Mini-invasive Spine Surgery for Neuromuscolar Scoliosis

Surgery Clinical Trial

— MISNM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06367933
• Other study ID #: MISNM
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Neuromuscular Scoliosis
• Scoliosis
• Spine Deformity
• Surgery
• Vertebral Fusion

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