Humeral FractureNCT07645768
Is Anterior Reversed Proximal Humeral Locking Plate System (PHILOS) a Safe Alternative to Conventional Posterior Double Plating in Extra-Articular Distal Shaft Humeral Fractures
A study testing Reversed PHILOS Plate and Posterior Double Plate Fixation in people with Humeral Fracture, run by Cairo University at 1 site in Egypt.
Trial summary
Extra-articular distal-third humeral shaft fractures are difficult to treat because stable fixation must be achieved while minimizing soft-tissue injury and the risk of nerve damage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Humeral Fracture
- What is being tested?
- Reversed PHILOS Plate and Posterior Double Plate Fixation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2025to Dec 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Acute extra-articular distal humeral shaft fracture.
- AO/OTA type 12-A (simple) or 12-B (wedge) fracture.
- Closed fracture.
- Isolated injury.
- Presentation within 14 days of injury.
- Ability to provide informed consent and comply with follow-up.
Who cannot join
- Open fractures.
- Pathological fractures.
- Previous surgery on the ipsilateral humerus.
- Polytrauma requiring staged fixation.
- Contraindication to general anesthesia.
- Inability to complete the required follow-up period.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Trauma and Orthopedic department, Faculty of Medicine, Cairo University
Cairo
About this study
Official title: Is Anterior Reversed Proximal Humeral Locking Plate System (PHILOS) a Safe Alternative to Conventional Posterior Double Plating in Extra-Articular Distal Shaft Humeral Fractures: A Randomized Controlled Trial
Extra-articular distal-third humeral shaft fractures are difficult to treat because stable fixation must be achieved while minimizing soft-tissue injury and the risk of nerve damage. Posterior double plating is a commonly used technique but requires extensive surgical exposure and routine handling of the radial and ulnar nerves. Anterior reversed proximal humeral locking plate system (PHILOS) fixation has emerged as a potential alternative that may provide adequate stability with less soft-tissue disruption.
This randomized controlled trial compares anterior reversed PHILOS plating with conventional posterior double plating in adult patients with extra-articular distal-third humeral shaft fractures. The study evaluates functional outcome using the Mayo Elbow Performance Score (MEPS) as primary outcome. Sexondary outcomes include: fracture union, operative parameters, range of motion, and complications including nerve injury, infection, and postoperative stiffness.
- Conditions
- Humeral Fracture
- Being tested
- Reversed PHILOS Plate, Posterior Double Plate Fixation
- Medical subject headings
- Humeral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reversed PHILOS PlateDevice
Fixation of extra-articular distal-third humeral shaft fractures using a reversed proximal humeral internal locking system (PHILOS) plate applied to the anterior surface of the humerus through an anterior approach. The construct was secured with locking screws proximal and distal to the fracture site.
Posterior Double Plate FixationDevice
Fixation of extra-articular distal-third humeral shaft fractures through a posterior approach using orthogonal double plates applied medially and posterolaterally after fracture reduction. Both radial and ulnar nerves were identified and protected during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Anterior Reversed PHILOS Plating | Experimental | Patients with extra-articular distal-third humeral shaft fractures treated using an anterior approach and fixation with a reversed Proximal Humeral Internal Locking System (PHILOS) plate. Receives: Device: Reversed PHILOS Plate |
| Posterior Double Plating | Experimental | Patients with extra-articular distal-third humeral shaft fractures treated using a posterior approach and fixation with orthogonal double plates applied medially and posterolaterally. Receives: Device: Posterior Double Plate Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mayo Elbow Performance Score (MEPS)
pain (45 points), range of motion (20 points), stability (10 points), and daily functional tasks (25 points). Total maximum score is 100 meaning best outcome and total minimum score is 10 indicating worst outcome
Measured: 24 months after surgery
Secondary outcomes (3)
Operative time
Measured: Intraoperative
Fracture Union
Measured: Upto 24 months after surgery
Nerve injury complications
Measured: Immediately postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Dec 2025
- Primary completion1 Jun 2026
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humeral FractureStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- Participants were randomly assigned in a 1:1 ratio to undergo either anterior reversed PHILOS plating or conventional posterior double plating for treatment of extra-articular distal-third humeral shaft fractures. Treatment allocation was performed using a computer-generated randomization sequence with allocation concealment through sealed opaque envelopes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Ahmed Shawky Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645768
- Sponsor's protocol ID
- N-275-2025
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 12 Jun 2026
- 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 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Anterior Reversed Proximal Humeral Locking Plate System (PHILOS) a Safe Alternative to Conventional Posterior Double Plating in Extra-Articular Distal Shaft Humeral Fractures: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07645768
- Acronym / sponsor ID
- N-275-2025
- Conditions
- Humeral Fracture
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Jun 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.
Extra-articular distal-third humeral shaft fractures are difficult to treat because stable fixation must be achieved while minimizing soft-tissue injury and the risk of nerve damage. Posterior double plating is a commonly used technique but requires extensive surgical exposure and routine handling of the radial and ulnar nerves. Anterior reversed proximal humeral locking plate system (PHILOS) fixation has emerged as a potential alternative that may provide adequate stability with less soft-tissue disruption.
This randomized controlled trial compares anterior reversed PHILOS plating with conventional posterior double plating in adult patients with extra-articular distal-third humeral shaft fractures. The study evaluates functional outcome using the Mayo Elbow Performance Score (MEPS) as primary outcome. Sexondary outcomes include: fracture union, operative parameters, range of motion, and complications including nerve injury, infection, and postoperative stiffness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to undergo either anterior reversed PHILOS plating or conventional posterior double plating for treatment of extra-articular distal-third humeral shaft fractures. Treatment allocation was performed using a computer-generated randomization sequence with allocation concealment through sealed opaque envelopes.
| Arm | Type | Receives |
|---|---|---|
| Anterior Reversed PHILOS Plating | Experimental | Device: Reversed PHILOS PlatePatients with extra-articular distal-third humeral shaft fractures treated using an anterior approach and fixation with a reversed Proximal Humeral Internal Locking System (PHILOS) plate. |
| Posterior Double Plating | Experimental | Device: Posterior Double Plate FixationPatients with extra-articular distal-third humeral shaft fractures treated using a posterior approach and fixation with orthogonal double plates applied medially and posterolaterally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 18 years or older.
- Acute extra-articular distal humeral shaft fracture.
- AO/OTA type 12-A (simple) or 12-B (wedge) fracture.
- Closed fracture.
- Isolated injury.
Key exclusion criteria (6 listed)
- Open fractures.
- Pathological fractures.
- Previous surgery on the ipsilateral humerus.
- Polytrauma requiring staged fixation.
- Contraindication to general anesthesia.
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 |
|---|---|---|
| Reversed PHILOS PlateFixation of extra-articular distal-third humeral shaft fractures using a reversed proximal humeral internal locking system (PHILOS) plate applied to the anterior surface of the humerus through an anterior approach. The construct was secured with locking screws proximal and distal to the fracture site. | Device | Anterior Reversed PHILOS Plating |
| Posterior Double Plate FixationFixation of extra-articular distal-third humeral shaft fractures through a posterior approach using orthogonal double plates applied medially and posterolaterally after fracture reduction. Both radial and ulnar nerves were identified and protected during the procedure. | Device | Posterior Double Plating |
Primary outcome
Mayo Elbow Performance Score (MEPS)
Time frame: 24 months after surgery
pain (45 points), range of motion (20 points), stability (10 points), and daily functional tasks (25 points). Total maximum score is 100 meaning best outcome and total minimum score is 10 indicating worst outcome
3 secondary outcomes
Operative time
Time frame: Intraoperative
Fracture Union
Time frame: Upto 24 months after surgery
Nerve injury complications
Time frame: Immediately postoperative
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 12 Jun 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reversed PHILOS Plate and Posterior Double Plate Fixation in people with Humeral Fracture, run by Cairo University at 1 site in Egypt.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. 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 Egypt. 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?
Mayo Elbow Performance Score (MEPS) (time frame: 24 months 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 12 Jun 2026.