Clinical trial NCT01880164: Cost Effectiveness of Nonoperative Management for Adult Spinal Deformity
Official title: Cost Effectiveness of Nonoperative Management for Adult Spinal Deformity Associated With Low Grade Scoliosis: A Prospective Pilot Study to Evaluate Disease Burden and Longitudinal Study Feasibility
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Deformity
Keywords: Scoliosis
Kyphosis
Sagittal plane deformity
Lead sponsor: International Spine Study Group Foundation
Sponsor class: OTHER
Collaborators: name: DePuy Spine
name: Medtronic
First posted: 2013-06-18
Enrollment: 21
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult spinal deformity patients

Brief summary: Quantify the efficacy and cost of nonoperative treatment modalities used for adult spinal deformity.

Detailed description: 1. Identify disease burden associated with adult spinal deformity (ASD) using quality adjusted life year (QALY) analysis.
2. Identify disease burden of specific demographic and radiographic features associated with ASD.
3. Compare disease burden of ASD to other musculoskeletal and non-musculoskeletal diseases.
4. Identify efficacy of specific nonoperative treatment modalities to treat ASD and identify specific clinical and radiographic features of ASD responsive to nonoperative treatment modalities.
5. Compare QALY and ICER values for different ASD nonoperative treatment modalities to previously established QALY and ICER for values for operative and nonoperative treatment modalities for degenerative hip and knee disease, coronary artery disease, insulin dependent diabetes, and hypertension.
6. Evaluate the cost and work hours associated with data collection and minimum 85% patient follow up.
7. Evaluate patient characteristics associated with poor patient compliance for study follow up including demographic, radiographic and HRQOL values and for reasons for cross-over to operative treatment for ASD.
8. Establish standardized data collection methodology for economic based outcome studies based upon patient demographics and HRQOL values.

Eligibility criteria: Inclusion Criteria:

1. Age 40-75 years of age at the time of enrollment.
2. ODI ≥30
3. Adult degenerative or idiopathic lumbar scoliosis 10-40° as measured by the Cobb angle technique
4. Sagittal plane deformity by SRS Schwab classification with at least one modifier ++ or two modifiers + and associated coronal cobb of at least 10 degrees

Exclusion Criteria:

1. Adult degenerative or idiopathic scoliosis with a curvature of the spine measuring \<10 degrees or \>40 degrees
2. Diagnosis of scoliosis other than degenerative or idiopathic (i.e. neuromuscular, congenital, etc.)
3. Cardiopulmonary disease or comorbidities that preclude surgical intervention
4. Patient not deemed surgical candidate by treating surgeon
5. Patient unwilling to commit to monthly phone interviews or completion of necessary questionnaires or inability to return for defined follow up time points. Patients unwilling to comply with study protocol will not be offered enrollment into the study, regardless of meeting inclusion criteria.

Primary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: Initial visit and six months post enrollment
Secondary outcomes:
measure: Radiographs
timeFrame: Initial visit (Day 1)
Other outcomes:
measure: SRS22r
timeFrame: Initial (Day1) and six months post enrollment
measure: EQ5D-3L
timeFrame: Initial (Day1) and six months post enrollment
measure: Work Productivity and Activity Impairment (WPAI:SHP)
timeFrame: Initial (Day1) and six months post enrollment
measure: NRS
timeFrame: Initial (Day1) and six months post enrollment
measure: Resource Utilization (RRU)
timeFrame: Initial clinic visit (Day1) , Phone interviews at 1, 2, 3, 4, and 5 months, and 6 months clinic visit
Locations:
city: Sacramento
country: United States
facility: University of California - Davis
state: California
city: San Francisco
country: United States
facility: University of California - San Francisco Medical Center
state: California
city: Denver
country: United States
facility: Rocky Mountain Scoliosis and Spine
state: Colorado
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: Norton Leatherman Spine Center
state: Kentucky
city: St. Louis
country: United States
facility: Washington University at St. Louis
state: Missouri
city: New York
country: United States
facility: NYU Hospital for Joint Diseases
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: Rocky Mountain Scoliosis and Spine
name: Shay Bess, MD
role: PRINCIPAL_INVESTIGATOR
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