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

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.

Study Overview

• Status: Recruiting
• Conditions: Lateral Malleolus Fractures
• Intervention / Treatment: Procedure: Double Compression Screw Fixation for Symptomatic Non-union of Lateral Malleolar Ankle Fractures

Detailed Description

Fractures involving the lateral malleolar are among the most frequent injuries to the lower extremity, commonly occurring as part of ankle injuries due to twisting mechanisms, falls, or sports-related trauma . These fractures are typically treated effectively with conservative management in stable cases or operative fixation in unstable or displaced patterns. Internal fixation using plate and screw constructs remains the gold standard for displaced fractures, especially when associated with syndesmotic injury or disruption of the ankle mortise . Despite favorable outcomes, complications such as delayed union and nonunion, although relatively rare in the lateral malleolar fractures, can present significant management dilemmas. Non-union refers to the failure of a fracture to heal within an expected time frame and may be classified as hypertrophic (due to inadequate stability) ,atrophic (due to impaired biological activity), oligotrophic or septic non-union .

Risk factors contributing to non-union include inadequate fixation, poor vascularity, infection, smoking, diabetes, and patient non-compliance. When nonunion occurs at the lateral malleolar, it may result in persistent lateral ankle pain, instability, mechanical dysfunction, altered gait mechanics, and decreased quality of life .

The lateral malleolus plays a critical role in maintaining ankle stability and congruity. It serves as a lateral buttress, resisting talar shift and external rotation.

A non-united fibular fracture, especially in the distal third, can disrupt this alignment and compromise the overall biomechanics of the ankle joint . Therefore, surgical intervention is typically warranted in symptomatic non-unions to restore anatomical alignment, re-establish joint stability, and facilitate bony healing Various surgical options have been described for the treatment of lateral malleolar non-unions, including open reduction and internal fixation (ORIF) with plate constructs, bone grafting (autograft or allograft), intramedullary fixation, and, in some cases, external fixation. While plate fixation provides strong stability, it is associated with soft tissue irritation, increased surgical exposure, and potential wound complications, especially in the distal fibula where soft tissue coverage is limited .

In contrast, intramedullary or percutaneous fixation methods, such as the use of compression screws, offer a less invasive approach with reduced morbidity and satisfactory biomechanical outcomes in selected cases . The double compression screw technique provides rigid fixation with minimal hardware prominence and soft tissue disruption. By achieving interfragmentary compression along the fracture line, this method enhances stability and promotes biological healing, making it a suitable option for treating select cases of fibular non-union, particularly in non-comminuted fractures and in patients where soft tissue preservation is essential .

The purpose of this study will be to evaluate the clinical and radiological outcomes of treating non-union of the lateral malleolar fracture by double compression screw fixation technique.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sohag Governorate
    • Sohag, Sohag Governorate, Egypt, 82511
      • Recruiting
      • Sohag University Hospital
      • Contact: Muhammed Mahmood Muhammed Ahmed‬; Phone Number: +201144818977; Email: Mohamed_m.ahmed_post@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: patient with symptomatic non-union of lateral malleolar ankle fractures

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
absence of pain	Clinical signs of union included absence of pain, return to normal function, and full weight-bearing without assistance. Pain intensity will be assessed using visual analogue score (VAS) (0 represents no pain while ten represents the worst pain)	12 weeks postoperative
foot function and range of motion	Foot function will be evaluated by foot and ankle ability measure (FAAM)	12 weeks postoperative

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Non union Lateral Malleolus fracture; Double Compression Screw Fixation; Lateral Malleolar Ankle Fractures
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Ankle Injuries; Ankle Fractures
• Other Study ID Numbers: Soh-Med-26-1-6MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No