Prospective Study of Motion Preservation Evaluation Below Fusions of the Spine in Adolescent Idiopathic Scoliosis (POM)
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|ClinicalTrials.gov Identifier: NCT01661998|
Recruitment Status : Enrolling by invitation
First Posted : August 10, 2012
Last Update Posted : April 13, 2018
|Condition or disease|
|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:
- Does motion differ at various post-operative time points (2 year post-op patients versus 5 or 10 year post-op patients)?
- Can predictive factors be identified with post-operative altered motion?
- 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.
|Study Type :||Observational|
|Actual Enrollment :||273 participants|
|Official Title:||Motion Preservation Evaluation Below Fusions of the Spine in Adolescent Idiopathic Scoliosis|
|Study Start Date :||June 2008|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
|Harms Study Group|
- 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. [ Time Frame: 10 years ]Data collected at patients 10 years visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01661998
|United States, California|
|Rady Children's Hospital|
|San Diego, California, United States, 92123|
|United States, New York|
|Scoliosis Associates & NYU Hospital for Joint Diseases|
|New York, New York, United States, 10017|
|United States, Pennsylvania|
|Shriners Hospital for Children|
|Philadelphia, Pennsylvania, United States, 19140|
|Study Director:||Peter Newton, MD||Rady Children's Hospital San Deigo|