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

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ClinicalTrials.gov Identifier: NCT01661998
Recruitment Status : Enrolling by invitation
First Posted : August 10, 2012
Last Update Posted : April 19, 2016
Sponsor:
Collaborator:
DePuy Spine
Information provided by (Responsible Party):
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.

Condition or disease
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 Type : Observational
Actual Enrollment : 273 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Motion Preservation Evaluation Below Fusions of the Spine in Adolescent Idiopathic Scoliosis
Study Start Date : June 2008
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis
U.S. FDA Resources

Group/Cohort
Harms Study Group



Primary Outcome Measures :
  1. Change in radiographic outcome for surgical treatment of idiopathic scoliosis from 2-5 years [ Time Frame: 5 years ]
    Data collected at patients 2-5 years visit.


Secondary Outcome Measures :
  1. Change in clinical outcomes for surgical treatment of idiopathic scoliosis from 2-5 years [ Time Frame: 5 years ]
    Data collected at patients 2-5 years visit.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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 2, 3, 4 or 5 year post-operative visit

Exclusion Criteria:

  • Patients will be excluded from study inclusion if they meet the following exclusion criteria:

    • Neuromuscular co-morbidity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01661998


Locations
United States, Delaware
A.I. DuPont Hosp for Children
Wilmington, Delaware, United States, 19803
United States, New York
Mamonides Medical Center
Brooklyn, New York, United States, 11219
Scoliosis Associates & NYU Hospital for Joint Diseases
New York, New York, United States, 10017
United States, Pennsylvania
Shriners Hospital for Children
Philadelphia, Pennsylvania, United States, 19140
Canada
British Columbia Children's Hospital
Vancouver, Canada
Sponsors and Collaborators
Setting Scoliosis Straight Foundation
DePuy Spine
Investigators
Study Director: Peter Newton, MD Rady Children's Hospital San Deigo

Additional Information:
Responsible Party: Setting Scoliosis Straight Foundation
ClinicalTrials.gov Identifier: NCT01661998     History of Changes
Other Study ID Numbers: 2009HSGF05
First Posted: August 10, 2012    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016

Keywords provided by Setting Scoliosis Straight Foundation:
Adolescent Idiopathic Scoliosis
Spinal Deformity
Treatment Outcomes

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases