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临床试验/NCT06065644
NCT06065644尚未招募不适用

Inducible Displacements of the Sacroiliac Joint Measured With CTMA

University of Bergen2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
2
主要终点
Movement

研究概览

简要总结

To evaluate the influence of different surgical treatment options for kyphoscoliosis we measure the movement of the SI joint with Radiostereometric analysis (RSA) after lumbar fixation with CT motion analysis (CTMA).

详细描述

CTMA is a high precision in vivo measuring method for motion. We intend to measure sacroiliac joint (SIJ) movement in long fixations compared to short fixations. The Center for Implant and Radiostereometric Research Oslo (CIRRO) has extensive experience with RSA and established state of the art measuring method of movement in the SIJ. We have compared the methode with CTMA and established a methode for CTMA measurements at CIRRO. We will measure the movement in the SIJ in patients that have long fixations of 3 or more segments down to S1 and compare it to one segment fixation in the level of L4/5. Null hypothesis

  • The SI movement will not increase because of long fixation down to sacrum, the SIJ will not work as an adjacent level and not compensatory increase the movement.
  • The increased movement will not result in low back pain and /or pseudo radicular pain to the lower limbs CTMA is a high accuracy measuring method comparable to RSA. With a precision of RSA of 1 degree for rotation we need 10 patients in each group to detect a difference of 2 degrees for power of 90% on an alpha = 99% confidence level. Taking drop-outs into account we need a group size of 15 resulting in 30 patients (Two- sided T-test).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Long fixations of 3 or more segments down to S1, (also including not correction surgery patients).
  • One segment fixations in the level of L4/5 regardless of olisthesis.

排除标准

  • Medical conditions that affect the SI joint (Sacroileitis, Ankylosing spondylitis, psoriasis, autoimmune illness)
  • Do not want to participate and not able to answer PROMs

结局指标

主要结局

Movement

时间窗: 12 months

Compare the induced movement of the SIJ joint Movement measured in millimeter around x, y, z axis 3 dimensional and usually in the range of -2-2 millimeters when comparing neutral position to provoked position.

次要结局

  • EQ 5D 5L(12 months)
  • Satisfaction og treatment and result on a 7 point likert scale(12 months)
  • NRS Numeric rating scale back pain and pain to the lower limbs(12 months)
  • Oswestry disability index(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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