NCT04929678终止不适用
A Prospective, Multi-Center Study of the Braive™ Growth Modulation System When Used in the Treatment of Pediatric Patients Diagnosed With Juvenile or Adolescent Idiopathic Scoliosis
Medtronic Spinal and Biologics4 个研究点 分布在 3 个国家目标入组 10 人开始时间: 2021年8月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Summary of Device-related Adverse Events up to 24 Months
研究概览
简要总结
The purpose of this study was to establish probable benefits and evaluate the safety and preliminary effectiveness of the Braive™ GMS when used in the treatment of pediatric progressive scoliosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A subject must meet all of the following inclusion criteria to participate in this study:
- •Has a diagnosis of juvenile or adolescent idiopathic scoliosis
- •Is skeletally immature with a Sanders Score of ≥2 to ≤5
- •Has failed conservative care as per investigator's assessment
- •Has a main thoracic Cobb angle between 30 and 60 degrees
- •Has a Lenke Classification of 1A, 1B, or 1C
- •Has kyphosis ≤ 40 degrees with a sagittal thoracic modifier N or negative
- •Informed Consent Form/Assent and Authorization to Use and Disclose Health Information (if applicable) have been signed by Parent/legal guardian and/or patient/participant per local requirement.
排除标准
- •A subject will be excluded from participating in this study for any of the following reasons:
- •Has undergone previous spinal fusion procedure(s) at the affected levels
- •Is pregnant or plans to become pregnant within the first 24-months of the study
- •Has a curve that requires instrumentation below L1
- •Has spinal MRI abnormalities (e.g., CHIARI malformation, Syrinx greater than 4mm, tethered cord)
- •Has any type of non-idiopathic scoliosis
- •Has a left-sided curve
- •Has an associated syndrome
- •Has a history of malignant hyperthermia
- •Has an active or significant risk of infection (immunocompromised)
- •Has inadequate tissue coverage over the operative site as per investigator's assessment
- •Has a suspected or documented allergy or intolerance to implant materials
- •Has a major psychiatric disorder / history of drug abuse that would interfere with the subject's ability to comply with study instructions or might confound the study interpretation as per investigator's assessment (DSM-5 can be used as a reference)
- •Is a ward of the court/state
- •Has had prior ipsilateral or contralateral chest surgery
- •Has severe chronic lung disease (e.g., asthma, bronchiectasis)
- •Has poor bone quality, as determined by the investigator, that may limit anterior fixation
- •Is unwilling or unable to return for follow-up visits and/or follow intra-operative and/or postoperative instructions
- •Concurrent participation in another clinical study that may add additional safety risks and/or confound study results
结局指标
主要结局
Summary of Device-related Adverse Events up to 24 Months
时间窗: Implanted surgery to 24 months
Device related adverse events are any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, related to the investigational medical device whether anticipated or unanticipated. Summary will be based on both Investigators and Medtronic relatedness assessment.
次要结局
- Assessment of Procedure-related Adverse Events up to 24 Months(Implanted surgery to 24 months)
- Assessment of Secondary Spinal Surgeries Related to the Original Study Device up to 24 Months.(Implanted surgery to 24 months)
- Assessment of Device Deficiency up to 24 Months(Implanted surgery to 24 months)
- Change From Baseline in Main Thoracic Cobb Angle at All Available Postoperative Time Points(Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months)
- Change From Baseline in Proximal Thoracic Cobb Angle at All Available Postoperative Timepoints(Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months)
- Change From Baseline in Thoracolumbar/Lumbar Cobb Angle at All Available Postoperative Timepoints(Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months)
- Change From Post-op Baseline in Instrumented Cobb Angle at All Available Postoperative Time Points.(Immediately after the surgery, 3, 6, 12, 18, 24 months)
- Change From Baseline in Thoracic Kyphosis at All Available Postoperative Timepoints(Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months)
- Change From Baseline in Lumbar Lordosis at All Available Postoperative Timepoints.(Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months)
- Change From Baseline in Coronal Balance at All Available Postoperative Timepoints.(Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months)
- Change From Baseline in Sagittal Balance at All Available Postoperative Timepoints(Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months)
- Change From Baseline in Total Vertical Thoracic Spine Height (T1-T12) at All Available Postoperative Timepoints.(Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months)
- Change From Baseline in Total Vertical Spine Height (T1-S1) at All Available Postoperative Timepoints(Baseline, immediately after the surgery, 3, 6, 12, 18, 24 months)
- Change From Baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at All Available Postoperative Timepoint(Baseline to 3, 6, 12, 18, 24 months)
- Status of Return to Full Activity Within 3 Months Per Scoliosis Research Society-22 Patient Questionnaire (SRS-22)(3 months.)
研究者
研究点 (4)
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