Mini-invasive Spine Surgery for Neuromuscolar Scoliosis

NCT06367933 | Completed

• 1 other identifier: MISNM
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromuscular Scoliosis; Spine Deformity; Surgery; Vertebral Fusion

Outcome Measures

Primary Outcomes (4)

• Visual Analogue Scale

  The VAS scale is an objective method of pain measurement

  At baseline (Day 0)

• Visual Analogue Scale

  The VAS scale is an objective method of pain measurement

  At 12 month follow-up

• Spine Correction

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

  12 months

• Spine Correction

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

  24 months

Study Arms (1)

experimental

EXPERIMENTAL

severe neuromuscolar scoliosis who need surgical correction

Procedure: mini-invasive spine surgery

Interventions

mini-invasive spine surgery PROCEDURE

spine deformity correction using a mini-invasive technique

experimental

Eligibility Criteria

• Age: 9 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (1)

• Modi HN, Hong JY, Mehta SS, Srinivasalu S, Suh SW, Yi JW, Yang JH, Song HR. Surgical correction and fusion using posterior-only pedicle screw construct for neuropathic scoliosis in patients with cerebral palsy: a three-year follow-up study. Spine (Phila Pa 1976). 2009 May 15;34(11):1167-75. doi: 10.1097/BRS.0b013e31819c38b7.

  PMID: 19444065 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 16, 2024
• Study Start: October 28, 2024
• Primary Completion: November 4, 2025
• Study Completion: December 31, 2025
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

IT (1)