The goal of this patient-oriented study is to obtain health-related quality of life (HRQOL) outcomes data on patients who present with adult symptomatic lumbar scoliosis (ASLS) pre- and post-treatment in order to facilitate the development of evidence-based treatment guidelines, improve patient care and optimize healthcare resource utilization. We are defining ASLS as Oswestry Disability Index (ODI) e20, Scoliosis Research Society (SRS) domain scores d4.0 and a Cobb measurement of e300 at baseline. This study will help us determine how much the current treatment, either nonoperative or operative, improves the lives of people with this pathology. Significance: The impetus for this critical effort is the significant burden of disease posed by adult scoliosis, which affects 2.5-4% of the North American population. The most symptomatic group of primary presentation ASLS patients are those between the ages of 40 and 80 with lumbar deformities - our target population for this study. This disease constitutes a significant problem in light of our aging population and the high cost of surgical treatment (at least $80,000 in hospital costs alone). Studies to date, however, have typically been limited, small, single institution and retrospective. The extent to which treatment benefits patients with ASLS is not well established. Preliminary data: The Spinal Deformity Study Group/Adult Deformity Outcomes section (SDSG/ADO), which was formed 7 years ago, has developed a multi-center effort specifically to study adult scoliosis and has established an infrastructure for collecting consistent multicenter data. The SDSG has 1) validated a disease-specific outcomes tool (the SRS patient-reported outcomes instrument) for adult spinal deformity;2) developed and validated disease-specific radiographic tools;3) analyzed outcomes for certain interventions for comparison of treatments;and 4) collected preliminary data regarding the impact of treatments on patient outcomes. Methods: The study will comprise a multicenter, prospective, randomized controlled trial (RCT) (30%) and consecutive cohort study (70%) of patients receiving current standard-of-care treatments and will use uniform clinical and radiographic assessments that have been validated by our group for assessment of these patients. Both nonoperative and operative care will be standardized within the 5 centers. Quality of life will be assessed by SRS-QOL, ODI, SF-12, numerical rating scale (NRS) back pain and leg pain scores. Functional measures will include a walking treadmill test to assess speed and endurance in patients at baseline and 2 years post-treatment. Primary Aims: Measure the impacts and compare the outcomes of nonoperative and operative treatments in ASLS patients. Innovation: No outcomes study exists in any current peer-reviewed literature to document the effect of both nonoperative and operative treatment on any aspect of primary presentation adult spinal deformity.

Public Health Relevance

The impetus for this critical effort is the significant burden of disease posed by adult symptomatic lumbar scoliosis (ASLS). This disease constitutes a growing problem in light of our aging population and the high cost of surgical treatment (at least $80,000 in hospital costs alone). Our study will facilitate the development of evidence-based treatment guidelines, improve patient care, and optimize healthcare resource utilization.

Agency
National Institute of Health (NIH)
Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Type
Research Project (R01)
Project #
1R01AR055176-01A2
Application #
7731002
Study Section
Neurological, Aging and Musculoskeletal Epidemiology (NAME)
Program Officer
Panagis, James S
Project Start
2009-09-01
Project End
2014-08-31
Budget Start
2009-09-01
Budget End
2010-08-31
Support Year
1
Fiscal Year
2009
Total Cost
$483,348
Indirect Cost
Name
Washington University
Department
Orthopedics
Type
Schools of Medicine
DUNS #
068552207
City
Saint Louis
State
MO
Country
United States
Zip Code
63130
Glassman, Steven D; Bridwell, Keith H; Shaffrey, Christopher I et al. (2018) Health-Related Quality of Life Scores Underestimate the Impact of Major Complications in Lumbar Degenerative Scoliosis Surgery. Spine Deform 6:67-71
Carreon, Leah Y; Kelly, Michael P; Crawford 3rd, Charles H et al. (2018) SRS-22R Minimum Clinically Important Difference and Substantial Clinical Benefit After Adult Lumbar Scoliosis Surgery. Spine Deform 6:79-83
Crawford 3rd, Charles H; Glassman, Steven D; Carreon, Leah Y et al. (2018) Prevalence and Indications for Unplanned Reoperations Following Index Surgery in the Adult Symptomatic Lumbar Scoliosis NIH-Sponsored Clinical Trial. Spine Deform 6:741-744
Pugely, Andrew J; Kelly, Michael P; Baldus, Christine R et al. (2018) Serious Adverse Events Significantly Reduce Patient-Reported Outcomes at 2-Year Follow-up: Nonoperative, Multicenter, Prospective NIH Study of 105 Patients. Spine (Phila Pa 1976) 43:747-753
Mannion, A F; Elfering, A; Bago, J et al. (2018) Factor analysis of the SRS-22 outcome assessment instrument in patients with adult spinal deformity. Eur Spine J 27:685-699
Kang, Daniel G; Baldus, Christine; Glassman, Steven D et al. (2017) Neurologic Deficits Have a Negative Impact on Patient-Related Outcomes in Primary Presentation Adult Symptomatic Lumbar Scoliosis Surgical Treatment at One-Year Follow-up. Spine (Phila Pa 1976) 42:479-489
Chapman Jr, Todd M; Baldus, Christine R; Lurie, Jon D et al. (2016) Baseline Patient-Reported Outcomes Correlate Weakly With Radiographic Parameters: A Multicenter, Prospective NIH Adult Symptomatic Lumbar Scoliosis Study of 286 Patients. Spine (Phila Pa 1976) 41:1701-1708
Neuman, Brian J; Baldus, Christine; Zebala, Lukas P et al. (2016) Patient Factors That Influence Decision Making: Randomization Versus Observational Nonoperative Versus Observational Operative Treatment for Adult Symptomatic Lumbar Scoliosis. Spine (Phila Pa 1976) 41:E349-58