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临床试验/NCT02826499
NCT02826499已完成不适用

Comparison of the Malposition Rates of the Vertebral Pedicle Screws Using the PediGuard Technique: PediGuard Technique Associated With Fluoroscopy and Fluoroscopy Alone

Brugmann University Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Pedicular effraction grade

研究概览

简要总结

Pedicular screwing has become the gold standard for intervertebral fixation required in degenerative, scoliotic, tumoral pathologies or for fractures. Several pedicular screwing methods exist.

The free hand pedicular screwing requires a high learning curve and has, as a consequence, a high malposition rate.

The placing of pedicular screws under fluoroscopic control is the most common technique as it is both reproducible and accessible. It is a two dimensional imaging technique. The profile incidence at the level of the spine is mostly used to spot the vertebral pedicle and the direction of the screw in the sagittal plane. However, there is no real control of the direction of the pedicular screw in the horizontal or frontal plane. The screw malposition rate is less important than with the 'free hand' technique but remains none of the less significant. Furthermore, fluoroscopy is an irradiating imaging technique, both for the patient and the staff.

New revolutionary techniques as the tridimensional navigation and the per-operatory tomodensitometry appeared in the last few years. The techniques give the best results when used concommitantly. The material has the advantage of being very precise. The pedicular screw malposition rate is minimal after a three-dimensional localisation. However, those systems require qualified staff and expose the patient and the nursing team to high radiation levels. The costs are higher and the surgery duration is globally longer. It is thus difficult to implement this technique in each belgian hospital.

Finally, the Pediguard technique appeared on the market. It is a guide for the perforation of the pedicular channel, with a probe at its extremity. This probe allows a real time measurement of the electric conductivity of the tissues that are being crossed. The conductivity measure is translated in a sound signal. Because the cortical bone has a low conductivity, the probe will emit a low intensity sound signal. The cancellous bone has a medium conductivity. Therefore, the probe will emit a medium sound signal. However, in the event of a breach in the pedicular cortical, as blood and periost have a high conductibility, the probe will emit a intense, rapid pace, sound signal.The Pediguard technique helps thus to anticipate a cortical effraction, by detecting the proximity of the cortical wall. It is efficient but remains relatively expensive.

The main objective of this study is to determine the precision of the placing of pedicular screws, with and without Pediguard system, under fluoroscopy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • All patients needing vertebral instrumentation with pedicular screwing

排除标准

  • Contra-indication to the placement of pedicular screws under fluoroscopy

研究组 & 干预措施

Fluoroscopy

Active Comparator

Vertebral instrumentation with pedicular screwing, performed under fluoroscopy.

干预措施: Fluoroscopy (Other)

Fluoroscopy and Pediguard

Experimental

Vertebral instrumentation with pedicular screwing, performed under fluoroscopy, with the Pediguard system.

干预措施: Pediguard (Device)

Fluoroscopy and Pediguard

Experimental

Vertebral instrumentation with pedicular screwing, performed under fluoroscopy, with the Pediguard system.

干预措施: Fluoroscopy (Other)

结局指标

主要结局

Pedicular effraction grade

时间窗: 1 year after surgery

Evaluation of screw malposition, performed under CT-scan and graded according to the following: 0 (no effraction), grade 1 (effraction up to 2 mm), grade 2 (effraction between 2 and 4 mm), grade 3 (effraction of more than 4 mm).

次要结局

  • Oswestry Disability Index (ODI)(1 year after surgery)
  • SF-36 questionnaire(1 year after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tamas Illes

Head of clinic

Brugmann University Hospital

研究点 (2)

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