Adolescent Idiopathic ScoliosisNCT06711757
Artificial Intelligence-based Models for Spine Malalignment Auto-analysis
An observational study of Adolescent Idiopathic Scoliosis, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This retrospective study aimed to enhance and validate a model for diagnosing adolescent idiopathic scoliosis (AIS) across multiple medical centers. The study included 2,763 participants from prestigious hospitals in mainland China and Hong Kong. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- How many people
- 3,015 participants
- Where
- 1 siteHong Kong
- Study dates
- 5 Jan 2022to 5 Nov 2024
- 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: Patients diagnosed with adolescent idiopathic scoliosis.
Who may be able to join
- Participants aged between 10 and 18 years old,
- A pathological confirmation of the presence or absence of AIS
Who cannot join
- Patients with other types of scoliosis, such as congenital or neuromuscular scoliosis
- Patients with skin diseases, such as acne, psoriasis, skin pigmentation and rash that can affect imaging
- Individuals that cannot stand up
- Cases where standing imaging was not feasible or other conditions that could impair image acquisition.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Digital Health Laboratory, Li Ka Shing Faculty of Medicine, The University of Hong Kong
Hong Kong
About this study
Official title: Artificial Intelligence-based Models Enabling Robust and Precise Spine Malalignment Auto-analysis in China: a Multicentre, Retrospective Cohort Study
This retrospective study aimed to enhance and validate a model for diagnosing adolescent idiopathic scoliosis (AIS) across multiple medical centers. The study included 2,763 participants from prestigious hospitals in mainland China and Hong Kong. X-rays were used to develop and validate the model, with data from different hospitals to ensure robustness. Participants aged 10-18 with confirmed AIS were enrolled, and data were deidentified for privacy. The model was optimized using training data and validated internally before being deployed for real-world application. A novel data augmentation technique was used to address data heterogeneity, and a standardized analysis platform, AlignProCARE, was employed for evaluation. X-rays were annotated with vertebra landmarks, and traditional and intensity-based data augmentation methods were applied for image processing. Coronal Cobb angle was used to evaluate spinal alignment, with severity classified as normal-mild, moderate, or severe. The model's performance was statistically assessed for accuracy in predicting Cobb angle and severity grading. Overall, the study aimed to provide a reliable diagnostic tool for AIS analysis in clinical practice, improving efficiency and standardization in diagnosis and treatment.
Read the detailed description
This retrospective study involved collecting posteroanterior whole-spine X-rays from 2,763 individuals at 5 renowned hospitals in mainland China and 2 hospitals in Hong Kong over a period from January 1, 2012, to April 4, 2021. X-rays from Queen Mary Hospital and Duchess of Kent Children's Hospital at Sandy Bay in Hong Kong, known as the QMH\&DKCH cohort, were specifically used for model development. Within this cohort, 86.5% (1686 out of 1950 patients) were randomly chosen as the training set for model development, while the remaining 13.5% (264 patients) formed the internal validation set to ensure the model's performance was independently tested. Additionally, data from five prominent hospitals in mainland China were compiled into external validation datasets to assess the model's efficacy. These hospitals included Peking Union Medical College Hospital, Nanfang Hospital, Jishuitan Hospital, Ruijin Hospital, and Huashan Hospital. All data were deidentified before being utilized for model development and validation. The study enrolled participants aged 10 to 18 years with confirmed presence or absence of adolescent idiopathic scoliosis (AIS). Demographic information such as age, sex, and BMI was extracted from medical records. Exclusion criteria were applied to ensure the study's specificity, excluding individuals with other types of scoliosis, skin diseases that could impact imaging, those unable to stand, and cases where standing imaging was not feasible. The study design, illustrated in Figure 1, consisted of two main phases: model development and real-world application. The model was optimized and validated using the QMH\&DKCH cohort data before being deployed on the AlignProCARE platform for clinical application across different centers. In the real-world application stage, five medical centers utilized the AlignProCARE software to upload and analyze patient X-ray images for diagnostic purposes.
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Adolescent idiopathic scoliosis, spine malalignment, artificial intelligence, data heterogeneity, multi-centre cohort study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| QMH&DKCH cohort | A total of 1,950 whole spine posteroanterior X-rays collected from two local hospitals (QMH and DKCH) were utilized for the development and internal validation of our model. | |
| PUMCH cohort | 314 whole spine posteroanterior X-rays from Peking Union Medical College Hospital, Beijing, China | |
| NFH cohort | 94 whole spine posteroanterior X-rays from Nanfang Hospital, Guangzhou, China | |
| JSTH cohort | 187 whole spine posteroanterior X-rays from Jishuitan Hospital, Beijing, China | |
| RJH cohort | 294 whole spine posteroanterior X-rays from Ruijin Hospital, Shanghai, China | |
| HSH cohort | 176 whole spine posteroanterior X-rays from Huashan Hospital, Shanghai, China |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cobb Angle prediction accuracy
Coronal Cobb angle was adopted as the standard measurement to evaluate the coronal alignment of each AIS patient. We evaluate the performance of our artificial intelligence model based on Cobb Angle prediction accuracy.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
AIS severity classification accuracy
Deformities with a CA exceeding 40° were deemed severe, those ranging from 20° to 40° were labelled as moderate, and angles from 0° to 20° were identified as normal to mild.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start5 Jan 2022
- Primary completion5 Oct 2024
- Study completion5 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 3,015 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Queen Mary Hospital, Hong Kong, The Duchess of Kent Children's Hospital at Sandy Bay, Ruijin Hospital, Huashan Hospital, Beijing Jishuitan Hospital, Nanfang Hospital, Southern Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711757
- Sponsor's protocol ID
- UW 24-350
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-based Models Enabling Robust and Precise Spine Malalignment Auto-analysis in China: a Multicentre, Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06711757
- Acronym / sponsor ID
- UW 24-350
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Adolescent idiopathic scoliosis, spine malalignment, artificial intelligence, data heterogeneity, multi-centre cohort study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,015 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Queen Mary Hospital, Hong Kong, The Duchess of Kent Children's Hospital at Sandy Bay, Ruijin Hospital, Huashan Hospital, Beijing Jishuitan Hospital, Nanfang Hospital, Southern Medical University
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 5 Oct 2024 (actual)
- Study completion
- 5 Nov 2024 (actual)
- First posted
- 2 Dec 2024 (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.
This retrospective study aimed to enhance and validate a model for diagnosing adolescent idiopathic scoliosis (AIS) across multiple medical centers. The study included 2,763 participants from prestigious hospitals in mainland China and Hong Kong. X-rays were used to develop and validate the model, with data from different hospitals to ensure robustness. Participants aged 10-18 with confirmed AIS were enrolled, and data were deidentified for privacy. The model was optimized using training data and validated internally before being deployed for real-world application. A novel data augmentation technique was used to address data heterogeneity, and a standardized analysis platform, AlignProCARE, was employed for evaluation. X-rays were annotated with vertebra landmarks, and traditional and intensity-based data augmentation methods were applied for image processing. Coronal Cobb angle was used to evaluate spinal alignment, with severity classified as normal-mild, moderate, or severe. The model's performance was statistically assessed for accuracy in predicting Cobb angle and severity grading. Overall, the study aimed to provide a reliable diagnostic tool for AIS analysis in clinical practice, improving efficiency and standardization in diagnosis and treatment.
Detailed description
This retrospective study involved collecting posteroanterior whole-spine X-rays from 2,763 individuals at 5 renowned hospitals in mainland China and 2 hospitals in Hong Kong over a period from January 1, 2012, to April 4, 2021. X-rays from Queen Mary Hospital and Duchess of Kent Children's Hospital at Sandy Bay in Hong Kong, known as the QMH\&DKCH cohort, were specifically used for model development. Within this cohort, 86.5% (1686 out of 1950 patients) were randomly chosen as the training set for model development, while the remaining 13.5% (264 patients) formed the internal validation set to ensure the model's performance was independently tested. Additionally, data from five prominent hospitals in mainland China were compiled into external validation datasets to assess the model's efficacy. These hospitals included Peking Union Medical College Hospital, Nanfang Hospital, Jishuitan Hospital, Ruijin Hospital, and Huashan Hospital. All data were deidentified before being utilized for model development and validation. The study enrolled participants aged 10 to 18 years with confirmed presence or absence of adolescent idiopathic scoliosis (AIS). Demographic information such as age, sex, and BMI was extracted from medical records. Exclusion criteria were applied to ensure the study's specificity, excluding individuals with other types of scoliosis, skin diseases that could impact imaging, those unable to stand, and cases where standing imaging was not feasible. The study design, illustrated in Figure 1, consisted of two main phases: model development and real-world application. The model was optimized and validated using the QMH\&DKCH cohort data before being deployed on the AlignProCARE platform for clinical application across different centers. In the real-world application stage, five medical centers utilized the AlignProCARE software to upload and analyze patient X-ray images for diagnostic purposes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| QMH&DKCH cohort | – | –A total of 1,950 whole spine posteroanterior X-rays collected from two local hospitals (QMH and DKCH) were utilized for the development and internal validation of our model. |
| PUMCH cohort | – | –314 whole spine posteroanterior X-rays from Peking Union Medical College Hospital, Beijing, China |
| NFH cohort | – | –94 whole spine posteroanterior X-rays from Nanfang Hospital, Guangzhou, China |
| JSTH cohort | – | –187 whole spine posteroanterior X-rays from Jishuitan Hospital, Beijing, China |
| RJH cohort | – | –294 whole spine posteroanterior X-rays from Ruijin Hospital, Shanghai, China |
| HSH cohort | – | –176 whole spine posteroanterior X-rays from Huashan Hospital, Shanghai, China |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients diagnosed with adolescent idiopathic scoliosis.
Key inclusion criteria (2 listed)
- Participants aged between 10 and 18 years old,
- A pathological confirmation of the presence or absence of AIS
Key exclusion criteria (4 listed)
- Patients with other types of scoliosis, such as congenital or neuromuscular scoliosis
- Patients with skin diseases, such as acne, psoriasis, skin pigmentation and rash that can affect imaging
- Individuals that cannot stand up
- Cases where standing imaging was not feasible or other conditions that could impair image acquisition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cobb Angle prediction accuracy
Time frame: through study completion, an average of 1 year
Coronal Cobb angle was adopted as the standard measurement to evaluate the coronal alignment of each AIS patient. We evaluate the performance of our artificial intelligence model based on Cobb Angle prediction accuracy.
1 secondary outcome
AIS severity classification accuracy
Time frame: through study completion, an average of 1 year
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 2 Dec 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 2 Dec 2024. 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?
Cobb Angle prediction accuracy (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2024.