NCT00974623终止不适用
A Prospective Patient Registry for Bone Graft Substitutes in Spinal Fusion: Patient Outcomes and Use in Clinical Practice
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 329
- 试验地点
- 14
- 主要终点
- Evidence of successful radiographic fusion
研究概览
简要总结
A multi-center, prospective, observational patient registry to collect information on the clinical outcomes and "real world" use of approved and commercially available bone graft substitutes, autograft and allograft.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has failed conservative treatment and is a candidate for spinal fusion surgery.
- •The patient is ≥18 years old and of legal age of consent.
- •The patient is, in the investigator's opinion, psychosocially, mentally, and physically able to fully comply with this protocol, including the post-operative regimen, required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
- •The patient is skeletally mature (epiphyses closed).
- •The patient has signed the IRB approved informed consent.
- •The patient is willing and able to participate in post-operative clinical and radiographic follow up evaluations for 2 years.
排除标准
- •Patient has systemic infection or infection at the surgical site.
- •Patient has a medical condition that would interfere with post-operative assessments and care (i.e., neuromuscular disease, psychiatric disease, paraplegia, quadriplegia, etc.).
- •Patient is in poor general health or any concurrent disease process that would place the patient in excessive risk to surgery (i.e., significant circulatory or pulmonary problems, or cardiac disease).
- •Patient has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the patient's ability to complete the protocol required follow-up.
- •The patient is pregnant/breastfeeding at the time of enrollment, or plans to become pregnant during the course of the study.
- •Patient is participating in another investigational study, which could confound results.
结局指标
主要结局
Evidence of successful radiographic fusion
时间窗: 6 months, 12 months & 24 months
次要结局
- Improvement of pain/function in comparison to pre-operative QOL scores(6 months, 12 months & 24 months)
- Maintenance or improvement in neurological status, as compared to baseline scores(6 months 12 months & 24 months)
研究者
研究点 (14)
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