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

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ClinicalTrials.gov Identifier: NCT03296228
Recruitment Status : Recruiting
First Posted : September 28, 2017
Last Update Posted : September 29, 2017
Sponsor:
Collaborator:
AOSpine International
Information provided by (Responsible Party):
Dr. Kenny Kwan, The University of Hong Kong

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.

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)

Detailed Description:

The Lenke Classification is the most widely-accepted classification for 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 UIV and 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
Estimated Enrollment : 100 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
Estimated Primary Completion Date : January 31, 2018
Estimated Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis X-Rays
Drug Information available for: X-Rays

Group/Cohort Intervention/treatment
Hong Kong
supine side-bending and fulcrum bending films
Radiation: Flexibility Radiographs (supine, supine side-bend, FB)
Supine, supine side-bend, fulcrum bend

Radiation: Flexibility Radiographs (awake traction)
awake traction

Turkey
supine side-bending, fulcrum bending, and traction under GA films
Radiation: Flexibility Radiographs (supine, supine side-bend, FB)
Supine, supine side-bend, fulcrum bend

Radiation: Flexibility Radiographs (STUGA)
supine traction under GA




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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
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.
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

Information from the National Library of Medicine

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


Contacts
Contact: Dr Kenny Kwan, BMBCh (Oxon) +85222554654 kyhkwan@hku.hk
Contact: Hui Yu Koh, BSc +85252393556 huiyu.koh@gmail.com

Locations
Hong Kong
Duchess of Kent Children's Hospital Recruiting
Hong Kong, Hong Kong
Contact: Dr Kenny Kwan, BMBCh (Oxon)    +852 22554654    kyhkwan@hku.hk   
Contact: Hui Yu Koh, BSc    +85252393556    huiyu.koh@gmail.com   
Principal Investigator: Dr Kenny Kwan, BMBCh (Oxon)         
Sub-Investigator: Professor Kenneth Cheung, MD(HK)         
Sub-Investigator: Dr Jason Cheung, MBBS(HK)         
Sponsors and Collaborators
The University of Hong Kong
AOSpine International
Investigators
Principal Investigator: Dr Kenny Kwan, BMBCh(Oxon) The University of Hong Kong

Publications:
Responsible Party: Dr. Kenny Kwan, Clinical Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03296228     History of Changes
Other Study ID Numbers: UW 16-208
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: September 29, 2017
Last Verified: September 2017
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

Keywords provided by Dr. Kenny Kwan, The University of Hong Kong:
AIS

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases