Adolescent Idiopathic Scoliosis
Conditions
Keywords
Adolescent Idiopathic Scoliosis, Spinal Deformity, Treatment Outcomes
Brief summary
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.
Detailed description
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: 1. Further elucidate the motion behavior of the distal unfused spinal segments, specifically: 1. Does motion differ at various post-operative time points (2 year post-op patients versus 5 or 10 year post-op patients)? 2. Can predictive factors be identified with post-operative altered motion? 2. Further elucidate the relationship of the motion in the unfused spinal segments to the lowest instrumented vertebrae. 3. 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)). 4. 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.
Interventions
None listed
Sponsors
DePuy Spine
Setting Scoliosis Straight Foundation
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
8 Years to 21 Years
Healthy volunteers
No
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: * Patient age \< 21 years * Male or female * Diagnosis of Adolescent Idiopathic Scoliosis * Any Lenke Classification type * Underwent surgical correction of the spinal deformity with a fusion * Are due for their 10 year post-operative visit
Exclusion criteria
* Patients will be excluded from study inclusion if they meet the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 10 years | Data collected at patients 10 years visit. |
Countries
United States
Outcome results
None listed