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Mini-invasive Spine Surgery for Neuromuscolar Scoliosis

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06367933
Acronym
MISNM
Enrollment
1
Registered
2024-04-16
Start date
2024-10-28
Completion date
2025-12-31
Last updated
2026-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Scoliosis, Spine Deformity, Surgery, Vertebral Fusion

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.

Interventions

PROCEDUREmini-invasive spine surgery

spine deformity correction using a mini-invasive technique

Sponsors

Istituto Ortopedico Rizzoli
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
9 Years to 25 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visual Analogue ScaleAt baseline (Day 0)The VAS scale is an objective method of pain measurement
Spine Correction12 monthsThe correction of the curvature of the back will be evaluated via x-ray

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026