A Prospective, Single-Arm, Multi-Center, Registry Post-Approval Study of Growth Modulation in the Treatment of Idiopathic Scoliosis With the REFLECT™ Scoliosis Correction System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Primary Safety
研究概览
简要总结
The purpose of this multi-center, prospective, single-arm registry Post-Approval Study (PAS) is to evaluate the radiographic and clinical outcomes of 100 patients with idiopathic scoliosis treated with the REFLECT™ Scoliosis Correction System, as a condition of HDE approval
详细描述
The REFLECT™ Scoliosis Correction System is designed for continued growth and mobility of the spine as well as straightening of the spine by holding the segments in a more natural anatomic position using non-rigid materials. REFLECT™ uses a growth modulation technique in which growth of the patient is used to achieve progressive scoliosis correction.
The REFLECT™ Scoliosis Correction System is indicated for skeletally immature patients who require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis, who have a major Cobb angle of 30 to 65 degrees whose osseous structure is dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging. Patients should have failed bracing and/or are intolerant to brace wear.
A total of 100 patients will be prospectively enrolled and treated at a minimum of 5 U.S. sites, with a maximum of 20 subjects at any one site, with sequential enrollment from each site. Patients will be followed for 5 years with evaluations at the following timepoints: preoperative, intraoperative, immediate postoperative (first erect), 6 weeks, 6 months, 12 months, 24 months, and 60 months. Primary and secondary outcomes from 100 patients enrolled and treated with REFLECT™ will be summarized.
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
- •Diagnosis of progressive idiopathic scoliosis
- •Preoperative major Cobb angle 30°-65°
- •Preoperative flexibility to ≤30° on side bending radiograph (left or right)
- •Skeletally immature at the time of surgery with Risser sign <5 or Sanders score <8
- •Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging
- •Failed or intolerant to bracing
- •Signed informed consent and/or assent forms specific to this study
排除标准
- •Prior spinal surgery at the level(s) to be treated
- •Documented poor bone quality, defined as a T-score of -1.5 or less
- •Presence of any systemic infection, local infection, or skin compromise at the surgical site
- •Any medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patient's unwillingness or inability to cooperate with post-operative care instructions
- •Unwillingness, inability, or living situation (e.g. custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and Informed Consent
- •Active participation in a drug or device study that is more than minimal risk such that participation would confound the measurements of the present study
研究组 & 干预措施
REFLECT
Enrolled patients are treated with the REFLECT Scoliosis System. This is an HDE-approved device.
干预措施: REFLECT Scoliosis Correction System (Device)
结局指标
主要结局
Primary Safety
时间窗: 60 months postoperative
Serious adverse events (SAEs) and device- or procedure-related adverse events (AEs)
Primary Probable Benefit
时间窗: 60 months postoperative
Maintenance of major Cobb angle less than or equal to 40°
次要结局
- SRS score(60 months postoperative)
- Device integrity(60 months postoperative)
- Failure analysis(60 months postoperative)
- Curve progression(60 months postoperative)
- Composite endpoint analysis(60 months postoperative)