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Search / Trial NCT05860673

Minimally Invasive Surgery vs Standard Posterior Approach in the Treatment of Developmental Idiopathic Scoliosis

Launched by ISTITUTO ORTOPEDICO RIZZOLI · May 8, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Posterior Spinal Fusion Mini Invasive Scoliosis Surgery Adolescent Idiopathic Scoliosis Randomized Trial

ClinConnect Summary

This clinical trial is comparing two different surgical methods for treating Adolescent Idiopathic Scoliosis (AIS), a condition that causes an abnormal curvature of the spine in young people. The trial aims to evaluate the outcomes of a newer, less invasive surgery called minimally invasive scoliosis surgery (MIS) against the traditional method known as posterior spinal fusion (PSF). Researchers will look at how well each technique works in terms of both health improvements and spine alignment after surgery.

To participate in this study, individuals should be between the ages of 12 and 25 and have a specific type of scoliosis affecting the thoracic (upper back) or lumbar (lower back) areas of the spine, with a curvature between 40° and 70°. Participants will need to provide consent and agree to follow-up appointments. The trial is currently recruiting, and everyone, regardless of gender, is encouraged to join if they meet the criteria. By participating, patients will contribute to important research that could help improve treatment options for scoliosis in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Patients with AIS
  • 2. Age between 12 and 25 years;
  • 3. Site of scoliotic curve: thoracic and/or lumbar;
  • 4. Preoperative radiographic range of the main scoliotic curve between 40° and 70° according to Cobb;
  • 5. Ability and consent of patients/parents to actively participate in the study and clinical follow-up.
  • Exclusion Criteria:
  • 1. Patients already treated surgically for scoliosis;
  • 2. Site of the scoliotic curve: cervical;
  • 3. Patients with scoliosis other than adolescent idiopathic scoliosis;
  • 4. Patients who do not fall within the described parameters;
  • 5. Unbalanced sagittal profile;
  • 6. Patients unable to consent or perform follow-ups.
  • 7. Pregnant women.

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

Trial Officials

Alessandro Gasbarrini, MD

Principal Investigator

Istituto Ortopedico Rizzoli - Chirurgia vertebrale

Bruna Maccaferri, MD

Study Chair

Istituto Ortopedico Rizzoli -Chirurgia Vertebrale

Francesco Vommaro, MD

Study Chair

Istituto Ortopedico Rizzoli -Chirurgia Vertebrale

Giovanni Ciani, MD

Study Chair

Istituto Ortopedico Rizzoli -Chirurgia Vertebrale

Lucrezia Leggi, MD

Study Chair

Istituto Ortopedico Rizzoli -Chirurgia Vertebrale

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported