Adolescent Idiopathic ScoliosisNCT03296228
Comparison of Dynamic Radiographs in Determining Fusion Level in Adolescent Idiopathic Scoliosis Correction
An observational study of Adolescent Idiopathic Scoliosis, run by The University of Hong Kong at 1 site in Hong Kong.
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… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Flexibility Radiographs (supine, supine side-bend, FB), Flexibility Radiographs (awake traction) and Flexibility Radiographs (STUGA)
- Type of treatment
- Surgery or procedure
- How many people
- 134 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 May 2016to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Patients diagnosed with AIS who reach the threshold for surgical correction.
- Patients aged 10 to 18 years
Who cannot join
- Neuromuscular deformity
- Prior fusion or spine surgery
- Spinal tumor diagnosis
- Congenital anomalies
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Flexibility Radiographs (supine, supine side-bend, FB), Flexibility Radiographs (awake traction), Flexibility Radiographs (STUGA)
- Keywords
- AIS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexibility Radiographs (supine, supine side-bend, FB)Radiation
Supine, supine side-bend, fulcrum bend
Flexibility Radiographs (awake traction)Radiation
awake traction
Flexibility Radiographs (STUGA)Radiation
supine traction under GA
| Study group | Role | What they receive |
|---|---|---|
| Hong Kong | Radiation: Flexibility Radiographs (supine, supine side-bend, FB)
supine side-bending and fulcrum bending films Receives: 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 Receives: Radiation: Flexibility Radiographs (supine, supine side-bend, FB); Radiation: Flexibility Radiographs (awake traction); Radiation: Flexibility Radiographs (STUGA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months to 9 months
Secondary outcomes (2)
Incorporate these findings into the Lenke Classification of AIS
To incorporate these findings into the Lenke Classification of AIS
Measured: 6 months to 9 months
Give new recommendations for fusion levels according to the flexibility assessment
To give new recommendations for fusion levels according to the flexibility assessment
Measured: 6 months to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start1 May 2016
- Primary completion1 May 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- AO Foundation, AO Spine
- Responsible party
- Principal investigator, Dr. Kenny Kwan, The University of Hong Kong
- Investigators
- Dr Kenny Kwan, BMBCh(Oxon), Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296228
- Sponsor's protocol ID
- UW 16-208
- Status last verified
- May 2020
- First submitted
- 22 Sep 2017
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16025034Clements 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.
PubMed 21358471Cheh 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.
PubMed 18007242Lenke 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.
PubMed 11507125Chow SC, Shao J, Wang H. Sample Size Calculations in Clinical Research. 2003. Marcel Dekker, New York
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dynamic Radiographs in Determining Fusion Level in Adolescent Idiopathic Scoliosis Correction
- ClinicalTrials.gov ID
- NCT03296228
- Acronym / sponsor ID
- UW 16-208
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- AIS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- AO Foundation, AO Spine
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 28 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hong Kong | – | Radiation: Flexibility Radiographs (supine, supine side-bend, FB)Radiation: Flexibility Radiographs (supine, supine side-bend, FB) supine side-bending and fulcrum bending films |
| Turkey | – | Radiation: Flexibility Radiographs (supine, supine side-bend, FB), Radiation: Flexibility Radiographs (awake traction), Radiation: Flexibility Radiographs (STUGA)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 |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- Patients diagnosed with AIS who reach the threshold for surgical correction.
- Patients aged 10 to 18 years
Key exclusion criteria (4 listed)
- Neuromuscular deformity
- Prior fusion or spine surgery
- Spinal tumor diagnosis
- Congenital anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flexibility Radiographs (supine, supine side-bend, FB)Supine, supine side-bend, fulcrum bend | Radiation | Hong Kong, Turkey |
| Flexibility Radiographs (awake traction)awake traction | Radiation | Turkey |
| Flexibility Radiographs (STUGA)supine traction under GA | Radiation | Turkey |
Primary outcome
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
2 secondary outcomes
Incorporate these findings into the Lenke Classification of AIS
Time frame: 6 months to 9 months
Give new recommendations for fusion levels according to the flexibility assessment
Time frame: 6 months to 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Background: PubMed 16025034Hamzaoglu 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.
- Background: PubMed 21358471Clements 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.
- Background: PubMed 18007242Cheh 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.
- Background: PubMed 11507125Lenke 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.
- BackgroundChow SC, Shao J, Wang H. Sample Size Calculations in Clinical Research. 2003. Marcel Dekker, New York
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Kenny Kwan, BMBCh(Oxon) principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Idiopathic Scoliosis, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigate the flexibility equivalence of different bending methods, and their predictability of the final outcome (time frame: 6 months to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03296228, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2020.