Single-Window Versus Two-Window Posterolateral Approach for Malleolar Fractures

NCT07481266 | Recruiting

• 1 other identifier: TABED 1-24-14
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective clinical trial is to compare the clinical outcomes and early wound complication rates of two different surgical techniques used during the posterolateral approach for ankle fractures. Participants with fractures involving the posterior and lateral malleoli will undergo surgery using either a single-window technique (using a posterior antiglide plate) or a two-window technique (using a lateral anatomic plate). The main question the study aims to answer is whether the single-window approach reduces soft-tissue complications by minimizing surgical dissection, without compromising fracture stability. Patients will be followed for 12 months to assess wound healing, ankle range of motion, implant irritation, and functional recovery.

Conditions

Ankle Fractures; Posterior Malleolus Fractures; Lateral Malleolus Fracture

Keywords

Posterolateral approach; Single-window technique; Posterior antiglide plate; Two-window technique; Wound complication; Trimalleolar fracture; Ankle Fractures

Outcome Measures

Primary Outcomes (1)

• Incidence of Wound Complications

  The total number of participants experiencing any early postoperative wound complications at the surgical site. This includes wound dehiscence, superficial or deep surgical site infection, wound edge necrosis, and delayed wound healing.

  Up to 3 months postoperatively

Secondary Outcomes (3)

• American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score

  6 and 12 months postoperatively

• Ankle Range of Motion (ROM)

  12 months postoperatively

• Visual Analog Scale (VAS) for Pain

  6 and 12 months postoperatively

Study Arms (2)

Single-Window Approach (Posterior Antiglide Plate)

EXPERIMENTAL

Patients in this arm will undergo surgical fixation of the ankle fracture using a single-window posterolateral approach. Both the posterior malleolus and the lateral malleolus (fibula) will be accessed and reduced through a single surgical interval medial to the peroneal tendons (between the peroneal tendons and the flexor hallucis longus muscle). The fibula will be fixed using a posterior antiglide plate. No additional lateral surgical window will be created.

Procedure: Posterior Antiglide Plating

Two-Window Approach (Lateral Anatomic Plate)

ACTIVE COMPARATOR

Patients in this arm will undergo surgical fixation of the unstable ankle fracture using a two-window posterolateral approach. The posterior malleolus will be accessed and fixed through the first interval medial to the peroneal tendons. A second surgical interval (lateral window) will be intentionally developed lateral to the peroneal tendons to access and fix the fibula using a standard lateral anatomic plate.

Procedure: Lateral Anatomic Plating

Interventions

Posterior Antiglide Plating PROCEDURE

Fixation of the fibular fracture utilizing a posterior antiglide plate configuration applied directly to the posterior surface of the fibula.

Single-Window Approach (Posterior Antiglide Plate)

Lateral Anatomic Plating PROCEDURE

Fixation of the fibular fracture utilizing a standard lateral anatomic plate configuration applied to the lateral surface of the fibula.

Two-Window Approach (Lateral Anatomic Plate)

Eligibility Criteria

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

You may qualify if:

• Patients aged between 18 and 65 years.
• Diagnosis of an acute, closed, unstable rotational ankle fracture with concomitant involvement of the posterior malleolus and lateral malleolus (trimalleolar or bimalleolar equivalent fractures).
• Fracture morphology explicitly indicating surgical reduction and internal fixation via a posterolateral approach (e.g., Bartonicek Type II, III, or IV).
• Ability to provide informed consent and willingness to comply with the 12-month postoperative rehabilitation and follow-up protocol.

You may not qualify if:

• Open fractures, severe tibial pilon variants, or fractures with intra-articular comminution extending beyond the posterior malleolus.
• Delayed surgical intervention exceeding 7 days from the initial trauma, leading to organized hematoma or compromised soft-tissue envelopes.
• Pre-existing conditions detrimental to soft-tissue healing and functional assessment, including severe peripheral arterial disease, uncontrolled diabetes mellitus with neuropathy, or severe ipsilateral ankle osteoarthritis.
• Previous history of ipsilateral ankle fractures or surgeries.

Sponsors & Collaborators

• muhammed kılıç: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Herbosa CG, Leucht P, Egol KA, Tejwani NC. The 2-Window Posterolateral vs Single-Window Approach for Ankle Fracture Fixation. Foot Ankle Int. 2023 Apr;44(4):297-307. doi: 10.1177/10711007231156163. Epub 2023 Mar 22.

  PMID: 36946551 BACKGROUND

• Deng Y, Staniforth TL, Zafar MS, Lau YJ. Posterior Antiglide Plating vs Lateral Neutralization Plating for Weber B Distal Fibular Fractures: A Systematic Review and Meta-analysis of Clinical and Biomechanical Studies. Foot Ankle Int. 2022 Jun;43(6):850-859. doi: 10.1177/10711007221079617. Epub 2022 Apr 2.

  PMID: 35373597 BACKGROUND

• Gu Y, Zhao L, Ren Y, Wang Y, Xu C, Jiang C. Modified Posterolateral Approach for the Treatment of 2-Part Fractures of the Posterior Malleolus Associated with Medial and Lateral Malleolar Fractures: 1 Incision, 2 Windows, 3 Steel Plates. Med Sci Monit. 2022 May 28;28:e936039. doi: 10.12659/MSM.936039.

  PMID: 35633024 BACKGROUND

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

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

Study Officials

• Muhammed Kilic, MD

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammed Kilic, MD

CONTACT

+905077707553; dr.kilic.06@gmail.com

Fatih İnci, Assoc Prof

CONTACT

+905052325821; fatihinci@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor evaluating the postoperative functional scores, range of motion, and wound complications will be blinded to the surgical approach group of the patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident in Orthopedics and Traumatology

Study Record Dates

• First Submitted: March 15, 2026
• First Posted: March 18, 2026
• Study Start: February 14, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)