N/A
N=286
A Multicenter Prospective Study of Quality of Life in Adult Scoliosis
Scoliosis
Bottom Line
View on ClinicalTrials.gov: NCT00854828 ↗Enrolled (actual)
286
Serious AEs
39.3%
Results posted
Sep 2021
Primary outcome: Primary: Scoliosis Research Society Quality of Life Questionnaire (SRS QOL) Subscore — 0.5; 0.5 score on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Surgical intervention (Procedure); Non-operative intervention (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Scoliosis Research Society Quality of Life Questionnaire (SRS QOL) Subscore |
0.5; 0.5 | <0.001 sig |
| PRIMARY Scoliosis Research Society Quality of Life (SRS QOL) Subscore |
0.7; 0.1 | — |
| SECONDARY Oswestry Disability Index (ODI) - Randomized Cohort |
-13; -9 | — |
| SECONDARY Oswestry Disability Index (ODI) |
-15; -2 | — |
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 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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT00854828). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.