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

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.

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Key information

Conditions

Adolescent Idiopathic Scoliosis

Age range

8 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rady Children's Hospital, San Diego, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Setting Scoliosis Straight Foundation

Other

Collaborators

DePuy Spine

Registry information

Official study title

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

Acronym: POM

Important dates

Study start: 2008
Primary completion: 2019
Study completion: 2019
First posted: Aug 10, 2012
Registry last updated: Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed