Evaluation of the Providence Nighttime Brace for the Treatment of Adolescence Idiopathic Scoliosis

A multicenter, prospective, non-randomized, single-arm observational study evaluating the Providence nighttime bracing system in patients diagnosed with adolescence idiopathic scoliosis.

Study Overview

• Status: Unknown
• Conditions: Adolescence Idiopathic Scoliosis
• Intervention / Treatment: Device: Providence Nighttime Bracing System; Device: Providence Nighttime Bracing System

Detailed Description

This study is designed as a multicenter, prospective, non-randomized, single arm observational study. A temperature probe and data logger will be attached to the Providence brace to monitor patient compliance wear time. Subjects will be blinded to temperature sensor readings to maximize objectivity of brace wear.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Macon, Georgia, United States, 31201
      • Recruiting
      • Georgia Pediatric Orthopaedics
      • Contact: Craig C Odum; Phone Number: 478-254-5377; Email: codum@orthoga.org
    • Macon, Georgia, United States, 31201
      • Recruiting
      • OrthoGeorgia
      • Contact: Craig C Odum; Phone Number: 478-254-5377; Email: codum@orthoga.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

up to 100 adolescent male/female will be enrolled at up to 4 sites in the US. Patients must be at least 10 years of age. Participants who receive treatment must have been diagnosed with adolescent idiopathic scoliosis without other significant spinal pathology. Appropriate participant selection will be accomplished through the integration of clinical and radiological parameters while ruling out other confounding sources of back pain or curvature. Subjects will be included who demonstrate a Cobb angle between 25-40 degrees. Participants must have radiographic evidence of a Risser grade of 0, 1, or 2. All chronic disease process and other possible sources for spinal curvature will be excluded by thorough history and physical examination.

Description

Inclusion Criteria:

• Subject/guardian is able to provide informed consent and must sign the Institutional Review Board approved Informed Consent Form;
• Clinical/radiographic diagnosis of adolescence idiopathic scoliosis;
• Male/female;
• Skeletally immature (Risser grade 0, 1, or 2);
• Cobb angle between 25-40 degrees;
• Pre-menarchal or post-menarchal by no more than 1 year at the time of diagnosis;
• Curve apex caudal to T6 vertebrae;
• Physical and mental ability to adhere to bracing protocol;
• Have agreed to refuse participation in another clinical trial for the duration of the study.

Exclusion Criteria:

• History of previous surgical intervention or other invasive treatment for AIS;
• History of orthotic treatment or other brace wear for the treatment of AIS;
• Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature;
• Tumor or malignant tumor in the spine;
• Inability to communicate clearly in the English language;
• Subjects with a Risser score ≥ 3;
• Plans to relocate within the next 2 years;
• Any subject the Principle Investigator deems as an unfit candidate.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adolescence idiopathic scoliosis; Patients must be at least 10 years of age with a risser score of 0, 1, or 2	Device: Providence Nighttime Bracing System; Providence Nighttime Bracing System; Device: Providence Nighttime Bracing System; The Providence brace is a polypropylene plastic, acrylic framed, system designed to apply corrective forces to scoliatic curves achieving correction or reduction of scoliosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Curve progression	The percentage of patients who have ≤5o curve progression and the percentage of patients who have ≥6 o progression at maturity;; The percentage of patients with curves exceeding 45o at maturity and the percentage who have had surgery recommended/undergone;; 2 year follow-up beyond maturity to determine the percentage of patients who subsequently undergo surgery. Routine follow-up visits will be scheduled 6 months apart (1st visit after brace fitting, 6, 12, 18 and 24 months) up to 24 months. At each of these visits, the patient will undergo a history & physical, PA radiographs, Cobb Angle assessment, Adams Forward Bending test, Neurological examination, outcome questionnaire's, concomitant medications, and adverse event recordings.	subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance	A temperature data logger will record and monitor patient compliance of brace wear. To not create undue awareness to these recordings patients will be informed the temperature readings are being monitored for patient comfort and ease of brace wear. Reconciliation of data logger recordings will be conducted every 3 months.	subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system
Functionality	Both study subjects and their guardians will be asked to fill out an Adolescent Health Assessment. Based on the Version 2.0 Pediatrics-Parent/ Adolescent Outcomes Instrument also commonly referred to as the PODCI ("Pediatric Outcomes Data Collection Instrument")	subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system
physical health and personal image	Both study subjects and their guardians will be asked to fill out an Adolescent Health Assessment. Based on the Version 2.0 Pediatrics-Parent/ Adolescent Outcomes Instrument also commonly referred to as the PODCI ("Pediatric Outcomes Data Collection Instrument")	subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system

Collaborators and Investigators

• Sponsor: OrthoGeorgia
• Investigators: Principal Investigator: William B Dasher, MD, OrthoGeorgia; Principal Investigator: Eric D Lincoln, DO, Georgia Pediatric Orthopaedics; Principal Investigator: Winston R Jeshuran, MD, OrthoGeorgia; Principal Investigator: Wayne Kelley, MD, OrthoGeorgia; Principal Investigator: Randolph Devereaux, PhD, Mercer University School of Medicine; Principal Investigator: Hamza H Awad, MD, PhD, Mercer University School of Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: August 22, 2014
• First Submitted That Met QC Criteria: August 26, 2014
• First Posted (Estimate): August 28, 2014

Study Record Updates

• Last Update Posted (Estimate): April 21, 2015
• Last Update Submitted That Met QC Criteria: April 20, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Adolescence Idiopathic Scoliosis; nighttime Bracing; Providence
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: OG12-04-13