Assess Clinical and Radiographic Outcomes of VIPER PRIME/Expedium Spine System and Fibergraft BG Putty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Fusion
研究概览
简要总结
The Viper Prime/Expedium spine systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracolumbar and sacral spine. The Fibergraft Bioactive Glass (BG) is engineered to mimic the body's natural bone healing process. While previous studies have compared the use of Viper prime/Expedium spine system in minimally invasive and open surgeries, these studies did not specifically study the clinical and radiographic outcomes of patients who have received these implants in addition to Fibergraft. We aim to recruit patients with degenerative disc disease, spondylolisthesis, trauma, and/or pseudarthrosis who require spine surgery under standard of care and use these implants. We will then follow these patients for a duration of two years to report their clinical and radiographic outcomes to determine fusion, complication rate, and revision surgeries if any.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Have a radiograph-based diagnosis of degenerative disc disease, spondylolisthesis, spinal trauma (i.e., fracture or dislocation), spinal stenosis, or deformity (i.e., scoliosis, kyphosis, and/or lordosis), spinal tumor, or pseudoarthrosis/failed fusion.
- •Pathology of the thoracolumbar or sacral spine.
- •Patients requiring fusion of 1-3 levels
- •Patients receiving the surgery/devices as standard of care prescribed by the treating physician.
排除标准
- •Patients < 18 years
- •Patients with a cervical spine pathology
- •Patients with spinal tumors
- •Patients with bone density (DEXA) scores < 2.0 will be excluded.
- •Current smokers and patients who quit smoking within 6 weeks prior to presentation will be excluded.
- •Patients with a BMI > 40kg/m2
- •Patients requiring fusion for more than 3 levels will be excluded
结局指标
主要结局
Fusion
时间窗: 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)
We will assess fusion with regular x-rays and CT scans at 1 and 2-year postoperatively.
次要结局
- Visual Analog Scale (VAS)(2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months))
- Oswestry Disability Index (ODI)(2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months))
- Short form survey-12(2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months))
研究者
Nitin Agarwal
Associate Professor, Neurosurgery
University of Pittsburgh