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

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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 273

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Rady Children's Hospital
  • New York
    • New York, New York, United States, 10017
      • Scoliosis Associates & NYU Hospital for Joint Diseases
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Shriners Hospital for Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (Child, Adult)
• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Harms Study Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Data collected at patients 10 years visit.	10 years

Collaborators and Investigators

• Sponsor: Setting Scoliosis Straight Foundation
• Collaborators: DePuy Spine
• Investigators: Study Director: Peter Newton, MD, Rady Children's Hospital San Deigo

Publications and helpful links

Helpful Links

• Setting Scoliosis Straight Website - highlighting the research of the Harms Study Group

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: July 10, 2012
• First Submitted That Met QC Criteria: August 7, 2012
• First Posted (Estimated): August 10, 2012

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Treatment Outcomes; Adolescent Idiopathic Scoliosis; Spinal Deformity
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: 2009HSGF05