Fibula Plating vs Intramedullary K-Wire in Bimalleolar Ankle Fractures (FP-KW)

Comparison Between Fibula Plating Versus Intramedullary K-Wire With Medial Malleolar Screw for the Fixation of Bimalleolar Fracture of Ankle

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.

Study Overview

• Status: Completed
• Conditions: Bimalleolar Ankle Fracture
• Intervention / Treatment: Device: Fibula Plating Intervention Arm

Detailed Description

This study was conducted to evaluate and compare the functional outcomes of two commonly employed surgical techniques for the management of bimalleolar ankle fractures: fibula plating and intramedullary K-wire fixation combined with medial malleolar screw fixation. Bimalleolar fractures of the ankle represent a significant portion of ankle injuries and are typically the result of rotational forces acting on the ankle joint. While low-energy mechanisms such as simple falls are common causes, there has been an increasing trend in high-energy trauma, particularly road traffic accidents, which has led to more complex fracture patterns with associated soft tissue injury.

The ankle joint is a highly complex structure composed of osseous and ligamentous components that function together to maintain stability and enable movement. Stability of the ankle depends not only on the integrity of the tibia, fibula, and talus but also on the surrounding ligamentous structures, particularly the deltoid ligament medially and the lateral ligament complex. Any disruption to this osteoligamentous unit can result in joint instability, altered biomechanics, and long-term functional impairment if not managed appropriately.

The deltoid ligament, in particular, plays a critical role in maintaining medial stability of the ankle joint. Injury to this ligament, whether partial or complete, can lead to significant instability, widening of the medial clear space, and potential long-term complications such as chronic pain, deformity, and post-traumatic arthritis. Therefore, a thorough clinical and radiological evaluation is essential in all cases of ankle fractures. Initial assessment should include neurovascular examination to rule out any compromise in circulation, as well as careful evaluation of soft tissue condition, as open fractures or severe soft tissue injury may significantly influence treatment options and prognosis.

Management of bimalleolar ankle fractures is generally surgical, as these injuries are considered unstable. Open reduction and internal fixation (ORIF) has long been considered the gold standard for treatment, particularly for achieving anatomical alignment, restoring joint congruity, and allowing early mobilization. Traditional fibular plating techniques provide rigid fixation and excellent stability; however, they require extensive soft tissue dissection, which may increase the risk of complications such as wound infection, skin necrosis, and delayed healing. These concerns have led to the exploration of less invasive fixation methods.

Intramedullary K-wire fixation represents a minimally invasive alternative that aims to reduce soft tissue disruption while still providing adequate stabilization of the fibula. This technique may be associated with reduced operative time, smaller incisions, and potentially fewer wound-related complications. However, concerns remain regarding the adequacy of fixation strength, maintenance of reduction, and overall functional outcomes when compared to traditional plating methods. Despite increasing use of this technique, there is limited high-quality comparative data evaluating its effectiveness, particularly in relation to early functional recovery.

Given these considerations, the present randomized controlled trial was designed to compare the outcomes of fibula plating versus intramedullary K-wire fixation with medial malleolar screw fixation in patients with bimalleolar ankle fractures. The study was conducted in the Orthopaedic Department of PGMI / Shaikh Zayed Hospital, Lahore, over a six-month period following ethical approval. A total of 200 patients who met the inclusion criteria were enrolled using a non-probability consecutive sampling technique. Inclusion criteria consisted of patients aged between 18 and 60 years of either gender presenting with radiographically confirmed bimalleolar ankle fractures. Patients with compound fractures, associated injuries, or those managed non-operatively were excluded from the study.

After obtaining informed consent, patients were randomly assigned into two equal groups using a lottery method. Group A underwent fibula plating, while Group B received intramedullary K-wire fixation. In both groups, fixation of the lateral malleolus was performed first, followed by fixation of the medial malleolus. All procedures were carried out under standardized surgical protocols with the patient positioned supine and a tourniquet applied after limb exsanguination to provide a bloodless field.

In the fibula plating group, a longitudinal incision was made along the posterior border of the fibula to expose the fracture site. Careful dissection was performed to avoid injury to nearby structures, including the short saphenous vein and the sural nerve. The fracture was exposed, reduced anatomically, and stabilized using a one-third tubular plate. In the intramedullary K-wire group, a less invasive approach was utilized. A small incision was made, and a K-wire was inserted into the intramedullary canal of the fibula under fluoroscopic guidance to maintain alignment and fixation.

The medial malleolus was addressed through an anteromedial approach. The fracture site was exposed, cleared of interposed soft tissue, and reduced anatomically. Temporary K-wire fixation was used to hold the reduction, followed by definitive fixation using a malleolar screw. After completing the procedure, the tourniquet was released, hemostasis was ensured, and wounds were closed in layers. A below-knee plaster of Paris slab was applied in all patients to provide additional support during the early postoperative period.

Postoperative management included administration of antibiotics, limb elevation, and encouragement of active toe movements to prevent stiffness and improve circulation. Sutures were removed on the 14th postoperative day, and patients were followed up regularly. The primary outcome measure was functional recovery, assessed using the Olerud-Molander Ankle (OMA) score at three months postoperatively. This scoring system evaluates ankle function across several domains, including pain, stiffness, swelling, stair climbing ability, use of supports, ability to perform daily activities, and participation in sports. The maximum score is 100, with higher scores indicating better functional outcomes.

The primary objective of the study was to determine whether there was a significant difference in functional outcomes between fibula plating and intramedullary K-wire fixation with medial malleolar screw, as measured by the OMA score. The study was designed with a hypothesis that the two techniques would yield different outcomes, thereby providing evidence to guide clinical decision-making and optimize treatment strategies for patients with bimalleolar ankle fractures.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, G855+7C8
      • Department of Orthopedic Surgery

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 18-60 years age, both genders
• Patients having bimalleolar fracture of ankle

Exclusion Criteria:

• Compound fractures
• Associated with other fractures
• Cases which were treated by non-operative methods

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fibula Plating Intervention Arm; Participants in this arm underwent open reduction and internal fixation of the fibula using a one-third tubular plate. A standard lateral approach was used to expose the fracture site, and careful soft tissue handling was performed to avoid neurovascular injury. The fracture was anatomically reduced and stabilized with a plate and screws under tourniquet control. Medial malleolar fractures were then fixed using a malleolar screw through an anteromedial approach. Postoperatively, patients were immobilized in a below-knee slab, received antibiotics, and were followed for functional outcome assessment using the OMA score at three months.	Device: Fibula Plating Intervention Arm; Fibula Plating Intervention Arm Intramedullary K-Wire Fixation Arm; Other Names: Intramedullary K-Wire Fixation Arm
Experimental: Intramedullary K-Wire Fixation Arm; Participants in this arm underwent intramedullary fixation of the fibula using a Kirschner wire inserted under fluoroscopic guidance through a small incision to minimize soft tissue disruption. Anatomical reduction was achieved and maintained with the K-wire within the fibular canal. The medial malleolus was then fixed using a malleolar screw through an anteromedial approach after temporary K-wire stabilization. The procedure was performed under tourniquet control. Postoperatively, patients were immobilized in a below-knee slab, received antibiotics, and were followed up, with functional outcomes assessed at three months using the OMA score.	Device: Fibula Plating Intervention Arm; Fibula Plating Intervention Arm Intramedullary K-Wire Fixation Arm; Other Names: Intramedullary K-Wire Fixation Arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Functional Outcome Using Olerud-Molander Ankle (OMA) Score at 3 Months Between Fibula Plating and Intramedullary K-Wire Fixation	The primary outcome measure was the functional outcome of patients assessed using the Olerud-Molander Ankle (OMA) score. This score evaluated ankle function based on pain, stiffness, swelling, stair climbing ability, use of supports, ability to perform daily activities, and participation in sports. The total score ranged from 0 to 100, with higher scores indicating better functional recovery. The OMA score was used to compare outcomes between the fibula plating group and the intramedullary K-wire with medial malleolar screw group.	3 months postoperatively after surgical intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Functional Outcome Stratified by Age, Gender, BMI, and Ankle Side Between Treatment Groups	The secondary outcome measure included comparison of the functional outcomes between the two groups after stratification based on age, gender, body mass index (BMI), and affected ankle side. The OMA score was used to assess functional recovery across these subgroups. This analysis helped determine whether demographic and clinical factors influenced the effectiveness of fibula plating versus intramedullary K-wire fixation in improving ankle function.	3 months postoperatively after surgical intervention

Collaborators and Investigators

• Sponsor: Shaikh Zayed Hospital, Lahore

Publications and helpful links

General Publications

• 13. Bijarniya DS, Bhati DL. Comparative study between fibula plating versus intramedullary k-wire with medial malleolar screw in fixation in bimalleolar fractures of ankle. Indian J Appl Res. 2022;12(1):16-9.

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2025
• Primary Completion (Actual): November 6, 2025
• Study Completion (Actual): November 6, 2025

Study Registration Dates

• First Submitted: March 28, 2026
• First Submitted That Met QC Criteria: March 28, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 28, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Fibula Plating, Intramedullary K-Wire, Bimalleolar Fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Ankle Injuries; Ankle Fractures
• Other Study ID Numbers: 02-TERC/NHRC-SZH/INT-SC; Shaikh Zayed Hospital, Lahore (Other Identifier: Shaikh Zayed Hospital, Lahore)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No