Post-market Surveillance Study of FLXfitTM 15 TLIF Interbody Fusion Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Visual Analogue Pain Scale: Leg
研究概览
简要总结
The purpose of this study is post-market, patient outcome research to evaluate medical device safety and effectiveness. The data collected will assess the safety of the FLXfit 15TM (studydevice) system.
详细描述
The purpose of this study is post-market, patient outcome research to evaluate medical device safety and effectiveness. The data collected will assess the safety of the FLXfit 15TM (study device) system, as measured by the rate of serious operative and post-operative complications. It will also assess the effectiveness as measured by radiographs (X-rays), CT scans, MRI scans, patient-reported, health-related quality of life questionnaires up to (24) months following the procedure, as compared to before surgery.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (18-70 y/o)
- •Male or Female
- •With the following conditions of the lumbar spine as confirmed by advanced imaging (CT or MRI), who is a candidate for primary spinal fusion procedure according to acceptable criteria for such medical conditions:
- •Degenerative disc disease with up to Grade I spondylolisthesis
- •Spondylolisthesis
- •Failure of at least 6-months conservative treatment
- •BMI < 40
- •Patient to approve no pregnancy during the 24 months of study and no participation in other studies in parallel to this one
- •Ability to read, understand, and sign informed consent
排除标准
- •Infection, local to the operative site
- •Signs of local inflammation
- •Fever or leukocytosis
- •Pregnancy
- •Significant mental disorder or condition that could compromise the patient's ability to remember and comply with preoperative and postoperative instructions (e.g. current treatment for a psychiatric/psychosocial disorder, senile dementia, Alzheimer's disease, traumatic head injury)
- •Prior surgical procedure (with the exception of decompression only procedure) at the index level(s) using the desired operative approach
- •Prior fusion procedure at an adjacent level
- •Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors or congenital abnormalities, fracture local to the operating site, elevation of segmentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count
- •Neuromuscular disorder that would engender unacceptable risk of instability, implant fixation failure, or complications in postoperative care
- •Active local infection in or near the operative region
- •Active systemic infection and/or disease
- •Severe osteoporosis or insufficient bone density, which in the medical opinion of the physician precludes surgery or contraindicates instrumentation
- •Endocrine or metabolic disorders known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, hypothyroidism)
- •Systemic disease that requires the chronic administration of nonsteroidal anti- inflammatory or steroidal drugs
- •Suspected or documented allergy or intolerance to implant's materials
- •Symptomatic cardiac disease
- •Patient unwilling to cooperate with postoperative instructions.
- •Any case where the implant components selected for use would be too large or too small to achieve a successful result.
- •Patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality.
- •Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance.
- •Prior fusion at the level to be treated.
- •Back VAS < 4/10
结局指标
主要结局
Visual Analogue Pain Scale: Leg
时间窗: 2-year
0 to 10 score; higher score means worse pain
Visual Analogue Pain Scale: Back
时间窗: 2-year
0 to 10 score; higher score means worse pain
Short Form-12 Health Survey
时间窗: 2-year
0 to 100 score; higher score means less patient disability
Oswestry Disability Index
时间窗: 2-year
0 to 100 score; higher score means greater patient disability
Fusion
时间窗: through study completion; 2 year
Did patient achieve fusion?
Patient Reported Outcomes Measurement Information System (PROMIS)
时间窗: 2-year
20 to 80 score; higher score means higher reported self-capability
次要结局
未报告次要终点
研究者
Kern Singh, MD
Attending Orthopedic Surgeon
Rush University Medical Center