Comparing minimally invasive surgery to standard surgery for adolescent idiopathic scoliosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comfort Tote to help recovery after scoliosis surgery in teens

  This study tests whether a therapeutic Comfort Tote can reduce pain and anxiety after surgery for adolescent idiopathic scoliosis.

  Recruiting Columbia University · New York, New York · NCT07632833

• Erector spinae plane block to reduce post-operative pain after posterior spinal fusion in children

  This will try giving an erector spinae plane block with ropivacaine to see if it reduces pain and the need for opioid pain medicine after posterior spinal fusion in children with adolescent idiopathic or neuromuscular scoliosis.

  Recruiting Phase 3 University of California, San Francisco · San Francisco, California · NCT07561827

• MRI-guided dynamic support for correcting adolescent scoliosis

  This pilot tests whether an MRI-compatible air-padded support with programmable pneumatic control can quickly reduce spinal curvature in 10–16-year-olds with mild to moderate adolescent idiopathic scoliosis.

  Recruiting Chinese University of Hong Kong · Tsim Sha Tsui, Kowloon · NCT07246122

• Detecting scoliosis progression without X-rays using Momentum Spine app

  This study tests whether the Momentum Spine app can reliably detect scoliosis progression in 8-18 year olds without radiographs and guide follow-up care.

  Recruiting Children's Hospital Los Angeles · Los Angeles, California · NCT06825611

• Examining how spinal manipulation affects motor control in adolescents with scoliosis

  This study is testing how spinal manipulation affects movement control in teenagers with scoliosis to see if it helps them improve their balance and muscle function.

  Recruiting The First Affiliated Hospital of Zhejiang Chinese Medical University · Hangzhou · NCT06758115

• Using a 3D camera to assess scoliosis in adolescents

  This study is testing a new way to check the spine of teenagers with scoliosis using a special 3D camera to see if it’s better and safer than traditional X-rays.

  Recruiting The First Affiliated Hospital of Zhejiang Chinese Medical University · Hangzhou, Zhejiang · NCT06717568

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.