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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06367933
Other study ID # MISNM
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 2024
Est. completion date May 2026

Study information

Verified date June 2024
Source Istituto Ortopedico Rizzoli
Contact Francesco Vommaro, MD
Phone 0516366
Email francesco.vommaro@ior.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date May 2026
Est. primary completion date May 2025
Accepts healthy volunteers No
Gender All
Age group 9 Years to 25 Years
Eligibility 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


Intervention

Procedure:
mini-invasive spine surgery
spine deformity correction using a mini-invasive technique

Locations

Country Name City State
Italy Istituto Ortopedico Rizzoli Bologna

Sponsors (1)

Lead Sponsor Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analogue Scale The VAS scale is an objective method of pain measurement At baseline (Day 0)
Primary Visual Analogue Scale The VAS scale is an objective method of pain measurement At 12 month follow-up
Primary Spine Correction The correction of the curvature of the back will be evaluated via x-ray 12 months
Primary Spine Correction The correction of the curvature of the back will be evaluated via x-ray 24 months
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