Clinical trial NCT02227537: Evaluation of the Providence Nighttime Brace for the Treatment of Adolescence Idiopathic Scoliosis
Official title: Evaluation of the Providence Nighttime Brace for the Treatment of Adolescence Idiopathic Scoliosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adolescence Idiopathic Scoliosis
Keywords: Adolescence Idiopathic Scoliosis
nighttime Bracing
Providence
Lead sponsor: OrthoGeorgia
Sponsor class: OTHER
First posted: 2014-08-28
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Curve progression
timeFrame: subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system
Secondary outcomes:
measure: Compliance
timeFrame: subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system
measure: Functionality
timeFrame: subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system
measure: physical health and personal image
timeFrame: subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system
Other outcomes:
Locations:
city: Macon
country: United States
facility: Georgia Pediatric Orthopaedics
state: Georgia
city: Macon
country: United States
facility: OrthoGeorgia
state: Georgia
Study officials:
affiliation: OrthoGeorgia
name: William B Dasher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Georgia Pediatric Orthopaedics
name: Eric D Lincoln, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: OrthoGeorgia
name: Winston R Jeshuran, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: OrthoGeorgia
name: Wayne Kelley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mercer University School of Medicine
name: Randolph Devereaux, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mercer University School of Medicine
name: Hamza H Awad, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: