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临床试验/NCT06367933
NCT06367933已完成不适用

Mini-invasive Fusion in Spine Surgery for Neuromuscolar Scoliosis: a Pilot Study

Istituto Ortopedico Rizzoli1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2024年10月28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
入组人数
1
试验地点
1
主要终点
Spine Correction

研究概览

简要总结

Neuromuscular scoliosis (SNM) are deformities related to the impairment of normal function of the central nervous system (CNS) and/or peripheral nervous system (PNS) resulting in alterations to the of the functional unit represented by the integrated motor sequence (SIM). At the level of the spine, dysfunction of the SIM results in altered dynamic support of the spine. This results in a control of the trunk that is not harmonious due to the lack of effective mechanisms of muscle compensation. In particular, a greater degree of pelvic tilt with respect to the ground plane, with an increase in the degree of the so-called pelvic obliquity (OP), a fundamental parameter in walking and maintaining the seated posture. Spinal deformity causes severe alterations of the rib cage resulting in respiratory failure that often requires ventilatory supports and is associated with frequent airway infections, including pneumonias, often fatal. SNMs also express other comorbidities: cardiac (heart failure), neurological (epilepsy), nutritional that necessitate careful management multidisciplinary and especially anesthesiological evaluation for the peri-operative management. The surgical treatment of SNM constitutes a topic that is still debated due to both the bio-mechanical peculiarities of SNM and the clinical features, particularly comorbidities, that characterize this patient population. Compared with idiopathic scoliosis surgery, in SNM there is a higher rate of complications. To date, most of the complications are respiratory in nature (23%), followed by complications mechanical of the implanted surgical instrumentation (13%), and surgical site infections (11%). Furthermore, there is evidence that SNM surgery correlates with increased blood loss intraoperative. To date, it is recognized in the literature that the safest and most effective surgical treatment for SNMs is arthrodesis posterior instrumented with pedicle screws extended to the pelvis. In the years, mini-invasive surgical techniques have become increasingly prominent. invasive with the goal of reducing operative time, blood loss and complications themselves.

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
9 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of SNM
  • Age 9 to 25 years
  • Male and female gender
  • Preoperative Cobb > 45° COBB
  • Preoperative pelvic obliquity > 10°
  • Extent of scoliotic curve (expressed in COBB degrees) on supine whole spine X-ray
  • ≤ 25% compared with magnitude of curve assessed on into spinal X-rays from supine sitting.
  • Loss of walking ability
  • Absence of emergency criteria for spinal surgery

排除标准

  • Scoliosis with etiology other than SNM
  • Pre-operative Cobb < 45° COBB
  • Preoperative pelvic obliquity < 10°
  • High anesthesiologic risk for severe respiratory deficit
  • Criteria for surgical urgency
  • Preserved ambulatory capacity
  • Patients who did not perform follow-up at the Rizzoli Orthopaedic Institute;
  • Patients whose parents/guardians have denied consent for access to their own medical records.
  • Language barrier

研究组 & 干预措施

experimental

Experimental

severe neuromuscolar scoliosis who need surgical correction

干预措施: mini-invasive spine surgery (Procedure)

结局指标

主要结局

Spine Correction

时间窗: 24 months

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

Visual Analogue Scale

时间窗: At 12 month follow-up

The VAS scale is an objective method of pain measurement

Visual Analogue Scale

时间窗: At baseline (Day 0)

The VAS scale is an objective method of pain measurement

Spine Correction

时间窗: 12 months

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

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 (1)

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