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

NCT03296228 | Completed

• 1 other identifier: UW 16-208
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

AIS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incorporate these findings into the Lenke Classification of AIS

  6 months to 9 months

• Give new recommendations for fusion levels according to the flexibility assessment

  6 months to 9 months

Study Arms (2)

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)

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); Radiation: Flexibility Radiographs (awake traction); Radiation: Flexibility Radiographs (STUGA)

Interventions

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

Supine, supine side-bend, fulcrum bend

Hong Kong; Turkey

Flexibility Radiographs (awake traction) RADIATION

awake traction

Turkey

Flexibility Radiographs (STUGA) RADIATION

supine traction under GA

Turkey

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will be divided into two phases. In Phase 1, an exploratory pilot study will be performed with up to 3 flexibility films done on the same patient in different spinal centres which are in Hong Kong and Turkey.

You may qualify if:

• Patients diagnosed with AIS who reach the threshold for surgical correction.
• Patients aged 10 to 18 years

You may not qualify if:

• Neuromuscular deformity
• Prior fusion or spine surgery
• Spinal tumor diagnosis
• Congenital anomalies

Sponsors & Collaborators

• The University of Hong Kong: lead
• AO Foundation, AO Spine: collaborator

Study Sites (1)

Duchess of Kent Children's Hospital

Hong Kong, Hong Kong

Location

Related Publications (5)

• 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.

  PMID: 16025034 BACKGROUND

• 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.

  PMID: 21358471 BACKGROUND

• 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.

  PMID: 18007242 BACKGROUND

• 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.

  PMID: 11507125 BACKGROUND

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

  BACKGROUND

MeSH Terms

Interventions

Supine Position

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Dr Kenny Kwan, BMBCh(Oxon)

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: September 28, 2017
• Study Start: May 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: December 31, 2018
• Last Updated: May 6, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)