ChildNCT04424498
Treatment of Displaced Radial Neck Combined With Olecranon Fractures
An observational study of Child, run by Children's Hospital of Chongqing Medical University at 1 site in China.
Trial summary
This study aimed to evaluate the outcomes of using absorbable rods and Kirschner Wires technique for severe displaced radial neck fractures combined with olecranon fractures in children. Read more about this study
- Who is it for?
- Ages 3 to 13 years
- Conditions the study is for
- Child
- What is being tested?
- Absorbable Rods and Kirschner Wires
- Type of treatment
- Surgery or procedure
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 1 Dec 2019
- Phase
- Observational
- 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 13 years
- All sexes
- No healthy volunteers
- Child
Study population: Medical records of patients who attended our hospital between Jan 2012 and Dec 2016 were retrospectively reviewed.
Who may be able to join
- open reduction of severe radial neck fractures combined with an olecranon fractures in the same elbow
- fixation performed using absorbable rods and K-wires
Who cannot join
- single radial head fractures or single olecranon fractures
- fixation performed with bands
- old fractures,
- Boyd incision was not used,
- guardians did not agree with the surgery
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400014
About this study
Official title: Absorbable Rods and Kirschner Wires for the Treatment of Displaced Radial Neck Combined With Olecranon Fractures in Children
This study aimed to evaluate the outcomes of using absorbable rods and Kirschner Wires technique for severe displaced radial neck fractures combined with olecranon fractures in children.
Read the detailed description
The most common fracture in children is the elbow fracture, and the three most common elbow fractures are supracondylar, lateral condylar, and medial epicondylar fractures. Elbow fractures are easy to diagnose and the treatment modalities are studied often. However, proximal radius fractures, which include radial neck and head fractures, remain challenging to diagnose and manage. In addition, proximal radius fractures are often combined with other fractures, most commonly, an olecranon fracture. Most radial neck fractures can be treated conservatively if the displacement is less than 3 mm and the angle is less than 30º. However, for severe Judet type III and type IV radial neck fractures, surgery is inevitable.
This study focused on radial neck fractures combined with an olecranon fracture. In this study, absorbable rods were used for fixation of radial head fractures, and with no need for removal of the inner fixation, we performed anatomy reduction via the same incision with direct vision of the olecranon, and we were able to fix the fractures with Kirschner wires (K-wires). In this retrospective study, we aimed to evaluate a treatment method for severe displaced radial neck combined with olecranon fractures in children using a Boyd incision, absorbable rods, and K-wires.
- Conditions
- Child
- Being tested
- Absorbable Rods and Kirschner Wires
- Keywords
- Kirschner wires, Absorbable rods, Radial neck fracture, Olecranon fracture
- Medical subject headings
- Radial Head and Neck Fractures, Olecranon Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absorbable Rods and Kirschner WiresProcedure or surgery
A Boyd incision was applied in all patients; olecranon fractures were reduced first and fixed with Kirschner wires. Then, the displaced radial neck fractures were reduced and fixed using absorbable rods.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mayo Elbow Performance Index score
MEPI results were categorized as follows: >90 points, excellent; 81-90 points, good; 61-80 points, fair; and <60 points, poor.
Measured: 3th month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Jun 2019
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuxi Su, Children's Hospital of Chongqing Medical University
- Investigators
- Yuxi Su, M.D., Principal investigator, Children's hospital of Chongqing Medical Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424498
- Sponsor's protocol ID
- CQMU20200016
- Status last verified
- Jun 2020
- First submitted
- 5 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- 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 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorbable Rods and Kirschner Wires for the Treatment of Displaced Radial Neck Combined With Olecranon Fractures in Children
- ClinicalTrials.gov ID
- NCT04424498
- Acronym / sponsor ID
- CQMU20200016
- Conditions
- Child
- Keywords
- Kirschner wires, Absorbable rods, Radial neck fracture, Olecranon fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Children's Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 11 Jun 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.
This study aimed to evaluate the outcomes of using absorbable rods and Kirschner Wires technique for severe displaced radial neck fractures combined with olecranon fractures in children.
Detailed description
The most common fracture in children is the elbow fracture, and the three most common elbow fractures are supracondylar, lateral condylar, and medial epicondylar fractures. Elbow fractures are easy to diagnose and the treatment modalities are studied often. However, proximal radius fractures, which include radial neck and head fractures, remain challenging to diagnose and manage. In addition, proximal radius fractures are often combined with other fractures, most commonly, an olecranon fracture. Most radial neck fractures can be treated conservatively if the displacement is less than 3 mm and the angle is less than 30º. However, for severe Judet type III and type IV radial neck fractures, surgery is inevitable.
This study focused on radial neck fractures combined with an olecranon fracture. In this study, absorbable rods were used for fixation of radial head fractures, and with no need for removal of the inner fixation, we performed anatomy reduction via the same incision with direct vision of the olecranon, and we were able to fix the fractures with Kirschner wires (K-wires). In this retrospective study, we aimed to evaluate a treatment method for severe displaced radial neck combined with olecranon fractures in children using a Boyd incision, absorbable rods, and K-wires.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 3 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Medical records of patients who attended our hospital between Jan 2012 and Dec 2016 were retrospectively reviewed.
Key inclusion criteria (2 listed)
- open reduction of severe radial neck fractures combined with an olecranon fractures in the same elbow
- fixation performed using absorbable rods and K-wires
Key exclusion criteria (5 listed)
- single radial head fractures or single olecranon fractures
- fixation performed with bands
- old fractures,
- Boyd incision was not used,
- guardians did not agree with the surgery
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 |
|---|---|---|
| Absorbable Rods and Kirschner WiresA Boyd incision was applied in all patients; olecranon fractures were reduced first and fixed with Kirschner wires. Then, the displaced radial neck fractures were reduced and fixed using absorbable rods. | Procedure or surgery | – |
Primary outcome
Mayo Elbow Performance Index score
Time frame: 3th month after surgery
MEPI results were categorized as follows: >90 points, excellent; 81-90 points, good; 61-80 points, fair; and <60 points, poor.
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 11 Jun 2020.
- 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.
Yuxi Su, M.D. principal investigator
Children's hospital of Chongqing Medical Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child, run by Children's Hospital of Chongqing Medical University at 1 site in China.
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 2 inclusion and 5 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 11 Jun 2020. 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 China. 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?
Mayo Elbow Performance Index score (time frame: 3th month after surgery). 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 11 Jun 2020.