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Ankle Syndesmotic Injury Associated With Pott's FractureNCT06945939

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

A study testing Fixation of Pott's fracture b and c in people with Ankle Syndesmotic Injury Associated With Pott's Fracture, run by Benha University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Fixation of Pott's fracture b and c
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
15 Apr 2025to 15 May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Mohamed Salah Shehata, Orthopedic resident contact

+2001156593716

mosala304@gmail.com

Sherif Eltregy, SST.professor contact

+2001221754037

Shareeftraigy07@gmail.com

About this study

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.

Read the 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(
Being tested
Fixation of Pott's fracture b and c
Keywords
Syndesmotic ankle injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fixation of Pott's fracture b and cProcedure or surgery

    Assessment of syndesmotic injury via X-ray, CT, ultrasound and intraoperative

Study groups in NCT06945939
Study groupRoleWhat they receive
Correlation between ultrasound findings vs intraoperative findings in syndesmotic ankle injuryActive comparatorCorrelation between ultrasound findings vs intraoperative findings in syndesmotic injury of Pott's B and c
Receives: Procedure: Fixation of Pott's fracture b and c

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Syndesmotic ankle injury in pott's fracture

    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.

    Measured: baseline

  2. Syndesmotic ankle injury in pott's fracture

    Intraoperative findings in pott's Weber b and c fracture guided with guided with arthroscopy and ORIF (open reduction and internal fixation).

    Measured: baseline

  3. Ankle syndesmotic injury in pott's fracture

    Preoperative X-ray and CT scanning

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2025
  2. Study start15 Apr 2025 (estimated)
  3. Primary completion15 Apr 2026 (estimated)
  4. Study completion15 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06945939
Sponsor's protocol ID
Ankle syndesmotic injury
Status last verified
Mar 2025
First submitted
13 Mar 2025
Last updated
27 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Swords M, Brilhault J, Sands A. Acute and Chronic Syndesmotic Injury: The Authors' Approach to Treatment. Foot Ankle Clin. 2018 Dec;23(4):625-637. doi: 10.1016/j.fcl.2018.07.007. Epub 2018 Sep 24.

    PubMed 30414657
  • Fort NM, Aiyer AA, Kaplan JR, Smyth NA, Kadakia AR. Management of acute injuries of the tibiofibular syndesmosis. Eur J Orthop Surg Traumatol. 2017 May;27(4):449-459. doi: 10.1007/s00590-017-1956-2. Epub 2017 Apr 8.

    PubMed 28391516
  • Kellett JJ, Lovell GA, Eriksen DA, Sampson MJ. Diagnostic imaging of ankle syndesmosis injuries: A general review. J Med Imaging Radiat Oncol. 2018 Apr;62(2):159-168. doi: 10.1111/1754-9485.12708. Epub 2018 Feb 5.

    PubMed 29399975
  • Akoh CC, Phisitkul P. Anatomic Ligament Repairs of Syndesmotic Injuries. Orthop Clin North Am. 2019 Jul;50(3):401-414. doi: 10.1016/j.ocl.2019.02.004. Epub 2019 Apr 16.

    PubMed 31084843
  • Shoji H, Teramoto A, Murahashi Y, Watanabe K, Yamashita T. Syndesmotic instability can be assessed by measuring the distance between the tibia and the fibula using an ultrasound without stress: a cadaver study. BMC Musculoskelet Disord. 2022 Mar 18;23(1):261. doi: 10.1186/s12891-022-05221-z.

    PubMed 35303853
  • Pogliacomi F, De Filippo M, Casalini D, Longhi A, Tacci F, Perotta R, Pagnini F, Tocco S, Ceccarelli F. Acute syndesmotic injuries in ankle fractures: From diagnosis to treatment and current concepts. World J Orthop. 2021 May 18;12(5):270-291. doi: 10.5312/wjo.v12.i5.270. eCollection 2021 May 18.

    PubMed 34055585
  • Hagemeijer NC, Saengsin J, Chang SH, Waryasz GR, Kerkhoffs GMMJ, Guss D, DiGiovanni CW. Diagnosing syndesmotic instability with dynamic ultrasound - establishing the natural variations in normal motion. Injury. 2020 Nov;51(11):2703-2709. doi: 10.1016/j.injury.2020.07.060. Epub 2020 Jul 27.

    PubMed 32741605
  • Baltes TPA, Arnaiz J, Geertsema L, Geertsema C, D'Hooghe P, Kerkhoffs GMMJ, Tol JL. Diagnostic value of ultrasonography in acute lateral and syndesmotic ligamentous ankle injuries. Eur Radiol. 2021 Apr;31(4):2610-2620. doi: 10.1007/s00330-020-07305-7. Epub 2020 Oct 7.

    PubMed 33026501
  • Elgafy H, Semaan HB, Blessinger B, Wassef A, Ebraheim NA. Computed tomography of normal distal tibiofibular syndesmosis. Skeletal Radiol. 2010 Jun;39(6):559-64. doi: 10.1007/s00256-009-0809-4. Epub 2009 Oct 15.

    PubMed 19830423
  • Kennedy JG, Soffe KE, Dalla Vedova P, Stephens MM, O'Brien T, Walsh MG, McManus F. Evaluation of the syndesmotic screw in low Weber C ankle fractures. J Orthop Trauma. 2000 Jun-Jul;14(5):359-66. doi: 10.1097/00005131-200006000-00010.

    PubMed 10926245
  • Hagemeijer NC, Lubberts B, Saengsin J, Bhimani R, Sato G, Waryasz GR, Kerkhoffs GMMJ, DiGiovanni CW, Guss D. Portable dynamic ultrasonography is a useful tool for the evaluation of suspected syndesmotic instability: a cadaveric study. Knee Surg Sports Traumatol Arthrosc. 2023 May;31(5):1986-1993. doi: 10.1007/s00167-022-07058-4. Epub 2022 Jul 26.

    PubMed 35881148

Questions about this trial

What is this clinical trial studying?

A study testing Fixation of Pott's fracture b and c in people with Ankle Syndesmotic Injury Associated With Pott's Fracture, run by Benha University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mohamed Salah Shehata, Orthopedic resident (+2001156593716, mosala304@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Syndesmotic ankle injury in pott's fracture (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06945939, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.

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