A Multicenter Prospective Study of Quality of Life in Adult Scoliosis

Completed · Not applicable

Conditions studied: Scoliosis

In brief

This is a multicenter study evaluating the effectiveness of nonoperative and operative treatments. The investigators wish to identify important clinical and radiographic determinants of outcomes in the management of adults with symptomatic lumbar scoliosis (ASLS). Note: Enrollment was complete July 2014. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) funding ended 2/28/17. We continue to follow enrolled subjects while we seek additional funding to follow all subjects through 8 years.

Key facts

Study ID

NCT00854828

Run by

Washington University School of Medicine

People needed

286

Starts

2010-04-01

Expected to finish

2017-02-28

Last updated by the study team

2021-09-14

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• aged 40 to 80 years with
• ASLS defined as lumbar curve with a coronal Cobb measurement ≥ 30°, and either of the following: Oswestry Disability Index (ODI) score ≥ 20 or SRS-QOL score ≤ 4.0 in the domains of pain, function and/or appearance.
• If assigned to surgical intervention (by randomization or patient preference), the intervention plan would include, at a minimum, the Cobb levels of the Thoracolumbar/lumbar spine.

You may not qualify if…

• Substantial cardiac, pulmonary, renal or metabolic disease that, in the judgment of the surgical team, would preclude performing an operative procedure without undue risk of morbidity and mortality
• Concomitant high-grade spondylolisthesis (Grade 3)
• Prior thoracic or multiple level lumbar laminectomy or decompression [single or two level lumbar decompression (e.g., herniated disc) will not be an exclusion]
• Prior thoracic or lumbar fusion
• Osteoporosis evidence by a dual-energy x-ray absorptiometry (DEXA) T-score <-3.0 at hip or lumbar spine for patients considered to be at risk (post menopausal females, males > 60 years of age, steroid dependent rheumatoid arthritics, status post organ transplantation, etc.). Patients may be randomized prior to obtaining DEXA results. Non Surgical patients may initiate non surgical treatments prior to completion of DEXA (if required) as non surgical treatments will not affect DEXA results but DEXA must be completed and results entered within 3 months of enrollment. Surgical patient must have DEXA prior to surgical intervention.
• Neuromuscular scoliosis (e.g., spinal muscular atrophy, cerebral palsy, Parkinson's Disease, post-polio syndrome, Charcot Marie Tooth disease)
• Congenital scoliosis in the lumbar spine. Congenital anomalies of the cervical or thoracic spine are acceptable.
• Spine tumor, infection or connective tissue disorder
• Cognitively impaired or unable/unwilling to comply with follow-up
• Pregnancy or planning on conceiving during time of study involvement
• Ankylosing Spondylitis
• Past history of vertebroplasty or kyphoplasty of the thoracic or lumbar spine

Where it is running

• Northwestern University — Chicago, Illinois, United States
• University of Louisville — Louisville, Kentucky, United States
• Maryland Spine Center — Baltimore, Maryland, United States
• Washington University — St Louis, Missouri, United States
• New York University — New York, New York, United States
• Hospital for Special Surgery — New York, New York, United States
• University of Virginia — Charlottesville, Virginia, United States
• Toronto Western Hospital — Toronto, Ontario, Canada
• Hopital du Sacre' — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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