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 range12 Years – 18 Years
SexALL
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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.