Magnesium-basedNCT04571905
MagnezixKids Study
A study testing Osteosynthesis with resorbable Material in people with Magnesium-based and Bioresrobable Implants, run by Thomas Krebs at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Magnesium-based, Bioresrobable Implants, Pediatric Elbow Fractures
- What is being tested?
- Osteosynthesis with resorbable Material
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2020to 12 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- - 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
Show all 21Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Childres Hospital of Eastern Switzerland
Sankt Gallen, 9006
About this study
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."
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
- Being tested
- Osteosynthesis with resorbable Material
- Medical subject headings
- Elbow Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteosynthesis with resorbable MaterialDevice
Also called Magnezix (Syntellix) screws
Osteosynthesis with Magnezix screws in fractures of the Epicondylus ulnaris and Condylus radialis under General anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Osteosynthesis with resorbable Material |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (4)
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)
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start1 Aug 2020
- Primary completion12 Jul 2023
- Study completion12 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnesium-basedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Krebs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Krebs, Ostschweizer Kinderspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571905
- Sponsor's protocol ID
- CTU 18.028
- Status last verified
- Sep 2023
- First submitted
- 11 Aug 2020
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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."
- ClinicalTrials.gov ID
- NCT04571905
- Acronym / sponsor ID
- CTU 18.028
- Conditions
- Magnesium-based, Bioresrobable Implants, Pediatric Elbow Fractures, Osteosynthesis, Childhood, Magnezix
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Thomas KrebsUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 12 Jul 2023 (actual)
- Study completion
- 12 Jul 2023 (actual)
- First posted
- 1 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Syntellix Treatment Arm | Other | Device: Osteosynthesis with resorbable MaterialGeneral 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 |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (21 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteosynthesis with resorbable MaterialAlso: Magnezix (Syntellix) screwsOsteosynthesis with Magnezix screws in fractures of the Epicondylus ulnaris and Condylus radialis under General anaesthesia | Device | Syntellix Treatment Arm |
Primary outcome
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).
4 secondary outcomes
Analgesic reuirement
Time frame: 12 months
ROM
Time frame: 12 months
Woundhealing
Time frame: 12 months
Clinical fracture consolidation after one year
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteosynthesis with resorbable Material in people with Magnesium-based and Bioresrobable Implants, run by Thomas Krebs at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and radiologic outcome (fracture consolidation) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.