Supracondylar Humerus FractureFractureNCT04780308
Pediatric Type III Supracondylar Humeral Fracture
An observational study of Supracondylar Humerus Fracture and Pediatric Fractures, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital.
Trial summary
The purpose of this study was to compare pin configuration effects on early secondary displacement in the surgical treatment of pediatric supracondylar humeral fractures (SCHF). Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Supracondylar Humerus Fracture, Pediatric Fractures
- What is being tested?
- Pediatric Garthland Type 3 supracondylar humeral fractures fixed by K-wires
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 20 Feb 2015
- How long will I take part?
- 12 Months
- 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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients under 16 years.
Who may be able to join
- Pediatric Gartland Type 3 supracondylar humeral fracture
- Patients operated between 2010-2013
- Patients under 16 years old
Who cannot join
- Pathological fractures
- Conservative treated supracondylar fractures
- Less than the 1-year follow-up
- Patients with incomplete postoperative follow-up
- Patients older than 16 years
- Pediatric Gartland Type 1 and 2 supracondylar humeral fracture
About this study
Official title: How Many K Wires do we Need in the Surgical Treatment of Pediatric Type III Supracondylar Humeral Fracture?
The purpose of this study was to compare pin configuration effects on early secondary displacement in the surgical treatment of pediatric supracondylar humeral fractures (SCHF).
Read the detailed description
The study consisted of 100 (68M, 32F) children who underwent surgery between 2010 and 2013 for Gartland Type 3 (SCHF). The patients divided into five groups according to the top in configurations (crossed 1 lateral 1 medial, crossed 2 lateral 1 medial, crossed 1 lateral 2 medial, 2 lateral divergent, and 3 lateral divergent). The average age at the time of injury was 7.34 (between 2 and 14 years). Bauman angle (BA), Humerocapital angle (HCA), Anterior humeral line (AHL), flexion range, extension range, and Carrying angle (CA) were compared at preoperative, postoperative 1st-day, postoperative last control, and non-operated side. The mean follow-up time 24,96±11,06 with a range of 12-54 months.
- Being tested
- Pediatric Garthland Type 3 supracondylar humeral fractures fixed by K-wires
- Keywords
- pediatric, supracondylar humeral fracture, k wires, closed reduction, pin configuration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric Garthland Type 3 supracondylar humeral fractures fixed by K-wiresProcedure or surgery
The effects of the different types of K-wire configuration on Pediatric Gartland Type 3 supracondylar humeral fractures were evaluated. Pediatric Gartland Type 3 supracondylar humeral fractures operated under general anesthesia with open or closed reduction. After reduction checked by fluoroscopy K-wires applied in different configurations.
| Study group | Role | What they receive |
|---|---|---|
| 1 medial 1 lateral K-wire | Pediatric Gartland Type 3 supracondylar humeral fractures fixed by 1 medial 1 lateral K-wire Receives: Procedure: Pediatric Garthland Type 3 supracondylar humeral fractures fixed by K-wires | |
| 1 medial 2 lateral K-wire | Pediatric Gartland Type 3 supracondylar humeral fractures fixed by 1 medial 2 lateral K-wire Receives: Procedure: Pediatric Garthland Type 3 supracondylar humeral fractures fixed by K-wires | |
| 2 medial 1 lateral K-wire | Pediatric Gartland Type 3 supracondylar humeral fractures fixed by 2 medial 1 lateral K-wire Receives: Procedure: Pediatric Garthland Type 3 supracondylar humeral fractures fixed by K-wires | |
| 2 lateral K-wire | Pediatric Gartland Type 3 supracondylar humeral fractures fixed by 2 lateral K-wire Receives: Procedure: Pediatric Garthland Type 3 supracondylar humeral fractures fixed by K-wires | |
| 3 lateral K-wire | Pediatric Gartland Type 3 supracondylar humeral fractures fixed by 3 lateral K-wire Receives: Procedure: Pediatric Garthland Type 3 supracondylar humeral fractures fixed by K-wires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baumann Angle
This angle is formed by the humeral axis and a straight line through the epiphyseal plate of the capitellum. Preoperative and postoperative angle differences are measured in anteroposterior and lateral X rays. These differences are measured for reduction quality and these parameters shows the success of the surgery.
Measured: postoperative 1. day, 1. month and 12. month
Anterior Humeral Line
A line drawn down the anterior surface of the humerus should intersect the middle third of the capitellum. Preoperative and postoperative angle differences are measured in anteroposterior and lateral X rays. These differences are measured for reduction quality and these parameters shows the success of the surgery.
Measured: postoperative 1. day, 1. month and 12. month
Humero-Capital Angle
On lateral X-ray angle between capitellum and humeral shaft. Preoperative and postoperative angle differences are measured in anteroposterior and lateral X rays. These differences are measured for reduction quality and these parameters shows the success of the surgery.
Measured: postoperative 1. day, 1. month and 12. month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start1 Jan 2010
- Primary completion31 Dec 2013
- Study completion20 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supracondylar Humerus FractureStudies 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
- Case-control
- Time perspective
- Other
- Enrolment
- 100 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alkan Bayrak, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780308
- Sponsor's protocol ID
- 2014/18/05
- Acronym
- Fracture
- Status last verified
- Feb 2021
- First submitted
- 7 Feb 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- 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 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Many K Wires do we Need in the Surgical Treatment of Pediatric Type III Supracondylar Humeral Fracture?
- ClinicalTrials.gov ID
- NCT04780308
- Acronym / sponsor ID
- Fracture / 2014/18/05
- Keywords
- pediatric, supracondylar humeral fracture, k wires, closed reduction, pin configuration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- 20 Feb 2015 (actual)
- First posted
- 3 Mar 2021 (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 purpose of this study was to compare pin configuration effects on early secondary displacement in the surgical treatment of pediatric supracondylar humeral fractures (SCHF).
Detailed description
The study consisted of 100 (68M, 32F) children who underwent surgery between 2010 and 2013 for Gartland Type 3 (SCHF). The patients divided into five groups according to the top in configurations (crossed 1 lateral 1 medial, crossed 2 lateral 1 medial, crossed 1 lateral 2 medial, 2 lateral divergent, and 3 lateral divergent). The average age at the time of injury was 7.34 (between 2 and 14 years). Bauman angle (BA), Humerocapital angle (HCA), Anterior humeral line (AHL), flexion range, extension range, and Carrying angle (CA) were compared at preoperative, postoperative 1st-day, postoperative last control, and non-operated side. The mean follow-up time 24,96±11,06 with a range of 12-54 months.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 medial 1 lateral K-wire | – | Procedure: Pediatric Garthland Type 3 supracondylar humeral fractures fixed by K-wiresPediatric Gartland Type 3 supracondylar humeral fractures fixed by 1 medial 1 lateral K-wire |
| 1 medial 2 lateral K-wire | – | Procedure: Pediatric Garthland Type 3 supracondylar humeral fractures fixed by K-wiresPediatric Gartland Type 3 supracondylar humeral fractures fixed by 1 medial 2 lateral K-wire |
| 2 medial 1 lateral K-wire | – | Procedure: Pediatric Garthland Type 3 supracondylar humeral fractures fixed by K-wiresPediatric Gartland Type 3 supracondylar humeral fractures fixed by 2 medial 1 lateral K-wire |
| 2 lateral K-wire | – | Procedure: Pediatric Garthland Type 3 supracondylar humeral fractures fixed by K-wiresPediatric Gartland Type 3 supracondylar humeral fractures fixed by 2 lateral K-wire |
| 3 lateral K-wire | – | Procedure: Pediatric Garthland Type 3 supracondylar humeral fractures fixed by K-wiresPediatric Gartland Type 3 supracondylar humeral fractures fixed by 3 lateral K-wire |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients under 16 years.
Key inclusion criteria (3 listed)
- Pediatric Gartland Type 3 supracondylar humeral fracture
- Patients operated between 2010-2013
- Patients under 16 years old
Key exclusion criteria (6 listed)
- Pathological fractures
- Conservative treated supracondylar fractures
- Less than the 1-year follow-up
- Patients with incomplete postoperative follow-up
- Patients older than 16 years
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 |
|---|---|---|
| Pediatric Garthland Type 3 supracondylar humeral fractures fixed by K-wiresThe effects of the different types of K-wire configuration on Pediatric Gartland Type 3 supracondylar humeral fractures were evaluated. Pediatric Gartland Type 3 supracondylar humeral fractures operated under general anesthesia with open or closed reduction. After reduction checked by fluoroscopy K-wires applied in different configurations. | Procedure or surgery | 1 medial 1 lateral K-wire, 1 medial 2 lateral K-wire, 2 lateral K-wire, 2 medial 1 lateral K-wire, 3 lateral K-wire |
Primary outcome
Baumann Angle
Time frame: postoperative 1. day, 1. month and 12. month
This angle is formed by the humeral axis and a straight line through the epiphyseal plate of the capitellum. Preoperative and postoperative angle differences are measured in anteroposterior and lateral X rays. These differences are measured for reduction quality and these parameters shows the success of the surgery.
Anterior Humeral Line
Time frame: postoperative 1. day, 1. month and 12. month
A line drawn down the anterior surface of the humerus should intersect the middle third of the capitellum. Preoperative and postoperative angle differences are measured in anteroposterior and lateral X rays. These differences are measured for reduction quality and these parameters shows the success of the surgery.
Humero-Capital Angle
Time frame: postoperative 1. day, 1. month and 12. month
On lateral X-ray angle between capitellum and humeral shaft. Preoperative and postoperative angle differences are measured in anteroposterior and lateral X rays. These differences are measured for reduction quality and these parameters shows the success of the surgery.
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 3 Mar 2021.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Supracondylar Humerus Fracture and Pediatric Fractures, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital.
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 6 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 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Baumann Angle (time frame: postoperative 1. day, 1. month and 12. month). The study lists 3 primary outcomes in all. 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 3 Mar 2021.