Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06367933
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-04-11
Brief Title:
Mini-invasive Spine Surgery for Neuromuscolar Scoliosis
Sponsor:
Istituto Ortopedico Rizzoli
Organization:
Istituto Ortopedico Rizzoli
Study Overview
Official Title:
Mini-invasive Fusion in Spine Surgery for Neuromuscolar Scoliosis a Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MISNM
Brief Summary:
Neuromuscular scoliosis SNM are deformities related to the impairment of normal function of the central nervous system CNS andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None