The OsteoStrand Plus Deformity Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Assessment of fusion for the demineralized bone matrix cohort vs bone morphogenic protein cohort
研究概览
简要总结
A clinical study evaluating outcomes for patients with spinal deformity.
详细描述
A clinical study evaluating deformity patients treated with Demineralized Bone Matrix as compared to patients treated with Bone Morphogenetic Protein.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •≥18 years of age
- •Indicated for deformity correction surgery
- •Require spinal fusion at four or more levels
- •Are willing to return for follow-up visits
- •Willing to sign the Informed Consent Forms
排除标准
- •Uncontrolled diabetes
- •Morbid obesity
- •history of alcohol or drug abuse
- •Corticosteroid use
- •Fever or leukocytosis
- •Systemic infection
- •Active malignancy
- •Elevation of white blood cell count
- •Osteoporosis
- •Disease of bone metabolism
- •Unsuitable or insufficient bone support
- •Skeletal immaturity
- •Prior fusion
- •Use of steroids, immune suppressants, osteoporosis medications
- •Use of internal bone stimulators
- •Institutionalized or a prisoner
- •Undergoing (Undergone) a worker's compensation case
- •Pregnancy (includes women who are currently pregnant, lactating or wishing to become pregnant during the study duration)
- •Participation in another research study involving another implant, product or drug that may affect the outcomes of this clinical study within the last 30 days, or planned during this clinical study
- •Any other condition that the Investigator determines is unacceptable for enrollment into this clinical study
研究组 & 干预措施
Demineralized Bone Matrix
Prospective cohort subjects undergoing deformity correction surgery that receive Demineralized Bone Matrix (DBM).
干预措施: Posterolateral Lumbar Fusion with Demineralized Bone Fibers (Procedure)
Bone Morphogenic Protein
Retrospective cohort subjects that underwent deformity correction surgery and received Bone Morphogenic Protein (BMP).
干预措施: Posterolateral Lumbar Fusion with Bone Morphogenic Protein (Procedure)
结局指标
主要结局
Assessment of fusion for the demineralized bone matrix cohort vs bone morphogenic protein cohort
时间窗: 12 Months
Proportion of spinal levels in the demineralized bone matrix cohort vs bone morphogenic protein cohort achieving fusion.
次要结局
- Clinical outcomes(24 Months)