Clinical trial NCT00854828: A Multicenter Prospective Study of Quality of Life in Adult Scoliosis
Official title: A Multicenter Prospective Study of Quality of Life in Adult Scoliosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scoliosis
Keywords: Symptomatic 40-80 y/o w/lumbar Cobb of 30 degrees
All Participants must be reasonable surgical candidate at enrollment
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: Northwestern University
name: New York University
name: University of Virginia
name: University of Louisville
name: Maryland Spine Center
name: Hospital for Special Surgery, New York
name: University Health Network, Toronto
name: Hopital du Sacre-Coeur de Montreal
name: Dartmouth College
First posted: 2009-03-03
Enrollment: 286
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There were 2 cohorts: Randomized and Observational, each with an operative and non-operative arm.
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Scoliosis Research Society Quality of Life Questionnaire (SRS QOL) Subscore
timeFrame: Baseline, 2-year
measure: Scoliosis Research Society Quality of Life (SRS QOL) Subscore
timeFrame: Baseline, 2-year
Secondary outcomes:
measure: Oswestry Disability Index (ODI) - Randomized Cohort
timeFrame: Baseline, 2-year
measure: Oswestry Disability Index (ODI)
timeFrame: Baseline, 2-year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Baltimore
country: United States
facility: Maryland Spine Center
state: Maryland
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: New York University
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hopital du Sacre'
state: Quebec
Study officials:
affiliation: Washington University School of Medicine
name: Keith H Bridwell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dartmouth-Hitchcock Medical Center
name: Jon Lurie, MD
role: STUDY_DIRECTOR
affiliation: University of Virginia
name: Christopher Shaffrey, MD
role: STUDY_DIRECTOR
References:
citation: Dial BL, Hills JM, Smith JS, Sardi JP, Lazaro B, Shaffrey CI, Bess S, Schwab FJ, Lafage V, Lafage R, Kelly MP, Bridwell KH. The impact of lumbar alignment targets on mechanical complications after adult lumbar scoliosis surgery. Eur Spine J. 2022 Jun;31(6):1573-1582. doi: 10.1007/s00586-022-07200-3. Epub 2022 Apr 15.