Sacroiliac Joint Stabilization in Long Fusion to the Pelvis: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 213
- 试验地点
- 61
- 主要终点
- Change from baseline in self-reported SI joint pain at 2 years
研究概览
简要总结
The purpose of this study is to compare outcomes of subjects undergoing multilevel lumbar fusion (MLF) surgery with and without the iFuse 3-D implants in the "bedrock" trajectory.
详细描述
This is a multicenter randomized controlled, postmarket clinical study to determine the differences between subjects undergoing standard MLF surgery with S2AI fixation in the pelvis vs the additional placement of iFuse 3-D in the bedrock configuration during MLF surgery. Subjects will be monitored for sacroiliac (SI) joint pain and at two years post surgery a CT scan will be taken to assess S2AI screw loosening or any other findings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21-75 at time of screening
- •Patient scheduled for multilevel (>3 levels) spinal fusion surgery with planned fixation to the pelvis using S2AI screws
- •Patient has signed study-specific informed consent form
- •Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements
排除标准
- •Indication for multilevel spine fusion surgery is any of the following:
- •Congenital neuromuscular disease
- •Prior pelvic fixation (i.e., patient already has S2AI or iliac bolts in place, current surgery indicated to revise this hardware)
- •Grade IV spondylolisthesis
- •Prior sacroiliac joint fusion/fixation on either side
- •Presence of spinal cord stimulator
- •Presence of severe hip pain that could impair functional and quality of life improvement from complex spine surgery
- •Surgeon plans to use iliac screw for pelvic fixation
- •Any known sacral or iliac pathology
- •Any condition or anatomy that makes treatment with the iFuse Implant System infeasible
- •Known metabolic bone disease
- •Severe osteoporosis
- •Known allergy to titanium or titanium alloys
- •Use of medications known to have detrimental effects on bone quality and soft-tissue healing
- •Neurologic condition that would interfere with postoperative physical therapy
- •Current local or systemic infection that raises the risk of surgery
- •Patient currently receiving or seeking short- or long-term worker's compensation and/or currently involved in injury litigation related to the SI joint or low back pain.
- •Currently pregnant or planning pregnancy in the next 2 years
- •Prisoner or a ward of the state.
- •Known or suspected drug or alcohol abuse
- •Uncontrolled psychiatric disease that could interfere with study participation
- •Fibromyalgia
结局指标
主要结局
Change from baseline in self-reported SI joint pain at 2 years
时间窗: 2 years
Change from baseline in self-reported SI joint pain on a 0 (no pain) -10 (worst imaginable pain) visual analog scale
Incidence of SI Joint pain
时间窗: 2 years
Proportion of subjects without SI joint pain at baseline who develop new onset SI joint pain by 2 years
Proportion with S2AI screw abnormality on CT scan
时间窗: 2 years
Proportion of subjects with any of following: S2AI screw breakage, loosening or pullout OR rod breakage distal to S1 on 2-year CT scan as interpreted by an independent bone radiologist
次要结局
- Change from baseline thoracic kyphosis at 2 years(2 years)
- Proportion of subjects requiring revision, removal, reoperation or supplemental fixation(2 years)
- Therapeutic injection or other non-medication based intervention(2 years)
- Scoliosis Research Society 22r Patient Questionnaire(2 years)
- Change from baseline pelvic incidence at 2 years(2 years)
- Oswestry Disability Index(2 years)
- EuroQol Group Health Questionnaire(2 years)
- Ambulatory and Work Status(2 years)
- Opioid Medication Use(2 years)
- Proportion of S2AI screw breakage(2 years)
- Proportion of S2AI screw loosening(2 years)
- iFuse-3D implant fully seated(2 years)
- iFuse-3D implant position(2 years)
- Proportion of abnormal bone reactions in the pelvis(2 years)
- Change from baseline pelvic tilt at 2 years(2 years)