Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-01-03 @ 10:01 AM
Study NCT ID:
NCT05146193
Status:
RECRUITING
Last Update Posted:
2025-03-25
First Post:
2021-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AI-Powered Scoliosis Auto-Analysis System Multicenter Development and Validations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D012600', 'term': 'Scoliosis'}, {'id': 'D013168', 'term': 'Spondylolisthesis'}], 'ancestors': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013169', 'term': 'Spondylolysis'}, {'id': 'D055009', 'term': 'Spondylosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2030-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2021-11-12', 'studyFirstSubmitQcDate': '2021-11-23', 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cobb angle', 'timeFrame': '1 year', 'description': 'Coronal Cobb angle of the spinal deformity. The most tilted end vertebrae away from the apex will be used for measurement of the Cobb angle.The anteroposterior radiograph is used to assess'}], 'secondaryOutcomes': [{'measure': 'Thoracic kyphosis', 'timeFrame': '1 year', 'description': 'Thoracic kyphosis T5-12: angle between upper endplate of T5 to lower endplate of T12 in the lateral radiograph'}, {'measure': 'Lumbar lordosis', 'timeFrame': '1 year', 'description': 'Lumbar lordosis L1-S1: angle between upper endplate of L1 to top of S1 in the lateral radiograph'}, {'measure': 'Pelvic tilt', 'timeFrame': '1 year', 'description': 'Pelvic tilt angle measurement in degrees in the lateral radiograph'}, {'measure': 'Sacral slope', 'timeFrame': '1 year', 'description': 'Sacral slope angle measurement in degrees in the lateral radiograph'}, {'measure': 'Pelvic incidence', 'timeFrame': '1 year', 'description': 'Pelvic incidence angle measurement in degrees in the lateral radiograph'}, {'measure': 'Maximum thoracic kyphosis', 'timeFrame': '1 year', 'description': 'Maximum thoracic kyphosis: angle measurement from the upper endplate of most tilted upper end vertebra to the lower endplate of the lower end vertebra of the thoracic spine in the sagittal plane radiograph'}, {'measure': 'Curve severity', 'timeFrame': '1 year', 'description': 'Severity classifications: normal-mild; moderate and severe'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adult deformity, scoliosis, spondylolisthesis'], 'conditions': ['Spinal Deformity']}, 'descriptionModule': {'briefSummary': 'The investigators aim to use artificial intelligence (AI) to help clinicians in diagnosing and assessing spinal deformities.', 'detailedDescription': "Background Spinal deformity is a prevalent spinal disorder in both paediatric and adult populations. The spine alignment need to be quantitively assessed for further treatment planning. However, the current practice requires spine surgeons to manually place landmarks of endplates and key vertebrae. The process is laborious and prone to inter- and intra-rater variance. Thus, the investigators have developed an AI-powered spine alignment assessment system (AlignProCARE) to facilitate clinicians in fast, accurate and consistent analytical results.\n\nThe investigators aim to test and improve the performance of the spine alignment auto-analysis in all patients with spinal deformities in multiple centers including Malaysia, China, and Japan\n\nObjectives:\n\n1. prospectively test the alignment assessment of patients' spinal deformities with whole spine X-rays (both PA and lateral) and nude back image with the assessment via AlignProCARE.\n2. Collect 500 labeled deformity radiographs and nude back images in both PA and lateral views per center. 150 patients need to be followed up with radiographs and nude back photos collected (all parameters measured again).\n3. Use transfer learning to update the current AlignProCARE for scoliosis analysis to form AlignProCARE+.\n\n4 Qualitatively analyse the AlignProCARE+ using an independent dataset."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All subjects with spinal deformities', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Idiopathic scoliosis, adult deformity (spondylolisthesis, idiopathic kyphosis, kyphoscoliosis, lordoscoliosis)\n\nExclusion Criteria:\n\n* Refusal for imaging, postoperative patients'}, 'identificationModule': {'nctId': 'NCT05146193', 'briefTitle': 'AI-Powered Scoliosis Auto-Analysis System Multicenter Development and Validations', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'AI-Powered Scoliosis Auto-Analysis System Multicenter Development and Validations', 'orgStudyIdInfo': {'id': 'AI_Scoliosis'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All subjects are diagnosed of having a spinal deformity', 'description': 'Routine care of patients with spinal deformities', 'interventionNames': ['Other: Nude back photo']}], 'interventions': [{'name': 'Nude back photo', 'type': 'OTHER', 'description': 'Nude back photo at baseline and at follow-ups for each patient and visual severity and curve type classifications', 'armGroupLabels': ['All subjects are diagnosed of having a spinal deformity']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Jason Cheung', 'role': 'CONTACT', 'email': 'cheungjp@hku.hk', 'phone': '85222554581', 'phoneExt': '85222554581'}], 'facility': "Duchess of Kent Children's Hospital", 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Jason Pui Yin Cheung, MD, MS', 'role': 'CONTACT', 'email': 'cheungjp@hku.hk', 'phone': '(852) 22554254'}, {'name': 'Teng Zhang, PhD', 'role': 'CONTACT', 'email': 'tgzhang@hku.hk', 'phone': '(852) 22554254'}], 'overallOfficials': [{'name': 'Jason Pui Yin Cheung, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Queen Mary Hospital, Duchess of Kent Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking Union Medical College', 'class': 'OTHER'}, {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}, {'name': 'University of Malaya', 'class': 'OTHER'}, {'name': 'Nara Medical University', 'class': 'OTHER'}, {'name': 'Hamamatsu University', 'class': 'OTHER'}, {'name': 'Ruijin Hospital', 'class': 'OTHER'}, {'name': 'Huashan Hospital', 'class': 'OTHER'}, {'name': 'Zhejiang University', 'class': 'OTHER'}, {'name': 'Ji Shui Tan Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Dr. Jason Pui Yin Cheung', 'investigatorAffiliation': 'The University of Hong Kong'}}}}