Evaluation of the Providence Nighttime Brace for the Treatment of Adolescence Idiopathic Scoliosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Curve progression
研究概览
简要总结
A multicenter, prospective, non-randomized, single-arm observational study evaluating the Providence nighttime bracing system in patients diagnosed with adolescence idiopathic scoliosis.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Curve progression
时间窗: subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system
* 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.
次要结局
- Compliance(subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system)
- Functionality(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(subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system)
研究者
William Dasher, MD
Orthopaedic Spine Surgeon
OrthoGeorgia