Sacral Fracture Fusion/Fixation for Rapid Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 14
- 主要终点
- Proportion of subjects with serious adverse event (SAE) probably or definitely related to a complication of sacral fracture and/or associated treatment (both arms) or probably or definitely related to iFuse-TORQ (surgery only).
研究概览
简要总结
To determine the safety and efficacy of concomitant sacral fracture fixation and sacroiliac (SI) joint fusion vs. non-surgical management for patients with debilitating sacral fragility or insufficiency fractures
详细描述
SAFFRON is a prospective, multicenter, randomized, controlled trial of surgical fixation of sacral insufficiency or fragility fractures (SFIF) with concomitant fusion of the sacroiliac (SI) joint vs. nonsurgical management (NSM). The goal of the study is to demonstrate the safety, performance, effectiveness, and cost-effectiveness of use of iFuse-TORQ™ in the treatment of sacral fragility or insufficiency fractures vs. NSM.
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
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 60 years of age at screening.
- •Posterior pelvic pain correlating with fracture location that began EITHER within 14 days of a low-energy traumatic event, OR in the last 60 days in the absence of a traumatic event
- •Imaging (X-ray, CT, or MRI) showing fracture of the sacrum (unilateral or bilateral)
- •Patient is either bedbound or must use a wheelchair to cover distances more than 50ft
- •Prior to fracture, patient was able to ambulate using a cane or unassisted
- •Medically stable to undergo either surgical or non-surgical treatment of index fracture.
- •Patient is willing and able to provide written informed consent
- •Patient is mentally able to comply with study protocol requirements
排除标准
- •Patient requires surgery to address fracture in the pelvic ring (NSM not feasible)
- •Anatomic anomalies/defects that would preclude safe and/or biomechanically acceptable placement of implants across the sacroiliac joint (SIJ) and into the sacrum
- •Sacral fracture potentially or definitely related to tumor
- •Any permanent implants already in the sacrum (including cement), ilium, or anterior pelvic ring that could interfere with placement of transiliac transsacral or iliosacral screws or iFuse-TORQ implants
- •History of recent (within 1 year) non-index pelvic fracture with nonunion of sacrum or ilium.
- •Other clinically active fragility fracture of spine, hip, arms, or legs that could impair recovery from sacral fracture
- •Uncontrolled psychiatric disease (e.g., dementia, schizophrenia, major depression, personality disorders) that could interfere with study participation or assessments
- •Prominent neurologic condition that would interfere with study participation including the use of electronic diaries (e.g., dementia) or recovery of mobility (e.g., severe diabetic neuropathy, multiple sclerosis)
- •Known allergy to titanium or titanium alloys
- •Current local or systemic infection that raises the risk of surgery.
- •Known or suspected active drug or alcohol abuse, including opioids.
- •Patient lives or plans to move more than 100 miles from the site during the course of the study.
- •Current enrollment in another investigational clinical trial related to fractures or osteoporosis
结局指标
主要结局
Proportion of subjects with serious adverse event (SAE) probably or definitely related to a complication of sacral fracture and/or associated treatment (both arms) or probably or definitely related to iFuse-TORQ (surgery only).
时间窗: 1 year
If randomized to surgery: Proportion of subjects with either: * Serious adverse event deemed probably or definitely related to iFuse-TORQ * Serious adverse event deemed probably or definitely a complication of sacral fracture and/or associated treatment If randomized to NSM: Proportion of subjects with: * Serious adverse event deemed probably or definitely a complication of sacral fracture and/or associated treatment
Time following treatment initiation to reach a 2-point improvement in mobility from baseline as measured using self-rated Modified Functional Mobility scale (MFMS).
时间窗: 1 year
The study's primary efficacy endpoint is the time required to achieve an improvement from baseline (study entry) of 2 or more points on the Modified Functional Mobility scale. The scale is administered on a weekly basis following the initiation of treatment until achieving a 2-point improvement or the subject crosses over.
次要结局
- Oswestry Disability Index(6 weeks)
- Continuous Summary Physical Performance Score (CSPPS)(1 year)
- Patient-Reported Outcomes Measurement Information System (PROMIS) physical function(6 weeks)
- Numeric Rating Scale pain score(6 weeks)