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Effect of Compliance Counseling on Brace Success in Patients With Idiopathic Scoliosis

NCT02412137 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2024-10-31

Study results available
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Summary

To measure the effectiveness of counseling on brace-wear compliance and curve progression in patients with adolescent idiopathic scoliosis. The investigators hypothesize that compliance is increased when it is measured and used to counsel patients, and therefore those patients will have less curve progression and fewer would need surgery.

A second purpose is to evaluate whether there is a correlation between BMI and brace effectiveness. Proposed theories for decreased effectiveness in patients with elevated BMI have included decreased compliance due to discomfort and decreased force exerted on the curve due to the larger habitus.

Conditions

  • Adolescent Idiopathic Scoliosis

Interventions

OTHER

Counseled cohort

This group will be counseled after brace temperature/date/time data is logged at each visit.

Sponsors & Collaborators

  • Texas Scottish Rite Hospital for Children

    lead OTHER

Principal Investigators

  • Lori Karol, MD · Texas Scottish Rite Hospital for Children

  • Brandon Ramo, MD · Texas Scottish Rite Hospital for Children

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2015-03-31
Completion
2020-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02412137 on ClinicalTrials.gov