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Scoliosis Survey to Development Treatment Decision Tool

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ClinicalTrials.gov Identifier: NCT03017755
Recruitment Status : Recruiting
First Posted : January 11, 2017
Last Update Posted : February 18, 2022
Sponsor:
Information provided by (Responsible Party):
Todd A. Milbrandt, M.D., Mayo Clinic

Study Description
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Brief Summary:
This is a survey to help understand the influences related to the decision for Adolescent Idiopathic Scoliosis treatment (observation vs. bracing vs. surgery). The investigator then plans to create a decision aid to help families when making a decision about the treatment choice being presented to them.

Condition or disease Intervention/treatment
Scoliosis; Adolescence Other: Survey for Patients Treated for Scoliosis and ther Families

Detailed Description:
This survey is designed to help understand the factors that families consider to help make treatment decisions related to Adolescent Idiopathic Scoliosis (AIS). The surveys will then be used to help create a shared decision making tool to help families better understand the treatment options and optimize clinical conversations surrounding AIS treatment.
Study Design
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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Your Scoliosis Journey: A Survey for Patients Treated for Scoliosis and Their Families
Actual Study Start Date : April 11, 2017
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: Survey for Patients Treated for Scoliosis and ther Families
    Your Scoliosis Journey: A Survey for Patients Treated for Scoliosis and ther Families

Outcome Measures
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Primary Outcome Measures :
  1. Number of subjects who completed the survey [ Time Frame: Baseline, approximately 3 years ]
    Number of subjects who completed the survey


Eligibility Criteria
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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adolecent Idiopathic Scoliosis (AIS) patients and their families
Criteria

Inclusion Criteria:

  • Subject (and/or parent of subject) who has previously been treated for Adolescent Idiopathic Scoliosis (AIS)

Exclusion Criteria:

  • Age less than or equal to 12 years
Contacts and Locations
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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): NCT03017755


Contacts
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Contact: Damian Paulson 507-293-6713 paulson.damian@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Natalie Pulido       scoliosis@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Todd A Milbrandt, MD Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Todd A. Milbrandt, M.D., MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03017755    
Other Study ID Numbers: 16-008212
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: February 18, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases