Lateral Condyle Fractures,Humerus,JakobⅡ Classification,ReductionJCHLCFNCT03447496
Surgical Treatment for the Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children
An observational study of Lateral Condyle Fractures,Humerus,JakobⅡ Classification,Reduction, run by Shunyou Chen at 1 site in China.
Trial summary
Multi-center Study on Surgical Treatment for the Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children. Read more about this study
- Who is it for?
- Ages Up to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Lateral Condyle Fractures,Humerus,JakobⅡ Classification,Reduction
- What is being tested?
- Closed reduction and Open reduction
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Jan 2018
- 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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Surgical Treatment for the Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children.
Who may be able to join
- Patients with fractures that met these criteria, underwent definitive surgery and had complete clinical and radiographic follow up until fracture union at either institution were included in this study.
Who cannot join
- Pathologic fractures, and fractures in patients with osteogenesis imperfecta, neuromuscular disorders or any systemic disease that was associated with a predisposition to fractures or altered fracture healing were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-center Study on Surgical Treatment for the Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children
Multi-center Study on Surgical Treatment for the Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children.
Read the detailed description
The Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children that were treated with closed or open reduction.
- Being tested
- Closed reduction, Open reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed reductionProcedure or surgery
The children were treated with closed reduction.
Open reductionProcedure or surgery
The children were treated with Open reduction.
| Study group | Role | What they receive |
|---|---|---|
| Closed reduction | The children were treated with closed reduction. Receives: Procedure: Closed reduction | |
| Open reduction | The children were treated with open reduction. Receives: Procedure: Open reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic union
Radiographic union in surgical treatment for the Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children.
Measured: Up to 12 weeks.
Secondary outcomes (1)
Fracture displacement
Fracture displacement in surgical treatment for the Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children.
Measured: Up to 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start1 Jan 2018
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Condyle Fractures,Humerus,JakobⅡ Classification,ReductionStudies 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
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shunyou Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shunyou Chen, The Fuzhou No 2 Hospital
- Investigators
- Chen Shunyou, Phd, Study director, The Fuzhou No 2 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447496
- Sponsor's protocol ID
- Shunyou Chen
- Acronym
- JCHLCF
- Status last verified
- Feb 2018
- First submitted
- 31 Jan 2018
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Study on Surgical Treatment for the Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children
- ClinicalTrials.gov ID
- NCT03447496
- Acronym / sponsor ID
- JCHLCF / Shunyou Chen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Shunyou ChenUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 27 Feb 2018 (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.
Multi-center Study on Surgical Treatment for the Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children.
Detailed description
The Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children that were treated with closed or open reduction.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed reduction | – | Procedure: Closed reductionThe children were treated with closed reduction. |
| Open reduction | – | Procedure: Open reductionThe children were treated with open reduction. |
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Surgical Treatment for the Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children.
Key inclusion criteria (1 listed)
- Patients with fractures that met these criteria, underwent definitive surgery and had complete clinical and radiographic follow up until fracture union at either institution were included in this study.
Key exclusion criteria (1 listed)
- Pathologic fractures, and fractures in patients with osteogenesis imperfecta, neuromuscular disorders or any systemic disease that was associated with a predisposition to fractures or altered fracture healing were excluded.
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 |
|---|---|---|
| Closed reductionThe children were treated with closed reduction. | Procedure or surgery | Closed reduction |
| Open reductionThe children were treated with Open reduction. | Procedure or surgery | Open reduction |
Primary outcome
Radiographic union
Time frame: Up to 12 weeks.
Radiographic union in surgical treatment for the Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children.
1 secondary outcome
Fracture displacement
Time frame: Up to 12 weeks.
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 19 Mar 2018.
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.
Chen Shunyou, Phd study director
The Fuzhou No 2 Hospital
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 Lateral Condyle Fractures,Humerus,JakobⅡ Classification,Reduction, run by Shunyou Chen 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 1 inclusion and 1 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 19 Mar 2018. 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?
Radiographic union (time frame: Up to 12 weeks.). 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 19 Mar 2018.