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

Completed

• Conditions: Adolescent Idiopathic Scoliosis

• Registration Number: NCT01661998
• Lead Sponsor: Setting Scoliosis Straight Foundation

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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2012-07-10
• Study First Submitted QC: 2012-08-07
• Study First Posted: 2012-08-10
• Status Verified: 2019-04
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 273

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 exclusion criteria:

  • Neuromuscular co-morbidity

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Shriners Hospital for Children; 🇺🇸 Philadelphia, Pennsylvania, United States

Rady Children's Hospital; 🇺🇸 San Diego, California, United States

Scoliosis Associates & NYU Hospital for Joint Diseases; 🇺🇸 New York, New York, United States