MagnezixKids Study

Not Applicable

Completed

• Conditions: Pediatric Elbow Fractures; Elbow Fracture; Magnesium-based; Bioresrobable Implants; Osteosynthesis; Childhood; Magnezix
• Interventions: Device: Osteosynthesis with resorbable Material

• Registration Number: NCT04571905
• Lead Sponsor: Thomas Krebs

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-01
• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-09-25
• Study First Posted: 2020-10-01
• Primary Completion: 2023-07-12
• Study Completion: 2023-07-12
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-05
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Syntellix Treatment Arm	Osteosynthesis with resorbable Material	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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)

Trial Locations

Locations (1)

Childres Hospital of Eastern Switzerland; 🇨🇭 Saint Gallen, Switzerland