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Decompression alone versus decompression with instrumental fusion the NORDSTEN degenerative spondylolisthesis trial (NORDSTEN-DS); study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Fusion in addition to decompression has become the standard treatment for lumbar spinal stenosis with degenerative spondylolisthesis (DS). The evidence for performing fusion among these patients is conflicting and there is a need for further investigation through studies of high quality. The present protocol describes an ongoing study with the primary aim of comparing the outcome between decompression alone and decompression with instrumented fusion. The secondary aim is to investigate whether predictors can be used to choose the best treatment for an individual. The trial, named the NORDSTEN-DS trial, is one of three studies in the Norwegian Degenerative Spinal Stenosis (NORDSTEN) study. METHODS:The NORDSTEN-DS trial is a block-randomized, controlled, multicenter, non-inferiority study with two parallel groups. The surgeons at the 15 participating hospitals decide whether a patient is eligible or not according to the inclusion and exclusion criteria. Participating patients are randomized to either a midline preserving decompression or a decompression followed by an instrumental fusion. Primary endpoint is the percentage of patients with an improvement in Oswestry Disability Index version 2.0 of more than 30% from baseline to 2-year follow-up. Secondary outcome measurements are the Zürich Claudication Questionnaire, Numeric Rating Scale for back and leg pain, Euroqol 5 dimensions questionnaire, Global perceived effect scale, complications and several radiological parameters. Analysis and interpretation of results will also be conducted after 5 and 10?years. CONCLUSION:The NORDSTEN/DS trial has the potential to provide Level 1 evidence of whether decompression alone should be advocated as the preferred method or not. Further on the study will investigate whether predictors exist and if they can be used to make the appropriate choice for surgical treatment for this patient group. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02051374 . First Posted: January 31, 2014. Last Update Posted: February 14, 2018.

SUBMITTER: Austevoll IM

PROVIDER: S-EPMC6320633 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Decompression alone versus decompression with instrumental fusion the NORDSTEN degenerative spondylolisthesis trial (NORDSTEN-DS); study protocol for a randomized controlled trial.

Austevoll Ivar Magne IM Hermansen Erland E Fagerland Morten M Rekeland Frode F Solberg Tore T Storheim Kjersti K Brox Jens Ivar JI Lønne Greger G Indrekvam Kari K Aaen Jørn J Grundnes Oliver O Hellum Christian C

BMC musculoskeletal disorders 20190105 1

<h4>Background</h4>Fusion in addition to decompression has become the standard treatment for lumbar spinal stenosis with degenerative spondylolisthesis (DS). The evidence for performing fusion among these patients is conflicting and there is a need for further investigation through studies of high quality. The present protocol describes an ongoing study with the primary aim of comparing the outcome between decompression alone and decompression with instrumented fusion. The secondary aim is to in ...[more]

PMID: 30611229

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Project description:BackgroundClinically, there are substantive practice variations in surgical management of degenerative lumbar spondylolisthesis. We aimed at evaluating whether decompression alone outcomes for patients with degenerative lumbar spondylolisthesis are comparable to those of decompression with fusion.MethodsIn this meta-analysis, the Embase, PubMed, and Cochrane Library databases were searched from inception to February 16th, 2022. Randomised controlled trials (RCTs) and cohort studies comparing decompression alone with decompression and fusion for patients with degenerative lumbar spondylolisthesis were included in this study. There were no language limitations. Odds ratio (OR), mean difference (MD) and 95% confidence interval (CI) were used to report results in the random-effects model. Main outcomes included Oswestry disability index (ODI), pain, clinical satisfaction, complication and reoperation rates. The study protocol was published in PROSPERO (CRD42022310645).FindingsThirty-three studies (6 RCTs and 27 cohort studies) involving 94 953 participants were included. Differences in post-operative ODI between decompression alone and decompression with fusion were not significant. A small difference for back (MD, 0.13; [95% CI, 0.08 to 0.18]; I 2:0.00%) and leg pain (MD, 0.30; [95% CI, 0.09 to 0.51]; I 2:48.35%) was observed on the 3rd post-operative month. The results did not reveal significant differences in leg pain and back pain between decompression alone and fusion groups on the 6th, 12th, and 24th post-operative months. Difference in clinical satisfaction between decompression alone and decompression with fusion were not significant from RCTs (OR, 0.26; [95% CI, 0.03 to 1.92]; I 2:83.27%). Complications (OR, 1.54; [95% CI, 1.16 to 2.05]; I 2:48.88%), operation time (MD, 83.39; [95% CI, 55.93 to 110.85]; I 2:98.75%), intra-operative blood loss (MD, 264.58; [95% CI, 174.99 to 354.16]; I 2:95.61%) and length of hospital stay (MD, 2.85; [95% CI, 1.60 to 4.10]; I 2:99.49%) were higher with fusion.InterpretationClinical effectiveness of decompression alone was comparable to that of decompression with fusion for degenerative lumbar spondylolisthesis. Decompression alone is recommended for patients with degenerative lumbar spondylolisthesis.FundingThis work was supported by grants from the National Natural Science Foundation of China (No. 81871818), Tangdu Hospital Seed Talent Program (Fei-Long Wei), Natural Science Basic Research Plan in Shaanxi Province of China (No.2019JM-265) and Social Talent Fund of Tangdu Hospital (No.2021SHRC034).

Project description:ObjectiveTo assess whether decompression alone is non-inferior to decompression with instrumented fusion five years after primary surgery in patients with degenerative lumbar spondylolisthesis.DesignFive year follow-up of a randomised, multicentre, non-inferiority trial (Nordsten-DS).Setting16 public orthopaedic and neurosurgical clinics in Norway.ParticipantsPatients aged 18-80 years with symptomatic lumbar spinal stenosis and a spondylolisthesis of 3 mm or more at the stenotic level.InterventionsDecompression surgery alone and decompression with additional instrumented fusion (1:1).Main outcome measuresThe primary outcome was a 30% or more reduction in Oswestry disability index from baseline to five year follow-up. The predefined non-inferiority margin was a -15 percentage point difference in the proportion of patients who met the primary outcome. Secondary outcomes included the mean change in Oswestry disability index, Zurich claudication questionnaire, numeric rating scale for leg and back pain, and EuroQol Group 5-Dimension (EQ-5D-3L) questionnaire.ResultsFrom 12 February 2014 to 18 December 2017, 267 participants were randomly assigned to decompression alone (n=134) and decompression with instrumented fusion (n=133). Of these, 230 (88%) responded to the five year questionnaire: 121 in the decompression group and 109 in the fusion group. Mean age at baseline was 66.2 years (SD 7.6), and 69% were women. In the modified intention-to-treat analysis with multiple imputation of missing data, 84 (63%) of 133 people in the decompression alone group and 81 (63%) of 129 people in the fusion group had a at least a 30% reduction in Oswestry disability index, a difference of 0.4 percentage points. (95% confidence interval (CI) -11.2 to 11.9). The respective results of the per protocol analysis were 65 (65%) of 100 in the decompression alone group and 59 (66%) of 89 in the fusion group, a difference of -1.3 percentage points (95% CI -14.5 to 12.2). Both 95% CIs were higher than the predefined non-inferiority margin of -15%. The mean change in Oswestry disability index from baseline to five years was -17.8 in both groups (mean difference 0.02 (95% CI -3.8 to 3.9)). Results of the other secondary outcomes were in the same direction as the primary outcome. From two to five year follow-up, a new lumbar operation occurred in six (5%) of 123 people in the decompression group and 11 (10%) of 113 people in the fusion group, with a total from baseline to five years of 21 (16%) of 129 people and 23 (18%) of 125, respectively.ConclusionsIn participants with degenerative spondylolisthesis, decompression alone was non-inferior to decompression with instrumented fusion five years after primary surgery. Proportions of subsequent surgeries at the index level or an adjacent lumbar level were no different between the groups.Trial registrationClinicalTrials.gov NCT02051374.

Project description:ImportanceConflicting evidence and large practice variation are present in the surgical treatment of degenerative spondylolisthesis. More than 90% of surgical procedures in the United States include instrumented fusion compared with 50% or less in other countries.ObjectiveTo evaluate whether the effectiveness of microdecompression alone is noninferior to decompression with instrumented fusion in a real-world setting.Design, setting, and participantsThis multicenter comparative effectiveness study with a noninferiority design assessed prospective data from the Norwegian Registry for Spine Surgery. From September 19, 2007, to December 21, 2015, 1376 patients at 35 Norwegian orthopedic and neurosurgical departments underwent surgery for lumbar spinal stenosis with degenerative spondylolisthesis without scoliosis. After excluding patients undergoing laminectomy alone, fusion without instrumentation, or surgery in more than 2 levels and those with a former operation at the index level, 794 patients were included in the analyses, regardless of missing or incomplete follow-up data, before propensity score matching. Data were analyzed from March 20 to October 30, 2018.ExposuresMicrodecompression alone or decompression with instrumented fusion.Main outcomes and measuresA reduction from baseline of 30% or greater in the Oswestry Disability Index at 12-month follow-up.ResultsAfter propensity score matching, 570 patients (413 female [72%]; mean [SD] age, 64.7 [9.5] years) were included for comparison, with 285 undergoing microdecompression (mean [SD] age, 64.6 [9.8] years; 205 female [72%]) and 285 undergoing decompression with instrumented fusion (mean [SD] age, 64.8 [9.2] years; 208 female [73%]). The proportion of each type of procedure varied between departments. However, changes in outcome scores varied within patients but not between departments. The proportion of patients with improvement in the Oswestry Disability Index of at least 30% was 150 of 219 (68%) in the microdecompression group and 155 of 215 (72%) in the instrumentation group. The 95% CI (-12% to 5%) for the difference of -4% was above the predefined margin of noninferiority (-15%). Microdecompression alone was associated with shorter operation time (mean [SD], 89 [44] vs 180 [65] minutes; P < .001) and shorter hospital stay (mean [SD], 2.5 [2.4] vs 6.4 [3.0] days; P < .001).Conclusions and relevanceAmong patients with degenerative spondylolisthesis, the clinical effectiveness of microdecompression alone was noninferior to that of decompression with instrumented fusion. Microdecompression alone was also associated with shorter durations of surgery and hospital stay, supporting the suggestion that the less invasive procedure should be considered for most patients.

Project description:ObjectiveTo determine the efficacy of adding instrumented spinal fusion to decompression to treat degenerative spondylolisthesis (DS).DesignSystematic review with meta-analysis.Data sourcesMEDLINE, Embase, Emcare, Cochrane Library, CINAHL, Scopus, ProQuest Dissertations & Theses Global, ClinicalTrials.gov and WHO International Clinical Trials Registry Platform from inception to May 2022.Eligibility criteria for study selectionRandomised controlled trials (RCTs) comparing decompression with instrumented fusion to decompression alone in patients with DS. Two reviewers independently screened the studies, assessed the risk of bias and extracted data. We provide the Grading of Recommendations, Assessment, Development and Evaluation assessment of the certainty of evidence (COE).ResultsWe identified 4514 records and included four trials with 523 participants. At a 2-year follow-up, adding fusion to decompression likely results in trivial difference in the Oswestry Disability Index (range 0-100, with higher values indicating greater impairment) with mean difference (MD) 0.86 (95% CI -4.53 to 6.26; moderate COE). Similar results were observed for back and leg pain measured on a scale of 0 to 100, with higher values indicating more severe pain. There was a slightly increased improvement in back pain (2-year follow-up) in the group without fusion shown by MD -5·92 points (95% CI -11.00 to -0.84; moderate COE). There was a trivial difference in leg pain between the groups, slightly favouring the one without fusion, with MD -1.25 points (95% CI -6.71 to 4.21; moderate COE). Our findings at 2-year follow-up suggest that omitting fusion may increase the reoperation rate slightly (OR 1.23; 0.70 to 2.17; low COE).ConclusionsEvidence suggests no benefits of adding instrumented fusion to decompression for treating DS. Isolated decompression seems sufficient for most patients. Further RCTs assessing spondylolisthesis stability are needed to determine which patients would benefit from fusion.Prospero registration numberCRD42022308267.

Project description:BackgroundThere have been lingering controversies reported decompression and plus fusion. And the relative safety of fusion in addition to standard decompression remains unclear. This study aimed to assess the effectiveness and safety of decompression alone or combined with fusion in lumbar spinal stenosis (LSS) with degenerative spondylolisthesis (DS).MethodsIn this systematic review and meta-analysis, we searched the databases of PubMed, Embase, Cochrane Library, and Web of Science for relevant literature from their inception to 28th December 2021. We identified the eligible studies based on the PICOS principles, populations (LSS with DS), interventions (decompression alone), controls (decompression combined with fusion), outcomes [overall reoperation rate, complications, Oswestry Disability Index (ODI), operative time, the amount of blood lost, length of stay (LOS), and visual analog scales (VAS)], study design (cohort studies). Quality assessment for individual study was performed with the Newcastle-Ottawa Scale (NOS).ResultsIn all, 12 articles involving a total of 14,693 patients were finally included in the study, the majority of patients underwent decompression alone (DA group: n=11,598) and the rest underwent decompression associated with fusion (FU group: n=3,095). The quality of most of the included studies was regarded as high quality. The results indicated that the FU group had a higher rate of complication [relative risk (RR): 1.770, 95% confidence interval (CI): 1.485 to 2.110], longer operative time [weighted mean difference (WMD): 51.037, 95% CI: 13.743 to 88.330], and increased blood loss (WMD: 258.354, 95% CI: 150.468 to 366.239) than the DA group (all P<0.05), with no significant differences for overall reoperation rate (RR: 0.879, 95% CI: 0.432 to 1.786), ODI (WMD: -2.569, 95% CI: -6.548 to 1.409), LOS (WMD: 3.838, 95% CI: -2.172 to 9.848), and VAS found between the two groups (P>0.05).ConclusionsIn patients with LSS + DS, the effectiveness and safety of decompression alone may be superior to decompression plus fusion in terms of complication rate, operative time, and the amount of bleeding. However, more high-quality literature is needed in the future to confirm the best treatment choice for patients with LSS + DS.

Project description:BackgroundAdult spinal deformity, especially sagittal imbalance, is affecting health-related quality-of-life (HRQOL) scores. There is a lack of emphasis in the comparison of cervical sagittal parameters in patients with degenerative cervical spondylolisthesis and degenerative cervical kyphosis. The aim of study is to determine the preoperative and postoperative cervical sagittal parameters in myeloradiculopathic patients with degenerative cervical spondylolisthesis and degenerative cervical kyphosis treated by anterior cervical discectomy and fusion (ACDF).MethodsA retrospective medical records and radiographic study of 30 adult patients were reviewed. Fifteen patients with degenerative cervical spondylolisthesis and 15 patients with degenerative cervical kyphosis have been performed ACDF from 2010-2020. We measured the preoperative and postoperative cervical sagittal parameters: C0-C2 angle, C1-C2 angle, C2-C7 angle, C2-C7 sagittal vertical axis (SVA), T1 slope, neck tilt angle and thoracic inlet angle. Minimum follow-up period was at least 2 years.ResultsPatients in degenerative cervical kyphosis group have C2-C7 angle less than degenerative cervical spondylolisthesis group (-14.88±7.32 vs. 9.60±13.60), leading to increase the mismatch between T1 slope and C2-C7 angle in kyphotic group and hyperlordosis of C0-C2 angle and C1-C2 angle (31.13±7.68, 37.88±5.08) compare with spondylolisthesis group (13±10.20, 24.60±10.70). Whereas patients with degenerative cervical spondylolisthesis have C2-C7 SVA (33.22±13.92) more than kyphosis group (13.70±13.60). After surgery, there is significant increase of the C2-C7 angle in the kyphosis group compare before and after surgery (-14.88±7.32 vs. 4.10±11.80). While the spondylolisthesis group has no significantly different parameters compare to before surgery. However, the postoperative cervical sagittal parameters of all patients are within the normal thresholds (T1-Slope minus C2-C7 lordosis <15° and C2-C7 SVA <40 mm).ConclusionsThe study demonstrates the difference of sagittal parameters between degenerative cervical spondylolisthesis and kyphosis before and after surgery. ACDF not only provides neural decompressive procedure, but also corrects the regional cervical sagittal parameters.

Project description:BackgroundManagement of degenerative spondylolisthesis with spinal stenosis is controversial. Surgery is widely used, but its effectiveness in comparison with that of nonsurgical treatment has not been demonstrated in controlled trials.MethodsSurgical candidates from 13 centers in 11 U.S. states who had at least 12 weeks of symptoms and image-confirmed degenerative spondylolisthesis were offered enrollment in a randomized cohort or an observational cohort. Treatment was standard decompressive laminectomy (with or without fusion) or usual nonsurgical care. The primary outcome measures were the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36) bodily pain and physical function scores (100-point scales, with higher scores indicating less severe symptoms) and the modified Oswestry Disability Index (100-point scale, with lower scores indicating less severe symptoms) at 6 weeks, 3 months, 6 months, 1 year, and 2 years.ResultsWe enrolled 304 patients in the randomized cohort and 303 in the observational cohort. The baseline characteristics of the two cohorts were similar. The one-year crossover rates were high in the randomized cohort (approximately 40% in each direction) but moderate in the observational cohort (17% crossover to surgery and 3% crossover to nonsurgical care). The intention-to-treat analysis for the randomized cohort showed no statistically significant effects for the primary outcomes. The as-treated analysis for both cohorts combined showed a significant advantage for surgery at 3 months that increased at 1 year and diminished only slightly at 2 years. The treatment effects at 2 years were 18.1 for bodily pain (95% confidence interval [CI], 14.5 to 21.7), 18.3 for physical function (95% CI, 14.6 to 21.9), and -16.7 for the Oswestry Disability Index (95% CI, -19.5 to -13.9). There was little evidence of harm from either treatment.ConclusionsIn nonrandomized as-treated comparisons with careful control for potentially confounding baseline factors, patients with degenerative spondylolisthesis and spinal stenosis treated surgically showed substantially greater improvement in pain and function during a period of 2 years than patients treated nonsurgically. (ClinicalTrials.gov number, NCT00000409 [ClinicalTrials.gov].).

Project description:Clinical trial subgroup analysis.To compare outcomes of different fusion techniques treating degenerative spondylolisthesis (DS). Summary of Background Data. Surgery has been shown to be more effective than nonoperative treatment out to 4 years. Questions remain regarding the differential effect of fusion technique.Surgical candidates from 13 centers in 11 states with at least 12 weeks of symptoms and confirmatory imaging showing stenosis and DS were studied. In addition to standard decompressive laminectomy, 1 of 3 fusion techniques was employed at the surgeon's discretion: posterolateral in situ fusion (PLF); posterolateral instrumented fusion with pedicle screws (PPS); or PPS plus interbody fusion (360 degrees). Main outcome measures were the SF-36 bodily pain (BP) and physical function (PF) scales and the modified Oswestry Disability Index (ODI) assessed at 6 weeks, 3 months, 6 months, and yearly to 4 years. The as-treated analysis combined the randomized and observational cohorts using mixed longitudinal models adjusting for potential confounders.Of 380 surgical patients, 21% (N = 80) received a PLF; 56% (N = 213) received a PPS; 17% (N = 63) received a 360 degrees; and 6% (N = 23) had decompression only without fusion. Early outcomes varied, favoring PLF compared to PPS at 6 weeks (PF: 12.73 vs. 6.22, P < 0.020) and 3 months (PF: 25.24 vs.18.95, P < 0.025) and PPS compared to 360 degrees at 6 weeks (ODI: -14.46 vs. -9.30, P < 0.03) and 3 months (ODI: -22.30 vs. -16.78, P < 0.02). At 2 years, 360 degrees had better outcomes: BP: 39.08 versus 29.17 PLF, P < 0.011; and versus 29.13 PPS, P < 0.002; PF: 31.93 versus 23.27 PLF, P < 0.021; and versus 25.29 PPS, P < 0.036. However, these differences were not maintained at 3- and 4-year follow-up, when there were no statistically significant differences between the 3 fusion groups.In patients with DS and associated spinal stenosis, no consistent differences in clinical outcomes were seen among fusion groups over 4 years.

Dataset Information

Decompression alone versus decompression with instrumental fusion the NORDSTEN degenerative spondylolisthesis trial (NORDSTEN-DS); study protocol for a randomized controlled trial.

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Decompression alone versus decompression with instrumental fusion the NORDSTEN degenerative spondylolisthesis trial (NORDSTEN-DS); study protocol for a randomized controlled trial.

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