跳至主要内容
临床试验/NCT05347056
NCT05347056Unknown不适用

The Effect of Vertebral Body Tethering on Lumbar Paraspinal Muscle Cross-Section Area, Lumbar Range of Motion and Trunk Muscle Strength in Adolescent Idiopathic Scoliosis

Istanbul University0 个研究点目标入组 16 人开始时间: 2022年5月9日最近更新:
适应症

试验速览

阶段
不适用
入组人数
16
主要终点
Comparison of VBT and STF group paraspinal muscles cross-section area

研究概览

简要总结

We aimed to compare the paraspinal muscle cross-section area and functional results of anterior vertebral tethering and selective thoracic fusion surgery.

详细描述

Idiopathic scoliosis is a three-dimensional deformity of the spine. It is defined as the curvature of the spine of 10° or more detected radiologically in the coronal plane. In scoliosis, changes in axial rotation in the transverse plane and physiological curvatures in the sagittal plane (decrease or increase in kyphosis, lordosis) occur.

The incidence of scoliosis is 2-3%, but up to 10% of patients need surgical treatment. Knowing the long-term effects of posterior spinal fusion is currently the gold standard treatment because it gives good results in deformity improvement. However, fusion surgery has disadvantages such as loss of motion in the spine and long-term development of adjacent segment disease and disc degeneration. It has also been suggested that spinal fusion causes iatrogenic damage to the paraspinal muscles (especially the multifidus), which is of great importance in the alignment and movement of the spine due to the posterior approach during surgery.

As a result of damage to the lumbar multifidus muscles and the development of fatty degeneration, problems such as spinal sagittal alignment disorders and chronic low back pain can be seen. In addition, fatty degeneration and atrophy of the paraspinal muscles may lead to the development of adjacent segment disease in the segments under fusion in the long term.

In selective thoracic fusion, by protecting the mobile segments in the lumbar region, the range of motion is preserved and iatrogenic damage of the lumbar paraspinal muscles is prevented. After selective thoracic fusion (STF), some improvement occurs in the deformity in the lumbar region. However, the risk of insufficient improvement and progression of the curve in the unfused lumbar segments, especially in immature patients, should be considered.

Anterior vertebra body tethering is a surgical technique that has been used more frequently in recent years, which is thought to prevent functional complications caused by spinal fusion.With this method, which allows the growth of the spine to continue, there is no need for fusion when treating progressive curvature. Short-term radiological results of this surgical technique have been reported frequently in recent years, but the literature on functional results (spine flexibility, trunk endurance, etc.) is very limited.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
12 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Males or females age 12 to 19 years old Diagnosis of idiopathic scoliosis At least 6 months have passed since surgical intervention Spina bifida occulta is permitted

排除标准

  • Pregnancy Prior spinal or chest surgery MRI abnormalities (including syrinx greater than 4mm, Chiari malformation, or tethered cord) Neuromuscular, thoracogenic, cardiogenic scoliosis, or any other non-idiopathic scoliosis Associated syndrome, including Marfan syndrome or neurofibromatosis

结局指标

主要结局

Comparison of VBT and STF group paraspinal muscles cross-section area

时间窗: 6 months to 3 years after surgery

The bilateral cross-sectional areas (CSA) of the multifidus (MF), erector spinae (ES) and psoas (P) muscles at all disc levels were measured by outlining the fascial boundary of the muscle

Comparison of pre-op and post-op paraspinal muscles cross-section area

时间窗: 6 months to 3 years after surgery

The bilateral cross-sectional areas (CSA) of the multifidus (MF), erector spinae (ES) and psoas (P)

次要结局

  • Comparison VBT and STF group lomber range of motion(6 months to 3 years after surgery)
  • Investigation of Quality of Life in Adolescent Idiopathic Scoliosis(6 months to 3 years after surgery)
  • Comparison of VBT and STF group trunk muscle strenght and endurance(6 months to 3 years after surgery)

研究者

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

Esin Nur Taşdemir

MD

Istanbul University

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