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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Cairo University
- Enrollment
- 68
- Locations
- 1
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcome assessment was performed by independent orthopedic surgeons who were blinded to treatment allocation. Radiological and functional outcomes were evaluated without knowledge of the intervention group.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Investigators
Mostafa Ahmed Shawky Mohamed
Lecturer
Cairo University