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Completed

NCT Number: NCT04571905

MagnezixKids Study

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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Key information

Conditions

Magnesium-based Arm Injuries Bioresrobable Implants Childhood Elbow Fracture Elbow Fractures Elbow Injuries Fractures, Bone Magnezix Osteosynthesis Pediatric Elbow Fractures Wounds and Injuries

Age range

3 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Childres Hospital of Eastern Switzerland

Sankt Gallen, 9006, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Osteosynthesis with resorbable Material

Device

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

Other names: Magnezix (Syntellix) screws

Primary outcomes

  1. Clinical and radiologic outcome (fracture consolidation)

    Time frame: 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 outcomes

  1. Analgesic reuirement

    Time frame: 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)

  2. ROM

    Time frame: 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).

  3. Woundhealing

    Time frame: 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.

  4. Clinical fracture consolidation after one year

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Thomas Krebs

Other

Registry information

Official study 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."

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 1, 2020
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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