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Completed

NCT Number: NCT06367933

Mini-invasive Spine Surgery for Neuromuscolar Scoliosis

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.

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Key information

Age range

9 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mini-invasive spine surgery

Procedure

spine deformity correction using a mini-invasive technique

Primary outcomes

  1. Visual Analogue Scale

    Time frame: At baseline (Day 0)

    The VAS scale is an objective method of pain measurement

  2. Visual Analogue Scale

    Time frame: At 12 month follow-up

    The VAS scale is an objective method of pain measurement

  3. Spine Correction

    Time frame: 12 months

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

  4. Spine Correction

    Time frame: 24 months

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

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Acronym: MISNM

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 16, 2024
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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