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| Name | Class |
|---|---|
| DePuy Spine | INDUSTRY |
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The purpose of this study is to evaluate the relationship of A) The distal fusion level B) The total length of fusion and the post-operative range of motion in the unfused vertebral segments below the fusion in patients with Adolescent Idiopathic Scoliosis.
The motion behavior in the unfused segments of the spine following instrumentation is poorly understood and the implications of hyper or hypo-mobility have not been clearly defined. The purpose of this study is to evaluate the relationship of A) The distal fusion level B) The total length of fusion and the post-operative range of motion in the unfused vertebral segments below the fusion in patients with Adolescent Idiopathic Scoliosis to answer the following specific clinical questions:
Further elucidate the motion behavior of the distal unfused spinal segments, specifically:
Further elucidate the relationship of the motion in the unfused spinal segments to the lowest instrumented vertebrae.
Determine the relationship of the total length of fusion to the motion in the unfused spinal segments (i.e. compare unfused motion in the distal unfused segments in Lenke 5/6 patients fused selectively (ThL/L only) versus nonselectively (TH and ThL/L)).
Determine the relationship between clinical examinations (i.e. reports of pain or functional limitations) and patient reported outcomes (Health Related Quality of Life Outcome Tools) to motion in the distal unfused segments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Harms Study Group |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluate post-operative range of motion in the unfused vertebral segments below the fusion in patients with Adolescent Idiopathic Scoliosis. Range of motion is assessed by side-bending to the left and to the right as well as bending forward. | Data collected at patients 10 years visit. | 10 years |
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Inclusion Criteria:
Patients presenting to the primary and co-investigator's facilities will be offered inclusion into the study if they meet the following inclusion criteria:
Exclusion Criteria:
Patients will be excluded from study inclusion if they meet the following exclusion criteria:
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Patients who present to the investigator's clinic, who meet the inclusion criteria will be offered enrollment in the study
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| Name | Affiliation | Role |
|---|---|---|
| Peter Newton, MD | Rady Children's Hospital San Deigo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rady Children's Hospital | San Diego | California | 92123 | United States | ||
| Scoliosis Associates & NYU Hospital for Joint Diseases |
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| Label | URL |
|---|---|
| Setting Scoliosis Straight Website - highlighting the research of the Harms Study Group | View source |
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| New York |
| New York |
| 10017 |
| United States |
| Shriners Hospital for Children | Philadelphia | Pennsylvania | 19140 | United States |