Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-29 @ 9:03 AM
Study NCT ID:
NCT06195033
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-08
First Post:
2023-12-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Controlled Clinical Trial of Internal Fixation of Intertrochanteric Fractures of Femur Guided by Conventional Versus IF-AI Artificial Intelligence Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-22', 'studyFirstSubmitDate': '2023-12-22', 'studyFirstSubmitQcDate': '2023-12-22', 'lastUpdatePostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fracture healing situation 36 weeks after surgery', 'timeFrame': '36 weeks after surgery', 'description': 'The results of surgical treatment of the patient were shown by imaging data at 36 weeks after surgery, and the treatment was considered successful without failure of internal fixation.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hip Fractures']}, 'descriptionModule': {'briefSummary': 'Our team has developed an AI software to guide the surgical protocol for femoral intertrochanteric fractures. This is a prospective randomized controlled clinical study that will include patients with femoral intertrochanteric fractures combining medial posterior and lateral wall fractures, and will randomly divide the patients into a traditional surgical protocol group and an AI-guided surgical protocol group. The efficacy and safety indexes such as operation time, blood loss, operation cost, infection rate, hospitalization time, postoperative pain score, fracture healing time, internal fixation failure rate and mortality rate were compared between the two groups to verify the efficacy and safety of AI-guided surgical treatment plan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Over 60 years old, male or female.\n2. Osteoporosis intertrochanteric fracture, which met the diagnostic criteria of X-ray intertrochanteric fracture, and osteoporosis T-value \\<2.5.\n3. Patients with 1mm resolution CT imaging data.\n4. Willing to participate in the project, sign the informed consent, and be able to complete the follow-up work.\n\nExclusion Criteria:\n\n1. Patients with pathological fractures, old fractures, stress fractures, and periprosthesis fractures;\n2. Patients lacking 1mm resolution CT imaging data;\n3. Severe malnutrition, heavy smoking, alcoholism and other systemic conditions affect fracture healing;\n4. Patients with severe medical diseases that cannot be operated on;\n5. Patients participating in other clinical studies.'}, 'identificationModule': {'nctId': 'NCT06195033', 'briefTitle': 'Randomized Controlled Clinical Trial of Internal Fixation of Intertrochanteric Fractures of Femur Guided by Conventional Versus IF-AI Artificial Intelligence Program', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Randomized Controlled Clinical Trial of Internal Fixation of Intertrochanteric Fractures of Femur Guided by Conventional Versus IF-AI Artificial Intelligence Program', 'orgStudyIdInfo': {'id': 'PekingUTH LY IF-AI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AI-guided surgical protocol group', 'interventionNames': ['Procedure: Surgical protocol guided by artificial intelligence software']}, {'type': 'NO_INTERVENTION', 'label': 'traditional surgical protocol group'}], 'interventions': [{'name': 'Surgical protocol guided by artificial intelligence software', 'type': 'PROCEDURE', 'description': 'At present, the indications for internal fixation of intertrochanteric fractures are not clear. We developed an artificial intelligence software to assist surgeons in determining whether to immobilize lateral and medial posterior wall fractures.', 'armGroupLabels': ['AI-guided surgical protocol group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}