Comparison of Dynamic Radiographs in Determining Fusion Level in Adolescent Idiopathic Scoliosis Correction
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ClinicalTrials.gov Identifier: NCT03296228 |
Recruitment Status :
Completed
First Posted : September 28, 2017
Last Update Posted : May 6, 2020
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Condition or disease | Intervention/treatment |
---|---|
Adolescent Idiopathic Scoliosis | Radiation: Flexibility Radiographs (supine, supine side-bend, FB) Radiation: Flexibility Radiographs (awake traction) Radiation: Flexibility Radiographs (STUGA) |
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.
Study Type : | Observational |
Actual Enrollment : | 134 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Comparison of Dynamic Radiographs in Determining Fusion Level in Adolescent Idiopathic Scoliosis Correction |
Actual Study Start Date : | May 1, 2016 |
Actual Primary Completion Date : | May 1, 2018 |
Actual Study Completion Date : | December 31, 2018 |

Group/Cohort | Intervention/treatment |
---|---|
Hong Kong
Radiation: Flexibility Radiographs (supine, supine side-bend, FB) supine side-bending and fulcrum bending films |
Radiation: Flexibility Radiographs (supine, supine side-bend, FB)
Supine, supine side-bend, fulcrum bend |
Turkey
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)
Supine, supine side-bend, fulcrum bend Radiation: Flexibility Radiographs (awake traction) awake traction Radiation: Flexibility Radiographs (STUGA) supine traction under GA |
- Investigate the flexibility equivalence of different bending methods, and their predictability of the final outcome [ Time Frame: 6 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
- Incorporate these findings into the Lenke Classification of AIS [ Time Frame: 6 months to 9 months ]To incorporate these findings into the Lenke Classification of AIS
- Give new recommendations for fusion levels according to the flexibility assessment [ Time Frame: 6 months to 9 months ]To give new recommendations for fusion levels according to the flexibility assessment

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Ages Eligible for Study: | 10 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03296228
Hong Kong | |
Duchess of Kent Children's Hospital | |
Hong Kong, Hong Kong |
Principal Investigator: | Dr Kenny Kwan, BMBCh(Oxon) | The University of Hong Kong |
Responsible Party: | Dr. Kenny Kwan, Clinical Assistant Professor, The University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT03296228 |
Other Study ID Numbers: |
UW 16-208 |
First Posted: | September 28, 2017 Key Record Dates |
Last Update Posted: | May 6, 2020 |
Last Verified: | May 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
AIS |
Scoliosis Spinal Curvatures Spinal Diseases Bone Diseases Musculoskeletal Diseases |