An observational study in Adolescent Idiopathic Scoliosis, sponsored by The University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-05-06.
Sponsored by The University of Hong Kong · Observational
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.
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.
The study will be divided into two phases. In Phase 1, an exploratory pilot study will be performed with up to 3 flexibility films done on the same patient in different spinal centres which are in Hong Kong and Turkey.
Exclusion Criteria:
Radiation: Flexibility Radiographs (supine, supine side-bend, FB) supine side-bending and fulcrum bending films
Radiation: Flexibility Radiographs (supine, supine side-bend, FB)
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) · Radiation: Flexibility Radiographs (awake traction) · Radiation: Flexibility Radiographs (STUGA)
Supine, supine side-bend, fulcrum bend
awake traction
supine traction under GA
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
Time frame: 6 months to 9 months
Incorporate these findings into the Lenke Classification of AIS
To incorporate these findings into the Lenke Classification of AIS
Time frame: 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
Time frame: 6 months to 9 months
Plan to share: No
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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The University of Hong Kong