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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Syntellix Treatment Arm | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteosynthesis with resorbable Material | Device | Osteosynthesis with Magnezix screws in fractures of the Epicondylus ulnaris and Condylus radialis under General anaesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 months |
| ROM |
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Inclusion Criteria:
Exclusion Criteria:
Absolute contraindications:
Relative contraindications:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childres Hospital of Eastern Switzerland | Sankt Gallen | 9006 | Switzerland |
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| ID | Term |
|---|---|
| D000092482 | Elbow Fractures |
| ID | Term |
|---|---|
| D000092464 | Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| ID | Term |
|---|---|
| D005593 | Fracture Fixation, Internal |
| ID | Term |
|---|---|
| D005592 | Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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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).
| 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. | 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. | 12 months |