Evaluation of Surgical Treatment of Idiopathic Scoliosis With Vertebral Body Tethering Versus Pos… (NCT07450326) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Surgical Treatment of Idiopathic Scoliosis With Vertebral Body Tethering Versus Posterior Spinal Fusion.
Italy12 participantsStarted 2024-11-22
Plain-language summary
The aim of this study is to evaluate the short, medium and long-term efficacy and safety of vertebral body tethering, based on the results obtained at 3-5 months of follow-up, exploring not only the ability to correct scoliosis, but also the safety and ability to preserve the natural motility of the spine. To this end, the geometric and kinematic parameters of the spine through gait analysis, both during the execution of motor tasks such as walking at a flat level, and in static, upright posture and during the execution of elementary trunk movements will be analyzed, comparing patients undergoing vertebral body tethering and posterior spinal fusion.
Who can participate
Age range
12 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients diagnosed with adolescent idiopathic scoliosis who underwent surgical correction using posterior spinal fusion or vertebral body tethering from 2019 to 2022 and provided informed consent;
* Males or females aged 12 to 18 years at the time of surgery;
* Sanders skeletal maturation age ≤ 6;
* Thoracic scoliotic curve ≥ 40° COBB and ≤ 60° COBB, measured on upright full spine x-rays, anterior-posterior pose.
Exclusion Criteria:
* Patients who had previously undergone spinal or thoracic surgery prior to adolescent idiopathic scoliosis correction;
* Surgically treated patients with scoliosis of a non-idiopathic etiology;
* Patients with anamnestic, clinical, and radiographic characteristics that do not fall within the indication window for the surgical technique of vertebral body tethering;
* Patients with severe intramedullary malformations (syringomyelia greater than 4 mm, Chiari malformation, or tethered cord);
* Structured scoliotic lumbar curve \> 35°, as measured by Cobb radiography.
* Patients who do not provide informed consent to the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.