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

NCT02412137 | Completed Results DMC

• 1 other identifier: 112007-014
• Study Type: interventional
• Target: 245
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Brace Progress Report (i.e. Informing the Patient How Often They Were Wearing the Brace Versus Not Informing the Patient)

  Final treatment outcome of bracing vs surgery (i.e. how many patients had surgery versus no surgery for their spinal deformity). For each patient this time frame varies, patient "A" may effectively wear a brace that controls their spinal deformity for 4 years and never need surgical intervention, patient "B" may effectively wear a brace for a year but has a spinal deformity that continues to get larger and need surgical intervention, and patient "C" may wear a brace less than prescribed (noncompliant) for 2 years and progress to surgery.

  up to 4 years, depending on length of bracing

Study Arms (2)

Counseled Patients

EXPERIMENTAL

The counseled cohort will have their brace wear compliance documented on the Brace Progress Report after the Orthotist downloads the time/temperature data onto a laptop from the sensor reader (A piece of computer hardware which the sensor clips into and is attached to the laptop via the USB port). The Orthotist will then reset the temperature logger discs and reinstall them into the padding in the inside front of the brace in order to monitor the next period of brace wear. This group will then be counseled for about 10 minutes or less regarding their brace-wear using the Brace Progress report as a checklist.

Other: Counseled cohort

Non-counseled patients

PLACEBO COMPARATOR

The non-counseled cohort will have their brace wear compliance documented on the Brace Progress Report after the Orthotist downloads the time/temperature data onto a laptop from the sensor reader (A piece of computer hardware which the sensor clips into and is attached to the laptop via the USB port). The Orthotist will then reset the temperature logger discs and reinstall them into the padding in the inside front of the brace in order to monitor the next period of brace wear. This group will not be counseled, and will only receive standard clinical care.

Other: Counseled cohort

Interventions

Counseled cohort OTHER

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

Counseled Patients; Non-counseled patients

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male and female patients of all races and ethnic backgrounds between the ages of 10 and 16, who have been or who are being treated for idiopathic scoliosis with a Boston brace at Texas Scottish Rite Hospital for Children. These patients will not have worn braces before and have scoliosis curves measuring from 25-45 degrees and are Risser 0, 1, or 2. Female patients will be premenarchal or \<1 year post menarchal.

You may not qualify if:

• Patients with juvenile scoliosis (age less than 10 years), patients with non-idiopathic scoliosis, patients with curves measuring \<25 degrees or \>45 degrees at the time of brace prescription, patients previously treated with spinal surgery or orthoses, girls who are greater than one year postmenarchal, and patients who are Risser 3, 4, or 5.
• Furthermore, if during the course of treatment a diagnosis of non-idiopathic scoliosis, i.e. if a spinal cord abnormality such as a syrinx, becomes apparent, the previously enrolled patient will be excluded from the study.

Sponsors & Collaborators

• Texas Scottish Rite Hospital for Children: lead

Related Publications (1)

• Alvarez I, Poppino K, Karol L, McIntosh AL. Lack of in-brace x-rays in compliant AIS patients wearing full-time TLSO braces associates with failure. J Orthop Surg Res. 2021 Aug 31;16(1):540. doi: 10.1186/s13018-021-02650-9.

  PMID: 34465348 DERIVED

Results Point of Contact

• Title: Dr. Brandon Ramo
• Organization: Texas Scottish Rite Hospital for Children

brandon.ramo@tsrh.org

2145597755

Study Officials

• Lori Karol, MD

  Texas Scottish Rite Hospital for Children

  PRINCIPAL INVESTIGATOR

• Brandon Ramo, MD

  Texas Scottish Rite Hospital for Children

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2015
• First Posted: April 8, 2015
• Study Start: December 1, 2007
• Primary Completion: March 1, 2015
• Study Completion: June 1, 2020
• Last Updated: October 31, 2024
• Results First Posted: October 31, 2024

Record last verified: 2024-10