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

Adolescent Idiopathic Scoliosis Clinical Trial

— POM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01661998
• Other study ID #: 2009HSGF05
• Status: Completed
• Start date: June 2008
• Est. completion date: December 2019

Study information

• Verified date: April 2019
• Source: Setting Scoliosis Straight Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Locations

Country	Name	City	State
United States	Scoliosis Associates & NYU Hospital for Joint Diseases	New York	New York
United States	Shriners Hospital for Children	Philadelphia	Pennsylvania
United States	Rady Children's Hospital	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Setting Scoliosis Straight Foundation	DePuy Spine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Data collected at patients 10 years visit.	10 years

External Links

•   Setting Scoliosis Straight Website - highlighting the research of the Harms Study Group