Clinical Trials Directory

Trials / Completed

CompletedNCT03296228

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

Status
Completed
Phase
Study type
Observational
Enrollment
134 (actual)
Sponsor
The University of Hong Kong · Academic / Other
Sex
All
Age
10 Years – 18 Years
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
RADIATIONFlexibility Radiographs (supine, supine side-bend, FB)Supine, supine side-bend, fulcrum bend
RADIATIONFlexibility Radiographs (awake traction)awake traction
RADIATIONFlexibility Radiographs (STUGA)supine traction under GA

Timeline

Start date
2016-05-01
Primary completion
2018-05-01
Completion
2018-12-31
First posted
2017-09-28
Last updated
2020-05-06

Locations

1 site across 1 country: Hong Kong

Source: ClinicalTrials.gov record NCT03296228. Inclusion in this directory is not an endorsement.