NCT03928041已完成不适用
A Prospective, Non-comparative, Multi-center, Post-market Clinical Study to Evaluate the Safety and Performance of PEEK-OPTIMA™ HA Enhanced Interbody Cages for the Treatment of Degenerative Disc Disease and Spondylolisthesis in the Lumbar Spine
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Invibio Ltd
- 入组人数
- 22
- 试验地点
- 4
- 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 interbody spinal fusion using the EVOS Lumbar Interbody System.
详细描述
This prospective, non-comparative, multi-center, post-market trial will evaluate the safety and efficacy of the PEEK-OPTIMA™ HA Enhance Interbody Cages System - EVOS- HA in patients suffering from degenerative disc disease and spondylolisthesis in the lumbar spine. The trial will capture clinical outcomes, radiographic and CT outcomes over a 24 month period post operatively. Two centers will be involved in the recruitment of 30 patients. All patients will be drawn from clinics which focus on this type of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Is the subject aged 18 years of age or older and skeletally mature?
- •Does the subject have a primary diagnosis of symptomatic degenerative disc disease (DDD) or symptomatic degenerative disc disease (DDD) with spondylolisthesis (Grade 1) at one or two contiguous levels from L2 to S1?
- •Does the subject have discogenic back pain with degeneration of the disc confirmed by medical history, radiographic examination and MRI (MRI must be obtained within the 6 months prior to subject surgery and radiographs obtained within 3 months prior to subject surgery)?
- •Is the subject judged by the Investigator to be suitable for transforaminal lumbar interbody fusion (TLIF) surgery based on their medical history?
- •Is the subject indicated for surgical treatment with the EVOS Lumbar Interbody System with autologous bone graft?
- •Has the subject completed at least 6 months of conservative non-operative treatment without obtaining adequate symptomatic relief?
- •If the subject is female and of childbearing age, do they have a negative pregnancy test (by Beta HCG qualitative analysis), or do they have a history of a surgical sterilisation, or a history of no menses in the past twelve months?
- •Is the subject, in the opinion of the Investigator, able to understand this clinical study, co-operate with the procedures and are they willing to return to the hospital for all the required post-operative follow-ups?
- •Is the subject able to give voluntary, written informed consent to participate in this clinical study and from whom consent has been obtained?
排除标准
- •Has the subject undergone previous spinal surgery at the affected disc level(s), excluding discectomy and laminectomy procedures?
- •Does the subject have evidence of tumour and/or malignant disease with resultant life expectancy of less than two years?
- •Does the subject have known osteoporosis or severe osteopenia as determined by the Investigator?
- •Does the subject have rheumatoid arthritis, ankylosing spondylitis or are they immunocompromised?
- •Does the subject have a known allergy to the material used in the instrumentation?
- •Does the subject have evidence of an active infection and/or do they have any condition that would compromise their participation and follow-up in this clinical study?
- •Is the subject receiving any drug treatment that may affect bone metabolism?
- •If the subject is female, are they pregnant or lactating?
- •Is the subject a current smoker, or have they stopped smoking less than 6 months ago?
- •Is the subject a known drug or alcohol abuser or do they have a baseline opioid use greater than 30 mg of morphine equivalent/day or do they have psychological disorders that could affect follow-up care or treatment outcomes?
- •Is the subject currently enrolled in a clinical study?
研究组 & 干预措施
single prospective study
Other
All subjects who are entered into this trial will receive the EVOS Lumbar Interbody System (EVOS- HA).
干预措施: Device: EVOS Lumbar Interbody System (EVOS-HA) (Device)
结局指标
主要结局
Interbody fusion rate
时间窗: 6 months post - operatively
Interbody fusion will be graded in accordance with Cook et al. 2004 where bridging bone is graded along the superior and inferior interfaces separately in 25% increments.
次要结局
- Functional Impairment(pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively)
- 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)
研究者
研究点 (4)
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