Clinical trial NCT06367933: Mini-invasive Spine Surgery for Neuromuscolar Scoliosis
Official title: Mini-invasive Fusion in Spine Surgery for Neuromuscolar Scoliosis: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuromuscular Scoliosis
Spine Deformity
Surgery
Vertebral Fusion
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 30
Sex: ALL
Minimum age (years): 9
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: At baseline (Day 0)
measure: Visual Analogue Scale
timeFrame: At 12 month follow-up
measure: Spine Correction
timeFrame: 12 months
measure: Spine Correction
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References:
citation: 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.