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

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03296228
• Other study ID #: UW 16-208
• Status: Completed
• Start date: May 1, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: May 2020
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: December 31, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

Radiation:
• Flexibility Radiographs (supine, supine side-bend, FB)
Supine, supine side-bend, fulcrum bend
• Flexibility Radiographs (awake traction)
awake traction
• Flexibility Radiographs (STUGA)
supine traction under GA

Locations

Country	Name	City	State
Hong Kong	Duchess of Kent Children's Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	AOSpine International

Country where clinical trial is conducted

Hong Kong, 

References & Publications (5)

Cheh G, Lenke LG, Lehman RA Jr, Kim YJ, Nunley R, Bridwell KH. The reliability of preoperative supine radiographs to predict the amount of curve flexibility in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2007 Nov 15;32(24):2668-72. — View Citation

Chow SC, Shao J, Wang H. Sample Size Calculations in Clinical Research. 2003. Marcel Dekker, New York

Clements DH, Marks M, Newton PO, Betz RR, Lenke L, Shufflebarger H; Harms Study Group. Did the Lenke classification change scoliosis treatment? Spine (Phila Pa 1976). 2011 Jun 15;36(14):1142-5. doi: 10.1097/BRS.0b013e318207e9c4. — View Citation

Hamzaoglu A, Talu U, Tezer M, Mirzanli C, Domanic U, Goksan SB. Assessment of curve flexibility in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2005 Jul 15;30(14):1637-42. — View Citation

Lenke LG, Betz RR, Harms J, Bridwell KH, Clements DH, Lowe TG, Blanke K. Adolescent idiopathic scoliosis: a new classification to determine extent of spinal arthrodesis. J Bone Joint Surg Am. 2001 Aug;83(8):1169-81. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigate the flexibility equivalence of different bending methods, and their predictability of the final outcome	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	6 months to 9 months
Secondary	Incorporate these findings into the Lenke Classification of AIS	To incorporate these findings into the Lenke Classification of AIS	6 months to 9 months
Secondary	Give new recommendations for fusion levels according to the flexibility assessment	To give new recommendations for fusion levels according to the flexibility assessment	6 months to 9 months