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Fibula Plating vs Intramedullary K-Wire in Bimalleolar Ankle Fractures

NCT07511478 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-04-06

No results posted yet for this study

Summary

This study was conducted to compare the functional outcomes of two commonly used fixation techniques for bimalleolar ankle fractures: fibula plating and intramedullary K-wire fixation with medial malleolar screw. Bimalleolar fractures are commonly caused by rotational injuries, often due to low-energy trauma such as falls, although high-energy mechanisms like road traffic accidents can result in more complex fracture patterns with associated soft tissue injury. The ankle joint is a complex osteoligamentous structure, and its stability depends on both proper bony alignment and intact ligamentous support, necessitating careful clinical and radiological assessment.

The deltoid ligament plays a key role in maintaining medial ankle stability, and its injury can lead to instability and poor functional outcomes. Initial evaluation should include neurovascular assessment and examination of soft tissues, as these factors influence management decisions. Most bimalleolar fractures are unstable and are treated surgically with open reduction and internal fixation. Fibula plating provides strong biomechanical stability but requires more extensive soft tissue dissection, increasing the risk of wound-related complications. In contrast, intramedullary K-wire fixation is a minimally invasive technique that may reduce soft tissue damage, though its functional effectiveness compared to plating remains unclear.

This randomized controlled trial was conducted at the Orthopaedic Department of PGMI / Shaikh Zayed Hospital, Lahore, over six months following ethical approval. A total of 200 patients aged 18-60 years with radiographically confirmed bimalleolar ankle fractures were included. After informed consent, patients were randomly assigned into two groups using the lottery method. Group A underwent fibula plating, while Group B received intramedullary K-wire fixation with medial malleolar screw.

Standardized surgical procedures were followed in both groups, with fixation of the lateral malleolus followed by the medial malleolus. Postoperatively, patients were immobilized and received routine care. Functional outcomes were assessed at three months using the Olerud-Molander Ankle score. The objective was to compare mean OMA scores between groups to determine the more effective technique for early functional recovery.

Conditions

  • Bimalleolar Ankle Fracture

Interventions

DEVICE

Fibula Plating Intervention Arm

Fibula Plating Intervention Arm Intramedullary K-Wire Fixation Arm

Sponsors & Collaborators

  • Shaikh Zayed Hospital, Lahore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-07
Primary Completion
2025-11-06
Completion
2025-11-06

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07511478 on ClinicalTrials.gov