NL-OMON53233尚未招募4 期
Minimally Invasive versus Open Lumbar Interbody Fusion Trial (MIOLIFT): a randomized controlled trial for surgical treatment of lumbar spondylolisthesis and foraminal stenosis - MIOLIFT
Zuyderland Medisch Centrum0 个研究点目标入组 198 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 198
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Indication for MITLIF (minimal invasive transforaminal lumbar interbody
- •fusion) or OTLIF (open transforaminal lumbar interbody fusion) surgery.
- •- Clinical mono uni- or bilateral lumbar radiculopathy or intermittent
- •neurogenic claudication caused by a single level degenerative foraminal
- •stenosis or isthmic, iatrogenic, or degenerative spondylolisthesis gr I or II
- •according to Meyerding classification at level L3L4, L4L5 or L5S1.
- •- Age over 18 years.
- •- Single level degenerative foraminal stenosis or isthmic, iatrogenic, or
- •degenerative spondylolisthesis causing central stenosis on MRI (or CT), of
- •which the anatomical level is corresponding to the clinical syndrome.
- •- Psychosocially, mentally, and physically able to fully comply with this study
- •- Informed consent prior to this study.
排除标准
- •- Previous radiotherapy at the intended surgical level.
- •- (Progressive) motor failure and/or anal sphincter disorders which urges
- •instant intervention.
- •- Active spinal infection.
- •- Immature bone (on-going growth).
- •- Active malignancy.
- •- Pregnancy.
- •- Symptomatic osteoporosis (Current or previous use of bisphosphonates).
- •- Contra-indications for anaesthesia or surgery.
- •- Inadequate command of the Dutch language.
研究者
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