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Search / Trial NCT04590807

Posterior Spinal Fusion With Pedicle Screws vs. Anterior Vertebral Body Tethering in Adolescent Idiopathic Scoliosis

Launched by TURKU UNIVERSITY HOSPITAL · Oct 15, 2020

Trial Information

Current as of August 23, 2025

Not yet recruiting

Keywords

Scoliosis Spinal Diseases

ClinConnect Summary

This clinical trial is studying two different surgical methods for treating adolescent idiopathic scoliosis, a condition that causes an abnormal curve of the spine in teenagers. The standard treatment currently used is called posterior spinal fusion with pedicle screws, which helps to straighten the spine but can limit movement. The trial is comparing this method to a newer technique called anterior vertebral body tethering (VBT), which aims to correct the spine while allowing for more flexibility and growth. Researchers want to see if VBT is just as effective as the traditional method in correcting the spine's curve and improving patients' overall quality of life after two years.

To be eligible for this trial, participants must be between 10 and 16 years old, have a specific type of scoliosis (Lenke type I A, B, or C), and have a curve angle between 40 and 60 degrees. They should also be able to show some flexibility in their spine. The trial will look at how well each treatment works, any complications that might arise, and how well patients can move their spines after surgery. Parents and guardians will need to give informed consent, meaning they'll be fully informed about the study and what it involves before agreeing to participate. This trial is still in the planning stages and has not yet started recruiting participants.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • AIS Lenke type I A,B or C
  • Age 10-16 years
  • Skeletally immature (Sanders classification between 2 and 5)
  • Cobb angle 40-60˚
  • 50% flexibility on supine bending films.
  • Selective thoracic fusion feasible
  • Exclusion Criteria:
  • Any other than idiopathic scoliosis
  • Less than 50% curve flexibility
  • Skeletal maturity (Sanders \>5)
  • Patients who have evidence of neurological disorders
  • Patients who have undergone intrathoracic surgery

About Turku University Hospital

Turku University Hospital (TYKS) is a leading academic medical center located in Turku, Finland, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a key institution within the University of Turku, TYKS integrates cutting-edge medical education with state-of-the-art clinical services, offering a broad spectrum of specialized care. The hospital actively participates in clinical trials, facilitating the translation of scientific discoveries into practical treatments, and enhancing patient outcomes. With a multidisciplinary approach and a focus on collaboration, TYKS aims to contribute significantly to the global medical community through its rigorous research initiatives and commitment to patient-centered care.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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