Mini-invasive Spine Surgery for Neuromuscolar Scoliosis

Not Applicable

Recruiting

• Conditions: Surgery; Neuromuscular Scoliosis; Vertebral Fusion; Spine Deformity
• Interventions: Procedure: mini-invasive spine surgery

• Registration Number: NCT06367933
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-11
• Study First Submitted QC: 2024-04-11
• Study First Posted: 2024-04-16
• Study Start: 2024-10-28
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Primary Completion: 2025-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental	mini-invasive spine surgery	severe neuromuscolar scoliosis who need surgical correction

Primary Outcome Measures

Name	Time	Method
Spine Correction	24 months	The correction of the curvature of the back will be evaluated via x-ray
Visual Analogue Scale	At 12 month follow-up	The VAS scale is an objective method of pain measurement

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy