NCT03910309终止不适用
A Prospective Investigation Comparing Bone Graft Extenders in Transforaminal Interbody Fusions (TLIF) With an Acid Etched Titanium Implant: A Clinical Outcomes and Cost Analysis
Titan Spine8 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2015年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 75
- 试验地点
- 8
- 主要终点
- Function measured by oswestry disability index
研究概览
简要总结
This is a prospective, multi-center controlled observational clinical study. All subjects will receive Titan Endoskeleton TT/TO acid etched titanium implant for the planned procedure. Each site will have a predetermined bonegraft extender to be used in all enrolled subjects at that site.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 18-75 years of age, and skeletally mature
- •Have clinical and radiological evidence of degenerative disc disease at one or two levels of the lumbar spine between L2-S
- •May also have spondylosis, spinal stenosis, or spondylolisthesis at these levels.
- •In the opinion of the treating surgeon, must already be a qualified candidate for lumbar fusion surgery including 6 months of conservative care prior to surgical intervention.
- •Psychosocially, mentally and physically able to comply with protocol, post-operative management and follow-up schedule.
- •Subject must understand and sign the written Informed Consent.
排除标准
- •Previous history of fusion surgery at the index level(s).
- •Clinical, laboratory and/or radiological evidence of back pain secondary to acute or chronic infection, malignancy, other space occupying lesions and metabolic bone demineralization diseases (e.g. osteomalacia, gout, Paget's disease etc.)
- •Osteoporosis defined as a DEXA bone density measurement T score ≤ 2.5 (Necessity for DEXA scan will be determined by investigator's standard of care)
- •Any terminal or autoimmune disease including but not limited to HIV infection, rheumatoid arthritis or lupus.
- •Any other concurrent medical disease that might impair normal healing process.
- •Morbid obesity (BMI ≥ 40 kg/m2).
- •Investigational drug or device use within 30 days.
- •Currently a prisoner.
- •Currently experiencing a major mental illness (psychosis, schizophrenia, major affective disorder) which may indicate that the symptoms are psychological rather than of physical origin.
结局指标
主要结局
Function measured by oswestry disability index
时间窗: 2 years
10 question score
Pain measured by VAS
时间窗: 2 years
1 to 10
次要结局
- Success of fusion(3 months, 6 months, 12 months, 24 months)
研究者
研究点 (8)
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