Humeral FracturesNCT04640727
ORIF Versus CRIF of Completely Displaced and Rotated Lateral Condylar Fractures of the Humerus in Children
An observational study of Humeral Fractures, run by Guangzhou Women and Children's Medical Center at 1 site in China.
Trial summary
Open reduction and internal fixation has been widely used in treating completely displaced and rotated lateral condylar fracture in children and it usually produces good results. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Humeral Fractures
- What is being tested?
- open reduction and closed reduction
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: After Internal Review Board approval, all Type III lateral condyle fractures according to Jakob classification were reviewed at our institution from 2017 to 2021
Who may be able to join
- completely displaced and rotated lateral condyle fractures of the humerus (Jakob Stage 3)
Who cannot join
- presented more than 7 days after the fracture , Capitulum humerus cannot be clearly identified on X-ray， had experienced a previous lateral condyle fractures on the same limbs, pathological fracture， open fracture， Combined with other fractures at the same time，
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Guangzhou Women & Children Medical Center
Guangzhou, Guangdong, 510000
About this study
Official title: ORIF Versus CRIF of Completely Displaced and Rotated Lateral Condylar Fractures of the Humerus in Children：a Ambispective Chort Study
Open reduction and internal fixation has been widely used in treating completely displaced and rotated lateral condylar fracture in children and it usually produces good results. Only a few studies reported Closed reduction and internal fixation is an effective treatment for completely displaced and rotated lateral condyle fractures of the humerus, but evidence on its effectiveness and safety is scarce. The aim of the trial was to compare functional and outcome use in patients treated completely displaced and rotated lateral condylar fracture with ORIF versus CRIF.
Read the detailed description
Lateral condylar humerus fractures are the second most common elbow fracture in children, accounting for approximately 17-20% of pediatric elbow fractures. Jakob et al. first described a novel classification based on the presence of cartilage bridging. It was modified by Foster et al. who identified the differences in outcomes between fractures with < 2 mm and ≥ 2 mm displacement. most surgeons preferred open reduction and internal fixation (ORIF) to insure anatomic reduction of these unstable intra-articular fractures. Only a few reports have focused on closed reduction and Percutaneous Pinning (CRPP) of lateral condylar humeral fractures. In most studies, this technique was used only in cases with displacement between 2 and 4mm. CRPP has shown several advantages over ORIF, including less dissection of soft tissue around the fragment, low risk of vessel damage, low risk of non-union and avascular necrosis (AVN) of distal humerus physeal, shorter operating room times, and avoidance of an open incision with an unaesthetic scar. Song et al. introduced a new classification and an internal oblique view to better assess the displacement of the fragment, and they managed to achieve closed reduction of the fracture, even in cases with displacement exceeding 4mm or those with rotational displacement (graded as stage 5 according Song classification and Type III according to Jakob classification). Because the study was not controlled, we could not tell the difference between cases treated with CRPP and the cases treated with ORIF directly.
Since May 1, 2019, at our Institution, we have been treating type III lateral condyle fractures with CRPP. The primary objective of this study was to report the efficacy and safety of CRPP of lateral condyle fracture. The secondary aim was to compare the outcomes between CRPP and ORIF.
- Conditions
- Humeral Fractures
- Being tested
- open reduction, closed reduction
- Keywords
- Open reduction and internal fixation, Closed reduction and internal fixation, completely displaced and rotated lateral condylar fracture
- Medical subject headings
- Humeral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open reductionProcedure or surgery
A sterile tourniquet is applied and an oblique posterolateral skin incision is made. Superficial dissection is carried out in the plane of the fracture hematoma until the distal lateral corner of the proximal fragment is identified. Once the metaphyseal side of the fracture has been identified, the dissection is carried across the joint to expose the medial articular surface. After exposure of the proximal fragment, the orientation of the distal fragment is defined and the soft tissues are sharply released off the anterior aspect of the distal fragment, with extension carried distally to the radial head. After irrigation and débridement of the fracture hematoma, the distal fragment is reduced with a towel clip. It is important to judge the reduction at the level of the articular surface rather than the metaphysis because plastic deformation or comminution of the metaphyseal fragment may be present. Pins (usually 0.062 inch) are placed percutaneously to secure the fracture.
closed reductionProcedure or surgery
we applied a gentle varus force to the elbow while the patient was under general anesthesia, and we attempted to reposition the rotated fragment by directly pushing or by using Kirschner wires as joysticks . After repositioning, we applied gradual direct compression to the distal fracture fragment anteromedially.We then applied slight valgus force to the elbow with the forearm supinated and the elbow fully extended to maintain the reduction. After the fracture reduction was confifirmed to be within 2 mm, especially as seen on the anteroposterior, lateral radiographs,and internal obliquewe used smooth Kirschner wires to perform percutaneous pinning
| Study group | Role | What they receive |
|---|---|---|
| open reduction and internal fixation | open reduction and internal fixation used in treating completely displaced and rotated lateral condylar fracture in children Receives: Procedure: open reduction | |
| closed reduction and internal fixation | closed reduction and internal fixation used in treating completely displaced and rotated lateral condylar fracture in children Receives: Procedure: closed reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hardacre criteria
Excellent：No limitation of Range of Motion， No alteration of Carrying Angle，No symptoms Good： Functional range of motion (lacking no more 15" of complete extension)，Inconspicuous alteration of Carrying Angle，No arthritic and neurologic symptoms Poor：Disabling loss of function， Conspicuous alteration of Carrying Angle，have Arthritic symptom, ulnar neuritis, roentgen findings of nonunion, avascular necrosis
Measured: 1 years follow up
Secondary outcomes (4)
duration of operation
From TIME OUT to long-arm cast immobilization completed
Measured: during the operation
amount of bleeding
From TIME OUT to long-arm cast immobilization completed
Measured: during the operation
Radiation exposure
From TIME OUT to long-arm cast immobilization completed
Measured: during the operation
The interepicondylar width (IEW)
The interepicondylar width (IEW) has previously been described to quantify the magnitude of lateral spurring. The IEW was measured on the initial injury radiograph as well as the postoperative radiograph obtained approximately 3 months after surgery. The magnitude of lateral spurring, expressed as a ratio of the postoperative to the injury IEW, was defined as normal if it was <1.05, mild spurring from 1.05 to 1.1, moderate spurring from 1.1 to 1.2, and severe spurring >1.2
Measured: 3 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start1 Dec 2020
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humeral FracturesStudies 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
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongwen Xu, Guangzhou Women and Children's Medical Center
- Investigators
- Hongwen Xu, doctor, Principal investigator, Guangzhou Women & Children Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640727
- Sponsor's protocol ID
- GuangzhouWCMC-004
- Status last verified
- Jan 2022
- First submitted
- 18 Nov 2020
- Last updated
- 20 Jan 2022
- 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 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ORIF Versus CRIF of Completely Displaced and Rotated Lateral Condylar Fractures of the Humerus in Children：a Ambispective Chort Study
- ClinicalTrials.gov ID
- NCT04640727
- Acronym / sponsor ID
- GuangzhouWCMC-004
- Conditions
- Humeral Fractures
- Keywords
- Open reduction and internal fixation, Closed reduction and internal fixation, completely displaced and rotated lateral condylar fracture
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 23 Nov 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.
Open reduction and internal fixation has been widely used in treating completely displaced and rotated lateral condylar fracture in children and it usually produces good results. Only a few studies reported Closed reduction and internal fixation is an effective treatment for completely displaced and rotated lateral condyle fractures of the humerus, but evidence on its effectiveness and safety is scarce. The aim of the trial was to compare functional and outcome use in patients treated completely displaced and rotated lateral condylar fracture with ORIF versus CRIF.
Detailed description
Lateral condylar humerus fractures are the second most common elbow fracture in children, accounting for approximately 17-20% of pediatric elbow fractures. Jakob et al. first described a novel classification based on the presence of cartilage bridging. It was modified by Foster et al. who identified the differences in outcomes between fractures with < 2 mm and ≥ 2 mm displacement. most surgeons preferred open reduction and internal fixation (ORIF) to insure anatomic reduction of these unstable intra-articular fractures. Only a few reports have focused on closed reduction and Percutaneous Pinning (CRPP) of lateral condylar humeral fractures. In most studies, this technique was used only in cases with displacement between 2 and 4mm. CRPP has shown several advantages over ORIF, including less dissection of soft tissue around the fragment, low risk of vessel damage, low risk of non-union and avascular necrosis (AVN) of distal humerus physeal, shorter operating room times, and avoidance of an open incision with an unaesthetic scar. Song et al. introduced a new classification and an internal oblique view to better assess the displacement of the fragment, and they managed to achieve closed reduction of the fracture, even in cases with displacement exceeding 4mm or those with rotational displacement (graded as stage 5 according Song classification and Type III according to Jakob classification). Because the study was not controlled, we could not tell the difference between cases treated with CRPP and the cases treated with ORIF directly.
Since May 1, 2019, at our Institution, we have been treating type III lateral condyle fractures with CRPP. The primary objective of this study was to report the efficacy and safety of CRPP of lateral condyle fracture. The secondary aim was to compare the outcomes between CRPP and ORIF.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| open reduction and internal fixation | – | Procedure: open reductionopen reduction and internal fixation used in treating completely displaced and rotated lateral condylar fracture in children |
| closed reduction and internal fixation | – | Procedure: closed reductionclosed reduction and internal fixation used in treating completely displaced and rotated lateral condylar fracture in children |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- After Internal Review Board approval, all Type III lateral condyle fractures according to Jakob classification were reviewed at our institution from 2017 to 2021
Key inclusion criteria (1 listed)
- completely displaced and rotated lateral condyle fractures of the humerus (Jakob Stage 3)
Key exclusion criteria (1 listed)
- presented more than 7 days after the fracture , Capitulum humerus cannot be clearly identified on X-ray， had experienced a previous lateral condyle fractures on the same limbs, pathological fracture， open fracture， Combined with other fractures at the same time，
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 |
|---|---|---|
| open reductionA sterile tourniquet is applied and an oblique posterolateral skin incision is made. Superficial dissection is carried out in the plane of the fracture hematoma until the distal lateral corner of the proximal fragment is identified. Once the metaphyseal side of the fracture has been identified, the dissection is carried across the joint to expose the medial articular surface. After exposure of the proximal fragment, the orientation of the distal fragment is defined and the soft tissues are sharply released off the anterior aspect of the distal fragment, with extension carried distally to the radial head. After irrigation and débridement of the fracture hematoma, the distal fragment is reduced with a towel clip. It is important to judge the reduction at the level of the articular surface rather than the metaphysis because plastic deformation or comminution of the metaphyseal fragment may be present. Pins (usually 0.062 inch) are placed percutaneously to secure the fracture. | Procedure or surgery | open reduction and internal fixation |
| closed reductionwe applied a gentle varus force to the elbow while the patient was under general anesthesia, and we attempted to reposition the rotated fragment by directly pushing or by using Kirschner wires as joysticks . After repositioning, we applied gradual direct compression to the distal fracture fragment anteromedially.We then applied slight valgus force to the elbow with the forearm supinated and the elbow fully extended to maintain the reduction. After the fracture reduction was confifirmed to be within 2 mm, especially as seen on the anteroposterior, lateral radiographs,and internal obliquewe used smooth Kirschner wires to perform percutaneous pinning | Procedure or surgery | closed reduction and internal fixation |
Primary outcome
Hardacre criteria
Time frame: 1 years follow up
Excellent：No limitation of Range of Motion， No alteration of Carrying Angle，No symptoms Good： Functional range of motion (lacking no more 15" of complete extension)，Inconspicuous alteration of Carrying Angle，No arthritic and neurologic symptoms Poor：Disabling loss of function， Conspicuous alteration of Carrying Angle，have Arthritic symptom, ulnar neuritis, roentgen findings of nonunion, avascular necrosis
4 secondary outcomes
duration of operation
Time frame: during the operation
amount of bleeding
Time frame: during the operation
Radiation exposure
Time frame: during the operation
The interepicondylar width (IEW)
Time frame: 3 months after the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Individual participant dataSharing planned: No
Related trials for Humeral Fractures
RecruitingObservational study
Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
Proximal Humeral Fracture, Reverse Total Shoulder Arthroplasty
Not yet recruiting
Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
Tibial Fracture, Femoral Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
RecruitingObservational study
Tornier Perform™ Reversed Monopost Study
Non-inflammatory Degenerative Joint Disease, Rhematoid Arthritis
Not yet recruiting
Study on Outcomes of Proximal Humerus Fractures
Proximal Humerus Fracture
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.
Hongwen Xu, doctor principal investigator
Guangzhou Women & Children Medical Center
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 Humeral Fractures, run by Guangzhou Women and Children's Medical Center 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: enrolling by invitation, as of the sponsor's last update on 20 Jan 2022. 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?
This study is still under way. Results are not available in the source record yet.
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?
Hardacre criteria (time frame: 1 years follow up). 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 20 Jan 2022.