Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-30 @ 11:31 PM
Study NCT ID:
NCT04423835
Status:
COMPLETED
Last Update Posted:
2020-06-11
First Post:
2020-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lateral Closing Wedge Osteotomy for Cubitus Varus Deformity in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000013', 'term': 'Congenital Abnormalities'}], 'ancestors': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-08', 'studyFirstSubmitDate': '2020-06-06', 'studyFirstSubmitQcDate': '2020-06-06', 'lastUpdatePostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Elbow appearance', 'timeFrame': '3th month after surgery', 'description': 'elbows were evaluated using radiography and appearence'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cubitus varus', 'supracondylar humerus fracture', 'osteotomy'], 'conditions': ['Deformity; Bone']}, 'descriptionModule': {'briefSummary': 'Humeral osteotomy is the most effective method for evident cubitus varus correction in children. Several osteotomy methods and fixation materials have been developed in the past. By applying the principles of deformity correction described by Paley, the investigators describe a novel corrective technique for cubitus varus involving lateral osteotomy using Kirschner wires.', 'detailedDescription': "Supracondylar humerus fractures (SHFs) account for approximately 10% of all pediatric fractures in children. Poorly treated SHFs can lead to the most common cubitus varus deformity especially in patients treated conservatively. The cosmetic aspect of this deformity is the main concern of patients, together with reduced remodeling ability. Inevitably, surgery is the first choice for such patients. Several osteotomy techniques and fixation materials have been developed in the last several decades. With the advent of three-dimensional printing techniques and computed tomography reconstruction methods, more accurate computing designs have been applied in the correction of cubitus varus. These techniques make the surgery more complex and require the performance of computed tomography (CT), resulting in high radiation exposure in children. Paley described the principles of deformity correction that are widely used for the lower limbs. These principles represent an alternative with easy application without the need of CT, with less occurrence of prominence and good cosmetic outcome. According to the Paley principles, all the vertex of the triangular osteotomy should site on the center of rotation of angulation (CORA) line, by doing this, the gun-butt deformity was corrected perfectly. More importantly, they help to accurately correct the anatomic axis of the upper limb. According to our knowledge, this is the first study describes the lateral closing wedge osteotomy for correction cubitus varus deformity in children by applying Paley's principles and fixation with K-wires.\n\nTaken together, the investigators aimed at verifying the feasibility of Paley's principles for deformity correction to treat cubitus varus in children."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All the patients were performed surgery between July 2015 and October 2017', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* surgery performed over 6 months after the occurrence of SHFs\n* difference in flexion angles of the affected and unaffected limbs of \\>15 degrees\n* recovery of elbow function pre-ostomy\n\nExclusion Criteria:\n\n* any other surgical approach used\n* consent not obtained from the patient's guardians\n* incomplete follow-up"}, 'identificationModule': {'nctId': 'NCT04423835', 'briefTitle': 'Lateral Closing Wedge Osteotomy for Cubitus Varus Deformity in Children', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Chongqing Medical University"}, 'officialTitle': "Applying Paley's Principles to Lateral Closing Wedge Osteotomy for Cubitus Varus Deformity in Children", 'orgStudyIdInfo': {'id': 'CQMU20200026'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'lateral closing osteotomy for cubitus varus deformity', 'description': "The osteotomy line of all patients was designed according to Paley's principles. The lateral incision was applied in all patients and the osteotomy lines were marked on the humerus with the assistance of C-arm radiographs.", 'interventionNames': ["Procedure: Paley's Principle osteotomy"]}], 'interventions': [{'name': "Paley's Principle osteotomy", 'type': 'PROCEDURE', 'otherNames': ["Applying Paley's Principles to Lateral Closing Wedge Osteotomy"], 'description': ". The osteotomy line of all patients was designed according to Paley's principles. The lateral incision was applied in all patients and the osteotomy lines were marked on the humerus with the assistance of C-arm radiographs. An isosceles triangle template was used for osteotomy, and the medial cortex was left intact. K-wires were used to fix the osteotomy laterally.", 'armGroupLabels': ['lateral closing osteotomy for cubitus varus deformity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400014', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': "Children's Hospital of Chongqing Medical University", 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Chongqing Medical University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice professor', 'investigatorFullName': 'Yuxi Su', 'investigatorAffiliation': "Children's Hospital of Chongqing Medical University"}}}}