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



Status:Enrolling by invitation
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:Any - 21
Updated:4/6/2019
Start Date:June 2008
End Date:December 2019

Use our guide to learn which trials are right for you!

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.

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.

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
We found this trial at
3
sites
San Diego, California 92123
?
mi
from
San Diego, CA
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19140
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials