Correlation Between Ultrasound Findings Vs Intraoperative Findings in Syndesmotic Injury in Pott's Fracture Weber b and c

April 18, 2025 updated by: Mohamed Salah Shehata, Benha University
This study aims to assess and compare ultrasound findings, radiographic findings and intraoperative findings in cases of Pott's fractures weber types B and C to evaluate the accuracy of ultrasound in diagnosis of syndesmotic injury.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Ankle fractures are among of the most frequently addressed injuries by orthopedic surgeons. Ankle fractures have an incidence rate about 107-145 per 100000 in adult population. Approximately 10% of these fractures are concomitant with syndesmotic injury. This percentage is doubled in patients who need open reduction and internal fixation( ORIF).As a result ,it is essential for orthopedic surgeons to accurately diagnose these injuries,which ocurr in up to 40% of weber type B pott's fracture and up to 80% in pott's c. Failure to properly diagnose or treat these injuries can lead to persistent ankle pain ,functional instability and early osteoarthritis. The ankle joint is a synovial joint that connects leg bones :the fibula which ends distally with lateral malleolus and the tibia which ends distally with tibial plafond , medial malleolus and posterior malleolus ,with the talus.It is a complex hinge joint.) 2.Kennedy JG, Soffe KE, Dalla Vedova P, Stephens MM, O'Brien T, Walsh MG, McManus F( Ankle syndesmosis injuries are common, but diagnosing and treating them can be challenging, often leading to differing opinions among healthcare providers. It is crucial for orthopedic surgeons to recognize the complex nature of these injuries, especially when they involve damage to the interosseous membrane. Patients may seek medical attention years after the initial injury, reporting gradual, worsening pain and swelling following physical activity. These symptoms can significantly affect their quality of life.

Diagnostic dilemma of syndesmotic injury in ankle fracture:

The are different modalities regarding the diagnosis:

  • X-ray imaging is one of the most commonly used methods for diagnosing ankle syndesmosis injuries. In a normal anteroposterior radiograph, the tibiofibular overlap should be greater than 6 mm, while in a mortise radiograph, it should exceed 1 mm when measured 1 cm above the tibial plafond. Similarly, the tibiofibular clear space should be less than 6 mm in both anteroposterior and mortise views at the same level. Additionally, the medial clear space should be equal to or less than the distance between the talar dome and the tibial plafond. A reduction in tibiofibular overlap, an increase in tibiofibular clear space, or an increase in medial clear space whether observed on weight-bearing or non weight-bearing radiographs suggests syndesmotic disruption.) 6. Pogliacomi F, De Filippo M, Casalini D, Longhi A, Tacci F, Perotta R, Pagnini F, Tocco S, Ceccarelli( While standard radiographic views are useful for evaluating moderate-to-severe ankle syndesmosis injuries, detecting subtle syndesmotic widening remains challenging.
  • Computed tomography (CT) provides a clear and direct visualization of the positional alignment of the distal tibiofibular syndesmosis. It allows precise measurement of the syndesmotic gap and facilitates comparison with the contralateral side. As a result, CT is particularly valuable for diagnosing ankle syndesmosis injuries when radiographic findings are inconclusive. A syndesmosis injury is generally indicated if the gap exceeds 6 mm or is more than 2 mm wider than the opposite side.Exposure to CT radiation can cause many hazards to patients.) 3.Elgafy H, Semaan HB, Blessinger B, Wassef A, Ebraheim NA(.
  • MRI is the preferred method for diagnosing syndesmosis injuries due to its high sensitivity and specificity. However, examination techniques particularly slice orientation and ankle positioning require standardization to ensure optimal visualization of the distal tibiofibular ligament. The oblique orientation of ligament fibers may result in false positives when compared to intraoperative findings. Additional associated injuries, such as anterior talofibular ligament tears, bone edema, osteochondral lesions, or distal tibiofibular joint incongruities, may also be present. These findings can include ligament discontinuity or irregular, curved, or indistinct ligament contours.The high cost and non availability of MRI hinder and limit it's use in clinical practice.) 8.Kellett JJ, Lovell GA, Eriksen DA, Sampson MJ. Diagnostic imaging of ankle syndesmosis injuries:(
  • Ultrasound offers a cost-effective and readily available option that could serve as a screening tool for syndesmotic ligamentous injuries in the ankle. The ultrasound evaluation begins by examining the anterior compartment to check for joint fluid, synovitis, and osteophytes on the tibia or talus. Tendons in the extensor, medial, and lateral compartments are evaluated in both longitudinal and transverse planes. The lateral compartment assessment focuses on the anterior talofibular ligament (ATFL) and calcaneofibular ligament (CFL). In the medial compartment, the deltoid ligament is assessed in the oblique coronal plane. The syndesmosis is imaged in all cases using the transverse plane through an anterior approach. The anterior-inferior tibiofibular ligament (AITFL) is inspected for continuity and contour, and the tibia-fibula distance (clear space) is measured.) 1.Hagemeijer NC, Lubberts B, Saengsin J, Bhimani R, Sato G, Waryasz GR, Kerkhoffs GMMJ, DiGiovanni CW, Guss D(

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mohamed Salah Shehata, Orthopedic resident
  • Phone Number: +2001156593716
  • Email: mosala304@gmail.com

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who will present at Benha university hospitals with ankle fractures weber type B,B/C and C. Patients will be enrolled in the study as long as they are generally fit for the operation and their functional requirements justify the procedure.The study will include only patients older than 18years old with closed fractures once their skin condition allows.

Exclusion Criteria:

  • Age less than 18y and more than 60yr.
  • Previous history of ipsilateral ankle fracture or fixation.
  • History of chronic ankle ankle instability or recurrent ankle sprains.
  • significant ankle or subtalar osteoarthritis.
  • Pathological ankle fracture .
  • Patients with open ankle fracture.
  • Patients with ankle fracture with vascular injury or neurological impairment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Correlation between ultrasound findings vs intraoperative findings in syndesmotic ankle injury
Correlation between ultrasound findings vs intraoperative findings in syndesmotic injury of Pott's B and c
Procedure: Fixation of Pott's fracture b and c
Assessment of syndesmotic injury via X-ray, CT, ultrasound and intraoperative

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Syndesmotic ankle injury in pott's fracture
Time Frame: baseline

Correlation between :1-ultrasound findings regarding syndesmotic injury in pott's fracture weber b and c:*AITFL (anterior inferior tibiofibular ligament)for continuity, contour and presence of hematoma.

  • PITFL(posterior inferior tibiofibular ligament) integrity.
  • Deltoid ligament integrity.
  • Measurement of tibiofibular clear space.
  • Measurement of Medial clear space. The transducer (LOGIQ P9-Linear transducer 8/15MH) positioned transverse1cm above ankle joint, where ligament is at its thickness.
baseline
Syndesmotic ankle injury in pott's fracture
Time Frame: baseline
Intraoperative findings in pott's Weber b and c fracture guided with guided with arthroscopy and ORIF (open reduction and internal fixation).
baseline
Ankle syndesmotic injury in pott's fracture
Time Frame: baseline
Preoperative X-ray and CT scanning
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2025

Primary Completion (Estimated)

April 15, 2026

Study Completion (Estimated)

May 15, 2026

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

April 18, 2025

First Posted (Actual)

April 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ankle syndesmotic injury

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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