"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."
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Thomas Krebs
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Clinical and radiologic outcome (fracture consolidation)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •poor skin/soft tissue conditions
- •uncooperative patient or patient with restricted intellectual capacity
- •no options for adequate postoperative treatment (e.g. temporary strain relief)
Arms & Interventions
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
Intervention: Osteosynthesis with resorbable Material (Device)
Outcomes
Primary Outcomes
Clinical and radiologic outcome (fracture consolidation)
Time Frame: 12 months
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 Outcomes
- Woundhealing(12 months)
- ROM(12 months)
- Clinical fracture consolidation after one year(12 months)
- Analgesic reuirement(12 months)
Investigators
Thomas Krebs
Surgeon in Chief, Member of the executive board
Ostschweizer Kinderspital