Scoliosis Survey to Develop Treatment Decision Tool

O&P News, July 2017

ClinicalTrials.gov identifier: NCT03017755

Purpose: This survey aims to help understand the influences related to the decision
for adolescent idiopathic scoliosis (AIS) treatment (observation vs. bracing vs.
surgery). The investigator plans to create a decision aid to help families make a
decision about the treatment choice being presented to them.

Study type: Observational

Study design: The study will use a cohort observational model and prospective time
perspective.

Estimated enrollment: 1,000

Eligibility criteria: The ages eligible for this study are 13 years or older. Both genders
are eligible. Healthy volunteers are not accepted. The sampling method is nonprobability
and the study population is AIS patients and their families. Inclusion
criteria: Subject and/or parent of subject who has previously been treated for AIS.
Exclusion criteria: Age younger than or equal to 12 years.

Study start date: April 11, 2017

Estimated study completion date: December 2018

Estimated primary completion date: December 2018 (final data collection date for
primary outcome measure)

Primary outcome measures: The primary outcome measure is to analyze the
number of subjects who have completed the survey (time frame: baseline,
approximately 3 years).

Secondary outcome measures: None

Sponsors and collaborators: Mayo Clinic
Contact: Vickie M. Treder, (507) 538-3561, treder.vickie@mayo.edu.
Information acquired from: Mayo Clinic, via ClinicalTrials.gov

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