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

NCT07539922 | Recruiting

• 1 other identifier: Soh-Med-26-1-6MS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Non union Lateral Malleolus fracture; Double Compression Screw Fixation; Lateral Malleolar Ankle Fractures

Outcome Measures

Primary Outcomes (1)

• union of lateral malleolar fracture

  Serial radiographs will be obtained at 2, 6, and 12 weeks postoperatively to assess union and screw position. Union will be confirmed by the presence of bridging trabeculae across the fracture site and resolution of fracture lines.

  12 weeks postoperative

Secondary Outcomes (2)

• absence of pain

  12 weeks postoperative

• foot function and range of motion

  12 weeks postoperative

Study Arms (1)

patient with symptomatic non-union of lateral malleolar ankle fractures

EXPERIMENTAL

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

Interventions

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

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.

patient with symptomatic non-union of lateral malleolar ankle fractures

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Sohag Governorate, 82511, Egypt

RECRUITING

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: orthopedic resident

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 20, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)