A Prospective, Non-comparative, Single-centre, Post-market Clinical Study to Evaluate the Safety and Performance of PEEK-OPTIMA™ HA Enhanced Interbody Cages for the Treatment of Degenerative Disc Disease in the Lumbar Spine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Invibio Ltd
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Interbody fusion rate
研究概览
简要总结
The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo spinal fusion using the Keos Lumbar Interbody Fusion Device.
详细描述
This prospective, non-comparative, single-center, post-market trial will evaluate the safety and efficacy of the PEEK-OPTIMA ™ HA Enhanced Keos Lumbar Interbody Fusion Device in patients suffering from degenerative disc disease, spondylolisthesis and retrolisthesis in the lumbar spine. The trial will capture clinical outcomes, radiographic and CT outcomes over a 24 month period post operatively. One centre will be involved in the recruitment of 30 patients the clinic involved will focus on this type of treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years of age or older.
- •Primary diagnosis of symptomatic degenerative disc disease (DDD) or symptomatic degenerative disc disease (DDD) with spondylolisthesis (Grade 1), or retrolisthesis, at one or two contiguous levels from L2 to S
- •Have discogenic back pain.
- •Suitable for transforaminal lumbar interbody fusion (TLIF) surgery.
- •Indicated for surgical treatment with the Keos Lumbar IBFD with autologous bone graft.
- •Completed at least 6 months of conservative non-operative treatment.
- •Female subjects of childbearing age must have a negative pregnancy test.
- •Able to understand this clinical study, co-operate with procedures.
- •Able to give voluntary, written informed consent to participate.
排除标准
- •Not undergone previous spinal surgery at the affected disc level(s).
- •Evidence of tumour and/or malignant disease.
- •Known osteoporosis or severe osteopenia.
- •Known rheumatoid arthritis, ankylosing spondylitis or who are immunocompromised.
- •Known allergy to the material used in the instrumentation.
- •Evidence of an active infection.
- •Any conditions outlined as contraindicated in the Instructions for Use.
- •Receiving any drug treatment that may affect bone metabolism.
- •Female subjects who are pregnant or lactating.
- •Current smokers or have stopped smoking less than 6 months ago.
- •Known drug or alcohol abusers.
- •Currently enrolled in a clinical study.
研究组 & 干预措施
Device
All subjects who are entered into this trial will receive the Keos Lumbar Interbody Fusion Device.
干预措施: Surgery with the Keos Lumbar Interbody Fusion Device (Device)
结局指标
主要结局
Interbody fusion rate
时间窗: 6 months post - operatively
Interbody fusion will be graded along the superior and inferior interfaces separately in 25% increments
次要结局
- To measure how much pain the subject is in according to a pain scale 0-10(6 weeks, 3, 6, 12 and 24 months post operatively)
- To measure the Quality of Life of the subject according to a set list of questions: Questionnaire SF-12(pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively)
- Functional Impairment(pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively)