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MagnezixKids Study

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ClinicalTrials.gov Identifier: NCT04571905
Recruitment Status : Recruiting
First Posted : October 1, 2020
Last Update Posted : October 1, 2020
Sponsor:
Information provided by (Responsible Party):
Thomas Krebs, Ostschweizer Kinderspital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Magnesium-based Bioresrobable Implants Pediatric Elbow Fractures Osteosynthesis Childhood Magnezix Elbow Fracture Device: Osteosynthesis with resorbable Material Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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."
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arms and Interventions
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Arm Intervention/treatment
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 Name: Magnezix (Syntellix) screws


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.



Eligibility Criteria
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Ages Eligible for Study:   3 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04571905


Contacts
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Contact: Christoph Matissek, MD +41 243 14 53 christoph.matissek@kispisg.ch
Contact: Thomas F Krebs, MD +41 243 19 05 thomas.krebs@kispisg.ch

Locations
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Switzerland
Childres Hospital of Eastern Switzerland Recruiting
Saint Gallen, Switzerland, 9006
Contact: Christoph Matissek, MD    +41 243 14 53    christoph.matissek@kispisg.ch   
Contact: Thomas F Krebs, MD    +41 243 19 05    thomas.krebs@kispisg.ch   
Sponsors and Collaborators
Thomas Krebs
More Information
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Responsible Party: Thomas Krebs, Surgeon in Chief, Member of the executive board, Ostschweizer Kinderspital
ClinicalTrials.gov Identifier: NCT04571905    
Other Study ID Numbers: CTU 18.028
First Posted: October 1, 2020    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries