A Prospective, Single Arm Clinical Trial Evaluating Clinical Outcome and Fusion Results Using the SiJoin® Transfixing Sacroiliac Fusion Device
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Fusion Status/Evaluation
研究概览
简要总结
The purpose of this clinical study is to evaluate fusion of the SI joint(s) and any reduction in VAS pain scores in a prospective cohort of patients utilizing the SiJoin® Transfixing Sacroiliac Fusion Device in patients that received sacroiliac fusion, without ancillary stabilization devices.
详细描述
Study Title: A prospective, single arm clinical trial evaluating clinical outcome and fusion results using the SiJoin® Transfixing Sacroiliac Fusion Device
Instrumentation SiJoin® Transfixing Sacroiliac Fusion Device Study Design: Non-randomized, prospective, single arm, single center clinical trial
Patient Population and Sample Size:
Patients (n≥25) from 1 clinical site, who have been medically evaluated, found appropriate for, and have agreed to treatment by sacroiliac joint fixation, including unilateral and/or bilateral sacroiliac fusion according to accepted medical standards using the SiJoin® Transfixing Sacroiliac Fusion Device.
Objectives: The primary objective of this study is:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have provided consent for research by signing the Information and Consent for research form;
- •Have given appropriate operative consent for a sacroiliac joint fixation procedure as standard of care using the SiJoin® Transfixing Sacroiliac Fusion Device;
- •Are skeletally mature male or female, and are at least 18 years of age at time of surgery;
- •Patient history confirms sacroiliac joint disfunction;
- •Failure of six months of conservative care;
- •Failure of NSAIDs;
- •Positive diagnosis injection of sacroiliac joint; and
- •Agree to adhere to post-surgical medically prescribed activity limitations and/or physical rehabilitation.
排除标准
- •Previous surgery or prior hardware in place at the target sacroiliac joint;
- •Deidentified data cannot be provided;
- •If female, pregnant at time of sacroiliac joint surgery;
- •Found to be inappropriate candidate for sacroiliac joint fixation;
- •Requires additional and/or other surgical technique and/or approach to the sacroiliac joint, which may in the opinion of the Primary Investigator confound measurement of outcome variables;
- •Has a medical disorder or is receiving medications that would be expected to interfere with osteogenesis;
- •Has active malignancy, or patient with a history of any malignancy (except non-melanoma skin cancer) with recurrence within 5 years or surgery;
- •Has active local or systemic infection or history of local or systemic infection, immune-deficiency, uncontrolled medical conditions, which in the opinion of the Investigator may increase patient risk or confound fusion results;
- •Has BMI >40%;
- •Has history of tobacco smoking within 6 months prior to operation;
- •Has history of alcoholism, medication or drug abuse, psychosis, is a prisoner, and/or has a personality disorder, poor motivation, emotional or intellectual issues that would likely make the patient unreliable for participation in the study;
- •Has history of diabetes;
- •Are participating in any other clinical trial;
- •Patient is an employee (or family members of employees) of the PI/site or Sponsor; or
- •Patient is limited or non-reader (e.g., blind, illiterate)
结局指标
主要结局
Fusion Status/Evaluation
时间窗: 12 Months
Evaluate the fusion status of SI Joints using CT scans with a grading system based on: 1. Complete fusion; or 2. No fusion.
Visual Analog Scale (VAS) Reduction
时间窗: 2-3 weeks, 3 Months, 6 Months, 12 Months
Scale: 0 (No Pain) - 10 (Worst Pain Possible) Composite endpoint of reduction from baseline in VAS back pain score by at least 2 points.
次要结局
- Ease of Use(12 months)
- Adverse Avents(12 months)
- Subsequent Surgical Interventions(12 months)