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

The University of Hong Kong (HKU) logo

The University of Hong Kong (HKU)

Status

Completed

Conditions

Adolescent Idiopathic Scoliosis

Treatments

Radiation: Flexibility Radiographs (awake traction)
Radiation: Flexibility Radiographs (supine, supine side-bend, FB)
Radiation: Flexibility Radiographs (STUGA)

Study type

Observational

Funder types

Other

Identifiers

NCT03296228
UW 16-208

Details and patient eligibility

About

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.

Full 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.

Enrollment

134 patients

Sex

All

Ages

10 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

134 participants in 2 patient groups

Hong Kong
Description:
Radiation: Flexibility Radiographs (supine, supine side-bend, FB) supine side-bending and fulcrum bending films
Treatment:
Radiation: Flexibility Radiographs (supine, supine side-bend, FB)
Turkey
Description:
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
Treatment:
Radiation: Flexibility Radiographs (STUGA)
Radiation: Flexibility Radiographs (supine, supine side-bend, FB)
Radiation: Flexibility Radiographs (awake traction)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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