Humeral FracturesNCT07558941
Conservative Versus Surgical Treatment of Gartland Type II Supracondylar Humeral Fractures in Children - Which One ?
A study testing Conservative treatment by casting and surgical treatment via percutaneous pinning UGA in people with Humeral Fractures, run by Assiut University.
Trial summary
The primary aim of this research is to compare the efficacy of conservative treatment versus surgical treatment for Gartland type II supracondylar humerus fractures in children. The comparison focuses on assessing differences in clinical outcomes functional recovery times, and complication rates between the two… Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Humeral Fractures
- What is being tested?
- Conservative treatment by casting and surgical treatment via percutaneous pinning UGA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Aug 2028
- Phase
- Interventional
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with Gartland type II supracondylar humerus fractures with age between 1-12 years old treated at the AUH
Who cannot join
- Gartland Type I, III, or IV fractures.
- Open fractures.
- Associated neurovascular injury (e.g., absent radial pulse, documented nerve palsy).
- Patients with another injury in the same limb
- Pathological fractures.
- Pre-existing elbow pathology or congenital deformity.
- Inability to comply with follow-up protocol.
About this study
Official title: Conservative Versus Surgical Treatment of Gartland Type II Supracondylar Humeral Fractures in Children - Randomized Controlled Trial
The primary aim of this research is to compare the efficacy of conservative treatment versus surgical treatment for Gartland type II supracondylar humerus fractures in children. The comparison focuses on assessing differences in clinical outcomes functional recovery times, and complication rates between the two treatment groups.
Read the detailed description
Supracondylar Humerus Fractures are the most common type of elbow fracture in children, typically occurring between the ages of five and seven. These injuries are critical due to their proximity to major neurovascular structures, making prompt and appropriate management essential to prevent severe complications. The vast majority (approximately 98%) of SCHFs are extension-type injuries, resulting from a fall onto an outstretched hand with the elbow hyperextended.
Classification: The Gartland System The classification is based on the degree of displacement of the distal fragment relative to the proximal fragment, as seen on a lateral radiograph.
Type I stable, nondisplaced fractures are managed non-operatively.
- Treatment: Immobilization in a long-arm cast or splint for 3 to 4 weeks, typically in 90 degrees of flexion, followed by early mobilization .
- Goal: Pain control and protection from further displacement. Type II FracturesThese fractures are unstable in extension but maintain some stability due to the intact posterior cortex. Management remains a point of controversy, with both conservative and surgical options being utilized.•Conservative Option: Closed reduction (CR) and casting, often reserved for less displaced or stable Type IIA fractures.•Surgical Option: Closed Reduction and Percutaneous Pinning (CRPP) is the preferred surgical method, especially for unstable Type IIB fractures (those with rotational instability).
Type III and IV are highly unstable fractures that require urgent intervention to achieve and maintain reduction .
Treatment: Closed Reduction and Percutaneous Pinning (CRPP) is the mainstay of treatment .Open reduction may be necessary if closed reduction fails or if there is a vascular compromise requiring exploration.
•Goal: Anatomical reduction and stable fixation to prevent malunion and neurovascular complications.
- Conditions
- Humeral Fractures
- Being tested
- Conservative treatment by casting, surgical treatment via percutaneous pinning UGA
- Medical subject headings
- Humeral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative treatment by castingOther
Closed reduction of Gartland type II supracondylar humeral fracture under appropriate analgesia or anesthesia, followed by immobilization using an above-elbow cast. Patients will undergo regular clinical and radiographic follow-up to monitor fracture alignment, healing, and functional recovery.
surgical treatment via percutaneous pinning UGAProcedure or surgery
surgical treatment vis Closed reduction and percutaneous pinning under general anesthesia. Postoperative care includes clinical and radiographic follow-up to assess fracture healing, alignment, and potential complications.
| Study group | Role | What they receive |
|---|---|---|
| Conservative treatment | Experimental | Children with Gartland type II supracondylar humeral fractures will be treated conservatively using closed reduction followed by immobilization in an above-elbow cast . Patients will be followed up clinically and radiologically at regular intervals to assess fracture alignment, healing, and functional outcomes. Receives: Other: Conservative treatment by casting |
| Surgical treatment group | Experimental | Children will undergo surgical treatment via Closed reduction and percutaneous pinning under general anesthesia. Postoperative follow-up will include clinical and radiological assessment of fracture healing, alignment, and complications. Receives: Procedure: surgical treatment via percutaneous pinning UGA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome assessed by Modified Disabilities of the Arm, Shoulder and Hand (QuickDASH) score
Functional outcome will be evaluated using the Modified QuickDASH questionnaire. Scores range from 0 to 100, with higher scores indicating greater disability.
Measured: 1 year
Secondary outcomes (8)
Elbow flexion range of motion (degrees)
Measured in degrees using a goniometer to assess maximum elbow flexion.
Measured: 1 month, 3 months, and 6 months post-intervention
Elbow extension range of motion (degrees)
Measured in degrees using a goniometer to assess maximum elbow extension.
Measured: 1 month, 3 months, and 6 months post-intervention
Pain assessed using Visual Analog Scale (VAS)
Pain is measured on a scale from 0 to 10, where 0 indicates no pain and 10 indicates worst possible pain.
Measured: 1 month, 3 months, and 6 months post-intervention
Baumann angle (degrees)
Measured on standard anteroposterior elbow radiographs to assess coronal alignment.
Measured: Immediately post-reduction and at 6 months
Anterior humeral line alignment (normal/abnormal)
Assessed on lateral elbow radiographs to evaluate sagittal alignment.
Measured: Immediately post-reduction and at 6 months
Loss of reduction (yes/no)
Defined as displacement of fracture fragments on follow-up radiographs.
Measured: Up to 6 months post-intervention
Incidence of nerve injury (yes/no)
Includes any documented motor or sensory nerve deficit following treatment.
Measured: Up to 6 months post-intervention
Incidence of infection (yes/no)
Includes superficial or deep infection related to treatment.
Measured: Up to 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Aug 2028 (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.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebraheem Ahmed Farouk Abdelraheem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558941
- Sponsor's protocol ID
- Supracondyler humeral fracture
- Status last verified
- Apr 2026
- First submitted
- 18 Apr 2026
- Last updated
- 30 Apr 2026
- 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 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Versus Surgical Treatment of Gartland Type II Supracondylar Humeral Fractures in Children - Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07558941
- Acronym / sponsor ID
- Supracondyler humeral fracture
- Conditions
- Humeral Fractures
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 30 Apr 2026 (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 primary aim of this research is to compare the efficacy of conservative treatment versus surgical treatment for Gartland type II supracondylar humerus fractures in children. The comparison focuses on assessing differences in clinical outcomes functional recovery times, and complication rates between the two treatment groups.
Detailed description
Supracondylar Humerus Fractures are the most common type of elbow fracture in children, typically occurring between the ages of five and seven. These injuries are critical due to their proximity to major neurovascular structures, making prompt and appropriate management essential to prevent severe complications. The vast majority (approximately 98%) of SCHFs are extension-type injuries, resulting from a fall onto an outstretched hand with the elbow hyperextended.
Classification: The Gartland System The classification is based on the degree of displacement of the distal fragment relative to the proximal fragment, as seen on a lateral radiograph.
Type I stable, nondisplaced fractures are managed non-operatively.
- Treatment: Immobilization in a long-arm cast or splint for 3 to 4 weeks, typically in 90 degrees of flexion, followed by early mobilization .
- Goal: Pain control and protection from further displacement. Type II FracturesThese fractures are unstable in extension but maintain some stability due to the intact posterior cortex. Management remains a point of controversy, with both conservative and surgical options being utilized.•Conservative Option: Closed reduction (CR) and casting, often reserved for less displaced or stable Type IIA fractures.•Surgical Option: Closed Reduction and Percutaneous Pinning (CRPP) is the preferred surgical method, especially for unstable Type IIB fractures (those with rotational instability).
Type III and IV are highly unstable fractures that require urgent intervention to achieve and maintain reduction .
Treatment: Closed Reduction and Percutaneous Pinning (CRPP) is the mainstay of treatment .Open reduction may be necessary if closed reduction fails or if there is a vascular compromise requiring exploration.
•Goal: Anatomical reduction and stable fixation to prevent malunion and neurovascular complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative treatment | Experimental | Other: Conservative treatment by castingChildren with Gartland type II supracondylar humeral fractures will be treated conservatively using closed reduction followed by immobilization in an above-elbow cast . Patients will be followed up clinically and radiologically at regular intervals to assess fracture alignment, healing, and functional outcomes. |
| Surgical treatment group | Experimental | Procedure: surgical treatment via percutaneous pinning UGAChildren will undergo surgical treatment via Closed reduction and percutaneous pinning under general anesthesia. Postoperative follow-up will include clinical and radiological assessment of fracture healing, alignment, and complications. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients with Gartland type II supracondylar humerus fractures with age between 1-12 years old treated at the AUH
Key exclusion criteria (7 listed)
- Gartland Type I, III, or IV fractures.
- Open fractures.
- Associated neurovascular injury (e.g., absent radial pulse, documented nerve palsy).
- Patients with another injury in the same limb
- Pathological fractures.
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 |
|---|---|---|
| Conservative treatment by castingClosed reduction of Gartland type II supracondylar humeral fracture under appropriate analgesia or anesthesia, followed by immobilization using an above-elbow cast. Patients will undergo regular clinical and radiographic follow-up to monitor fracture alignment, healing, and functional recovery. | Other | Conservative treatment |
| surgical treatment via percutaneous pinning UGAsurgical treatment vis Closed reduction and percutaneous pinning under general anesthesia. Postoperative care includes clinical and radiographic follow-up to assess fracture healing, alignment, and potential complications. | Procedure or surgery | Surgical treatment group |
Primary outcome
Functional outcome assessed by Modified Disabilities of the Arm, Shoulder and Hand (QuickDASH) score
Time frame: 1 year
Functional outcome will be evaluated using the Modified QuickDASH questionnaire. Scores range from 0 to 100, with higher scores indicating greater disability.
8 secondary outcomes
Elbow flexion range of motion (degrees)
Time frame: 1 month, 3 months, and 6 months post-intervention
Elbow extension range of motion (degrees)
Time frame: 1 month, 3 months, and 6 months post-intervention
Pain assessed using Visual Analog Scale (VAS)
Time frame: 1 month, 3 months, and 6 months post-intervention
Baumann angle (degrees)
Time frame: Immediately post-reduction and at 6 months
Anterior humeral line alignment (normal/abnormal)
Time frame: Immediately post-reduction and at 6 months
Loss of reduction (yes/no)
Time frame: Up to 6 months post-intervention
Incidence of nerve injury (yes/no)
Time frame: Up to 6 months post-intervention
Incidence of infection (yes/no)
Time frame: Up to 6 months post-intervention
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 30 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative treatment by casting and surgical treatment via percutaneous pinning UGA in people with Humeral Fractures, run by Assiut University.
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 7 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: opening soon, as of the sponsor's last update on 30 Apr 2026. 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?
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?
Functional outcome assessed by Modified Disabilities of the Arm, Shoulder and Hand (QuickDASH) score (time frame: 1 year). 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 30 Apr 2026.