跳至主要内容
临床试验/NCT06396286
NCT06396286进行中(未招募)不适用

Spine Surgery for Lenke 1 Adolescent Idiopathic Scoliosis: a Pilot Study

Istituto Ortopedico Rizzoli2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年6月12日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
20
试验地点
2
主要终点
Spine Correction

研究概览

简要总结

Idiopathic scoliosis of developmental age (AIS) is the most vertebral deformity in the adolescent population, with a prevalence of 1-3%. The treatment of AIS depends on the morphology and extent of the curve and the growth potential residual, can range from simple clinical-radiological monitoring, to the use of braces to, in the most severe cases, correction surgical correction. The indication for surgical correction of AIS depends on the location, extent and flexibility of the scoliotic curve and not least on the patient's age or, better, the skeletal age. The primary goal of surgery is to correcting the deformity by preventing its progression, preserving as many motion segments as possible; secondarily, the surgery aims to restore the coronal and sagittal balance of the spine.

详细描述

Historically, the first internal fixation system used for the correction and arthrodesis of AIS is the Harrington system. The his implant provided minimal invasion of the canal vertebral canal, providing predictable correction of the deformity vertebral but with limited ability to provide control of the sagittal plane, being unable to effectively derotate the spine. Over the years, implants have been applied "second-generation" vertebrae that allow for fixation spinal by implanting pedicle screws and hooks and are more effective in correcting the curve, achieved through distraction and compression maneuvers (Cotrel-Debousset), up to to direct derotation maneuvers using of uniplanar screws that allow effective reduction of the hump costal. These techniques require the implantation of a higher density of surgical instrumentation, requiring more time surgery, greater intraoperative blood loss, greater greater risk of intraoperative neurological damage, and greater reduction spinal mobility. In addition, in recent years there has been increasing emphasis on emphasizing how lower density of the surgical instrumentation conditions the stiffness and tension of the arthrodesis system, resulting in better postoperative outcomes. Although there is awareness of the importance of reducing the invasiveness of the surgical approach, to date the most frequently adopted for the surgical correction of AIS is the vertebral fusion by instrumented arthrodesis, performed using a posterior approach (posterior spinal fusion - PSF). This technique involves a wide median incision with implantation of screws pedicle screws at the level of the vertebral soma, joined together by means of two longitudinal bars, placed lateral to the line of the spinoses. This surgical technique is invasive and is associated with substantial blood loss, severe postoperative pain, as well as the infectious risk of the surgical site. The choice of vertebral levels to be included in arthrodesis follows the classification according to Lenke, which distinguishes different types of curves. In particular, curves of type Lenke 1 would lend themselves to a less invasive approach because they are structured only at the thoracic level being therefore correctable therefore with a more selective approach. Compared with traditional the single bar has the advantage of treating the spine surgically only halfway, that is, on a single side with respect to the plane of the spinoses, i.e., the cut surgery exposes only the posterior arches of the concavity of the scoliotic curve, this results in less tissue damage, reduces the blood loss and consequently reduces infectious risk and allows early mobilization with reduced post surgery.

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
12 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Spine Correction

时间窗: at 12 months

The correction of the curvature of the back will be evaluated via x-ray

Quality of Life 1

时间窗: at 12 months

The "Scoliosis Research Society 22" is a multidimensional questionnaire covering the four non-management domains of pain, function, self-image, and mental health (5 items per domain), along with 2 items to assess the patient's satisfaction with management of their deformity

Quality of Life 2

时间窗: at 12 months

The Oswestry Disability Index (ODI) a patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from back pain.

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 (2)

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