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临床试验/NCT05003219
NCT05003219已完成不适用

Long Term Clinical Outcome of Single Open Door Laminoplasty With Preservation of Unilateral Muscular Ligament Complex

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
400
试验地点
1
主要终点
mJOA

研究概览

简要总结

To collect and measure the preoperative and postoperative clinical data of the patients undergoing single open-door expansive laminoplasty with preservation of musclar ligament complex through posterior cervical approach in our hospital and summarize the long-term clinical effect and postoperative imaging changes and analyze the long-term clinical effect of this operation

详细描述

Objective

To collect and measure the preoperative and postoperative clinical data of the patients undergoing single open-door expansive laminoplasty with preservation of musclar ligament complex through posterior cervical approach in our hospital. To summarize the long-term clinical effect and postoperative imaging changes and to analyze the long-term clinical effect of this operation on cervical spondylosis. To provide scientific basis for clinical work and theoretical research in the future.

This study was a retrospective study, and the medical records of posterior cervical open-door expansive laminoplasty with musclar ligament complex preservation in the orthopedics department of our hospital from 2006 to 2017 were collected, and the patients with complete diagnosis and treatment data were selected for analysis and research.The preoperative and postoperative changes of the patients were studied by combining the patient's case and imaging examination (MR, CT, X plain film) and other diagnosis and treatment data.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

接受健康志愿者

入选标准

  • Age 18-70, gender unlimited;
  • The patient was diagnosed with cervical spondylosis and met the indications of posterior cervical laminoplasty;
  • Basis of serious diseases of heart, brain, lung, kidney or other important organs, preoperative ASA score I-II;
  • Agree to participate in the study and sign the informed consent;

排除标准

  • Preoperative ASA score ≥III;
  • One-stage combined anterior and posterior surgery of cervical spine;
  • Correction of cervical deformity;
  • Patients with gastric emptied disorders (such as gastroesophageal reflux, chronic history of aspiration, delayed gastric emptied), complete obstruction of the digestive tract, and inability to use enteral preparations;
  • Patients with high risk conditions, such as severe cardio-renal insufficiency, affecting the safety evaluation of the trial;
  • People with mental disorders, alcohol dependence or drug abuse history;
  • women in the period of lactation and pregnancy;
  • People with allergic constitution or previous allergies to a variety of drugs;
  • Other researchers consider it inappropriate to participate in this study

结局指标

主要结局

mJOA

时间窗: 2 years after operation

Modified Japanese Orthopaedic Association score

NDI

时间窗: 2 years after operation

neck disability index

AS

时间窗: 2 years after operation

axial syndrome

C5 palsy

时间窗: 2 years after operation

C5 palsy after operation

neck and shoulder VAS

时间窗: 2 years after operation

neck and shoulder visual analogue score

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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