A Prospective Registry Study Evaluating the Safety and Efficacy of Fibrin for Chronic Multi-level Discogenic Low Back Pain
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Oswestry Disability Index (ODI)
研究概览
简要总结
Intra-annular injections of non-autologous fibrin for moderate to severe chronic low back pain (LBP).
详细描述
The purpose of this study is to analyze data available in the PIs Regenerative Orthobiologics Registry (ROR) and corresponding patient charts that will either support or refute the efficacy of Intra-annular fibrin as treatment for moderate to severe low back pain. Additionally, we seek to retrospectively identify possible predisposing factors that are correlated with positive outcomes with respect to patient-reported pain and function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Recipient of Intra-annular fibrin injection for annular defects identified radographically and by annulogram
排除标准
- •Scoliosis greater than 20 degrees
- •Spondylolysis
- •Spondylolisthesis greater than Grade 1
- •Disc extrusion
- •Disc herniations or bulges > 4mm causing severe stenosis
- •Prior lumbar surgery or intradiscal procedure (i.e. intradiscal electrothermal therapy, nucleoplasty)
- •Cauda equina syndrome
- •Active malignancy or tumor as source of symptoms
- •Evidence of prior lumbar vertebral body fracture or trauma
- •Foraminal stenosis at the affected levels resulting in severe thecal sac compression
- •Dynamic instability on lumbar flexion/extension radiographs
- •Positive response to diagnostic medial branch block or facet joint injection or sacroiliac joint injection
- •Known bleeding disorder
- •Known or suspected hypersensitivity or allergy to drugs or components of the fibrin sealant, including aprotinin, used in the procedure
- •Presence of ferromagnetic implants that would interfere with MRI evaluations
- •Active or pending workers' compensation claims or other litigation related to the condition.
- •Pregnant or plans to become pregnant over the course of study participation (2 years)
研究组 & 干预措施
Fibrin Group
Experimental: Non-Autologuos Fibrin (NAF) Subjects in the NAF arm received an injection of non-autologous fibrin
干预措施: Fibrin sealant (Drug)
结局指标
主要结局
Oswestry Disability Index (ODI)
时间窗: Two Years
The Oswestry Disability Index (ODI) is a questionnaire used by clinicians and researchers to quantify disability for low back pain. Scale for the ODI is from 0 (best) - 100 (worst).
次要结局
- PROMIS Physical Health(Two Years)
- PROMIS Mental Health(Two Years)
- Visual Analog Scale (VAS) for leg pain(Two Years)
- Numeric Rating Scale (NRS)(Two Years)
- EURO Quality of Life (EuroQol)(Two Years)
- Visual Analog Scale (VAS) for back pain(Two Years)
- North American Spine Society (NASS) for patient satisfaction(Two Years)