Status:
COMPLETED
A Multicenter Prospective Study of Quality of Life in Adult Scoliosis
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Northwestern University
Conditions:
Scoliosis
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
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 th...
Detailed 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 follo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2017
Estimated Enrollment :
286 Patients enrolled
Trial Details
Trial ID
NCT00854828
Start Date
April 1 2010
End Date
February 28 2017
Last Update
September 14 2021
Active Locations (9)
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1
Northwestern University
Chicago, Illinois, United States, 60611
2
University of Louisville
Louisville, Kentucky, United States, 40202
3
Maryland Spine Center
Baltimore, Maryland, United States, 21212
4
Washington University
St Louis, Missouri, United States, 63110