A Multicenter Prospective Study of Quality of Life in Adult Scoliosis
This trial is active, not recruiting.
|Treatments||surgical intervention, non operative intervention|
|Sponsor||Washington University School of Medicine|
|Collaborator||National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)|
|Start date||January 2010|
|End date||September 2016|
|Trial size||300 participants|
|Trial identifier||NCT00854828, R01AR055176-01A2|
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).
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Chicago, IL||Northwestern University||no longer recruiting|
|Louisville, KY||University of Louisville||no longer recruiting|
|Baltimore, MD||Maryland Spine Center||no longer recruiting|
|St. Louis, MO||Washington University||no longer recruiting|
|New York City, NY||New York University||no longer recruiting|
|NYC, NY||Hospital for Special Surgery||no longer recruiting|
|Charlottesville, VA||University of Virginia||no longer recruiting|
|Toronto, Canada||Toronto Western Hospital||no longer recruiting|
|Montreal, Canada||Hopital du Sacre'||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Scoliosis Research Society Quality of Life Questionnaire
time frame: baseline and post intervention at months 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48
Oswestry Disability Index
time frame: baseline & post-intervention at months 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48
time frame: baseline and post-intervention at year 1, 2, 3, 4
Patient follow up documentation
time frame: Post intervention at months 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48
Male or female participants from 40 years up to 80 years old.
- 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.
- 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
|Official title||A Multicenter Prospective Study of Quality of Life in Adult Scoliosis|
|Principal investigator||Keith H Bridwell, MD|
|Description||Specific Aim #1: Compare the outcomes of surgery and nonoperative treatment in patients aged 40 to 80 with ASLS defined as a lumbar curve with a coronal Cobb measurement ≥ 30°, and either of the following: Oswestry (ODI) score of 20 or more; or Scoliosis Research Society Quality of Life instrument (SRS-QOL) score of 4.0 or less, in the domains of pain, function and/or appearance. Specific Aim #2: Evaluate the impact of patient factors (age, gender, socioeconomic status, education) and comorbidities [mental health, body mass index (BMI) and bone mineral density (BMD)] on adverse events and treatment outcomes for both the nonoperative and operative arms. Incorporate these variables into a prediction model to help identify those patients most likely to benefit from either a surgical or nonoperative approach|
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