Mini-invasive surgery for neuromuscular scoliosis
Mini-invasive Fusion in Spine Surgery for Neuromuscolar Scoliosis: a Pilot Study
This study is testing a less invasive spine surgery to see if it can help young people with neuromuscular scoliosis improve their trunk control and reduce complications from their spinal deformities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 9 Years to 25 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06367933 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on the use of mini-invasive spine surgery to treat neuromuscular scoliosis, a condition characterized by spinal deformities due to dysfunction in the central and peripheral nervous systems. The study aims to improve trunk control and reduce complications associated with severe spinal deformities, such as respiratory failure and infections. Eligible participants include individuals aged 9 to 25 years with specific criteria related to their spinal curvature and pelvic obliquity. The intervention seeks to enhance the quality of life for patients suffering from this debilitating condition.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 9 to 25 years diagnosed with neuromuscular scoliosis and exhibiting specific spinal curvature measurements.
Not a fit: Patients with scoliosis due to causes other than neuromuscular issues or those who retain ambulatory capacity may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life and functional outcomes for patients with neuromuscular scoliosis.
How similar studies have performed: Other studies have shown promise in using minimally invasive techniques for spinal surgery, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bologna
- Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)
Study contacts
- Study coordinator: Francesco Vommaro, MD
- Email: francesco.vommaro@ior.it
- Phone: 0516366
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.