Comparing minimally invasive surgery to standard surgery for adolescent idiopathic scoliosis
Minimally Invasive Surgery vs Standard Posterior Approach in the Treatment of Developmental Idiopathic Scoliosis: Randomized Trial.
This study is testing whether a new, less invasive surgery for scoliosis can work just as well as the traditional surgery for teens and young adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 12 Years to 25 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT05860673 on ClinicalTrials.gov |
What this trial studies
This randomized trial evaluates the clinical and radiographic outcomes of adolescents with idiopathic scoliosis treated using a minimally invasive surgery (MIS) technique compared to the traditional posterior spinal fusion (PSF) technique. Patients aged 12 to 25 with specific curve measurements will be randomly assigned to one of the two surgical approaches. The study aims to determine if MIS is non-inferior to PSF in terms of curve correction while potentially offering benefits such as reduced postoperative pain and lower transfusion risks. Follow-up evaluations will occur at multiple intervals post-surgery to assess outcomes.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12 to 25 with adolescent idiopathic scoliosis and a scoliotic curve between 40° and 70°.
Not a fit: Patients who have previously undergone surgery for scoliosis or have conditions outside of adolescent idiopathic scoliosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive surgical option for treating adolescent idiopathic scoliosis with comparable outcomes to traditional methods.
How similar studies have performed: Other studies have shown promising results with minimally invasive techniques in spinal surgery, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bologna
- Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Alessandro Gasbarrini, MD — Istituto Ortopedico Rizzoli - Chirurgia vertebrale
- Study coordinator: Alessandro Gasbarrini, MD
- Email: alessandro.gasbarrini@ior.it
- Phone: 6366528
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.