Is Anterior Reversed Proximal Humeral Locking Plate System (PHILOS) a Safe Alternative to Conventional Posterior Double Plating in Extra-Articular Distal Shaft Humeral Fractures
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
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
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Cairo, Egypten
- Trauma and Orthopedic department, Faculty of Medicine, Cairo University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Anterior Reversed PHILOS Plating
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.
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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.
|
|
Experimentell: Posterior Double Plating
Patients with extra-articular distal-third humeral shaft fractures treated using a posterior approach and fixation with orthogonal double plates applied medially and posterolaterally.
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Mayo Elbow Performance Score (MEPS)
Tidsram: 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
|
24 months after surgery
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Drifttid
Tidsram: Intraoperativ
|
Intraoperativ
|
|
Fracture Union
Tidsram: Upto 24 months after surgery
|
Upto 24 months after surgery
|
|
Nerve injury complications
Tidsram: Immediately postoperative
|
Immediately postoperative
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- N-275-2025
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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