Pelvic Fixation and Fusion During Multilevel Spinal Surgery
概览
- 阶段
- 不适用
- 干预措施
- iFuse Bedrock Granite Implant System
- 疾病 / 适应症
- Spinal Fusion
- 发起方
- SI-BONE, Inc.
- 入组人数
- 200
- 试验地点
- 9
- 主要终点
- Postoperative incidence of SI joint pain in subject without SI joint pain at baseline
- 状态
- 进行中（未招募）
- 最后更新
- 3个月前
概览
简要总结
PAULA aims to collect data on the safety, performance, and effectiveness of iFuse Bedrock Granite (GRANITE) in patients who have spinal fusion surgery with pelvic fixation/ fusion.
详细描述
PAULA is a multicenter, open label, single-arm observational clinical study consisting of prospective and retrospective study cohorts. The goal of the study is to collect data on the safety, performance, and effectiveness of GRANITE.
研究者
入排标准
入选标准
- •≥ 18 years of age at screening.
- •Patient is scheduled for spinal fusion with pelvic fixation/fusion using iFuse Bedrock Granite
- •Patient is willing and able to provide written informed consent
排除标准
- •Any known anatomic issues or permanent implants already in the pelvis that could interfere with placement of the study device(s)
- •Prominent neurologic or uncontrolled psychiatric condition that would interfere with study participation
- •Known allergy to titanium or titanium alloys
- •Current local or systemic infection that raises the risk of surgery
- •Currently pregnant or planning pregnancy in the next 2 years
- •Known or suspected active drug or alcohol abuse, including opioids
- •Patient is a prisoner or ward of the state
- •Patient is enrolled in an investigational clinical trial related to the spine
研究组 & 干预措施
Prospective
Participants who have scheduled spinal fusion with pelvic fixation/fusion using iFuse Bedrock Granite. These participants will be followed for 2 years.
干预措施: iFuse Bedrock Granite Implant System
结局指标
主要结局
Postoperative incidence of SI joint pain in subject without SI joint pain at baseline
时间窗: 2 years
Postoperative incidence of serious adverse events probably or definitely related to GRANITE
时间窗: 2 years
Radiographic
时间窗: 12 month and 24 months
Bony apposition to the implant at 12 and 24 months as assessed by CT scan
Postoperative incidence of device failures related to GRANITE (e.g., rod disengagement, screw pullout)
时间窗: 2 years
Postoperative incidence of L5-S1 pseudoarthrosis
时间窗: 2 years
Change in Quality of Life PROs
时间窗: 6 month, 12 month and 24 months
Scores on PROs at follow up timepoints compared to baseline
Postoperative incidence of pelvic construct failure
时间窗: 2 years
Failure is defined as: * Breakage of any implants placed into sacrum or ilium * Rod breakage in the lumbosacral region * Pelvic implant loosening that either causes new or worsened pain or requires surgical adjustment/revision