Double compression screw repair for symptomatic, non-healing outer ankle (lateral malleolus) fractures
Double Compression Screw Fixation for Symptomatic Non-union of Lateral Malleolar Ankle Fractures
This trial will test whether using two compression screws to fix a non-healing outer ankle bone helps adults (18–65) heal, have less pain, and regain function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Sohag University Academic / other |
| Locations | 1 site (Sohag, Sohag Governorate) |
| Trial ID | NCT07539922 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–65 with a radiographically confirmed transverse Weber type A lateral malleolus non-union (≥6 months), adequate bone stock for screw fixation, and no active local infection or pathological fracture are the intended candidates.
Not a fit: Patients with active or prior osteomyelitis, pathological fractures, gross deformity or major bone loss requiring complex reconstruction, or inadequate bone for screw fixation are unlikely to benefit from this technique.
Why it matters
Potential benefit: If successful, the technique could provide a reliable, less bulky fixation option that increases union rates and reduces pain and disability for people with lateral malleolar non-union.
How similar studies have performed: While internal fixation for distal fibular fractures is well established and case series report good outcomes with screw fixation for select non-unions, there are limited controlled data specifically on double compression screw fixation for this indication.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Sohag, Sohag Governorate
- Sohag University Hospital — Sohag, Sohag Governorate, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.