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

NCT ID: NCT03296228

Last Updated: 2020-05-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 134 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-01
• Study Completion Date: 2018-12-31

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.

Conditions

Adolescent Idiopathic Scoliosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Hong Kong

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

supine side-bending and fulcrum bending films

Flexibility Radiographs (supine, supine side-bend, FB)

Intervention Type: RADIATION

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

Flexibility Radiographs (supine, supine side-bend, FB)

Intervention Type: RADIATION

Supine, supine side-bend, fulcrum bend

Flexibility Radiographs (awake traction)

Intervention Type: RADIATION

awake traction

Flexibility Radiographs (STUGA)

Intervention Type: RADIATION

supine traction under GA

Interventions

Flexibility Radiographs (supine, supine side-bend, FB)

Supine, supine side-bend, fulcrum bend

Intervention Type: RADIATION

Flexibility Radiographs (awake traction)

awake traction

Intervention Type: RADIATION

Flexibility Radiographs (STUGA)

supine traction under GA

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AO Foundation, AO Spine

OTHER

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Kenny Kwan

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr Kenny Kwan, BMBCh(Oxon)

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

Duchess of Kent Children's Hospital

Hong Kong, , Hong Kong

Countries

Hong Kong

References

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. doi: 10.1097/01.brs.0000170580.92177.d2.

Reference Type: BACKGROUND

PMID: 16025034 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21358471 (View on PubMed)

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. doi: 10.1097/BRS.0b013e31815a5269.

Reference Type: BACKGROUND

PMID: 18007242 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11507125 (View on PubMed)

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

Reference Type: BACKGROUND

Other Identifiers

UW 16-208

Identifier Type: -

Identifier Source: org_study_id