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Trial record 16 of 22 for:    aospine

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03296228
Recruitment Status : Completed
First Posted : September 28, 2017
Last Update Posted : November 20, 2019
Sponsor:
Collaborator:
AOSpine International
Information provided by (Responsible Party):
Dr. Kenny Kwan, The University of Hong Kong

Tracking Information
First Submitted Date September 22, 2017
First Posted Date September 28, 2017
Last Update Posted Date November 20, 2019
Actual Study Start Date May 1, 2016
Actual Primary Completion Date May 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 22, 2017)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 22, 2017)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparison of Dynamic Radiographs in Determining Fusion Level in Adolescent Idiopathic Scoliosis Correction
Official Title Comparison of Dynamic Radiographs in Determining Fusion Level in Adolescent Idiopathic Scoliosis Correction
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Adolescent Idiopathic Scoliosis
Intervention
  • 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
Study Groups/Cohorts
  • Hong Kong

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

    supine side-bending and fulcrum bending films

    Intervention: 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

    Interventions:
    • Radiation: Flexibility Radiographs (supine, supine side-bend, FB)
    • Radiation: Flexibility Radiographs (awake traction)
    • Radiation: Flexibility Radiographs (STUGA)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 18, 2019)
134
Original Estimated Enrollment
 (submitted: September 22, 2017)
100
Actual Study Completion Date December 31, 2018
Actual Primary Completion Date May 1, 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 10 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number NCT03296228
Other Study ID Numbers UW 16-208
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Dr. Kenny Kwan, The University of Hong Kong
Study Sponsor The University of Hong Kong
Collaborators AOSpine International
Investigators
Principal Investigator: Dr Kenny Kwan, BMBCh(Oxon) The University of Hong Kong
PRS Account The University of Hong Kong
Verification Date November 2019