MagnezixKids Study

"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."

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 Overview

• Status: Completed
• Conditions: Elbow Fracture; Magnesium-based; Bioresrobable Implants; Pediatric Elbow Fractures; Osteosynthesis; Childhood; Magnezix
• Intervention / Treatment: Device: Osteosynthesis with resorbable Material

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Saint Gallen, Switzerland, 9006
    • Childres Hospital of Eastern Switzerland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 15 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Device: Osteosynthesis with resorbable Material; Osteosynthesis with Magnezix screws in fractures of the Epicondylus ulnaris and Condylus radialis under General anaesthesia; Other Names: Magnezix (Syntellix) screws

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Thomas Krebs

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): July 12, 2023
• Study Completion (Actual): July 12, 2023

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Estimated): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Elbow Injuries; Fractures, Bone; Elbow Fractures
• Other Study ID Numbers: CTU 18.028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No