Double compression screw repair for symptomatic, non-healing outer ankle (lateral malleolus) fractures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center interventional study enrolling adults with radiologically confirmed non-union of the distal fibula (lateral malleolus) at least six months after injury. Eligible participants have transverse Weber type A non-unions with adequate bone stock and no active infection or pathological fracture. Participants undergo surgical fixation using two compression screws and are followed with clinical exams and radiographs/CT to document union, symptoms, function, and complications. Outcomes will include time to radiographic union, pain and functional scores, and any reoperations or adverse events.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

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

Where it's running

• Sohag University Hospital
  Sohag, Sohag Governorate, Egypt Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.