NL-OMON50249招募中不适用
umbar Interbody Fusion Trial (LIFT): A randomized controlled multicenter trial for surgical treatment of lumbar spondylolisthesis. - LIFT
Zuyderland Medisch Centrum0 个研究点目标入组 160 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
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
- •1. Indication for TLIF (transforaminal lumbar interbody fusion) of PLIF
- •(posterior lumbar interbody fusion) surgery.
- •2. Clinical mono uni-or bilateral lumbar radiculopathy or intermittent
- •neurogenic claudication caused by a single level isthmic, degenerative or
- •iatrogenic spondylolisthesis gr I, II or III according to Meyerding
- •classification at level L3L4, L4L5 or L5S1.
- •3. Age over 18 years.
- •4. Single level spondylolisthesis with central or foraminal stenosis on MRI (or
- •CT), of which the anatomical level is corresponding to the clinical syndrome.
- •5. Psychosocially, mentally, and physically able to fully comply with this
- •study protocol.
- •6. Informed consent prior to this study., Inclusioncriteria of informal
- •caregivers of patients:
- •1. The patient where the ICG offers his care, has to participate in the
- •LIFT-study.
- •2. Age over 18 years
- •3. Psychosocially, mentally, and physically able to fully comply with this
- •study protocol.
- •4. Informed consent prior to this study.
排除标准
- •1. Previous radiotherapy at the intended surgical level.
- •2. (Progressive) motor failure and/or anal sphincter disorders which urges
- •instant intervention.
- •3. Active spinal infection.
- •4. Immature bone (on-going growth).
- •5. Active malignancy.
- •6. Pregnancy.
- •7. Symptomatic osteoporosis (based on DEXA-scan).
- •8. Contra-indications for anaesthesia or surgery.
- •9. Inadequate command of the Dutch language., Exclusioncriteria of informal
- •caregivers of patients:
- •1. Inadequate command of the Dutch language.
研究者
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