CTRI/2025/06/089874尚未招募4 期
Assessment of lumbar fusion and its significance on functional outcome following the usage of Micro and Nano-textured Titanium Cages - A prospective single–blinded randomized controlled pilot study trial comparing nanotextured Titanium cages versus PEEK cages.
Medtronics India1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年7月25日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Assessment of lumbar spine fusion
研究概览
简要总结
The purpose of this randomized controlled trial is to assess and compare radiographic fusion and clinical outcome in patients who undergo Transforminal lumbar interbody fusion procedure,supplemented with pedicle screw instrumentation using one of the following interbody cages Titanium cages with roughened micro and nano textured surface cages vs poly-ether-ether-ketone cages This study will capture clinical and radiological outcomes on patients upto 1 year postoperatively Both cages will be used in conjunction with a autograft locally harvested during the decompression procedure
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject is scheduled to undergo interbody spinal fusion surgery using either the nanotechnology titanium cage or PEEK cage in conjunction with local autograft and supplementation with a pedicle screw system The subject must in the investigators opinion be psychosocially mentally and physically able to fully comply with this protocol including the required follow-up visits and have the ability to understand and give written informed consent.
排除标准
- •Subjects with previous lumbar fusion surgery.
- •Subject has inadequate tissue coverage over the operative site.
- •Subject has an open wound local to the operative area, or rapid joint disease, bone absorption, or osteoporosis.
- •Subject has a condition requiring medications that may interfere with bone or soft tissue healing (i.e., oral or parenteral glucocorticoids, immunosuppressives, methotrexate, etc.).
- •Subject has an active local or systemic infection.
- •Subject has a metal sensitivity/foreign body sensitivity.
- •Subject is morbidly obese, defined as a body mass index (BMI) greater than
- •Subject has any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study.
结局指标
主要结局
Assessment of lumbar spine fusion
时间窗: 3 months, 6 months and 12 months
次要结局
- Clinical improvement after spoine fusion(3 months, 6 months and 12 months)
研究者
研究点 (1)
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