Scoliosis; Adolescence, Spine Fusion
Conditions
Keywords
gait analysis, vertebral body tethering
Brief 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.
Interventions
Gait analysis analyzes the overall biomechanics of the spine from a kinematic point of view through motion analysis with stereophotogrammetry which allows measurements of vertebral motion on two of the three anatomical planes.
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical scoliosis correction | 4 years after surgery | measurement of cobb angle after surgery |
| Gait Analysis | 4 years after surgery | Evaluation of the preservation of spinal functionality at an average of 48 months after surgical correction of scoliosis, through the measurement and correlation of geometric and kinematic parameters of the trunk and spine using instrumental movement analysis, by measuring the relative angles between segments of the spine and trunk, following the protocol of Leardini et al. 2011 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interoperative complications | 4 years after surgery | Record intraoperative and postoperative events, such as symptoms and/or complications arising from the patient's admission |
| Range of Motion | 4 years after surgery | Evaluation of the degree of flexibility of the spine (in flexion, extension and lateral bending) and comparison between pre- and post-operative values, measuring the spino-pelvic geometric parameters (static) and comparing them with the kinematic parameters (dynamic) by comparing the two groups of the study. |
Countries
Italy