RecruitingNot ApplicableNCT07539922

Double Compression Screw Fixation for Symptomatic Non-union of Lateral Malleolar Ankle Fractures


Sponsor

Sohag University

Enrollment

10 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria6

  • Age from 18 to 65 years.
  • Both sexes.
  • Transvers, non-united Weber type A Lateral Malleolar ankle fracture classification
  • Non-union classified as atrophic, oligotrophic, or hypertrophic
  • Radiologically confirmed non-union of distal fibular fracture (failure to unite after ≥ 6 months post-injury).
  • Adequate bone stock on radiographs/CT suitable for screw fixation.

Exclusion Criteria3

  • Active or previous osteomyelitis or local infection at the fracture site.
  • Pathological fractures.
  • Non-union with gross deformity or significant bone loss requiring complex reconstruction or bone transport

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Interventions

PROCEDUREDouble 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.


Locations(1)

Sohag University Hospital

Sohag, Sohag Governorate, Egypt

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NCT07539922