LOIS: Long-Term Follow-Up in INSITE/SIFI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 12
- 主要终点
- Subject Success
研究概览
简要总结
The purpose of this study is to evaluate the long term safety and effectiveness of SI joint fusion using the iFuse Implant System in patients with degenerative sacroiliitis (DS) and/or sacroiliac joint disruptions (SD).
Study Design: This study is extended follow-up from two ongoing multicenter prospective US clinical trials. All participants have already undergone the surgical procedure of interest (SI joint fusion with iFuse Implant System). The two ongoing trials are:
- SIFI:( Sacroiliac Joint Fusion with iFuse Implant System) a single-arm trial of patients with degenerative sacroiliitis or sacroiliac joint disruption who underwent iFuse placement, and
- INSITE(Investigation of Sacroiliac Fusion Treatment): a randomized clinical trial of the same patient population who underwent either non-surgical treatment or iFuse placement
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient enrolled and treated in SIFI or patient initially randomized to iFuse and treated in INSITE. Note: Patient may be in the initial follow up period associated with SIFI or INSITE at the same time they consent for this study and "extend" their post-operative follow up.
- •Patient has signed study-specific LOIS 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
- •Treated with iFuse as a "crossover" in INSITE.
- •Currently pregnant or planning pregnancy within 5 years of iFuse Implant.
- •Patient is a prisoner or a ward of the state.
- •Known or suspected active drug or alcohol abuse.
- •Inadequately treated psychiatric illness (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation.
- •Unwilling to perform the long-term follow up requirements of this study.
- •Patient has any condition that could substantially prevent long-term follow-up.
- •Unwilling to return to site at pre-specified study visits.
结局指标
主要结局
Subject Success
时间窗: 3 years on LOIS (5 years post-op)
Composite endpoint of success defined as improvement in VAS (Visual Analog Scale) recorded at SIFI or INSITE Baseline VAS back pain score by ≥20 mm; Absence of device-related SAE (Serious Adverse Events) ; Absence of neurological worsening related to the sacral spine,\& Absence of surgical re-intervention on the target SI joint(s).
Radiographic (CT) apposition of bone to sacral and iliac sides of implant
时间窗: 3 years on LOIS (5 years post-op)
Proportion of subjects (with CT) who had at least 30% apposition of bone to sacral and iliac sides in at least 2 of 3 iFuse implants.
次要结局
- CT scans showing bridging bone(3 years on LOIS (5 years post-op))
- SAE (Serious Adverse Events) occurrence rate(3 years on LOIS)
- VAS (Visual Analog Scale)(3 years on LOIS (5 years post-op))
- Oswestry Disability Index (ODI) Questionnaire(3 years on LOIS (5 years post-op))
- Improvement in quality of life (QOL)(3 years on LOIS (5 years post-op))
- non-working subjects returning to work(3 years on LOIS (5 years post-op))