A Multicenter Prospective Study of Quality of Life in Adult Scoliosis

Not Applicable

Completed

Conditions: Scoliosis

Interventions: Procedure: Surgical intervention
Other: Non-operative intervention

Registration Number: NCT00854828

Lead Sponsor: Washington University School of Medicine

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 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.

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 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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 286

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical Intervention	Surgical intervention	-
Non-Operative Intervention	Non-operative intervention	-

Primary Outcome Measures

Name	Time	Method
Scoliosis Research Society Quality of Life (SRS QOL) Subscore	Baseline, 2-year	Change was calculated as the SRS QOL Subscore value at 2-year as-treated follow-up minus the value at Baseline in the Observational cohort. SRS QOL Subscore value range is 1 to 5, where 5 is the best score and 1 is the worst score possible.
Scoliosis Research Society Quality of Life Questionnaire (SRS QOL) Subscore	Baseline, 2-year	Change was calculated as the SRS QOL Subscore value at 2-year minus the value at Baseline for Randomized Cohort (Intent-to-Treat analysis). SRS QOL Subscore value range is 1 to 5, where 5 is the best score and 1 is the worst score possible.

Secondary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI) - Randomized Cohort	Baseline, 2-year	Change was calculated as the ODI score at 2-year minus the value at Baseline in Randomized Cohort (intent-to-treat analysis). ODI score range is 0 to 100, where 0 is the best score and 100 is the worst score possible.
Oswestry Disability Index (ODI)	Baseline, 2-year	Change was calculated as the ODI score at 2-year as treated follow-up minus the value at baseline. ODI score range is 0 to 100, where 0 is the best score and 100 is the worst score possible.

Trial Locations

Locations (9): Washington University
🇺🇸
Saint 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
Hopital du Sacre'
🇨🇦
Montreal, Quebec, Canada
University of Louisville
🇺🇸
Louisville, Kentucky, United States
Maryland Spine Center
🇺🇸
Baltimore, Maryland, United States
Northwestern University
🇺🇸
Chicago, Illinois, United States
Toronto Western Hospital
🇨🇦
Toronto, Ontario, Canada