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.
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
- Conditions the study is for
- Ankle Syndesmotic Injury Associated With Pott's Fracture
- 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.
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 group | Role | What they receive |
|---|---|---|
| Correlation between ultrasound findings vs intraoperative findings in syndesmotic ankle injury | Active comparator | Correlation 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.
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
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
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.
- First posted27 Apr 2025
- Study start15 Apr 2025 (estimated)
- Primary completion15 Apr 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Ankle Syndesmotic Injury Associated With Pott's FractureStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Salah Shehata, Benha University
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 30414657Fort 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 28391516Kellett 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 29399975Akoh 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 31084843Shoji 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 35303853Pogliacomi 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 34055585Hagemeijer 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 32741605Baltes 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 33026501Elgafy 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 19830423Kennedy 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 10926245Hagemeijer 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Ultrasound Findings Vs Intraoperative Findings in Syndesmotic Injury in Pott's Fracture Weber b and c
- ClinicalTrials.gov ID
- NCT06945939
- Acronym / sponsor ID
- Ankle syndesmotic injury
- Keywords
- Syndesmotic ankle injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Correlation between ultrasound findings vs intraoperative findings in syndesmotic ankle injury | Active comparator | Procedure: Fixation of Pott's fracture b and cCorrelation between ultrasound findings vs intraoperative findings in syndesmotic injury of Pott's B and c |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fixation of Pott's fracture b and cAssessment of syndesmotic injury via X-ray, CT, ultrasound and intraoperative | Procedure or surgery | Correlation between ultrasound findings vs intraoperative findings in syndesmotic ankle injury |
Primary outcome
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.
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).
Ankle syndesmotic injury in pott's fracture
Time frame: baseline
Preoperative X-ray and CT scanning
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Background: PubMed 30414657Swords 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.
- Background: PubMed 28391516Fort 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.
- Background: PubMed 29399975Kellett 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.
- Background: PubMed 31084843Akoh 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.
- Background: PubMed 35303853Shoji 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.
- Background: PubMed 34055585Pogliacomi 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.
- Background: PubMed 32741605Hagemeijer 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.
- Background: PubMed 33026501Baltes 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.
- Background: PubMed 19830423Elgafy 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.
- Background: PubMed 10926245Kennedy 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.
- Background: PubMed 35881148Hagemeijer 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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.