Neuromuscular ScoliosisMISNMNCT06367933
Mini-invasive Spine Surgery for Neuromuscolar Scoliosis
A study testing mini-invasive spine surgery in people with Neuromuscular Scoliosis and Spine Deformity, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Ages 9 to 25 years
- Conditions the study is for
- Neuromuscular Scoliosis, Spine Deformity, Surgery
- What is being tested?
- mini-invasive spine surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteItaly
- Study dates
- 28 Oct 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- ≤ 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mini-invasive Fusion in Spine Surgery for Neuromuscolar Scoliosis: a Pilot Study
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
- Being tested
- mini-invasive spine surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mini-invasive spine surgeryProcedure or surgery
spine deformity correction using a mini-invasive technique
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | severe neuromuscolar scoliosis who need surgical correction Receives: Procedure: mini-invasive spine surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
The VAS scale is an objective method of pain measurement
Measured: At baseline (Day 0)
Visual Analogue Scale
The VAS scale is an objective method of pain measurement
Measured: At 12 month follow-up
Spine Correction
The correction of the curvature of the back will be evaluated via x-ray
Measured: 12 months
Spine Correction
The correction of the curvature of the back will be evaluated via x-ray
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start28 Oct 2024
- Primary completion4 Nov 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular ScoliosisStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367933
- Sponsor's protocol ID
- MISNM
- Acronym
- MISNM
- Status last verified
- Feb 2026
- First submitted
- 11 Apr 2024
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 19444065
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mini-invasive Fusion in Spine Surgery for Neuromuscolar Scoliosis: a Pilot Study
- ClinicalTrials.gov ID
- NCT06367933
- Acronym / sponsor ID
- MISNM / MISNM
- Conditions
- Neuromuscular Scoliosis, Spine Deformity, Surgery, Vertebral Fusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 4 Nov 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Procedure: mini-invasive spine surgerysevere neuromuscolar scoliosis who need surgical correction |
Who may qualify
- Ages
- 9 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Diagnosis of SNM
- Age 9 to 25 years
- Male and female gender
- Preoperative Cobb > 45° COBB
- Preoperative pelvic obliquity > 10°
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mini-invasive spine surgeryspine deformity correction using a mini-invasive technique | Procedure or surgery | experimental |
Primary outcome
Visual Analogue Scale
Time frame: At baseline (Day 0)
The VAS scale is an objective method of pain measurement
Visual Analogue Scale
Time frame: At 12 month follow-up
The VAS scale is an objective method of pain measurement
Spine Correction
Time frame: 12 months
The correction of the curvature of the back will be evaluated via x-ray
Spine Correction
Time frame: 24 months
The correction of the curvature of the back will be evaluated via x-ray
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Background: PubMed 19444065Modi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mini-invasive spine surgery in people with Neuromuscular Scoliosis and Spine Deformity, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: At baseline (Day 0)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06367933, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.