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NCT Number: NCT07645768

Is Anterior Reversed Proximal Humeral Locking Plate System (PHILOS) a Safe Alternative to Conventional Posterior Double Plating in Extra-Articular Distal Shaft Humeral Fractures

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Humeral Fracture Arm Injuries Fractures, Bone Humeral Fractures Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Trauma and Orthopedic department, Faculty of Medicine, Cairo University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Reversed PHILOS Plate

Device

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 Fixation

Device

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Operative time

    Time frame: Intraoperative

  2. Fracture Union

    Time frame: Upto 24 months after surgery

  3. Nerve injury complications

    Time frame: Immediately postoperative

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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