A Retrospective Review of Clinical and Radiographic Outcomes Following the Use of the REFLECT™ Scoliosis Correction System in the Treatment of Idiopathic Scoliosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- REFLECT Cord Breakage/Separation
研究概览
简要总结
This study reviews medical records of children and adolescents treated for idiopathic scoliosis (a sideways curve of the spine with no known cause) using the REFLECT™ Scoliosis Correction System.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following criteria to be included in the study:
- •Requires surgical treatment to obtain and maintain correction of idiopathic scoliosis
- •Skeletally immature
- •Major Cobb angle of 30° and 65°
- •Bone structure adequate to safely accommodate screw fixation
- •Failed bracing treatment and/or intolerant to brace wear
- •Treated with the REFLECT™ Scoliosis Correction System, using single or dual REFLECT cord(s) per curve
- •Availability of medical and radiographic records evaluating the product under study preoperatively through a minimum of 12 months postoperative
排除标准
- •Patients were excluded from the study if they met any of the following conditions:
- •Presence of any systemic infection, local infection, or skin compromise at the surgical site
- •Prior spinal surgery at the level(s) to be treated
- •Known poor bone quality, defined as a T-score of -1.5 or less
- •Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, or patient unwillingness or inability to cooperate with postoperative care instructions
研究组 & 干预措施
4.0 Group
4.0 mm diameter REFLECT cords were used to treat patients.
干预措施: Scoliosis Correction System (Device)
5.0 Group
5.0 mm diameter REFLECT cords were used to treat patients.
干预措施: Scoliosis Correction System (Device)
结局指标
主要结局
REFLECT Cord Breakage/Separation
时间窗: by latest available time point (minimum 12 months postoperative)
Comparison of REFLECT cord breakage/separation rate (radiographically suspected or confirmed) in 4.0 mm vs. 5.0 mm cords
Subsequent Surgeries Related to Cord Breakage
时间窗: by latest available time point (minimum 12 months postoperative)
Rate of subsequent surgeries at the treatment levels associated with REFLECT cord breakage/separation
次要结局
- Complications Profile(up to the latest available follow-up visit, with a required minimum of 12 months after surgery.)
- All Subsequent Surgeries(up to the latest available follow-up visit, with a required minimum of 12 months after surgery.)
- Change in Curve(From baseline (preoperative) to each postoperative time point.)