Spinal Deformity
Conditions
Keywords
Scoliosis, Kyphosis, Sagittal plane deformity
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.
Interventions
None listed
Sponsors
DePuy Spine
Medtronic
Shay Bess
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index (ODI) | Initial visit and six months post enrollment | This questionnaire has been designed to provide information as to how back pain affects ability to manage in everyday life. Score must be equal to or greater than 30 for eligibility to enroll. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographs | Initial visit (Day 1) | Coronal and sagittal radiographic views of the spine obtained to assess coronal curvature and sagittal balance. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Work Productivity and Activity Impairment (WPAI:SHP) | Initial (Day1) and six months post enrollment | Assess ability to work and perform regular activities as relates to spinal deformity. |
| SRS22r | Initial (Day1) and six months post enrollment | Assess pain, function, self image, and mental health. |
| Resource Utilization (RRU) | Initial clinic visit (Day1) , Phone interviews at 1, 2, 3, 4, and 5 months, and 6 months clinic visit | Document nonoperative treatment modalities, such as observation only, pain medicine, physical therapy, chiropractic care, injections, diagnostic radiology, emergency visits, and other therapies. Analysis of this data will determine cost associated with nonoperative care for adult spinal disorders. |
| NRS | Initial (Day1) and six months post enrollment | Assess back and leg pain. |
| EQ5D-3L | Initial (Day1) and six months post enrollment | Assess health state (best imaginable vs worst imaginable). |
Countries
United States
Outcome results
None listed