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Completed

NCT Number: NCT03296228

Comparison of Dynamic Radiographs in Determining Fusion Level in Adolescent Idiopathic Scoliosis Correction

The purpose of this study is to identify the flexibility radiograph(s) that can most accurately predict the curve behaviour after surgical correction of AIS. With these findings, the investigators hope to give further guidance for the selection of fusion levels and to incorporate different dynamic radiographs into the Lenke Classification, leading to a more universal application that can consistently lead to good surgical and clinical outcome.

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Key information

Conditions

Adolescent Idiopathic Scoliosis

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duchess of Kent Children's Hospital

Hong Kong

About this study

The Lenke Classification is the most widely-accepted classification for Adolescent Idiopathic Scoliosis (AIS) in the world. Its recommendations for fusion of the minor curves depend on its structurality. It defines a minor curve as structural if there is inflexibility on side-bending more than 25 . However, a recent Delphi survey from a panel of experts in AIS management showed that there was no consensus as to which type of dynamic radiograph was optimal. Up to two thirds of the surgeons did not use side-bending as a routine, and hence they cannot apply the Lenke Classification accurately in clinical practice nor follow its recommendations for fusion.

Furthermore, the current classification does not give specific recommendations regarding the selection of fusion levels and does not take into account the clinical appearance of the patients which impact on treatment. Consequently, there are still controversies regarding the Upper Instrumented Vertebra (UIV) and Lowest Instrumented Vertebra (LIV) selections, and following the recommendations may not allow fusion of the least number of segments nor give best clinical results eg shoulder balance.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients diagnosed with AIS who reach the threshold for surgical correction.
  • Patients aged 10 to 18 years

Exclusion criteria

  • Neuromuscular deformity
  • Prior fusion or spine surgery
  • Spinal tumor diagnosis
  • Congenital anomalies

Treatment and study plan

Flexibility Radiographs (supine, supine side-bend, FB)

Radiation

Supine, supine side-bend, fulcrum bend

Flexibility Radiographs (awake traction)

Radiation

awake traction

Flexibility Radiographs (STUGA)

Radiation

supine traction under GA

Primary outcomes

  1. Investigate the flexibility equivalence of different bending methods, and their predictability of the final outcome

    Time frame: 6 months to 9 months

    To investigate the flexibility equivalence of different bending methods: supine side-bending, fulcrum bending (FB) and supine Halter traction without GA (awake), and their predictability of the final outcome

Secondary outcomes

  1. Incorporate these findings into the Lenke Classification of AIS

    Time frame: 6 months to 9 months

    To incorporate these findings into the Lenke Classification of AIS

  2. Give new recommendations for fusion levels according to the flexibility assessment

    Time frame: 6 months to 9 months

    To give new recommendations for fusion levels according to the flexibility assessment

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • AO Foundation, AO Spine

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 28, 2017
Registry last updated
May 6, 2020

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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