Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
NCT ID:
NCT00854828
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 \<-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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT00854828
Study Brief:
Protocol Section:
NCT00854828