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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Intraoperative | |
| Fracture Union | Upto 24 months after surgery | |
| Nerve injury complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trauma and Orthopedic department, Faculty of Medicine, Cairo University | Cairo | Egypt |
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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.
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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.
|
| 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. |
|
| Immediately postoperative |
| ID | Term |
|---|---|
| D006810 | Humeral Fractures |
| ID | Term |
|---|---|
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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