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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03296228
Enrollment
134
Registered
2017-09-28
Start date
2016-05-01
Completion date
2018-12-31
Last updated
2020-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Idiopathic Scoliosis

Keywords

AIS

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.

Interventions

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

Sponsors

AO Foundation, AO Spine
CollaboratorOTHER
The University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Investigate the flexibility equivalence of different bending methods, and their predictability of the final outcome6 months to 9 monthsTo 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

MeasureTime frameDescription
Incorporate these findings into the Lenke Classification of AIS6 months to 9 monthsTo incorporate these findings into the Lenke Classification of AIS
Give new recommendations for fusion levels according to the flexibility assessment6 months to 9 monthsTo give new recommendations for fusion levels according to the flexibility assessment

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026