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临床试验/NCT05982808
NCT05982808尚未招募不适用

A Novel Surgical Technique of CLIF Correction VS. Conventional Corrective Strategy on the Treatment of Adult Complex Spinal Deformity With a Multicenter Randomized Controlled Trial

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2024年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
420
试验地点
1
主要终点
ODI score

研究概览

简要总结

The present study intends to: 1)establish a multi-center large-sample randomized controlled trial to explore the technical advantages and surgical indications of the novel surgical technique of CLIF correction for ASD compared with the conventional correction strategy; 2)analyze the postoperative clinical and imaging results, and to explore the related complications and preventive measures; 3) establish 2-year follow-up to further quantify the clinical and radiographical outcomes of CLIF correction.

详细描述

Adult spinal deformity (ASD) is the most common spinal deformity in the elder, which often causes the low back pain and/or physical deformity. Severe cases need surgical treatment. Because the conventional posterior approach had the disadvantages of big trauma and slow recovery, and the elder were always complicated with complicated medical diseases, the perioperative risk was high. At present, the novel surgical technique of CLIF correction was a popular way for ASD treatment. Preliminary results showed that it had less trauma, shorter operation time, faster recovery, fewer complications and remarkable clinical and adiographical outcomes. Therefore, the present study intends to: 1) establish a multi-center large-sample randomized controlled trial to explore the technical advantages and surgical indications of the novel CLIF correction for ASD treatment compared with the conventional correction strategy; 2) establish 2-year follow-up to further quantify the clinical and radiographical outcomes, and to explore the related complications and preventive measures;. Therefore, the present project aims to explore the best surgical plan for treating ASD by studying the safety and effectiveness of the novel CLIF correction, and provide new surgical strategies for minimally invasive and Individualized treatment for ASD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •adult spinal deformtiy;
  • •40yrs≤age≤80yrs;
  • •Lenke-Silva classification II-V grade;
  • •ineffective with conservative treatment;

排除标准

  • •severe osteoprosis with T value <-2.5;
  • •with preliminary spinal surgery;
  • •ASA score≥III grade;
  • •more than II degree spondylisthesis;
  • •with mental disease;

研究组 & 干预措施

Novel CLIF correction

Experimental

ASD patients with novel CLIF correction

干预措施: CLIF correction (Procedure)

conventional correction strategy

Active Comparator

ASD patients with conventional correction strategy

干预措施: conventional correction strategy (Procedure)

结局指标

主要结局

ODI score

时间窗: 2 year after surgery

ODI score is Oswestry Disability Index(0-100), indicating the back pain; the higher score, the greater back pain

次要结局

  • SF-36 score(2 year after surgery)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wang Zhiwei, MD

Principal Investigator

Second Affiliated Hospital, School of Medicine, Zhejiang University

研究点 (1)

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