Humeral Fracture
Conditions
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.
Interventions
DEVICEReversed PHILOS Plate
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.
DEVICEPosterior Double Plate Fixation
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.
Sponsors
Cairo University
Study design
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults aged 18 years or older. 2. Acute extra-articular distal humeral shaft fracture. 3. AO/OTA type 12-A (simple) or 12-B (wedge) fracture. 4. Closed fracture. 5. Isolated injury. 6. Presentation within 14 days of injury. 7. Ability to provide informed consent and comply with follow-up.
Exclusion criteria
1. Open fractures. 2. Pathological fractures. 3. Previous surgery on the ipsilateral humerus. 4. Polytrauma requiring staged fixation. 5. Contraindication to general anesthesia. 6. Inability to complete the required follow-up period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mayo Elbow Performance Score (MEPS) | 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
| Measure | Time frame |
|---|---|
| Operative time | Intraoperative |
| Fracture Union | Upto 24 months after surgery |
| Nerve injury complications | Immediately postoperative |
Countries
Egypt
Outcome results
None listed