A Prospective Study of the InterFuse T(tm)
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- fusion rates
研究概览
简要总结
The purpose of this post-approval study is to demonstrate that the InterFuse T modular lumbar interbody device is at least equal in safety and efficacy to other (standard of care) TLIF devices.
详细描述
The primary objective of this post-market study is to collect data to asses the long term outcome of the InterFuse T (tm) device in [patients undergoing interbody fusion.
The primary endpoints of the investigation will include assessment of the maintenance of disc height and fusion rates demonstrated by radiographic evidence based on plain radiographs. Fusion is defined as a bone bridging across the disc space at the level of the InterFuse T implant. Length of stay, implant migration, implant subsidence, re-operation rate and opioid use will be recorded. It is anticipated that outcomes with the InterFuse T Interbody Fusion Device will be comparable to or better than the historical published results for other non-modular TLIF devices and to the control device used concurrently in the study
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •meets indications for an interbody fusion (determined by the study investigator)
- •Has documented conservative (non-operative ) treatment for at least 3 months
- •Has a VAS back pain of > or = 60mm
- •Has an ODI > or = 40%
- •at least 18 years of age and skeletally mature
- •Willing and able to comply with study requirements
- •Patient's condition is appropriate for surgery
- •Agreed to participate in study
排除标准
- •Has severe osteoporosis or osteopenia
- •Grade 3 or higher Spondylolisthesis
- •Diffuse multilevel neoplastic disease such that no adjacent normal segment exists for engagement or instrumentation
- •Body Mass Index (BMI) > 40
- •Patient has active infection
- •Patient is pregnant or planning to become pregnant
- •Patient is mentally ill or has history of drug abuse
- •Patient has known allergy to Polyetheretherketone (PEEK), stainless steel or Tantalum
- •Patient is currently enrolled in an investigational spine study
- •Has rheumatoid arthritis, ankylosing spondylitis or other autoimmune disease
- •patient bhas symptomatic fibrous arachnoiditis
结局指标
主要结局
fusion rates
时间窗: 12 months
Assessment of the fusion rates as demonstrated by radiographic evidence.
次要结局
- Maintenance of disk height(12 months)
- Oswestry Disability Score (ODI)(12 months)
- SF-36(12 months)
- Visual Analog Scale (VAS)(up to 12 months)