Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-01-01 @ 12:21 AM
Study NCT ID:
NCT04571905
Status:
COMPLETED
Last Update Posted:
2023-09-06
First Post:
2020-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MagnezixKids Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092482', 'term': 'Elbow Fractures'}], 'ancestors': [{'id': 'D000092464', 'term': 'Elbow Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005593', 'term': 'Fracture Fixation, Internal'}], 'ancestors': [{'id': 'D005592', 'term': 'Fracture Fixation'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-05', 'studyFirstSubmitDate': '2020-08-11', 'studyFirstSubmitQcDate': '2020-09-25', 'lastUpdatePostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical and radiologic outcome (fracture consolidation)', 'timeFrame': '12 months', 'description': 'radiologic outcome after osteosynthesis with magnesium based screws in children with a primary or secondary (within 7 days from trauma) dislocated fracture of the Epicondyles ulnaris or Condylus radialis Fracture alignment is measured as dislocation distance (mm). Appropriate alignement is a postopera-tive dehiscence or dislocation of less than 5 mm in Epicondylus ulnaris fractures and less than 2 mm in Condylus radialis fractures, according to literature (26/27/31).'}], 'secondaryOutcomes': [{'measure': 'Analgesic reuirement', 'timeFrame': '12 months', 'description': 'Analgesic requirement via Pain score (Visual Analog Scale, VAS, Range from 1 (no pain) to 10 (strongest pain)) (27) at every study visit (except visit 1: preop. assessment)'}, {'measure': 'ROM', 'timeFrame': '12 months', 'description': 'Clinical reassessment at Routine follow-ups at every study visit\n\n\\- An Arc \\>100° shows a good functional result, arc 50-100° is a fair (acceptable) result, arc \\<50° shows a poor (unsatisfactory) result, according to the Mayo elbow performance index (see appendix).'}, {'measure': 'Woundhealing', 'timeFrame': '12 months', 'description': 'Clinical reassessment at Routine follow-ups at every study visit\n\n\\- Classification in normal or delayed/impaired. Signs for im-pairment are local secretion, swelling, reddening or wound dehiscence.'}, {'measure': 'Clinical fracture consolidation after one year', 'timeFrame': '12 months', 'description': 'Clinical reassessment at Routine follow-ups at every study visit\n\n\\- Clinical signs for good consolidation are: no pain while palpating the fracture site.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Magnesium-based', 'Bioresrobable Implants', 'Pediatric Elbow Fractures', 'Osteosynthesis', 'Childhood', 'Magnezix', 'Elbow Fracture']}, 'descriptionModule': {'briefSummary': 'The overall objective of the study is to describe the outcomes of osteosyn-thesis with magnesium based screws in children with a primary or second-ary (within 7 days from trauma) dislocated fracture of the Epicondyles ul-naris or Condylus radialis, and to compare them with outcomes of conven-tional osteosynthesis using steel screws.\n\nIf our results suggest non-inferiority of osteosynthesis with magnesium-based screws, the procedure could be tested formally in a subsequent full-size study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* primary or secondary (within 7 days from trauma) dislocated fracture of the Epicondyles ulnaris or Condylus radialis (indication for operative treatment according to international standard: Dislocation of more than 2 mm in Condylus radials fractures and more than 5 mm in Epicondylus ulnas fractures )\n* Age 3-15 years\n* Informed Consent as documented by signature\n\nExclusion Criteria:\n\n* \\- open fractures or complex multi fragment fractures that require dif-ferent osteosynthetic procedures than screw fixation\n* severe local accompanying injury (injury to nerves/vessels)\n* polytrauma patients\n* fracture age \\> 7 days\n* preexisting ipsilateral elbow fracture\n* relevant comorbidities, which have influence on fracture and wound healing\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant or the legal representatives\n* Previous enrolment into the current study\n* Enrolment of the investigator's family members and other dependent persons\n* Any of the following applicable absolute and relative contraindica-tions listed in the MAGNEZIX® CBS and CSc 4.8 mm instruction for use :\n\nAbsolute contraindications:\n\n* insufficient or avascular bone mass for anchorage of the implant, ex-cept osteochondral fractures and dissecates\n* confirmation or suspected septic infectious surgical site\n* application in the area of the epiphyseal plates\n\nRelative contraindications:\n\n* acute sepsis\n* alcohol, nicotine and/or drug abuse\n* epilepsy\n* poor skin/soft tissue conditions\n* uncooperative patient or patient with restricted intellectual capacity\n* no options for adequate postoperative treatment (e.g. temporary strain relief)"}, 'identificationModule': {'nctId': 'NCT04571905', 'briefTitle': 'MagnezixKids Study', 'organization': {'class': 'OTHER', 'fullName': 'Ostschweizer Kinderspital'}, 'officialTitle': '"Magnesium-based, Bioresorbable Implants for Pediatric Elbow Fractures, a Single Center Pilot Study for Osteosynthesis With Magnezix Screws in Fractures of the Epicondylus Ulnaris and Condylus Radialis."', 'orgStudyIdInfo': {'id': 'CTU 18.028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Syntellix Treatment Arm', 'description': 'General anaesthesia, open fracture reduction, insertion of the appropriate screw with x-ray control and documentation intraoperatively, cast immobilisation Use of bioresorbable Magnezix CS or CBS Screws, if intraoperatively suitable bioresorbable screws not available, use of conventional ostesynthesis screws', 'interventionNames': ['Device: Osteosynthesis with resorbable Material']}], 'interventions': [{'name': 'Osteosynthesis with resorbable Material', 'type': 'DEVICE', 'otherNames': ['Magnezix (Syntellix) screws'], 'description': 'Osteosynthesis with Magnezix screws in fractures of the Epicondylus ulnaris and Condylus radialis under General anaesthesia', 'armGroupLabels': ['Syntellix Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9006', 'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'Childres Hospital of Eastern Switzerland', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Krebs', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Surgeon in Chief, Member of the executive board', 'investigatorFullName': 'Thomas Krebs', 'investigatorAffiliation': 'Ostschweizer Kinderspital'}}}}