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
| Type | Name | Description |
|---|---|---|
| RADIATION | Flexibility Radiographs (supine, supine side-bend, FB) | Supine, supine side-bend, fulcrum bend |
| RADIATION | Flexibility Radiographs (awake traction) | awake traction |
| RADIATION | Flexibility 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.