NCT01661998

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
273

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 10, 2012

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 22, 2023

Status Verified

April 1, 2019

Enrollment Period

11.5 years

First QC Date

July 10, 2012

Last Update Submit

November 21, 2023

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Adolescent Idiopathic ScoliosisSpinal DeformityTreatment Outcomes

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Harms Study Group

Eligibility Criteria

Age8 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients who present to the investigator's clinic, who meet the inclusion criteria will be offered enrollment in the study

You may qualify if:

  • 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

You may not qualify if:

  • Neuromuscular co-morbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Rady Children's Hospital

San Diego, California, 92123, United States

Location

Scoliosis Associates & NYU Hospital for Joint Diseases

New York, New York, 10017, United States

Location

Shriners Hospital for Children

Philadelphia, Pennsylvania, 19140, United States

Location

Related Links

Study Officials

  • Peter Newton, MD

    Rady Children's Hospital San Deigo

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2012

First Posted

August 10, 2012

Study Start

June 1, 2008

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

November 22, 2023

Record last verified: 2019-04

Locations

US(3)