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Search / Trial NCT06367933

Mini-invasive Spine Surgery for Neuromuscolar Scoliosis

Launched by ISTITUTO ORTOPEDICO RIZZOLI · Apr 11, 2024

Trial Information

Current as of August 21, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new type of surgery called mini-invasive spine surgery for young people with neuromuscular scoliosis (SNM). Neuromuscular scoliosis is a condition where the spine curves abnormally due to problems with the brain or nerves, which can lead to difficulties in walking and serious issues with breathing. The goal of this trial is to see if this less invasive surgical method can reduce recovery time, blood loss, and the risk of complications compared to traditional surgery.

To participate in this trial, candidates must be between 9 and 25 years old and have a diagnosis of SNM with a significant spinal curve. They should also have difficulty walking and meet specific measurements on their spine X-rays. Participants will receive the new type of surgery and will be closely monitored for their recovery and any complications. This trial is currently recruiting, and it aims to improve care for patients with this challenging condition while minimizing risks associated with surgery.

Gender

ALL

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

About Istituto Ortopedico Rizzoli

Istituto Ortopedico Rizzoli is a renowned orthopedic research and treatment institute based in Bologna, Italy, dedicated to advancing musculoskeletal health through innovative clinical trials and cutting-edge medical practices. With a strong emphasis on research, the institute collaborates with leading experts in orthopedics, rehabilitation, and related fields to develop and evaluate new therapies and surgical techniques. Committed to improving patient outcomes, Istituto Ortopedico Rizzoli not only focuses on high-quality clinical care but also fosters a robust research environment that supports the translation of scientific findings into clinical applications.

Locations

Bologna, , Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported