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

NCT07645768 | Active Not Recruiting

• 1 other identifier: N-275-2025
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Humeral Fracture

Outcome Measures

Primary Outcomes (1)

• 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

  24 months after surgery

Secondary Outcomes (3)

• Operative time

  Intraoperative

• Fracture Union

  Upto 24 months after surgery

• Nerve injury complications

  Immediately postoperative

Study Arms (2)

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.

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.

Device: Posterior Double Plate Fixation

Interventions

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.

Anterior Reversed PHILOS Plating

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.

Posterior Double Plating

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Trauma and Orthopedic department, Faculty of Medicine, Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Humeral Fractures

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 12, 2026
• Study Start: December 1, 2025
• Primary Completion: June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)