Clinical Trials Directory

Trials / Completed

CompletedNCT06367933

Mini-invasive Spine Surgery for Neuromuscolar Scoliosis

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
1 (actual)
Sponsor
Istituto Ortopedico Rizzoli · Academic / Other
Sex
All
Age
9 Years – 25 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREmini-invasive spine surgeryspine deformity correction using a mini-invasive technique

Timeline

Start date
2024-10-28
Primary completion
2025-11-04
Completion
2025-12-31
First posted
2024-04-16
Last updated
2026-02-23

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT06367933. Inclusion in this directory is not an endorsement.