跳至主要内容
临床试验/NCT03472131
NCT03472131已完成不适用

Unilateral Posterolateral Approach for Disc Debridement and Titanium Cage Insertion Supplemented by Contralateral Transfascial Screw Fixation for Sick Patients Suffering From Septic Thoracolumbosacral Spondylodiscitis

University Hospital of Patras0 个研究点目标入组 20 人开始时间: 2004年1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
已完成
发起方
入组人数
20
主要终点
The extent of spinal cord injury (SCI) defined by the American Spinal Injury Association (ASIA) Impairment Scale

研究概览

简要总结

This retrospective study assess the efficacy and safety of a posterolateral unilateral approach for debridement and titanium cage insertion supplemented by contralateral transfascial screw fixation for sick patients suffering from septic thoracolumbosacral spondylodiskitis. Hematogenous pyogenic spondylodiskitis requires surgical intervention in cases of development of neurological signs, spinal instability, progressive spinal deformity and abscess. When operative treatment is indicated, an anterior approach by open thoracotomy or by a thoraco-abdominal approach or combined anterior and posterior approaches are recommended. In cases of severe sick patients anterior approach is associated with high morbidity and mortality.

详细描述

Twenty consecutive sick (ASA>III) patients, 14 men and 6 women, aged 64±14 years, suffering from single level septic thoracolumbosacral spondylodiskitis underwent an one-stage less invasively unilateral posterolateral decompression, insertion of titanium cage& pedicle screw fixation plus contralateral transfascial pedicle screw fixation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Single-level thoracic, thoracolumbar, lumbar or lumbosacral spondylodiskitis
  • Medical comorbidities were present in all 20 patients. These included diabetes mellitus, chronic renal insufficiency, advanced heart insufficiency, hypertension, cortisone abuse, drug abuse and/or advanced age (>65y).

排除标准

  • 未提供

研究组 & 干预措施

Septic spondylodiscitis

Experimental

A unilateral posterolateral approach and debridement with titanium cage insertion supplemented by screw fixation for severe sick patients suffering from septic spondylodiscitis

干预措施: Titanium cage insertion supplemented by screw fixation (Other)

Septic spondylodiscitis

Experimental

A unilateral posterolateral approach and debridement with titanium cage insertion supplemented by screw fixation for severe sick patients suffering from septic spondylodiscitis

干预措施: Unilateral Posterolateral Approach and Debridement (Procedure)

结局指标

主要结局

The extent of spinal cord injury (SCI) defined by the American Spinal Injury Association (ASIA) Impairment Scale

时间窗: 2 years

Grade A Complete lack of motor and sensory function below the level of injury (including the anal area) Grade B Some sensation below the level of the injury (including anal sensation) Grade C Some muscle movement is spared below the level of injury, but 50 percent of the muscles below the level of injury cannot move against gravity. Grade D Most (more than 50 percent) of the muscles that are spared below the level of injury are strong enough to move against gravity. Grade E All neurologic function has returned.

次要结局

  • Survival rate at 2,5 years(2,5 years)
  • Survival rate at 10 years(10 years)

研究者

发起方
University Hospital of Patras
申办方类型
Other
责任方
Principal Investigator
主要研究者

Vasileios Syrimpeis

Orthopaedic Surgeon

University Hospital of Patras

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