Back to resultsMagnezixKids Study
Primary Purpose
Magnesium-based, Bioresrobable Implants, Pediatric Elbow Fractures
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Osteosynthesis with resorbable Material
Sponsored by
About this trial
This is an interventional treatment trial for Magnesium-based
Eligibility Criteria
Inclusion Criteria:
- 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 )
- Age 3-15 years
- Informed Consent as documented by signature
Exclusion Criteria:
- - open fractures or complex multi fragment fractures that require dif-ferent osteosynthetic procedures than screw fixation
- 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)
Sites / Locations
- Childres Hospital of Eastern Switzerland
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Syntellix Treatment Arm
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
Outcomes
Primary Outcome Measures
Clinical and radiologic outcome (fracture consolidation)
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).
Secondary Outcome Measures
Analgesic reuirement
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)
ROM
Clinical reassessment at Routine follow-ups at every study visit
- 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).
Woundhealing
Clinical reassessment at Routine follow-ups at every study visit
- Classification in normal or delayed/impaired. Signs for im-pairment are local secretion, swelling, reddening or wound dehiscence.
Clinical fracture consolidation after one year
Clinical reassessment at Routine follow-ups at every study visit
- Clinical signs for good consolidation are: no pain while palpating the fracture site.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04571905
Brief Title
MagnezixKids Study
Official Title
"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."
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
July 12, 2023 (Actual)
Study Completion Date
July 12, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thomas Krebs
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
If our results suggest non-inferiority of osteosynthesis with magnesium-based screws, the procedure could be tested formally in a subsequent full-size study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Magnesium-based, Bioresrobable Implants, Pediatric Elbow Fractures, Osteosynthesis, Childhood, Magnezix, Elbow Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Syntellix Treatment Arm
Arm Type
Other
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
Intervention Type
Device
Intervention Name(s)
Osteosynthesis with resorbable Material
Other Intervention Name(s)
Magnezix (Syntellix) screws
Intervention Description
Osteosynthesis with Magnezix screws in fractures of the Epicondylus ulnaris and Condylus radialis under General anaesthesia
Primary Outcome Measure Information:
Title
Clinical and radiologic outcome (fracture consolidation)
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).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Analgesic reuirement
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)
Time Frame
12 months
Title
ROM
Description
Clinical reassessment at Routine follow-ups at every study visit
- 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).
Time Frame
12 months
Title
Woundhealing
Description
Clinical reassessment at Routine follow-ups at every study visit
- Classification in normal or delayed/impaired. Signs for im-pairment are local secretion, swelling, reddening or wound dehiscence.
Time Frame
12 months
Title
Clinical fracture consolidation after one year
Description
Clinical reassessment at Routine follow-ups at every study visit
- Clinical signs for good consolidation are: no pain while palpating the fracture site.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 )
Age 3-15 years
Informed Consent as documented by signature
Exclusion Criteria:
- open fractures or complex multi fragment fractures that require dif-ferent osteosynthetic procedures than screw fixation
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)
Facility Information:
Facility Name
Childres Hospital of Eastern Switzerland
City
Saint Gallen
ZIP/Postal Code
9006
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
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