Clinical trial NCT01661998: Prospective Study of Motion Preservation Evaluation Below Fusions of the Spine in Adolescent Idiopathic Scoliosis
Official title: Motion Preservation Evaluation Below Fusions of the Spine in Adolescent Idiopathic Scoliosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adolescent Idiopathic Scoliosis
Keywords: Adolescent Idiopathic Scoliosis
Spinal Deformity
Treatment Outcomes
Lead sponsor: Setting Scoliosis Straight Foundation
Sponsor class: OTHER
Collaborators: name: DePuy Spine
First posted: 2012-08-10
Enrollment: 273
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who present to the investigator's clinic, who meet the inclusion criteria will be offered enrollment in the study

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: New York
country: United States
facility: Scoliosis Associates & NYU Hospital for Joint Diseases
state: New York
city: Philadelphia
country: United States
facility: Shriners Hospital for Children
state: Pennsylvania
Study officials:
affiliation: Rady Children's Hospital San Deigo
name: Peter Newton, MD
role: STUDY_DIRECTOR
References: