NCT01661998

Prospective Study of Motion Preservation Evaluation Below Fusions of the Spine in Adolescent Idiopathic Scoliosis

Motion Preservation Evaluation Below Fusions of the Spine in Adolescent Idiopathic Scoliosis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 273 (actual)
• Sponsor: Setting Scoliosis Straight Foundation · Academic / Other
• Sex: All
• Age: 8 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adolescent Idiopathic Scoliosis

Timeline

• Start date: 2008-06-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2012-08-10
• Last updated: 2023-11-22

Locations

3 sites across 1 country: United States