Trial record 2 of 31 for:    "adolescent idiopathic scoliosis"

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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
DePuy Spine
Information provided by (Responsible Party):
Setting Scoliosis Straight Foundation
ClinicalTrials.gov Identifier:
NCT01661998
First received: July 10, 2012
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

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
Adolescent Idiopathic Scoliosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Motion Preservation Evaluation Below Fusions of the Spine in Adolescent Idiopathic Scoliosis

Resource links provided by NLM:


Further study details as provided by Setting Scoliosis Straight Foundation:

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


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


Enrollment: 273
Study Start Date: June 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Harms Study Group

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

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Setting Scoliosis Straight Foundation
ClinicalTrials.gov Identifier: NCT01661998     History of Changes
Other Study ID Numbers: 2009HSGF05
Study First Received: July 10, 2012
Last Updated: December 20, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014