Surgery for Adolescent Idiopathic Scoliosis
Spine Surgery for Lenke 1 Adolescent Idiopathic Scoliosis: a Pilot Study
NA · Istituto Ortopedico Rizzoli · NCT06396286
This study is testing a new type of surgery for teenagers with scoliosis to see if using a single rod can correct their spine while helping them recover better and keep their movement.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 12 Years to 21 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli (other) |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06396286 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on the surgical correction of adolescent idiopathic scoliosis (AIS) in patients aged 12 to 21 with specific curve characteristics. The study aims to evaluate the effectiveness of a single rod intervention in correcting the spinal deformity while minimizing invasiveness and preserving spinal mobility. Participants will undergo surgery to correct their thoracic scoliotic curve, with careful monitoring of preoperative and postoperative outcomes. The trial seeks to improve surgical techniques and patient recovery in adolescents with AIS.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12 to 21 diagnosed with Lenke type I thoracic scoliotic curves and a Cobb angle between 40° and 70°.
Not a fit: Patients with scoliosis of a different etiology, those with Cobb angles greater than 70°, or those who have previously undergone scoliosis surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and quality of life for adolescents with scoliosis.
How similar studies have performed: Other studies have shown success with similar surgical interventions for scoliosis, but this specific approach using a single rod is being evaluated for its unique benefits.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION CRITERIA: * Diagnosis of AIS; * Male and female sex; * Age between 12 and 21; * Thoracic scoliotic curve, type I according to Lenke's classification; * Preoperative radiographic range of the main scoliotic curve between 40° and 70° Cobb; * Reducibility of the curve on bending radiographs by 30%; * Signature of the informed consent of patients/parents to actively participate in the study and clinical follow-up. EXCLUSION CRITERIA: * Scoliosis with an etiology different from AIS; * pre-operative COBB \> 70°; * Patients already treated surgically for scoliosis; * Location of the scoliotic curve: Lenke 2-6; * Patients who do not fall within the parameters described; * Patients unable to express consent or carry out follow-ups; * Language barrier; * Pregnant women.
Where this trial is running
Bologna
- Istituto Ortopedico Rizzoli — Bologna, Italy (RECRUITING)
Study contacts
- Study coordinator: Francesco Vommaro, MD
- Email: francesco.vommaro@ior.it
- Phone: 0516366
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.
Conditions: Scoliosis, Spine Deformity, Adolescent Idiopathic Scoliosis