Double Compression Screw Fixation for Symptomatic Non-union of Lateral Malleolar Ankle Fractures
NCT07539922 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2026-04-20
Summary
The aim of this prospective clinical trial study is to evaluate the clinical and radiological outcomes of treating non-union of the lateral malleolar ankle fractures by double compression screw fixation technique.
Conditions
- Lateral Malleolus Fractures
Interventions
- PROCEDURE
-
Double Compression Screw Fixation for Symptomatic Non-union of Lateral Malleolar Ankle Fractures
A lateral approach to the distal fibula will be made, centered over the non-union site. Dissection will be carried down through the subcutaneous tissue with care to protect the superficial peroneal nerve. Minimal soft tissue striping will be performed to preserve vascularity. The fibular non-union site will be exposed, and fibrous tissue interposed at the fracture line will be carefully debrided using curettes and rongeurs, the sclerotic edges of the non-union will be freshened until punctate bleeding bone (the "Paprika sign") will be observed. The fracture will be anatomically reduced under direct visualization and temporarily held with reduction clamps, under fluoroscopic guidance, insert appropriate guide wire then 6.5 mm Double compression screws will be inserted across the fracture site in perpendicular orientation, from distal to proximal, traversing the non-union zone. Screw trajectory will be chosen to maximize bone purchase while avoiding joint penetration or screw collision.
Sponsors & Collaborators
-
Sohag University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-01
- Primary Completion
- 2026-11-30
- Completion
- 2027-02-28
Countries
- Egypt
Study Locations
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