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Evaluation of Surgical Treatment of Idiopathic Scoliosis With Vertebral Body Tethering Versus Posterior Spinal Fusion.

Evaluation of Surgical Treatment of Idiopathic Scoliosis With Vertebral Body Tethering (VBT) Versus Posterior Spinal Fusion (PSF).

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07450326
Enrollment
12
Registered
2026-03-04
Start date
2024-11-22
Completion date
2025-01-31
Last updated
2026-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis; Adolescence, Spine Fusion

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

PROCEDUREgait analysis

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

Istituto Ortopedico Rizzoli
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
12 Years to 18 Years

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

MeasureTime frameDescription
Surgical scoliosis correction4 years after surgerymeasurement of cobb angle after surgery
Gait Analysis4 years after surgeryEvaluation 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

MeasureTime frameDescription
Interoperative complications4 years after surgeryRecord intraoperative and postoperative events, such as symptoms and/or complications arising from the patient's admission
Range of Motion4 years after surgeryEvaluation 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026