Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
17 participants
INTERVENTIONAL
2020-08-01
2023-07-12
Brief Summary
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If our results suggest non-inferiority of osteosynthesis with magnesium-based screws, the procedure could be tested formally in a subsequent full-size study.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Syntellix Treatment Arm
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
Osteosynthesis with resorbable Material
Osteosynthesis with Magnezix screws in fractures of the Epicondylus ulnaris and Condylus radialis under General anaesthesia
Interventions
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Osteosynthesis with resorbable Material
Osteosynthesis with Magnezix screws in fractures of the Epicondylus ulnaris and Condylus radialis under General anaesthesia
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 3-15 years
* Informed Consent as documented by signature
Exclusion Criteria
* severe local accompanying injury (injury to nerves/vessels)
* polytrauma patients
* fracture age \> 7 days
* preexisting ipsilateral elbow fracture
* relevant comorbidities, which have influence on fracture and wound healing
* 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
* Previous enrolment into the current study
* Enrolment of the investigator's family members and other dependent persons
* Any of the following applicable absolute and relative contraindica-tions listed in the MAGNEZIX® CBS and CSc 4.8 mm instruction for use :
Absolute contraindications:
* insufficient or avascular bone mass for anchorage of the implant, ex-cept osteochondral fractures and dissecates
* confirmation or suspected septic infectious surgical site
* application in the area of the epiphyseal plates
Relative contraindications:
* acute sepsis
* alcohol, nicotine and/or drug abuse
* epilepsy
* poor skin/soft tissue conditions
* uncooperative patient or patient with restricted intellectual capacity
* no options for adequate postoperative treatment (e.g. temporary strain relief)
3 Years
15 Years
ALL
No
Sponsors
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Thomas Krebs
OTHER
Responsible Party
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Thomas Krebs
Surgeon in Chief, Member of the executive board
Locations
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Childres Hospital of Eastern Switzerland
Sankt Gallen, , Switzerland
Countries
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Other Identifiers
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CTU 18.028
Identifier Type: -
Identifier Source: org_study_id
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