Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2026-02-17 @ 7:05 PM
Study NCT ID:
NCT02733666
Status:
COMPLETED
Last Update Posted:
2016-04-12
First Post:
2016-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internal Fixation of Lateral Humeral Condyle Fractures With Absorbable Screws in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006810', 'term': 'Humeral Fractures'}], 'ancestors': [{'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-08', 'studyFirstSubmitDate': '2016-03-25', 'studyFirstSubmitQcDate': '2016-04-05', 'lastUpdatePostDateStruct': {'date': '2016-04-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Elbow Motion angle in degree', 'timeFrame': '6 months after surgery.', 'description': 'The orginal position was anatomy position （neutral position），Then，test the angle measured in degree of the elbow motion flexion, pronation and supination'}, {'measure': 'Strength in Newton (N)', 'timeFrame': '6 months after surgery.', 'description': 'Compared to the normal hand, the investigators defined it normal to moderate loss and severe loss'}, {'measure': 'stability', 'timeFrame': '6 months after surgery.', 'description': 'Compared to the normal hand, the investigators defined the elbow stability from normal to mild loss , moderate loss and severe loss'}, {'measure': 'Pain', 'timeFrame': '6 months after surgery.', 'description': 'According to the level 0 \\~ 10 to pain grading:0 to 3 for mild pain,4 to 6 for moderate pain,7 or more for severe pain'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Absorbable screw', 'Internal fixation', 'Children'], 'conditions': ['Humeral Fractures']}, 'descriptionModule': {'briefSummary': 'Lateral humeral condyle fractures are the second most common elbow fractures in children. Displaced and rotated fractures require stabilization and reduction. Kirschner wires (K-wires) are most commonly used for fracture fixation. Here, the investigators introduce a new fixation method involving absorbable screws. The investigators aimed to determine if it is feasible to treat lateral humeral condyle fractures with absorbable screws by comparing the functional outcomes obtained using screw fixation vs. K-wire fixation.', 'detailedDescription': "Methods: Between May 2007 and September 2010, 86 participants (age, 1.6-13 years; average age, 6.7 years) were randomly divided into two groups. All participants had been diagnosed with lateral condyle fractures classified as Jacobs type II (unstable) or III. Closed reduction failed in all participants. Therefore, open reduction was performed under general anesthesia. One absorbable screw was used for fixation in the experimental group, while two 1.8-mm K-wires were used in the control group. At 4-6 weeks postoperatively, the participants' plaster casts were removed, and functional training was started."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll participants had been diagnosed with lateral condyle fractures classified as Jacobs type II (unstable) or III\n\nExclusion Criteria:\n\nparticipants had not been diagnosed with lateral condyle fractures classified as Jacobs type II (unstable) or III'}, 'identificationModule': {'nctId': 'NCT02733666', 'briefTitle': 'Internal Fixation of Lateral Humeral Condyle Fractures With Absorbable Screws in Children', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Chongqing Medical University"}, 'officialTitle': 'Open Reduction and Internal Fixation of Lateral Humeral Condyle Fractures With Absorbable Screws in Children', 'orgStudyIdInfo': {'id': 'Yuxi-2016-3-25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Absorbable screw group', 'description': 'One absorbable screw was used for fixation in the experimental group', 'interventionNames': ['Procedure: Absorbable screw group']}, {'type': 'NO_INTERVENTION', 'label': 'K-wires group', 'description': 'two 1.8-mm K-wires were used for the fixation in the control group. The K-wires were the most common used by the orthopaedic surgeon.'}], 'interventions': [{'name': 'Absorbable screw group', 'type': 'PROCEDURE', 'description': 'Open reduction was performed and one absorbable screw was used for fixation in the experimental group', 'armGroupLabels': ['Absorbable screw group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Chongqing Medical University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Vice chief of the orthopeadic department of Children's Hospital of Chongqing Medical Univeristy", 'investigatorFullName': 'Yuxi Su', 'investigatorAffiliation': "Children's Hospital of Chongqing Medical University"}}}}