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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Adolescent Idiopathic Scoliosis

Intervention / Treatment
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* Radiation: Flexibility Radiographs (supine, supine side-bend, FB)
* Radiation: Flexibility Radiographs (awake traction)
* Radiation: Flexibility Radiographs (STUGA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hong Kong<br>Radiation: Flexibility Radiographs (supine, supine side-bend, FB) supine side-bending and fulcrum bending films | Radiation: Flexibility Radiographs (supine, supine side-bend, FB)<br>* Supine, supine side-bend, fulcrum bend<br>|
| Turkey<br>Radiation: Flexibility Radiographs (supine, supine side-bend, FB) Radiation: Flexibility Radiographs (awake traction) Radiation: Flexibility Radiographs (STUGA) supine side-bending, fulcrum bending films, awake traction and supine traction under GA | Radiation: Flexibility Radiographs (supine, supine side-bend, FB)<br>* Supine, supine side-bend, fulcrum bend<br>Radiation: Flexibility Radiographs (awake traction)<br>* awake traction<br>Radiation: Flexibility Radiographs (STUGA)<br>* supine traction under GA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate the flexibility equivalence of different bending methods, and their predictability of the final outcome | 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 | 6 months to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incorporate these findings into the Lenke Classification of AIS | To incorporate these findings into the Lenke Classification of AIS | 6 months to 9 months | 
| Give new recommendations for fusion levels according to the flexibility assessment | To give new recommendations for fusion levels according to the flexibility assessment | 6 months to 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AIS