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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Osteosynthesis with Magnezix screws in fractures of the Epicondylus ulnaris and Condylus radialis under General anaesthesia
Childres Hospital of Eastern Switzerland
Sankt Gallen, Switzerland
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).
Time frame: 12 months
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)
Time frame: 12 months
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).
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 12 months
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