Prospective Study of Motion Preservation Evaluation Below Fusions of the Spine in Adolescent Idiopathic Scoliosis
NCT ID: NCT01661998
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
273 participants
OBSERVATIONAL
2008-06-30
2019-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Harms Study Group
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
8 Years
21 Years
ALL
No
Sponsors
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DePuy Spine
INDUSTRY
Setting Scoliosis Straight Foundation
OTHER
Responsible Party
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Principal Investigators
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Peter Newton, MD
Role: STUDY_DIRECTOR
Rady Children's Hospital San Deigo
Locations
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Rady Children's Hospital
San Diego, California, United States
Scoliosis Associates & NYU Hospital for Joint Diseases
New York, New York, United States
Shriners Hospital for Children
Philadelphia, Pennsylvania, United States
Countries
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Related Links
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Setting Scoliosis Straight Website - highlighting the research of the Harms Study Group
Other Identifiers
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2009HSGF05
Identifier Type: -
Identifier Source: org_study_id