Scoliosis; AdolescenceNCT07450326
Evaluation of Surgical Treatment of Idiopathic Scoliosis With Vertebral Body Tethering Versus Posterior Spinal Fusion.
An observational study of Scoliosis; Adolescence and Spine Fusion, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Scoliosis; Adolescence, Spine Fusion
- What is being tested?
- gait analysis
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- 22 Nov 2024to 31 Jan 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Scoliosis; Adolescence, Spine Fusion
- Being tested
- gait analysis
- Keywords
- gait analysis, vertebral body tethering
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gait analysisProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: gait analysis | |
| posterior spinal fusion | Scoliosis patients undergoing traditional surgical treatment, using posterior spinal fusion. Receives: Procedure: gait analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical scoliosis correction
measurement of cobb angle after surgery
Measured: 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
Measured: 4 years after surgery
Secondary outcomes (2)
Interoperative complications
Record intraoperative and postoperative events, such as symptoms and/or complications arising from the patient's admission
Measured: 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.
Measured: 4 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start22 Nov 2024
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis; AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450326
- Sponsor's protocol ID
- GT24
- Status last verified
- Feb 2026
- First submitted
- 23 Dec 2025
- Last updated
- 4 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided