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

Completed
Conditions
Adolescent Idiopathic Scoliosis
Interventions
Radiation: Flexibility Radiographs (supine, supine side-bend, FB)
Radiation: Flexibility Radiographs (awake traction)
Radiation: Flexibility Radiographs (STUGA)
Registration Number
NCT03296228
Lead Sponsor
The University of Hong Kong
Brief 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
134
Inclusion Criteria
  • Patients diagnosed with AIS who reach the threshold for surgical correction.
  • Patients aged 10 to 18 years
Read More
Exclusion Criteria
  • Neuromuscular deformity
  • Prior fusion or spine surgery
  • Spinal tumor diagnosis
  • Congenital anomalies
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
TurkeyFlexibility Radiographs (STUGA)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
Hong KongFlexibility Radiographs (supine, supine side-bend, FB)Radiation: Flexibility Radiographs (supine, supine side-bend, FB) supine side-bending and fulcrum bending films
TurkeyFlexibility 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
TurkeyFlexibility Radiographs (awake traction)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
Primary Outcome Measures
NameTimeMethod
Investigate the flexibility equivalence of different bending methods, and their predictability of the final outcome6 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 Outcome Measures
NameTimeMethod
Incorporate these findings into the Lenke Classification of AIS6 months to 9 months

To incorporate these findings into the Lenke Classification of AIS

Give new recommendations for fusion levels according to the flexibility assessment6 months to 9 months

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

Trial Locations

Locations (1)

Duchess of Kent Children's Hospital

🇭🇰

Hong Kong, Hong Kong

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