Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-02-22 @ 4:13 AM
Study NCT ID:
NCT02633904
Status:
UNKNOWN
Last Update Posted:
2015-12-17
First Post:
2015-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Femoral Shortening Osteotomy in the Developmental Dislocation of the Hip (FSODDH)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006617', 'term': 'Hip Dislocation'}, {'id': 'D005271', 'term': 'Femur Head Necrosis'}], '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'}, {'id': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010027', 'term': 'Osteotomy'}], 'ancestors': [{'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-16', 'studyFirstSubmitDate': '2015-12-10', 'studyFirstSubmitQcDate': '2015-12-16', 'lastUpdatePostDateStruct': {'date': '2015-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Femur Head Necrosis', 'timeFrame': '2 years', 'description': 'Radiological evaluation was performed using standard anterior-posterior radiographs of the pelvis. The presence and grade of femur head necrosis was evaluated according to the method presented by Bucholz and Odgen.'}, {'measure': 'Redislocation', 'timeFrame': '2 years', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.'}, {'measure': 'Acetabular index', 'timeFrame': '2 years', 'description': 'Standardized radiographs have been traditionally used in the surveillance of hip dysplasia by measuring the acetabular index, which is the angle subtended between the Hilgenreiner line and a line drawn from the triradiate cartilage to the lateral edge of the acetabulum.'}], 'secondaryOutcomes': [{'measure': 'Duration of operation', 'timeFrame': '1 month', 'description': 'The time during the operation measured by minute.'}, {'measure': 'Blood loss', 'timeFrame': '1 month', 'description': 'The blood lost during the operation measured by milliliter.'}, {'measure': 'Cost', 'timeFrame': '1 month', 'description': 'The cost of hospitalization.'}, {'measure': 'Hospital stays', 'timeFrame': '1 month', 'description': 'The days stayed in hospital.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hip Dislocation', 'Congenital', 'osteotomy', 'Femur Head Necrosis'], 'conditions': ['Hip Dislocation', 'Femur Head Necrosis']}, 'referencesModule': {'references': [{'pmid': '19934701', 'type': 'RESULT', 'citation': 'Sankar WN, Tang EY, Moseley CF. Predictors of the need for femoral shortening osteotomy during open treatment of developmental dislocation of the hip. J Pediatr Orthop. 2009 Dec;29(8):868-71. doi: 10.1097/BPO.0b013e3181c29cb2.'}, {'pmid': '21643924', 'type': 'RESULT', 'citation': 'Pospischill R, Weninger J, Ganger R, Altenhuber J, Grill F. Does open reduction of the developmental dislocated hip increase the risk of osteonecrosis? Clin Orthop Relat Res. 2012 Jan;470(1):250-60. doi: 10.1007/s11999-011-1929-4. Epub 2011 Jun 4.'}]}, 'descriptionModule': {'briefSummary': 'Although older children and high dislocations may be more likely to require a femoral shortening osteotomy, the ultimate decision about whether or not to shorten a given femur should depend on the ease of femoral head reduction in that specific patient. Adding a femoral shortening procedure increases operating time and blood loss, adds a second incision, and necessitates future hardware removal. In addition, an unnecessary femoral shortening osteotomy could overly decrease the soft tissue tension around the joint, putting the hip at risk for redislocation. This study was designed to explore an algorithm based on strict age and radiographic criteria that identify those without the need of femoral osteotomy.', 'detailedDescription': "Developmental dislocation of the hip (DDH) is a common disease in children, and its incidence in China is about 9 ‰.There are many different methods in the treatment of DDH. Although older children and high dislocations may be more likely to require a femoral shortening osteotomy, the ultimate decision about whether or not to shorten a given femur should depend on the ease of femoral head reduction in that specific patient. Adding a femoral shortening procedure increases operating time and blood loss, adds a second incision, and necessitates future hardware removal. In addition, an unnecessary femoral shortening osteotomy could overly decrease the soft tissue tension around the joint, putting the hip at risk for redislocation. This study was designed to explore an algorithm based on strict age and radiographic criteria that identify those without the need of femoral osteotomy. From the investigators'clinical experiences and the published papers, younger patients (\\<24 month of age) and low dislocations (Tonnis level I or II) were more likely to avoid a femoral shortening osteotomy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '18 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Unilateral DDH,age 18-24month.\n2. Tonnis degree I or II.\n3. Not receive any open treatment.\n\nExclusion Criteria:\n\n1. Teratologic hip dislocations,\n2. Patients with mental, neurological disorders (such as hypoxic-ischemic encephalopathy, epilepsy and dementia) or significant barriers to growth, cerebral palsy, multiple joint contractures disease, dysfunction of liver and kidney , blood disorders, immune deficiency disease and ECG abnormalities.\n3. Any children with prior hip surgery were excluded from the series.\n4. Parents refused further treatment.'}, 'identificationModule': {'nctId': 'NCT02633904', 'acronym': 'FSODDH', 'briefTitle': 'Investigation of the Femoral Shortening Osteotomy in the Developmental Dislocation of the Hip (FSODDH)', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'Investigation of the Value of Femoral Shortening Osteotomy During Open Treatment of Developmental Dislocation of the Hip in Waliking Age Group', 'orgStudyIdInfo': {'id': 'FSODDH'}, 'secondaryIdInfos': [{'id': 'He Jin Peng', 'type': 'REGISTRY', 'domain': 'Tongji Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Osteotomy', 'description': 'Femoral osteotomy are applied in the open treatment of Developmental Dislocation of the Hip （DDH）.', 'interventionNames': ['Procedure: Osteotomy']}, {'type': 'EXPERIMENTAL', 'label': 'Non-osteotomy', 'description': 'Femoral osteotomy are not applied in the open treatment of Developmental Dislocation of the Hip （DDH）.', 'interventionNames': ['Procedure: Non-osteotomy']}], 'interventions': [{'name': 'Osteotomy', 'type': 'PROCEDURE', 'description': 'Femoral osteotomy are applied in the open treatment of Developmental Dislocation of the Hip （DDH）.', 'armGroupLabels': ['Osteotomy']}, {'name': 'Non-osteotomy', 'type': 'PROCEDURE', 'description': 'Femoral osteotomy are not applied in the open treatment of Developmental Dislocation of the Hip （DDH）.', 'armGroupLabels': ['Non-osteotomy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Peng J He, Doctor', 'role': 'CONTACT', 'email': '619921411@qq.com', 'phone': '+86-15071032254'}], 'overallOfficials': [{'name': 'Fan J Shao, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The single-center data will be published in the form of case-control study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'He Jin Peng', 'class': 'OTHER'}, 'collaborators': [{'name': "Hunan Children's Hospital", 'class': 'OTHER_GOV'}, {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, {'name': "Guangzhou Women and Children's Medical Center", 'class': 'OTHER'}, {'name': "Wuhan Women and Children's Medical Center", 'class': 'OTHER'}, {'name': "Shenzhen Children's Hospital", 'class': 'OTHER_GOV'}, {'name': 'Foshan Hospital of Traditional Chinese Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Resident doctor', 'investigatorFullName': 'He Jin Peng', 'investigatorAffiliation': 'Tongji Hospital'}}}}