo em Inglês | MEDLINE | ID: mdl-38323820

RESUMO

BACKGROUND AND OBJECTIVES: Functional status, pain, and quality of life usually improve after surgery for degenerative cervical myelopathy (DCM), but a subset of patients report worsening. The objective was to define cutoff values for worsening on the Neck Disability Index (NDI) and identify prognostic factors associated with worsening of pain-related disability 12 months after DCM surgery. METHODS: In this prognostic study based on prospectively collected data from the Norwegian Registry for Spine Surgery, the NDI was the primary outcome. Receiver operating characteristics curve analyses were used to obtain cutoff values, using the global perceived effect scale as an external anchor. Univariable and multivariable analyses were performed using mixed logistic regression to evaluate the relationship between potential prognostic factors and the NDI. RESULTS: Among the 1508 patients undergoing surgery for myelopathy, 1248 (82.7%) were followed for either 3 or 12 months. Of these, 317 (25.4%) were classified to belong to the worsening group according to the mean NDI percentage change cutoff of 3.3. Multivariable analyses showed that smoking (odds ratio [OR] 3.4: 95% CI 1.2-9.5: P < .001), low educational level (OR 2.5: 95% CI 1.0-6.5: P < .001), and American Society of Anesthesiologists grade >II (OR 2.2: 95% CI 0.7-5.6: P = .004) were associated with worsening. Patients with more severe neck pain (OR 0.8: 95% CI 0.7-1.0: P = .003) and arm pain (OR 0.8: 95% CI 0.7-1.0; P = .007) at baseline were less likely to report worsening. CONCLUSION: We defined a cutoff value of 3.3 for worsening after DCM surgery using the mean NDI percentage change. The independent prognostic factors associated with worsening of pain-related disability were smoking, low educational level, and American Society of Anesthesiologists grade >II. Patients with more severe neck and arm pain at baseline were less likely to report worsening at 12 months.

8.
JAMA Netw Open ; 7(2): e2355024, 2024 Feb 05.
Artigo em Inglês | MEDLINE | ID: mdl-38324310

RESUMO

Importance: Lumber disc herniation surgery can reduce pain and disability. However, a sizable minority of individuals experience minimal benefit, necessitating the development of accurate prediction models. Objective: To develop and validate prediction models for disability and pain 12 months after lumbar disc herniation surgery. Design, Setting, and Participants: A prospective, multicenter, registry-based prognostic study was conducted on a cohort of individuals undergoing lumbar disc herniation surgery from January 1, 2007, to May 31, 2021. Patients in the Norwegian Registry for Spine Surgery from all public and private hospitals in Norway performing spine surgery were included. Data analysis was performed from January to June 2023. Exposures: Microdiscectomy or open discectomy. Main Outcomes and Measures: Treatment success at 12 months, defined as improvement in Oswestry Disability Index (ODI) of 22 points or more; Numeric Rating Scale (NRS) back pain improvement of 2 or more points, and NRS leg pain improvement of 4 or more points. Machine learning models were trained for model development and internal-external cross-validation applied over geographic regions to validate the models. Model performance was assessed through discrimination (C statistic) and calibration (slope and intercept). Results: Analysis included 22 707 surgical cases (21 161 patients) (ODI model) (mean [SD] age, 47.0 [14.0] years; 12 952 [57.0%] males). Treatment nonsuccess was experienced by 33% (ODI), 27% (NRS back pain), and 31% (NRS leg pain) of the patients. In internal-external cross-validation, the selected machine learning models showed consistent discrimination and calibration across all 5 regions. The C statistic ranged from 0.81 to 0.84 (pooled random-effects meta-analysis estimate, 0.82; 95% CI, 0.81-0.84) for the ODI model. Calibration slopes (point estimates, 0.94-1.03; pooled estimate, 0.99; 95% CI, 0.93-1.06) and calibration intercepts (point estimates, -0.05 to 0.11; pooled estimate, 0.01; 95% CI, -0.07 to 0.10) were also consistent across regions. For NRS back pain, the C statistic ranged from 0.75 to 0.80 (pooled estimate, 0.77; 95% CI, 0.75-0.79); for NRS leg pain, the C statistic ranged from 0.74 to 0.77 (pooled estimate, 0.75; 95% CI, 0.74-0.76). Only minor heterogeneity was found in calibration slopes and intercepts. Conclusion: The findings of this study suggest that the models developed can inform patients and clinicians about individual prognosis and aid in surgical decision-making.


Assuntos
Dor nas Costas , Deslocamento do Disco Intervertebral , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Calibragem , Deslocamento do Disco Intervertebral/cirurgia , Aprendizado de Máquina , Nonoxinol , Estudos Prospectivos , Adulto
9.
Spine J ; 24(6): 1015-1021, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38266826

RESUMO

BACKGROUND: Lumbar spinal stenosis (LSS) is characterized by pain that radiates to the buttocks and/or legs, aggravated by walking and relieved by forward flexion. There is poor correlation between clinical symptoms and severity of stenosis on MRI, and multilevel stenosis has not been described to present worse symptoms or treatment outcomes, compared with patients with single-level stenosis. In patients with one level with severe stenosis combined with an adjacent level with moderate stenosis, the surgeon must decide whether to decompress only the narrowest level or both, to achieve the best possible outcome. The potential benefits of performing surgery on an adjacent moderate stenosis is debated, and the scientific evidence in scarce. PURPOSE: The aim of the present study was to investigate whether patients with a level of adjacent moderate stenosis, along with an index stenosis, benefitted from a dual-level decompression (DLD) compared with a single-level decompression (SLD). Furthermore, to investigate whether DLD patients had longer duration of surgery and hospital stay, higher rates of complications and/or lower rate of reoperations compared with SLD patients. STUDY DESIGN: Prospective cohort study. PATIENT SAMPLE: We analyzed data from the Norwegian Degenerative Spondylisthesis and Spinal Stenosis study- Spinal Stenosis Trial (NORDSTEN-SST). In this randomized multicenter study, 437 patients were included, evaluating clinical outcomes of three different surgical treatment options for LSS. Patients with degenerative spondylolisthesis were excluded. METHOD: Based on preoperative MRI, the present analysis included all patients who had a moderate stenosis (defined as Schizas B or C) in addition to a predefined index stenosis (the level with the smallest cross-sectional area). We compared patients who, based on the surgeons` choice, received a dual-level decompression, with those receiving a single-level decompression. OUTCOME MEASURES: The primary outcome was mean change in the Oswestry Disability Index (ODI) score from baseline to 2-year follow up. Secondary outcomes were proportion of success (30% reduction in ODI score), the Numeric Rating Scales for back and leg pain (NRS), the EuroQol 5-dimensional questionnaire utility index (EQ-5D), the Zurich Claudication Questionnaire (ZCQ), the Global Perceived Effect (GPE)-scale, duration of surgery, duration of hospital stay, perioperative complications and reoperation rates. RESULTS: Among the 222 patients, included in the analysis, 108 underwent DLD and 114 underwent SLD. There was no difference in change scores for any of the investigated patient-reported outcomes between the groups after 2 years. However, the DLD group had longer duration of surgery and longer length of hospital stay. There was no difference in reoperation rates or perioperative complications. CONCLUSION: This study, alongside the NORDSTEN-LSS trial on patients with adjacent moderate stenosis as well as an index stenosis, showed no superior clinical effectiveness for dual-level surgery compared with single-level surgery.


Assuntos
Descompressão Cirúrgica , Vértebras Lombares , Estenose Espinal , Humanos , Estenose Espinal/cirurgia , Descompressão Cirúrgica/métodos , Vértebras Lombares/cirurgia , Masculino , Feminino , Idoso , Estudos Prospectivos , Pessoa de Meia-Idade , Resultado do Tratamento
10.
Neurosurgery ; 94(3): 454-460, 2024 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-37823669

RESUMO

BACKGROUND AND OBJECTIVES: Degenerative cervical myelopathy (DCM) is a frequent cause of spinal cord dysfunction, and surgical treatment is considered safe and effective. Long-term results after surgery are limited. This study investigated long-term clinical outcomes through data from the Norwegian registry for spine surgery. METHODS: Patients operated at the university hospitals serving Central and Northern Norway were approached for long-term follow-up after 3 to 8 years. The primary outcome was change in the Neck Disability Index, and the secondary outcomes were changes in the European Myelopathy Scale score, quality of life (EuroQoL EQ-5D); numeric rating scales (NRS) for headache, neck pain, and arm pain; and perceived benefit of surgery assessed by the Global Perceived Effect scale from 1 year to long-term follow-up. RESULTS: We included 144 patients operated between January 2013 and June 2018. In total, 123 participants (85.4%) provided patient-reported outcome measures (PROMs) at long-term follow-up. There was no significant change in PROMs from 1 year to long-term follow-up, including Neck Disability Index (mean 1.0, 95% CI -2.1-4.1, P = .53), European Myelopathy Scale score (mean -0.3, 95% CI -0.7-0.1, P = .09), EQ-5D index score (mean -0.02, 95% CI -0.09-0.05, P = .51), NRS neck pain (mean 0.3 95% CI -0.2-0.9, P = .22), NRS arm pain (mean -0.1, 95% CI -0.8-0.5, P = .70), and NRS headache (mean 0.4, 95% CI -0.1-0.9, P = .11). According to Global Perceived Effect assessments, 106/121 patients (87.6%) reported to be stable or improved ("complete recovery," "much better," "slightly better," or "unchanged") at long-term follow-up compared with 88.1% at 1 year. Dichotomizing the outcome data based on severity of DCM did not demonstrate significant changes either. CONCLUSION: Long-term follow-up of patients undergoing surgery for DCM demonstrates persistence of statistically significant and clinically meaningful improvement across a wide range of PROMs.


Assuntos
Cervicalgia , Doenças da Medula Espinal , Humanos , Qualidade de Vida , Pescoço , Doenças da Medula Espinal/cirurgia , Cefaleia , Resultado do Tratamento , Vértebras Cervicais/cirurgia
11.
Eur Spine J ; 32(11): 3713-3730, 2023 11.
Artigo em Inglês | MEDLINE | ID: mdl-37718341

RESUMO

PURPOSE: To review and describe the development, methods and cohort of the lumbosacral part of the Norwegian registry for spine surgery (NORspine). METHODS: NORspine was established in 2007. It is government funded, covers all providers and captures consecutive cases undergoing operations for degenerative disorders. Patients' participation is voluntary and requires informed consent. A set of baseline-, process- and outcome-variables (3 and 12 months) recommended by the International Consortium for Health Outcome Measurement is reported by surgeons and patients. The main outcome is the Oswestry disability index (ODI) at 12 months. RESULTS: We show satisfactory data quality assessed by completeness, timeliness, accuracy, relevance and comparability. The coverage rate has been 100% since 2016 and the capture rate has increased to 74% in 2021. The cohort consists of 60,647 (47.6% women) cases with mean age 55.7 years, registered during the years 2007 through 2021. The proportions > 70 years and with an American Society of Anaesthesiologists' Physical Classification System (ASA) score > II has increased gradually to 26.1% and 19.3%, respectively. Mean ODI at baseline was 43.0 (standard deviation 17.3). Most cases were operated with decompression for disc herniation (n = 26,557, 43.8%) or spinal stenosis (n = 26,545, 43.8%), and 7417 (12.2%) with additional or primary fusion. The response rate at 12 months follow-up was 71.6%. CONCLUSION: NORspine is a well-designed population-based comprehensive national clinical quality registry. The register's methods ensure appropriate data for quality surveillance and improvement, and research.


Assuntos
Deslocamento do Disco Intervertebral , Estenose Espinal , Humanos , Feminino , Pessoa de Meia-Idade , Masculino , Vértebras Lombares/cirurgia , Estenose Espinal/cirurgia , Deslocamento do Disco Intervertebral/cirurgia , Sistema de Registros , Noruega/epidemiologia
12.
Eur Spine J ; 32(12): 4162-4173, 2023 12.
Artigo em Inglês | MEDLINE | ID: mdl-37395780

RESUMO

PURPOSE: To provide an overview of the The Norwegian Degenerative spondylolisthesis and spinal stenosis (NORDSTEN)-study and the organizational structure, and to evaluate the study population. METHODS: The NORDSTEN is a multicentre study with 10 year follow-up, conducted at 18 public hospitals. NORDSTEN includes three studies: (1) The randomized spinal stenosis trial comparing the impact of three different decompression techniques; (2) the randomized degenerative spondylolisthesis trial investigating whether decompression surgery alone is as good as decompression with instrumented fusion; (3) the observational cohort tracking the natural course of LSS in patients without planned surgical treatment. A range of clinical and radiological data are collected at defined time points. To administer, guide, monitor and assist the surgical units and the researchers involved, the NORDSTEN national project organization was established. Corresponding clinical data from the Norwegian Registry for Spine Surgery (NORspine) were used to assess if the randomized NORDSTEN-population at baseline was representative for LSS patients treated in routine surgical practice. RESULTS: A total of 988 LSS patients with or without spondylolistheses were included from 2014 to 2018. The clinical trials did not find any difference in the efficacy of the surgical methods evaluated. The NORDSTEN patients were similar to those being consecutively operated at the same hospitals and reported to the NORspine during the same time period. CONCLUSION: The NORDSTEN study provides opportunity to investigate clinical course of LSS with or without surgical interventions. The NORDSTEN-study population were similar to LSS patients treated in routine surgical practice, supporting the external validity of previously published results. TRIAL REGISTRATION: ClinicalTrials.gov; NCT02007083 10/12/2013, NCT02051374 31/01/2014 and NCT03562936 20/06/2018.


Assuntos
Fusão Vertebral , Estenose Espinal , Espondilolistese , Humanos , Estenose Espinal/diagnóstico por imagem , Estenose Espinal/epidemiologia , Estenose Espinal/cirurgia , Espondilolistese/diagnóstico por imagem , Espondilolistese/epidemiologia , Espondilolistese/cirurgia , Descompressão Cirúrgica/métodos , Resultado do Tratamento , Vértebras Lombares/diagnóstico por imagem , Vértebras Lombares/cirurgia , Fusão Vertebral/efeitos adversos , Noruega/epidemiologia
13.
Acta Neurochir (Wien) ; 165(8): 2121-2129, 2023 08.
Artigo em Inglês | MEDLINE | ID: mdl-37407851

RESUMO

BACKGROUND: We aim to investigate associations between preoperative radiological findings of lumbar foraminal stenosis with clinical outcomes after posterior microsurgical decompression in patients with predominantly central lumbar spinal stenosis (LSS). METHODS: The study was an additional analysis in the NORDSTEN Spinal Stenosis Trial. In total, 230 men and 207 women (mean age 66.8 (SD 8.3)) were included. All patients underwent an MRI including T1- and T2-weighted sequences. Grade of foraminal stenosis was dichotomized into none to moderate (0-1) and severe (2-3) category using Lee's classification system. The Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ), and numeric rating scale (NRS) for back and leg pain were collected at baseline and at 2-year follow-up. Primary outcome was a reduction of 30% or more on the ODI score. Secondary outcomes included the mean improvement on the ODI, ZCQ, and NRS scores. We performed multivariable regression analyses with the radiological variates foraminal stenosis, Pfirrmann grade, Schizas score, dural sac cross-sectional area, and the possible plausible confounders: patients' gender, age, smoking status, and BMI. RESULTS: The cohort of 437 patients presented a high degree of degenerative changes at baseline. Of 414 patients with adequate imaging of potential foraminal stenosis, 402 were labeled in the none to moderate category and 12 in the severe category. Of the patients with none to moderate foraminal stenosis, 71% achieved at least 30% improvement in ODI. Among the patients with severe foraminal stenosis, 36% achieved at least 30% improvement in ODI. A significant association between severe foraminal stenosis and less chance of reaching the target of 30% improvement in the ODI score after surgery was detected: OR 0.22 (95% CI 0.06, 0.83), p=0.03. When investigating outcome as continuous variables, a similar association between severe foraminal stenosis and less improved ODI with a mean difference of 9.28 points (95%CI 0.47, 18.09; p=0.04) was found. Significant association between severe foraminal stenosis and less improved NRS pain in the lumbar region was also detected with a mean difference of 1.89 (95% CI 0.30, 3.49; p=0.02). No significant association was suggested between severe foraminal stenosis and ZCQ or NRS leg pain. CONCLUSION: In patients operated with posterior microsurgical decompression for LSS, a preoperative severe lumbar foraminal stenosis was associated with higher proportion of patients with less than 30% improvement in ODI. TRIAL REGISTRATION: The study is registered at ClinicalTrials.gov (22.11.2013) under the identifier NCT02007083.


Assuntos
Estenose Espinal , Idoso , Feminino , Humanos , Masculino , Constrição Patológica/cirurgia , Descompressão Cirúrgica/métodos , Vértebras Lombares/diagnóstico por imagem , Vértebras Lombares/cirurgia , Dor/cirurgia , Medição da Dor/métodos , Estenose Espinal/complicações , Estenose Espinal/diagnóstico por imagem , Estenose Espinal/cirurgia , Resultado do Tratamento
14.
Occup Environ Med ; 80(8): 447-454, 2023 08.
Artigo em Inglês | MEDLINE | ID: mdl-37423749

RESUMO

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 non-applicants. 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.


Assuntos
Vértebras Lombares , Região Lombossacral , Humanos , Estudos de Coortes , Vértebras Lombares/cirurgia , Sistema de Registros , Dor , Resultado do Tratamento
15.
Spine J ; 23(11): 1613-1622, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37355044

RESUMO

BACKGROUND CONTEXT: Patients with spinal stenosis and degenerative spondylolisthesis are treated surgically with decompression alone or decompression with fusion. However, there is debate regarding which subgroups of patients may benefit from additional fusion. PURPOSE: To investigate possible treatment effect modifiers and prognostic variables among patients operated for spinal stenosis and degenerative spondylolisthesis. DESIGN: A secondary exploratory study using data from the Norwegian Degenerative Spondylolisthesis and Spinal Stenosis (NORDSTEN-DS) trial. Patients were randomized to decompression alone or decompression with instrumented fusion. PATIENT SAMPLE: The sample in this study consists of 267 patients from a randomized multicenter trial involving 16 hospitals in Norway. Patients were enrolled from February 12, 2014, to December 18, 2017. The study did not include patients with degenerative scoliosis, severe foraminal stenosis, multilevel spondylolisthesis, or previous surgery. OUTCOME MEASURES: The primary outcome was an improvement of ≥ 30% on the Oswestry Disability Index score (ODI) from baseline to 2-year follow-up. METHODS: When investigating possible variables that could modify the treatment effect, we analyzed the treatment arms separately. When testing for prognostic factors we analyzed the whole cohort (both treatment groups). We used univariate and multiple regression analyses. The selection of variables was done a priori, according to the published trial protocol. RESULTS: Of the 267 patients included in the trial (183 female [67%]; mean [SD] age, 66 [7.6] years), complete baseline data for the variables required for the present analysis were available for 205 of the 267 individuals. We did not find any clinical or radiological variables at baseline that modified the treatment effect. Thus, none of the commonly used criteria for selecting patients for fusion surgery influenced the chosen primary outcome in the two treatment arms. For the whole cohort, less comorbidity (American Society of Anesthesiologists Classification [ASA], OR = 4.35; 95% confidence interval (CI [1.16-16.67]) and more preoperative leg pain (OR = 1.23; CI [1.02-1.50]) were significantly associated with an improved primary outcome. CONCLUSIONS: In this study on patients with degenerative spondylolisthesis, neither previously defined instability criteria nor other pre-specified baseline variables were associated with better clinical outcome if fusion surgery was performed. None of the analyzed variables can be applied to guide the decision for fusion surgery in patients with degenerative spondylolisthesis. For both treatment groups, less comorbidity and more leg pain were associated with improved outcome 2 years after surgery. TRIAL REGISTRATION: NORDSTEN-DS ClinicalTrials.gov, NCT02051374.

16.
Spine (Phila Pa 1976) ; 48(14): 969-977, 2023 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-37163646

RESUMO

STUDY DESIGN: Prospective pharmacoepidemiologic study. OBJECTIVE: To investigate clinical and sociodemographic factors associated with persistent opioid use in the years following spine surgery among patients with persistent opioid use preceding lumbar spine surgery. SUMMARY OF BACKGROUND DATA: It is unknown whether successful spine surgery leads to a cessation of preoperative persistent opioid use. MATERIALS AND METHODS: Data from the Norwegian Registry for Spine Surgery and the Norwegian Prescription Database were linked for patients operated for degenerative lumbar spine disorders between 2007 and 2017. The primary outcome measure was persistent opioid use in the second year after surgery. Functional disability was measured with the Oswestry Disability Index (ODI). Factors associated with persistent opioid use in the year before, and two years following, surgery were identified using multivariable logistic regression analysis. The variables included in the analysis were selected based on their demonstrated role in prior studies. RESULTS: The prevalence of persistent opioid use was 8.7% in the year before surgery. Approximately two-thirds of patients also met the criteria for persistent opioid use the second year after surgery. Among patients who did not meet the criteria for persistent opioid use the year before surgery, 991 (3.3%) patients developed persistent opioid use in the second year following surgery. The strongest association was exhibited by high doses of benzodiazepines in the year preceding surgery (OR 1.7, 95% CI 1.26 to 2.19, P <0.001). Among patients without persistent opioid use, the most influential factor associated with new-onset persistent opioid use in the second year after surgery was the use of high doses of benzodiazepines (OR 1.8, 95% CI 1.26 to 2.44, P <0.001), high doses of z -hypnotics (OR 2.6, 95% CI 2.10 to 3.23, P <0.001) and previous surgery at the same lumbar level (OR 1.37, 95% CI 1.11 to 1.68, P =0.003). CONCLUSION: A substantial proportion of patients reported sustained opioid use after surgery. Patients with persistent opioid use before surgery should be supported to taper off opioid treatment. Special efforts appear to be required to taper off opioid use in patients using high doses of benzodiazepines. LEVEL OF EVIDENCE: 2; Prospective observational study.


Assuntos
Analgésicos Opioides , Transtornos Relacionados ao Uso de Opioides , Humanos , Analgésicos Opioides/uso terapêutico , Estudos Prospectivos , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Sistema de Registros , Benzodiazepinas/uso terapêutico , Prescrições , Noruega/epidemiologia , Vértebras Lombares/cirurgia
17.
BMC Musculoskelet Disord ; 24(1): 164, 2023 Mar 04.
Artigo em Inglês | MEDLINE | ID: mdl-36871007

RESUMO

BACKGROUND: Loss to follow-up may bias outcome assessments in medical registries. This cohort study aimed to analyze and compare patients who failed to respond with those that responded to the Norwegian Registry for Spine Surgery (NORspine). METHODS: We analyzed a cohort of 474 consecutive patients operated for lumbar spinal stenosis at four public hospitals in Norway during a two-year period. These patients reported sociodemographic data, preoperative symptoms, and Oswestry Disability Index (ODI), numerical rating scales (NRS) for back and leg pain to NORspine at baseline and 12 months postoperatively. We contacted all patients who did not respond to NORspine after 12 months. Those who responded were termed responsive non-respondents and compared to 12 months respondents. RESULTS: One hundred forty (30%) did not respond to NORspine 12 months after surgery and 123 were available for additional follow-up. Sixty-four of the 123 non-respondents (52%) responded to a cross-sectional survey done at a median of 50 (36-64) months after surgery. At baseline, non-respondents were younger 63 (SD 11.7) vs. 68 (SD 9.9) years (mean difference (95% CI) 4.7 years (2.6 to 6.7); p = < 0.001) and more frequently smokers 41 (30%) vs. 70 (21%) RR (95%CI) = 1.40 (1.01 to 1.95); p = 0.044. There were no other relevant differences in other sociodemographic variables or preoperative symptoms. We found no differences in the effect of surgery on non-respondents vs. respondents (ODI (SD) = 28.2 (19.9) vs. 25.2 (18.9), MD (95%CI) = 3.0 ( -2.1 to 8.1); p = 0.250). CONCLUSION: We found that 30% of patients did not respond to NORspine at 12 months after spine surgery. Non-respondents were somewhat younger and smoked more frequently than respondents; however, there were no differences in patient-reported outcome measures. Our findings suggest that attrition bias in NORspine was random and due to non-modifiable factors.


Assuntos
Avaliação de Resultados em Cuidados de Saúde , Humanos , Estudos de Coortes , Estudos Transversais , Noruega , Sistema de Registros
18.
Bone Joint J ; 105-B(4): 422-430, 2023 Mar 15.
Artigo em Inglês | MEDLINE | ID: mdl-36924173

RESUMO

Repeated lumbar spine surgery has been associated with inferior clinical outcomes. This study aimed to examine and quantify the impact of this association in a national clinical register cohort. This is a population-based study from the Norwegian Registry for Spine surgery (NORspine). We included 26,723 consecutive cases operated for lumbar spinal stenosis or lumbar disc herniation from January 2007 to December 2018. The primary outcome was the Oswestry Disability Index (ODI), presented as the proportions reaching a patient-acceptable symptom state (PASS; defined as an ODI raw score ≤ 22) and ODI raw and change scores at 12-month follow-up. Secondary outcomes were the Global Perceived Effect scale, the numerical rating scale for pain, the EuroQoL five-dimensions health questionnaire, occurrence of perioperative complications and wound infections, and working capability. Binary logistic regression analysis was conducted to examine how the number of previous operations influenced the odds of not reaching a PASS. The proportion reaching a PASS decreased from 66.0% (95% confidence interval (CI) 65.4 to 66.7) in cases with no previous operation to 22.0% (95% CI 15.2 to 30.3) in cases with four or more previous operations (p < 0.001). The odds of not reaching a PASS were 2.1 (95% CI 1.9 to 2.2) in cases with one previous operation, 2.6 (95% CI 2.3 to 3.0) in cases with two, 4.4 (95% CI 3.4 to 5.5) in cases with three, and 6.9 (95% CI 4.5 to 10.5) in cases with four or more previous operations. The ODI raw and change scores and the secondary outcomes showed similar trends. We found a dose-response relationship between increasing number of previous operations and inferior outcomes among patients operated for degenerative conditions in the lumbar spine. This information should be considered in the shared decision-making process prior to elective spine surgery.


Assuntos
Deslocamento do Disco Intervertebral , Estenose Espinal , Humanos , Deslocamento do Disco Intervertebral/cirurgia , Estenose Espinal/cirurgia , Vértebras Lombares/cirurgia , Região Lombossacral , Medidas de Resultados Relatados pelo Paciente , Resultado do Tratamento
19.
Spine (Phila Pa 1976) ; 48(10): 688-694, 2023 May 15.
Artigo em Inglês | MEDLINE | ID: mdl-36809364

RESUMO

STUDY DESIGN: Prospective cohort study. OBJECTIVE: The aim was to investigate the association between postoperative dural sac cross-sectional area (DSCA) after decompressive surgery for lumbar spinal stenosis and clinical outcome. Furthermore, to investigate if there is a minimum threshold for how extensive a posterior decompression needs to be to achieve a satisfactory clinical result. SUMMARY OF BACKGROUND DATA: There is limited scientific evidence for how extensive lumbar decompression needs to be to obtain a good clinical outcome in patients with symptomatic lumbar spinal stenosis. MATERIALS AND METHODS: All patients were included in the Spinal Stenosis Trial of the NORwegian Degenerative spondylolisthesis and spinal STENosis (NORDSTEN)-study. The patients underwent decompression according to three different methods. DSCA measured on lumbar magnetic resonance imaging at baseline and at three months follow-up, and patient-reported outcome at baseline and at two-year follow-up were registered in a total of 393 patients. Mean age was 68 (SD: 8.3), proportion of males were 204/393 (52%), proportion of smokers were 80/393 (20%), and mean body mass index was 27.8 (SD: 4.2).The cohort was divided into quintiles based on the achieved DSCA postoperatively, the numeric, and relative increase of DSCA, and the association between the increase in DSCA and clinical outcome were evaluated. RESULTS: At baseline, the mean DSCA in the whole cohort was 51.1 mm 2 (SD: 21.1). Postoperatively the area increased to a mean area of 120.6 mm 2 (SD: 46.9). The change in Oswestry disability index in the quintile with the largest DSCA was -22.0 (95% CI: -25.6 to -18), and in the quintile with the lowest DSCA the Oswestry disability index change was -18.9 (95% CI: -22.4 to -15.3). There were only minor differences in clinical improvement for patients in the different DSCA quintiles. CONCLUSION: Less aggressive decompression performed similarly to wider decompression across multiple different patient-reported outcome measures at two years following surgery.


Assuntos
Estenose Espinal , Idoso , Humanos , Masculino , Descompressão Cirúrgica/efeitos adversos , Vértebras Lombares/diagnóstico por imagem , Vértebras Lombares/cirurgia , Vértebras Lombares/patologia , Estudos Prospectivos , Radiografia , Estenose Espinal/diagnóstico por imagem , Estenose Espinal/cirurgia , Estenose Espinal/patologia , Resultado do Tratamento
20.
Acta Neurochir (Wien) ; 165(3): 779-787, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-36795223

RESUMO

BACKGROUND: Few studies of high quality exist on return to work (RTW) rate after surgery for degenerative cervical myelopathy (DCM). This study aims to examine the RTW rate in patients undergoing surgery for DCM. METHODS: Nationwide prospectively collected data were obtained from the Norwegian Registry for Spine Surgery and the Norwegian Labour and Welfare Administration. The primary outcome was return to work, defined as being at work at a given time postoperatively without any medical income-compensation benefits. Secondary endpoints included the neck disability index (NDI) and quality of life measured by EuroQol-5D (EQ-5D). RESULTS: Among 439 patients operated for DCM between 2012 and 2018, 20% of the patients received a medical income-compensation benefit one year before surgery. This number increased steadily towards the operation at which timepoint 100% received benefits. By 12 months after surgery, 65% had returned to work. By 36 months, 75% had returned to work. Patients that returned to work were more likely to be non-smokers and to have a college education. They had less comorbidity, more were without benefit 1-year pre-surgery, and significantly more patients were employed at operation date. Average days of sick leave in the year before surgery were significantly less in the RTW group, and they had a significantly lower baseline NDI and EQ-5D All PROMs reached statistical significance at 12 months, in favor of the group that achieved RTW. CONCLUSION: At 12 months following surgery, 65% had returned to work. At the end of the 36-month follow-up period, 75% had returned to work, 5% less than the working percentage in the beginning of the follow-up period. This study demonstrates that a large percentage of patients return to work after surgical treatment for DCM.


Assuntos
Retorno ao Trabalho , Doenças da Medula Espinal , Humanos , Resultado do Tratamento , Qualidade de Vida , Doenças da Medula Espinal/cirurgia , Sistema de Registros , Vértebras Cervicais/cirurgia
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