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).

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.

Study Overview

• Status: Completed
• Conditions: Scoliosis; Adolescence; Spine Fusion
• Intervention / Treatment: Procedure: gait analysis

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Istituto Ortopedico Rizzoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; Scoliosis patients undergoing traditional surgical treatment, using posterior spinal fusion.	Procedure: gait 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interoperative complications	Record intraoperative and postoperative events, such as symptoms and/or complications arising from the patient's admission	4 years after surgery
Range of Motion	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.	4 years after surgery

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2024
• Primary Completion (Actual): January 31, 2025
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: December 23, 2025
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: gait analysis; vertebral body tethering
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Curvatures; Scoliosis; Diagnostic Techniques and Procedures; Diagnosis; Population Characteristics; Physical Examination; Health; Physical Fitness; Gait; Physical Functional Performance; Gait Analysis
• Other Study ID Numbers: GT24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No