Objective: The Adult Symptomatic Lumbar Scoliosis (ASLS) study is a prospective multicenter trial with randomized and observational cohorts comparing operative and nonoperative treatment for ASLS. The objective of the present study was to perform a post hoc analysis of the ASLS trial to examine factors related to failure of nonoperative treatment in ASLS.
Methods: Patients from the ASLS trial who initially received at least 6 months of nonoperative treatment were followed for up to 8 years after trial enrollment.
Objective: Previous reports of rod fracture (RF) in adult spinal deformity are limited by heterogeneous cohorts, low follow-up rates, and relatively short follow-up durations. Since the majority of RFs present > 2 years after surgery, true occurrence and revision rates remain unclear. The objectives of this study were to better understand the risk factors for RF and assess its occurrence and revision rates following primary thoracolumbar fusions to the sacrum/pelvis for adult symptomatic lumbar scoliosis (ASLS) in a prospective series with long-term follow-up.
View Article and Find Full Text PDFObjective: Proximal junctional failure (PJF) is a severe form of proximal junctional kyphosis. Previous reports on PJF have been limited by heterogeneous cohorts and relatively short follow-ups. The authors' objectives herein were to identify risk factors for PJF and to assess its long-term incidence and revision rates in a homogeneous cohort.
View Article and Find Full Text PDFObjective: Although the health impact of adult symptomatic lumbar scoliosis (ASLS) is substantial, these patients often have other orthopedic problems that have not been previously quantified. The objective of this study was to assess disease burden of other orthopedic conditions in patients with ASLS based on a retrospective review of a prospective multicenter cohort.
Methods: The ASLS-1 study is an NIH-sponsored prospective multicenter study designed to assess operative versus nonoperative treatment for ASLS.
Objective: Although short-term adult symptomatic lumbar scoliosis (ASLS) studies favor operative over nonoperative treatment, longer outcomes are critical for assessment of treatment durability, especially for operative treatment, because the majority of implant failures and nonunions present between 2 and 5 years after surgery. The objectives of this study were to assess the durability of treatment outcomes for operative versus nonoperative treatment of ASLS, to report the rates and types of associated serious adverse events (SAEs), and to determine the potential impact of treatment-related SAEs on outcomes.
Methods: The ASLS-1 (Adult Symptomatic Lumbar Scoliosis-1) trial is an NIH-sponsored multicenter prospective study to assess operative versus nonoperative ASLS treatment.
Study Design: Longitudinal comparative cohort.
Objective: The purpose of this study is to report on the cost-effectiveness of surgical versus non-surgical treatment for Adult Symptomatic Lumbar Scoliosis (ASLS) using the as-treated data and provide a comparison to previously reported intent-to-treat (ITT) analysis. Adult spinal deformity is a relatively prevalent condition for which surgical treatment has become increasingly common but concerns surrounding complications, revision rates and cost-effectiveness remain unresolved.
Objective: Adult symptomatic lumbar scoliosis (ASLS) is a common and disabling condition. The ASLS-1 was a multicenter, dual-arm study (with randomized and observational cohorts) examining operative and nonoperative care on health-related quality of life in ASLS. An aim of ASLS-1 was to determine patient and radiographic factors that modify the effect of operative treatment for ASLS.
View Article and Find Full Text PDFStudy Design: Secondary analysis using data from the NIH-sponsored study on adult symptomatic lumbar scoliosis (ASLS) that included randomized and observational arms.
Objective: The aim of this study was to perform an intent-to-treat cost-effectiveness study comparing operative (Op) versus nonoperative (NonOp) care for ASLS.
Summary Of Background Data: The appropriate treatment approach for ASLS continues to be ill-defined.
Study Design: Secondary analysis of prospective multicenter cohort.
Objective: To assess effect of serious adverse events (SAEs) on 2- and 4-year patient-reported outcomes measures (PROMs) in patients surgically treated for adult symptomatic lumbar scoliosis (ASLS).
Summary Of Background Data: Operative treatment for ASLS can improve health-related quality of life, but has high rates of SAEs.
Background: The 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.
Methods: Patients 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.
Study Design: Longitudinal cohort.
Objective: To report on the prevalence and indications for unplanned reoperations following index surgery in the Adult Symptomatic Lumbar Scoliosis NIH-sponsored Clinical Trial.
Summary Of Background Data: Reoperation following adult spinal deformity surgery exposes the patient to additional surgical risk, increases the cost of care, and decreases the potential cost-effectiveness of the intervention.
Study Design: Longitudinal cohort.
Objectives: To determine if the minimum clinically important difference (MCID) and substantial clinical benefit (SCB) thresholds for the Scoliosis Research Society-22R (SRS22R) domains in patients with degenerative lumbar scoliosis are similar to those in patients with adult spinal deformity (ASD) with fusions extending into the thoracic spine.
Summary Of Background Data: The MCID and SCB thresholds for the SRS22R domains in patients with ASD and adolescent idiopathic scoliosis have been reported.
Study Design: Retrospective cohort.
Objective: To examine Charlson Comorbidity Index (CCMI) as a marker for deterioration in health status not reflected in standard Health Related Quality of Life (HRQOL) measures.
Summary Of Background Data: HRQOL has become a primary metric for assessing outcomes following spinal deformity surgery.
Study Design: This is an analysis of a prospective 2-year study on nonoperative patients enrolled in the Adult Symptomatic Lumbar Scoliosis (ASLS) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) trial.
Objective: The purpose was to evaluate the impact of serious adverse events (SAEs) on patient-reported outcomes (PROs) in nonoperative management of ASLS as measured by Scoliosis Research Society-22 (SRS-22), Oswestry Disability Index (ODI), and Short Form-12 (SF-12) at 2-year follow-up.
Summary Of Background Data: Little is known about PROs in the nonoperative management of ASLS or the prevalence and impact of SAEs on PROs.
Study Design: Level III, Retrospective observational study.
Objective: To determine if there is an increased risk of developing cancer after exposure to high-dose recombinant human bone morphogenetic protein-2 (rhBMP-2) and if risk is dose and/or exposure-dependent.
Summary Of Background Data: Concerns have been raised regarding a relationship between rhBMP-2 and cancer.
Study Design: A retrospective analysis of prospective, multicenter National Institute of Health clinical trial.
Objective: 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).
Summary Of Background Data: There are limited studies evaluating the impact of new neurologic deficits on PROs following surgery for primary presentation adult lumbar scoliosis.
Study Design: A prospective study with randomized and observational cohorts.
Objective: 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.
Summary Of Background Data: 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.
Study Design: Retrospective.
Objective: To investigate the relationship between the amount of correction achieved (K°) and extent of vertebral column shortening (mm) with posterior vertebral column resection (PVCR).
Summary Of Background Data: There is no scientific reference to the correlation between K° and column shortening (mm) with PVCR.
Study Design: Retrospective review of prospective database.
Objective: To investigate the long-term results after extension of previous long spine fusions to the sacrum.
Summary Of Background Data: Long spine fusions not involving the sacrum may be complicated by distal degeneration and require subsequent extension to the sacrum.
Background: : Multiple studies have reported on the prevalence of proximal junctional kyphosis (PJK) following spinal deformity surgery; however, none have demonstrated its significance with respect to functional outcome scores or revision surgery.
Objective: : To evaluate if 20° is a possible critical PJK angle in primary adult scoliosis surgery patients as a threshold for worse patient-reported outcomes.
Methods: : Clinical and radiographic data of 90 consecutive primary surgical patients at a single institution (2002-2007) with adult idiopathic/degenerative scoliosis and 2-year minimum follow-up were analyzed.
Study Design: A retrospective review.
Objective: To quantify the exact impact of non-insulin-dependent diabetes mellitus (NIDDM) on operative complications and additional surgeries associated with spinal deformity surgery.
Summary Of Background Data: There are many references supporting diabetes mellitus (DM) as one of the major risk factors for perioperative complications in spinal surgery.
Study Design: Retrospective clinicoradiographic analysis.
Objective: To compare the upper thoracic (UT) and lower thoracic (LT) spines as the upper instrumented vertebra in primary fusions to the sacrum for adult scoliosis.
Summary Of Background Data: The optimal level at which a fusion to the sacrum is terminated proximally for adult scoliosis remains controversial.
Background: Ossification of the anterior longitudinal ligament and the anulus adjacent to an anterior cervical arthrodesis has been termed adjacent-level ossification development. Initial studies suggested an association with the placement of plates <5 mm from an adjacent disc space. A follow-up study demonstrated that this ossification rarely occurs in association with arthrodeses without plate fixation.
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