MagnezixKids Study

NCT04571905 | Completed DMC

• 1 other identifier: CTU 18.028
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Magnesium-based; Bioresrobable Implants; Pediatric Elbow Fractures; Osteosynthesis; Childhood; Magnezix; Elbow Fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Analgesic reuirement

  12 months

• ROM

  12 months

• Woundhealing

  12 months

• Clinical fracture consolidation after one year

  12 months

Study Arms (1)

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

Device: Osteosynthesis with resorbable Material

Interventions

Osteosynthesis with resorbable Material DEVICE

Osteosynthesis with Magnezix screws in fractures of the Epicondylus ulnaris and Condylus radialis under General anaesthesia

Also known as: Magnezix (Syntellix) screws

Syntellix Treatment Arm

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• \- 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:

Sponsors & Collaborators

• Thomas Krebs: lead

Study Sites (1)

Childres Hospital of Eastern Switzerland

Sankt Gallen, 9006, Switzerland

Location

MeSH Terms

Conditions

Elbow Fractures

Interventions

Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Elbow Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Surgeon in Chief, Member of the executive board

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: October 1, 2020
• Study Start: August 1, 2020
• Primary Completion: July 12, 2023
• Study Completion: July 12, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)