Mini-invasive Spine Surgery for Neuromuscolar Scoliosis

NCT ID: NCT06367933

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-28
• Study Completion Date: 2026-05-31

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.

Conditions

Neuromuscular Scoliosis; Spine Deformity; Surgery; Vertebral Fusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

experimental

severe neuromuscolar scoliosis who need surgical correction

Group Type: EXPERIMENTAL

mini-invasive spine surgery

Intervention Type: PROCEDURE

spine deformity correction using a mini-invasive technique

Interventions

mini-invasive spine surgery

spine deformity correction using a mini-invasive technique

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Francesco Vommaro, MD

Role: CONTACT

francesco.vommaro@ior.it

0516366 ext. 163

Facility Contacts

Bruna Maccaferri

Role: primary

bruna.maccaferri@ior.it

+39-051636163

References

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.

Reference Type: BACKGROUND

PMID: 19444065 (View on PubMed)

Other Identifiers

MISNM

Identifier Type: -

Identifier Source: org_study_id