Bioresrobable Implants, Childhood, Elbow Fracture, Magnesium-based, Magnezix, Osteosynthesis, Pediatric Elbow Fractures
Conditions
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.
Interventions
DEVICEOsteosynthesis with resorbable Material
Osteosynthesis with Magnezix screws in fractures of the Epicondylus ulnaris and Condylus radialis under General anaesthesia
Sponsors
Thomas Krebs
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 15 Years
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 * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical and radiologic outcome (fracture consolidation) | 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
| Measure | Time frame | Description |
|---|---|---|
| Woundhealing | 12 months | 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 | 12 months | Clinical reassessment at Routine follow-ups at every study visit \- Clinical signs for good consolidation are: no pain while palpating the fracture site. |
| Analgesic reuirement | 12 months | 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 | 12 months | 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). |
Countries
Switzerland
Outcome results
None listed