Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 11:12 PM
Study NCT ID:
NCT05243134
Status:
RECRUITING
Last Update Posted:
2022-02-16
First Post:
2021-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Anatomic Deformities on the Clinical Efficacy in the Patients With Patellar Dislocation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D031222', 'term': 'Patellar Dislocation'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}], 'ancestors': [{'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-07', 'studyFirstSubmitDate': '2021-11-23', 'studyFirstSubmitQcDate': '2022-02-07', 'lastUpdatePostDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with redislocation of their patella after surgery as confirmed by clinical physical examination', 'timeFrame': 'Three years after surgery', 'description': 'We can determine patellar redislocation by physical examination. In participants with redislocation of their patella, the patella (kneecap) slips out of its normal position. Often the knee is partly bent, painful and swollen.The patella is also often felt and seen out of place. We recored the number of participants with redislocation of their patella after surgery.'}, {'measure': 'International Knee Documentation Committee(IKDC) score', 'timeFrame': 'Three years after surgery', 'description': 'The entire IKDC form, which includes a demographic form, current health assessment form, subjective knee evaluation form, knee history form, surgical documentation form, and knee examination form, may be used as separate forms. The knee history form and surgical documentation form are provided for convenience. All researchers are required to complete the subjective knee evaluation and knee examination form. Instructions for scoring the subjective knee evaluation form and the knee examination form are provided on the back of the forms. Total score 100, ≥75 being considered excellent.'}, {'measure': 'Magnatic Resonance Imaging evaluation', 'timeFrame': 'Three years after surgery', 'description': 'All patients undergoing anterior cruciate ligament reconstruction underwent MRI imaging evaluation of both knees. Use International Cartilage Repair Society(ICRS) score to evaluate, total score is 12, classified into four grades,grade Ⅰ: normal (12), grade Ⅱ: nearly normal (8-11), grade Ⅲ: abnormal (4-7), grade Ⅳ: severely abnormal (1-3).'}], 'secondaryOutcomes': [{'measure': 'Skeletal force line and various angles by X-ray evaluation', 'timeFrame': 'Preoperative', 'description': 'X-ray was used to evaluate the skeletal force line and various angles of patients. Use Qvadriceps Angle to evaluate quadriceps force line and patellar ligament force line. The normal Angle is 18-22° for the adult standing position.Above or below this range is considered abnormal.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patellar dislocation', 'Anatomic deformity', 'trochlear dysplasia', 'treatment'], 'conditions': ['Patellar Dislocation', 'Anatomic Abnormality', 'Trochlear Dysplasia', 'Femoral Anteversion', 'Treatment', 'Sport Injury']}, 'referencesModule': {'references': [{'pmid': '36088618', 'type': 'DERIVED', 'citation': 'Xu Z, Song Y, Deng R, Ye J, Wang X, Wang H, Yu JK. CT and MRI measurements of tibial tubercle lateralization in patients with patellar dislocation were not equivalent but could be interchangeable. Knee Surg Sports Traumatol Arthrosc. 2023 Jan;31(1):349-357. doi: 10.1007/s00167-022-07119-8. Epub 2022 Sep 11.'}]}, 'descriptionModule': {'briefSummary': 'All the data of patients with patellar dislocation will be collected to evaluate the anatomic deformities. The data includes X-ray, CT, MRI examinations, medical records, and physical examination information. Finally, we correlate the anatomic deformities with clinical efficacy. To search for the risk factors that lead to patellar dislocation and influence the therapeutic effect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '14 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with patellar dislocation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Patients with patellar dislocation.\n\nExclusion Criteria:\n\n* Patients with significant ligamentous knee injury.\n* Previous fracture or surgery of the lower limb.\n* Patellar dislocation caused by car accidents or other high-energy force directly on the patella.'}, 'identificationModule': {'nctId': 'NCT05243134', 'briefTitle': 'The Influence of Anatomic Deformities on the Clinical Efficacy in the Patients With Patellar Dislocation', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'The Influence of Anatomic Deformities on the Clinical Efficacy in the Patients With Patellar Dislocation', 'orgStudyIdInfo': {'id': 'IRB00006761-M2021423'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study Group', 'description': 'Patients with at least one type of anatomic deformity', 'interventionNames': ['Other: Collect the clinical data']}, {'label': 'Control group', 'description': 'Patients without anatomic deformity', 'interventionNames': ['Other: Collect the clinical data']}], 'interventions': [{'name': 'Collect the clinical data', 'type': 'OTHER', 'description': 'We analyze the influence of the anatomic deformity on the clinical efficacy at the follow-up.', 'armGroupLabels': ['Control group', 'Study Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jia-kuo Yu, MD', 'role': 'CONTACT', 'email': 'yujiakuo@126.com', 'phone': '86-10-82267392'}], 'facility': 'Institute of Sports Medicine, Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jia_kuo Yu', 'role': 'CONTACT', 'email': 'yujiakuo@126.com', 'phone': '01082267392'}, {'name': 'Lin Lin', 'role': 'CONTACT', 'phone': '01082267392'}], 'overallOfficials': [{'name': 'Lin Lin', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Peking University Third Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}