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Neurologic Deficits Have a Negative Impact on Patient-Related Outcomes in Primary Presentation Adult Symptomatic Lumbar Scoliosis Surgical Treatment at One-Year Follow-up.

ABSTRACT: A retrospective analysis of prospective, multicenter National Institute of Health clinical trial.The aim of this study was to assess the rate of neurologic complications and impact of new neurologic deficits on 1-year postoperative patient-reported outcomes (PROs).There are limited studies evaluating the impact of new neurologic deficits on PROs following surgery for primary presentation adult lumbar scoliosis.Patients were divided into two groups: new postoperative neurological deficit (Def) or no deficit (NoDef). Preoperative and 1-year follow-up PROs were analyzed [Scoliosis Research Society (SRS) Questionnaire, Oswestry Disability Index (ODI), Short Form-12 Physical/Mental Health Composite Scores (PCS/MCS), and back/leg pain Numerical Rating Scale (NRS)].One hundred forty-one patients: 14 Def (9.9%), 127 NoDef (90.1%). No differences were observed in demographic, radiographic, or PRO data between groups preoperatively. Def group had longer surgical procedures (8.3 vs. 6.9?hours, P?=?0.030), greater blood loss (2832 vs. 2606?mL, P?=?0.022), and longer hospitalizations (10.6 vs. 7.8 days, P?=?0.004). NoDef group reported significant improvement in all PROs from preop to 1-year postoperative. Def group only had improvement in SRS Pain (2.7 preop to 3.4 postop, P?=?0.037) and self-image domains (2.7 to 3.6, p?=?0.004), and NRS back pain (6.6 to 3.2, P?=?0.004) scores with significant worsening of NRS leg pain (4.1 to 6.1, P?=?0.045). Group comparisons of 1-year postop PROs found that Def group reported more NRS leg pain (6.1 vs. 1.7, P?

SUBMITTER: Kang DG

PROVIDER: S-EPMC5373095 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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Neurologic Deficits Have a Negative Impact on Patient-Related Outcomes in Primary Presentation Adult Symptomatic Lumbar Scoliosis Surgical Treatment at One-Year Follow-up.

Kang Daniel G DG Baldus Christine C Glassman Steven D SD Shaffrey Christopher I CI Lurie Jon D JD Bridwell Keith H KH

Spine 20170401 7

<h4>Study design</h4>A retrospective analysis of prospective, multicenter National Institute of Health clinical trial.<h4>Objective</h4>The aim of this study was to assess the rate of neurologic complications and impact of new neurologic deficits on 1-year postoperative patient-reported outcomes (PROs).<h4>Summary of background data</h4>There are limited studies evaluating the impact of new neurologic deficits on PROs following surgery for primary presentation adult lumbar scoliosis.<h4>Methods< ...[more]

PMID: 28351071

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Project description:Sotos syndrome is caused by a gene deletion with an autosomal dominant pattern of inheritance. Cerebral gigantism, hypotonia and joint hyperextensibility are characteristic features of this syndrome. A percentage of these patients develop progressive scoliosis early in life. In the literature, few studies on the evolution of scoliosis in Sotos syndrome have been published. We retrospectively evaluated eight patients diagnosed with Sotos syndrome and scoliosis treated at the Garrahan Children Hospital between 1988 and March 2009. Clinical charts and imaging studies were assessed. Eight patients (19%) presented with scoliosis and seven of them (87.5%) required surgical treatment. The mean follow-up was 9.5 years (range 3-18). Mean age at first consultation was 5.2 years (range 1.1-11.2). Mean Cobb angle for scoliosis at first consultation was 34.3° (range 20°-42°) and the mean Cobb angle for kyphosis was 45.6° (range 30°-90°). Mean age at surgery was 11.2 years (range 3.7-18.10). The surgical procedures performed were instrumented posterior arthrodesis, alone or combined with anterior arthrodesis, instrumented anterior arthrodesis, while one patient is currently in treatment with growing rods. Preoperative mean Cobb angle for scoliosis was 72.3° (range 54°-130°) and for kyphosis was 59.8° (range 30°-108°); postoperative mean Cobb angle for scoliosis was 45.5° (range 6°-90°) and for kyphosis was 40.2° (range 30°-80°). There were three early complications (pleural effusion in two cases and death due to sepsis in one) and two late complications (kyphosis above the instrumentation area and dislodgement of the proximal hooks). Incidence of scoliosis in Sotos syndrome is high and thus close monitoring of patients with Sotos syndrome during growth is important for early detection of this entity. Joint hyperextensibility and hypotonia that are characteristic of the syndrome should be considered at the moment of surgery to avoid short fusions.

Project description:BackgroundThe effectiveness of operative compared with nonoperative treatment at initial presentation (no prior fusion) for adult lumbar scoliosis has not, to our knowledge, been evaluated in controlled trials. The goals of this study were to evaluate the effects of operative and nonoperative treatment and to assess the benefits of these treatments to help treating physicians determine whether patients are better managed operatively or nonoperatively.MethodsPatients with adult symptomatic lumbar scoliosis (aged 40 to 80 years, with a coronal Cobb angle measurement of ≥30° and an Oswestry Disability Index [ODI] score of ≥20 or Scoliosis Research Society [SRS]-22 score of ≤4.0) from 9 North American centers were enrolled in concurrent randomized or observational cohorts to evaluate operative versus nonoperative treatment. The primary outcomes were differences in the mean change from baseline in the SRS-22 subscore and ODI at 2-year follow-up. For the randomized cohort, the initial sample-size calculation estimated that 41 patients per group (82 total) would provide 80% power with alpha equal to 0.05, anticipating 10% loss to follow-up and 20% nonadherence in the nonoperative arm. However, an interim sample-size calculation estimated that 18 patients per group would be sufficient.ResultsSixty-three patients were enrolled in the randomized cohort: 30 in the operative group and 33 in the nonoperative group. Two hundred and twenty-three patients were enrolled in the observational cohort: 112 in the operative group and 111 in the nonoperative group. The intention-to-treat analysis of the randomized cohort found that, at 2 years of follow-up, outcomes did not differ between the groups. Nonadherence was high in the randomized cohort (64% nonoperative-to-operative crossover). In the as-treated analysis of the randomized cohort, operative treatment was associated with greater improvement at the 2-year follow-up in the SRS-22 subscore (adjusted mean difference, 0.7 [95% confidence interval (CI), 0.5 to 1.0]) and in the ODI (adjusted mean difference, -16 [95% CI, -22 to -10]) (p < 0.001 for both). Surgery was also superior to nonoperative care in the observational cohort at 2 years after treatment on the basis of SRS-22 subscore and ODI outcomes (p < 0.001). In an overall responder analysis, more operative patients achieved improvement meeting or exceeding the minimal clinically important difference (MCID) in the SRS-22 subscore (85.7% versus 38.7%; p < 0.001) and the ODI (77.4% versus 38.3%; p < 0.001). Thirty-four revision surgeries were performed in 24 (14%) of the operative patients.ConclusionsOn the basis of as-treated and MCID analyses, if a patient with adult symptomatic lumbar scoliosis is satisfied with current spine-related health, nonoperative treatment is advised, with the understanding that improvement is unlikely. If a patient is not satisfied with current spine health and expects improvement, surgery is preferred.Level of evidenceTherapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Project description:A prospective study with randomized and observational cohorts.The aim of this study was to determine baseline variables affecting adult symptomatic lumbar scoliosis (ASLS) decision making to participate in randomization (RAND), observational nonsurgical (OBS-NS), or observational surgical (OBS-S) cohorts.Multiple factors play a key role in a patient's decision to be randomized or to choose an OBS-NS or OBS-S course for ASLS. Studies evaluating these factors are limited.Eligible candidates (patients with ASLS and no prior spinal fusion deformity surgery) from 9 centers participated in a RAND, OBS-NS, or OBS-S cohort study. Baseline variables (demographics, socioeconomics, patient-reported outcomes [PROs], Functional Treadmill Test, radiographs) were analyzed.Two hundred ninety-five patients were enrolled: 67 RAND, 115 OBS-NS, 113 OBS-S. Subanalysis of older patients (60-80 years) found 54% of OBS-NS had college degrees compared with 82% of RAND and 71% of OBS-S (P = 0.010). Patients deciding to be part of a RAND cohort have similar clinical characteristics to the OBS-S cohort. OBS-S had more symptomatic spinal stenosis (57% vs. 39%, P = 0.029) and worse scores than OBS-NS on the basis of PROs (Back Pain Numerical Rating Scale [NRS 6.3 vs. 5.5, P = 0.007]; Scoliosis Research Society [SRS] Pain [2.8 vs. 3.0, P = 0.018], Function [3.1 vs. 3.4, P = 0.019] and Self-Image [2.7 vs. 3.1, P = 0.002]; Oswestry Disability Index (ODI) [36.9 vs. 31.8, P = 0.029]; post-Treadmill back [5.8 vs. 4.4, P = 0.002] and leg [4.3 vs. 3.1, P = 0.037] pain NRS and larger lumbar coronal Cobb angles (56.5 degrees vs. 48.8 degrees, P < 0.001). RAND had more baseline motor deficits (10.4% vs. 1.7%, P = 0.036) and worse scores than OBS-NS on the basis of ODI (38.8 vs. 31.8, P = 0.006), SRS Function [3.1 vs. 3.4, P = 0.034], and Self-Image [2.7 vs. 3.1, P = 0.007].Patients with worse PROs, more back pain, more back and leg pain with ambulation, and larger lumbar Cobb angles are more inclined to select surgical over nonsurgical management.

Dataset Information

Neurologic Deficits Have a Negative Impact on Patient-Related Outcomes in Primary Presentation Adult Symptomatic Lumbar Scoliosis Surgical Treatment at One-Year Follow-up.

Publications

Neurologic Deficits Have a Negative Impact on Patient-Related Outcomes in Primary Presentation Adult Symptomatic Lumbar Scoliosis Surgical Treatment at One-Year Follow-up.

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