Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-01-03 @ 8:36 PM
Study NCT ID:
NCT02163603
Status:
UNKNOWN
Last Update Posted:
2016-03-21
First Post:
2014-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial on the Opportunity and Treatment of Residual Deformity After Reduction in Developmental Dislocation of the Hip
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006617', 'term': 'Hip Dislocation'}], 'ancestors': [{'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'lastUpdateSubmitDate': '2016-03-18', 'studyFirstSubmitDate': '2014-05-06', 'studyFirstSubmitQcDate': '2014-06-11', 'lastUpdatePostDateStruct': {'date': '2016-03-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early treatment can achieve good results in the residual deformity after reduction in developmental dislocation of the hip', 'timeFrame': '3 years', 'description': 'Acetabular index of all ages were measured ，and the acetabular index of patients getting early treatment (pelvis osteotomy ) is normal in all ages according to "The measurements of normal acetabular index and Sharp acetabular angle in Chinese hips" publised on Chinese Journal of Orthopaedics in 2010.'}]}, 'conditionsModule': {'conditions': ['Developmental Dislocation of the Hip', 'Congenital Dislocation of Hip', 'Residual Deformity', 'Reduction']}, 'descriptionModule': {'briefSummary': 'Developmental dislocation of the hip is a common disease in children, and its incidence in China is about 9 ‰.The pathological changes of it is complex. The reluxation , subluxation and residual deformity and other complications are relatively common after treatment. The X-ray appears great acetabular index and wide medial gap , small central-edge angle. As there is no effective methods for treating such complications , investigators conducted this trial to find and prove optimal intervention time and treatment programs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '1 Year', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The south of China', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The inclusion criteria consists of patients with large acetabular index ,small central-edge angle after reduction in developmental dislocation of the hip\n\nExclusion Criteria:\n\n* Age \\>14 years\n* Patients are complicated with mental, neurological disorders (such as hypoxic-ischemic encephalopathy, epilepsy and dementia) or significant barriers to growth.\n* Patients are complicated with cerebral palsy, multiple joint contractures disease.\n* Children are complicated with dysfunction of liver and kidney , blood disorders, immune deficiency disease and ECG abnormalities.\n* Parents refused further treatment.'}, 'identificationModule': {'nctId': 'NCT02163603', 'briefTitle': 'A Trial on the Opportunity and Treatment of Residual Deformity After Reduction in Developmental Dislocation of the Hip', 'organization': {'class': 'OTHER', 'fullName': "Guangzhou Women and Children's Medical Center"}, 'officialTitle': 'A Multi-center Study on the Opportunity and Treatment of Residual Deformity After Reduction in Developmental Dislocation of the Hip', 'orgStudyIdInfo': {'id': 'GuangzhouWCMC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pelvic osteotomy', 'interventionNames': ['Procedure: Pelvic osteotomy']}], 'interventions': [{'name': 'Pelvic osteotomy', 'type': 'PROCEDURE', 'armGroupLabels': ['Pelvic osteotomy']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hongwen Xu', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tongji Hospital', 'class': 'OTHER'}, {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, {'name': "Hunan Children's Hospital", 'class': 'OTHER_GOV'}, {'name': "Shenzhen Children's Hospital", 'class': 'OTHER_GOV'}, {'name': 'Foshan Hospital of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': "Wuhan Women and Children's Medical Center", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': "Guangzhou Women and Children's Medical Center", 'investigatorFullName': 'Hongwen Xu', 'investigatorAffiliation': "Guangzhou Women and Children's Medical Center"}}}}