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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bologna, , Italy
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