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Completed

NCT Number: NCT07450326

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

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.

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Key information

Conditions

Scoliosis; Adolescence Bone Diseases Musculoskeletal Diseases Scoliosis Spinal Curvatures Spinal Diseases Spine Fusion

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Surgical scoliosis correction

    Time frame: 4 years after surgery

    measurement of cobb angle after surgery

  2. Gait Analysis

    Time frame: 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 outcomes

  1. Interoperative complications

    Time frame: 4 years after surgery

    Record intraoperative and postoperative events, such as symptoms and/or complications arising from the patient's admission

  2. Range of Motion

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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