Assess Clinical and Radiographic Outcomes of Conduit Cages and Fibergraft in Cervical and Lumbar Procedures
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 Conduit cages are intended to restore the intervertebral height and to facilitate the intervertebral body fusion in the cervical and lumbar spine in skeletally mature patients with degenerative disc disease and instabilities at one or more levels of the spine. The Fibergraft Bioactive Glass (BG) is engineered to mimic the body's natural bone healing process. While previous studies have described the use of conduit cages in interbody fixation procedures, 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, and instabilities at one to multilevel contiguous levels between C2-T1 and 1-2 contiguous levels between L2-S1 of the spine with accompanying radicular symptoms, ruptured or herniated discs, and pseudarthrosis and spondylodesis. 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, ruptured or herniated discs,
- •Pathology of the cervical or lumbar spine.
- •Pathology to be between C2-T1 in the cervical group.
- •Pathology to be between L2-S1 in the lumbar group.
- •Patients with 1-2 contiguous levels in both ACDF and Lumbar groups.
- •Patients receiving the surgery/devices as standard of care prescribed by the treating physician.
排除标准
- •Patients < 18 years
- •BMI > 40 kg/m2 to be excluded
- •Patients with a bone density (DEXA) score of <2.0 to be excluded
- •3 or more levels for ACDF or Lumbar interbody to be excluded
- •Patients with previous pseudoarthrosis or failed spondylodesis to be excluded
- •Current smokers and patients who quit smoking within 6 weeks prior to presentation 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(2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months))
- SF-12(2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months))
- Neck Disability Index(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