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| Name | Class |
|---|---|
| DePuy Spine | INDUSTRY |
| Medtronic | INDUSTRY |
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Quantify the efficacy and cost of nonoperative treatment modalities used for adult spinal deformity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nonoperative | Adult spinal deformity (degenerative or idiopathic) with an ODI of 30 or greater |
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| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index (ODI) | 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. | Initial visit and six months post enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographs | Coronal and sagittal radiographic views of the spine obtained to assess coronal curvature and sagittal balance. | Initial visit (Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| SRS22r | Assess pain, function, self image, and mental health. | Initial (Day1) and six months post enrollment |
| EQ5D-3L | Assess health state (best imaginable vs worst imaginable). |
Inclusion Criteria:
Exclusion Criteria:
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Adult spinal deformity patients
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| Name | Affiliation | Role |
|---|---|---|
| Shay Bess, MD | Rocky Mountain Scoliosis and Spine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California - Davis | Sacramento | California | 95817 | United States | ||
| University of California - San Francisco Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19420361 | Background | Avorn J. Debate about funding comparative-effectiveness research. N Engl J Med. 2009 May 7;360(19):1927-9. doi: 10.1056/NEJMp0902427. No abstract available. | |
| 18794764 | Background | Baldus C, Bridwell KH, Harrast J, Edwards C 2nd, Glassman S, Horton W, Lenke LG, Lowe T, Mardjetko S, Ondra S, Schwab F, Shaffrey C. Age-gender matched comparison of SRS instrument scores between adult deformity and normal adults: are all SRS domains disease specific? Spine (Phila Pa 1976). 2008 Sep 15;33(20):2214-8. doi: 10.1097/BRS.0b013e31817c0466. |
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| ID | Term |
|---|---|
| D012600 | Scoliosis |
| D007738 | Kyphosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| Initial (Day1) and six months post enrollment |
| Work Productivity and Activity Impairment (WPAI:SHP) | Assess ability to work and perform regular activities as relates to spinal deformity. | Initial (Day1) and six months post enrollment |
| NRS | Assess back and leg pain. | Initial (Day1) and six months post enrollment |
| Resource Utilization (RRU) | 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. | Initial clinic visit (Day1) , Phone interviews at 1, 2, 3, 4, and 5 months, and 6 months clinic visit |
| San Francisco |
| California |
| 94143 |
| United States |
| Rocky Mountain Scoliosis and Spine | Denver | Colorado | 80205 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Norton Leatherman Spine Center | Louisville | Kentucky | 40202 | United States |
| Washington University at St. Louis | St Louis | Missouri | 63110 | United States |
| NYU Hospital for Joint Diseases | New York | New York | 10010 | United States |
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| Oregon Health Sciences University | Portland | Oregon | 97239 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| 14501930 | Background | Berven S, Deviren V, Demir-Deviren S, Hu SS, Bradford DS. Studies in the modified Scoliosis Research Society Outcomes Instrument in adults: validation, reliability, and discriminatory capacity. Spine (Phila Pa 1976). 2003 Sep 15;28(18):2164-9; discussion 2169. doi: 10.1097/01.BRS.0000084666.53553.D6. |
| 20703148 | Background | Bonham AC, Rich EC, Davis DA, Longnecker DE, Heinig SJ. Commentary: Putting evidence to work: an expanded research agenda for academic medicine in the era of health care reform. Acad Med. 2010 Oct;85(10):1551-3. doi: 10.1097/ACM.0b013e3181effdbc. |
| 17873814 | Background | Bridwell KH, Berven S, Glassman S, Hamill C, Horton WC 3rd, Lenke LG, Schwab F, Baldus C, Shainline M. Is the SRS-22 instrument responsive to change in adult scoliosis patients having primary spinal deformity surgery? Spine (Phila Pa 1976). 2007 Sep 15;32(20):2220-5. doi: 10.1097/BRS.0b013e31814cf120. |
| 19752703 | Background | Bridwell KH, Glassman S, Horton W, Shaffrey C, Schwab F, Zebala LP, Lenke LG, Hilton JF, Shainline M, Baldus C, Wootten D. Does treatment (nonoperative and operative) improve the two-year quality of life in patients with adult symptomatic lumbar scoliosis: a prospective multicenter evidence-based medicine study. Spine (Phila Pa 1976). 2009 Sep 15;34(20):2171-8. doi: 10.1097/BRS.0b013e3181a8fdc8. |
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| 19420360 | Background | Garber AM, Tunis SR. Does comparative-effectiveness research threaten personalized medicine? N Engl J Med. 2009 May 7;360(19):1925-7. doi: 10.1056/NEJMp0901355. No abstract available. |
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| 16166889 | Background | Glassman SD, Bridwell K, Dimar JR, Horton W, Berven S, Schwab F. The impact of positive sagittal balance in adult spinal deformity. Spine (Phila Pa 1976). 2005 Sep 15;30(18):2024-9. doi: 10.1097/01.brs.0000179086.30449.96. |
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