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

NCT07450326 | Completed

• 1 other identifier: GT24
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis; Adolescence; Spine Fusion

Keywords

gait analysis; vertebral body tethering

Outcome Measures

Primary Outcomes (2)

• Surgical scoliosis correction

  measurement of cobb angle after surgery

  4 years after surgery

• Gait Analysis

  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

  4 years after surgery

Secondary Outcomes (2)

• Interoperative complications

  4 years after surgery

• Range of Motion

  4 years after surgery

Study Arms (2)

vertebral body tethering

Scoliosis patients undergoing surgical treatment with vertebral body tethering, a technique that involves inserting screws into the vertebral bodies on the convex side of the scoliotic curve, via thoracoscopic access; the screws are then connected to a band, which, when tensioned, shortens the convex side of the scoliosis.

Procedure: gait analysis

posterior spinal fusion

Scoliosis patients undergoing traditional surgical treatment, using posterior spinal fusion.

Procedure: gait analysis

Interventions

gait analysis PROCEDURE

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.

posterior spinal fusion; vertebral body tethering

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Scoliosis

Interventions

Gait Analysis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Gait; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Functional Performance; Physical Fitness; Health; Population Characteristics

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: March 4, 2026
• Study Start: November 22, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: March 4, 2026

Record last verified: 2026-02

Locations

IT (1)