MagnezixKids Study

Elbow Fracture Clinical Trial

Official title:

"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."

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04571905
• Other study ID #: CTU 18.028
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: July 12, 2023

Study information

• Verified date: September 2023
• Source: Ostschweizer Kinderspital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 12, 2023
• Est. primary completion date: July 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 15 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bioresrobable Implants
• Childhood
• Elbow Fracture
• Elbow Fractures
• Fractures, Bone
• Magnesium-based
• Magnezix
• Osteosynthesis
• Pediatric Elbow Fractures

Intervention

Device:
• Osteosynthesis with resorbable Material
Osteosynthesis with Magnezix screws in fractures of the Epicondylus ulnaris and Condylus radialis under General anaesthesia

Locations

Country	Name	City	State
Switzerland	Childres Hospital of Eastern Switzerland	Saint Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Krebs

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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