Ultrasound Therapy; ComplicationsNCT04834479
Assessment of Accuracy of Ultrasonography in Diagnosis of Non-osseous Lateral Ankle Instability in Comparison With Magnetic Resonance Imaging
An observational study of Ultrasound Therapy; Complications, run by Assiut University at 2 sites in Egypt.
Trial summary
Chronic ankle instability (CAI) is a condition that often develops after repeated ankle sprains, increasing the susceptibility of the ankle to move into excessive inversion when walking on unsteady surfaces. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ultrasound Therapy; Complications
- What is being tested?
- Ankle US and Ankle MRI
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- 2 sitesEgypt
- Study dates
- 3 Apr 2021to 30 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: fifty four patients complaining of acute or chronic lateral ankle pain and instability will be included in this study.
Who may be able to join
- Patients complaining of acute or chronic lateral ankle pain and instability.
Who cannot join
- Previous ankle surgery
- Interventional intra-articular procedures (previous arthroscope, injections)
- Systemic inflammatory disorders (collagen diseases)
- Diagnosed osseous lesion
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Not yet recruiting
Mariana Raafat Fouad
Asyut, 71511
Raafat, 01018838879, lokassamir@gmail.com
Raafat, 01013918240, lokassamir@gmail.com
- Recruiting
Mariana Raafat Fouad
Asyut, 71511
Mariana 28 Raafat, MS, 01018838879 ext. 28, Lokassamir@Gmail.com
Lokas 28 Samir, MS, 01012918240 ext. 28, Lokassamir@gmail.com
About this study
Chronic ankle instability (CAI) is a condition that often develops after repeated ankle sprains, increasing the susceptibility of the ankle to move into excessive inversion when walking on unsteady surfaces. Approximately 74% of acute ankle sprains result in persistent symptoms, 30% of which progress to chronic ankle instability. Arthroscopic examination and magnetic resonance imaging (MRI) are considered the two most accurate methods of diagnosing injuries to lateral collateral ligaments. Ultrasound has been proven able to detect soft tissue injuries, However, the use of ultrasound and its' ability to accurately diagnose CAI is still under debate. The aim of this study is to investigate the diagnostic accuracy of ultrasonography for the assessment of non-osseous lateral ankle instability in comparison with magnetic resonance imaging (MRI).
Read the detailed description
Chronic ankle instability (CAI) is a condition that often develops after repeated ankle sprains, increasing the susceptibility of the ankle to move into excessive inversion when walking on unsteady surfaces. Approximately 74% of acute ankle sprains result in persistent symptoms, 30% of which progress to chronic ankle instability.[1-3] CAI is diagnosed in individuals who report pain and tenderness on the lateral aspect of the ankle, or persistent swelling and discomfort for greater than six months with a history of re-injury or clinical instability of the ankle joint.[4, 5] The primary cause of damage to the structural stability of the ankle joint is trauma by forced inversion and plantarflexion. The lateral collateral ligaments, which are more commonly affected by acute sprains, include the anterior talofibular ligament (ATFL), the calcaneofibular ligament (CFL), and the posterior talofibular ligament (PTFL). The ATFL is primarily responsible for preventing excessive supination and anterior translation, while also restricting plantar flexion and internal rotation.
Common diagnostic tools used to identify ankle instability include clinical testing (like Anterior Drawer Test), imaging and arthroscopy. Arthroscopic examination and magnetic resonance imaging (MRI) are considered the two most accurate methods of diagnosing injuries to lateral collateral ligaments. [7] In a retrospective study conducted by Joshy et al., in which 24 patients underwent arthroscopy and MRI of the ankle, MRI was found to have both high specificity (100%) and high sensitivity (100%) for ATFL disruption. [8-10] Ultrasound has been proven able to detect soft tissue injuries, and has even become the gold standard for the detection of injuries to the patellar and Achilles tendons. [2, 11] However, the use of ultrasound and its' ability to accurately diagnose CAI is still under debate.
When imaging the ankle, ultrasound should be able to detect synovial lesions, ligamentous injury, and distinguish soft tissue from osseous impingement.[8] Dynamic ultrasound should be also used to discover dislocation of the peroneal tendons, or intra-sheath dislocation, which is indicated by an intact retinaculum with subluxation of the peroneal tendons within the groove.[11] Aim of the work: The aim of this study is to investigate the diagnostic accuracy of ultrasonography for the assessment of non-osseous lateral ankle instability in comparison with magnetic resonance imaging (MRI).
Patients and Methods:
fifty four patients complaining of acute or chronic lateral ankle instability will be included in this study.
Inclusion criteria:
Patients complaining of acute or chronic lateral ankle instability.
Exclusion criteria:
- Previous ankle surgery
- Interventional intra-articular procedures (previous arthroscope, injections)
- Systemic inflammatory disorders (collagen diseases)
- Diagnosed osseous lesions.
Methods:
All patients will be subjected to:
Thorough history taking and clinical provisional diagnosis. Plain X-ray of the affected ankle in AP and lateral views to exclude any osseous lesions.
Real-time high resolution ultrasonography of the affected ankle joint MRI for the affected ankle joint.
Ultrasound Technique:
The ultrasonographic examination of the ankle begins with the patient in supine position. Longitudinal scanning of the ankle was first performed to get an overall view of the tibio-talar joint and to detect joint effusion. Thereafter, slight inversion of the foot is performed while the patient in the same position to examine the lateral collateral ligaments and peroneal tendons. The Anterior talo-fibular ligament (ATFL) is first examined in oblique transverse plane from the tip of lateral malleolus, antero-medially and slightly downward, till the talus. Then, the Calcaneo Fibular ligament (CFL) is examined in oblique longitudinal plane from the lateral malleolar tip downward and slightly backward to the lateral surface of the calcaneus.
Regarding the peroneal tendons, they are examined from their supra-malleolar musculo-tendinous junction, and then just behind the lateral malleolus till their infra-malleolar course in both longitudinal and transverse planes.
MRI examination All patients will have MRI imaging of the affected ankle(s) on a high field-strength scanners.
Positioning:
Every patient lies supine with the ankle and foot in neutral position and plantar flexion of 20-30 degrees for reducing the "magic angle" artifact. No movement allowed during examination by supporting the ankle using pads.
Protocol:
The patients are examined by different pulse sequences including T1, T2, proton density, gradient echo and STIR. The examinations will be done in different planes.
Our usual protocol of examination is Sagittal T1WIs, Axial T1WIs T2WIs and proton density images, coronal T1WIs as well as Sagittal or coronal STIR.
Other parameters applied include slice thickness ranged from 3 to 5 mm, matrix 256/192 or 512/224, number of excitation 2 to 3 and field of view ranged from 12 to 16 cm, better kept <14 cm.
- Conditions
- Ultrasound Therapy; Complications
- Being tested
- Ankle US and Ankle MRI
- Keywords
- Lateral ankle instability, US, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle US and Ankle MRIDevice
Ankle US and Ankle MRI
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the accuracy, sensitivity and specificity of Ultrasonography in assessment of lateral ankle disorders causing ankle instability and pain in comparison to MRI.
To study the accuracy, sensitivity and specificity of Ultrasonography in assessment of lateral ankle disorders causing ankle instability and pain in comparison to MRI.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start3 Apr 2021 (estimated)
- Primary completion30 Jan 2022 (estimated)
- Study completion30 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Ultrasound Therapy; ComplicationsStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Raafat Fouad, Assiut University
- Investigators
- Mariana Raafat, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834479
- Sponsor's protocol ID
- 17100620
- Status last verified
- Mar 2021
- First submitted
- 4 Apr 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wikstrom EA, Hubbard-Turner T, McKeon PO. Understanding and treating lateral ankle sprains and their consequences: a constraints-based approach. Sports Med. 2013 Jun;43(6):385-93. doi: 10.1007/s40279-013-0043-z.
PubMed 23580392Radwan A, Bakowski J, Dew S, Greenwald B, Hyde E, Webber N. EFFECTIVENESS OF ULTRASONOGRAPHY IN DIAGNOSING CHRONIC LATERAL ANKLE INSTABILITY:A SYSTEMATIC REVIEW. Int J Sports Phys Ther. 2016 Apr;11(2):164-74.
PubMed 27104050Delahunt E, Bleakley CM, Bossard DS, Caulfield BM, Docherty CL, Doherty C, Fourchet F, Fong DT, Hertel J, Hiller CE, Kaminski TW, McKeon PO, Refshauge KM, Remus A, Verhagen E, Vicenzino BT, Wikstrom EA, Gribble PA. Clinical assessment of acute lateral ankle sprain injuries (ROAST): 2019 consensus statement and recommendations of the International Ankle Consortium. Br J Sports Med. 2018 Oct;52(20):1304-1310. doi: 10.1136/bjsports-2017-098885. Epub 2018 Jun 9.
PubMed 29886432Houston MN, Van Lunen BL, Hoch MC. Health-related quality of life in individuals with chronic ankle instability. J Athl Train. 2014 Nov-Dec;49(6):758-63. doi: 10.4085/1062-6050-49.3.54.
PubMed 25299444van Ochten JM, van Middelkoop M, Meuffels D, Bierma-Zeinstra SM. Chronic complaints after ankle sprains: a systematic review on effectiveness of treatments. J Orthop Sports Phys Ther. 2014 Nov;44(11):862-71, C1-23. doi: 10.2519/jospt.2014.5221. Epub 2014 Oct 9.
PubMed 25299494Croy T, Saliba SA, Saliba E, Anderson MW, Hertel J. Differences in lateral ankle laxity measured via stress ultrasonography in individuals with chronic ankle instability, ankle sprain copers, and healthy individuals. J Orthop Sports Phys Ther. 2012 Jul;42(7):593-600. doi: 10.2519/jospt.2012.3923. Epub 2012 Mar 23.
PubMed 22446334Polzer H, Kanz KG, Prall WC, Haasters F, Ockert B, Mutschler W, Grote S. Diagnosis and treatment of acute ankle injuries: development of an evidence-based algorithm. Orthop Rev (Pavia). 2012 Jan 2;4(1):e5. doi: 10.4081/or.2012.e5. Epub 2011 Dec 14.
PubMed 22577506Joshy S, Abdulkadir U, Chaganti S, Sullivan B, Hariharan K. Accuracy of MRI scan in the diagnosis of ligamentous and chondral pathology in the ankle. Foot Ankle Surg. 2010 Jun;16(2):78-80. doi: 10.1016/j.fas.2009.05.012. Epub 2009 Jul 8.
PubMed 20483139Jung HG, Kim NR, Kim TH, Eom JS, Lee DO. Magnetic Resonance Imaging and Stress Radiography in Chronic Lateral Ankle Instability. Foot Ankle Int. 2017 Jun;38(6):621-626. doi: 10.1177/1071100717693207. Epub 2017 Feb 1.
PubMed 28552041Morvan A, Klouche S, Thes A, Hardy P, Bauer T. Reliability and validity of preoperative MRI for surgical decision making in chronic lateral ankle instability. Eur J Orthop Surg Traumatol. 2018 May;28(4):713-719. doi: 10.1007/s00590-017-2116-4. Epub 2018 Jan 3.
PubMed 29299765
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Accuracy of Ultrasonography in Diagnosis of Non-osseous Lateral Ankle Instability in Comparison With Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT04834479
- Acronym / sponsor ID
- 17100620
- Conditions
- Ultrasound Therapy; Complications
- Keywords
- Lateral ankle instability, US, MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 3 Apr 2021 (estimated)
- Primary completion
- 30 Jan 2022 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 8 Apr 2021 (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.
Chronic ankle instability (CAI) is a condition that often develops after repeated ankle sprains, increasing the susceptibility of the ankle to move into excessive inversion when walking on unsteady surfaces. Approximately 74% of acute ankle sprains result in persistent symptoms, 30% of which progress to chronic ankle instability. Arthroscopic examination and magnetic resonance imaging (MRI) are considered the two most accurate methods of diagnosing injuries to lateral collateral ligaments. Ultrasound has been proven able to detect soft tissue injuries, However, the use of ultrasound and its' ability to accurately diagnose CAI is still under debate. The aim of this study is to investigate the diagnostic accuracy of ultrasonography for the assessment of non-osseous lateral ankle instability in comparison with magnetic resonance imaging (MRI).
Detailed description
Chronic ankle instability (CAI) is a condition that often develops after repeated ankle sprains, increasing the susceptibility of the ankle to move into excessive inversion when walking on unsteady surfaces. Approximately 74% of acute ankle sprains result in persistent symptoms, 30% of which progress to chronic ankle instability.[1-3] CAI is diagnosed in individuals who report pain and tenderness on the lateral aspect of the ankle, or persistent swelling and discomfort for greater than six months with a history of re-injury or clinical instability of the ankle joint.[4, 5] The primary cause of damage to the structural stability of the ankle joint is trauma by forced inversion and plantarflexion. The lateral collateral ligaments, which are more commonly affected by acute sprains, include the anterior talofibular ligament (ATFL), the calcaneofibular ligament (CFL), and the posterior talofibular ligament (PTFL). The ATFL is primarily responsible for preventing excessive supination and anterior translation, while also restricting plantar flexion and internal rotation.
Common diagnostic tools used to identify ankle instability include clinical testing (like Anterior Drawer Test), imaging and arthroscopy. Arthroscopic examination and magnetic resonance imaging (MRI) are considered the two most accurate methods of diagnosing injuries to lateral collateral ligaments. [7] In a retrospective study conducted by Joshy et al., in which 24 patients underwent arthroscopy and MRI of the ankle, MRI was found to have both high specificity (100%) and high sensitivity (100%) for ATFL disruption. [8-10] Ultrasound has been proven able to detect soft tissue injuries, and has even become the gold standard for the detection of injuries to the patellar and Achilles tendons. [2, 11] However, the use of ultrasound and its' ability to accurately diagnose CAI is still under debate.
When imaging the ankle, ultrasound should be able to detect synovial lesions, ligamentous injury, and distinguish soft tissue from osseous impingement.[8] Dynamic ultrasound should be also used to discover dislocation of the peroneal tendons, or intra-sheath dislocation, which is indicated by an intact retinaculum with subluxation of the peroneal tendons within the groove.[11] Aim of the work: The aim of this study is to investigate the diagnostic accuracy of ultrasonography for the assessment of non-osseous lateral ankle instability in comparison with magnetic resonance imaging (MRI).
Patients and Methods:
fifty four patients complaining of acute or chronic lateral ankle instability will be included in this study.
Inclusion criteria:
Patients complaining of acute or chronic lateral ankle instability.
Exclusion criteria:
- Previous ankle surgery
- Interventional intra-articular procedures (previous arthroscope, injections)
- Systemic inflammatory disorders (collagen diseases)
- Diagnosed osseous lesions.
Methods:
All patients will be subjected to:
Thorough history taking and clinical provisional diagnosis. Plain X-ray of the affected ankle in AP and lateral views to exclude any osseous lesions.
Real-time high resolution ultrasonography of the affected ankle joint MRI for the affected ankle joint.
Ultrasound Technique:
The ultrasonographic examination of the ankle begins with the patient in supine position. Longitudinal scanning of the ankle was first performed to get an overall view of the tibio-talar joint and to detect joint effusion. Thereafter, slight inversion of the foot is performed while the patient in the same position to examine the lateral collateral ligaments and peroneal tendons. The Anterior talo-fibular ligament (ATFL) is first examined in oblique transverse plane from the tip of lateral malleolus, antero-medially and slightly downward, till the talus. Then, the Calcaneo Fibular ligament (CFL) is examined in oblique longitudinal plane from the lateral malleolar tip downward and slightly backward to the lateral surface of the calcaneus.
Regarding the peroneal tendons, they are examined from their supra-malleolar musculo-tendinous junction, and then just behind the lateral malleolus till their infra-malleolar course in both longitudinal and transverse planes.
MRI examination All patients will have MRI imaging of the affected ankle(s) on a high field-strength scanners.
Positioning:
Every patient lies supine with the ankle and foot in neutral position and plantar flexion of 20-30 degrees for reducing the "magic angle" artifact. No movement allowed during examination by supporting the ankle using pads.
Protocol:
The patients are examined by different pulse sequences including T1, T2, proton density, gradient echo and STIR. The examinations will be done in different planes.
Our usual protocol of examination is Sagittal T1WIs, Axial T1WIs T2WIs and proton density images, coronal T1WIs as well as Sagittal or coronal STIR.
Other parameters applied include slice thickness ranged from 3 to 5 mm, matrix 256/192 or 512/224, number of excitation 2 to 3 and field of view ranged from 12 to 16 cm, better kept <14 cm.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- fifty four patients complaining of acute or chronic lateral ankle pain and instability will be included in this study.
Key inclusion criteria (1 listed)
- Patients complaining of acute or chronic lateral ankle pain and instability.
Key exclusion criteria (4 listed)
- Previous ankle surgery
- Interventional intra-articular procedures (previous arthroscope, injections)
- Systemic inflammatory disorders (collagen diseases)
- Diagnosed osseous lesion
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 |
|---|---|---|
| Ankle US and Ankle MRIAnkle US and Ankle MRI | Device | – |
Primary outcome
To study the accuracy, sensitivity and specificity of Ultrasonography in assessment of lateral ankle disorders causing ankle instability and pain in comparison to MRI.
Time frame: 1 year
To study the accuracy, sensitivity and specificity of Ultrasonography in assessment of lateral ankle disorders causing ankle instability and pain in comparison to MRI.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Background: PubMed 23580392Wikstrom EA, Hubbard-Turner T, McKeon PO. Understanding and treating lateral ankle sprains and their consequences: a constraints-based approach. Sports Med. 2013 Jun;43(6):385-93. doi: 10.1007/s40279-013-0043-z.
- Background: PubMed 27104050Radwan A, Bakowski J, Dew S, Greenwald B, Hyde E, Webber N. EFFECTIVENESS OF ULTRASONOGRAPHY IN DIAGNOSING CHRONIC LATERAL ANKLE INSTABILITY:A SYSTEMATIC REVIEW. Int J Sports Phys Ther. 2016 Apr;11(2):164-74.
- Background: PubMed 29886432Delahunt E, Bleakley CM, Bossard DS, Caulfield BM, Docherty CL, Doherty C, Fourchet F, Fong DT, Hertel J, Hiller CE, Kaminski TW, McKeon PO, Refshauge KM, Remus A, Verhagen E, Vicenzino BT, Wikstrom EA, Gribble PA. Clinical assessment of acute lateral ankle sprain injuries (ROAST): 2019 consensus statement and recommendations of the International Ankle Consortium. Br J Sports Med. 2018 Oct;52(20):1304-1310. doi: 10.1136/bjsports-2017-098885. Epub 2018 Jun 9.
- Background: PubMed 25299444Houston MN, Van Lunen BL, Hoch MC. Health-related quality of life in individuals with chronic ankle instability. J Athl Train. 2014 Nov-Dec;49(6):758-63. doi: 10.4085/1062-6050-49.3.54.
- Background: PubMed 25299494van Ochten JM, van Middelkoop M, Meuffels D, Bierma-Zeinstra SM. Chronic complaints after ankle sprains: a systematic review on effectiveness of treatments. J Orthop Sports Phys Ther. 2014 Nov;44(11):862-71, C1-23. doi: 10.2519/jospt.2014.5221. Epub 2014 Oct 9.
- Background: PubMed 22446334Croy T, Saliba SA, Saliba E, Anderson MW, Hertel J. Differences in lateral ankle laxity measured via stress ultrasonography in individuals with chronic ankle instability, ankle sprain copers, and healthy individuals. J Orthop Sports Phys Ther. 2012 Jul;42(7):593-600. doi: 10.2519/jospt.2012.3923. Epub 2012 Mar 23.
- Background: PubMed 22577506Polzer H, Kanz KG, Prall WC, Haasters F, Ockert B, Mutschler W, Grote S. Diagnosis and treatment of acute ankle injuries: development of an evidence-based algorithm. Orthop Rev (Pavia). 2012 Jan 2;4(1):e5. doi: 10.4081/or.2012.e5. Epub 2011 Dec 14.
- Background: PubMed 20483139Joshy S, Abdulkadir U, Chaganti S, Sullivan B, Hariharan K. Accuracy of MRI scan in the diagnosis of ligamentous and chondral pathology in the ankle. Foot Ankle Surg. 2010 Jun;16(2):78-80. doi: 10.1016/j.fas.2009.05.012. Epub 2009 Jul 8.
- Background: PubMed 28552041Jung HG, Kim NR, Kim TH, Eom JS, Lee DO. Magnetic Resonance Imaging and Stress Radiography in Chronic Lateral Ankle Instability. Foot Ankle Int. 2017 Jun;38(6):621-626. doi: 10.1177/1071100717693207. Epub 2017 Feb 1.
- Background: PubMed 29299765Morvan A, Klouche S, Thes A, Hardy P, Bauer T. Reliability and validity of preoperative MRI for surgical decision making in chronic lateral ankle instability. Eur J Orthop Surg Traumatol. 2018 May;28(4):713-719. doi: 10.1007/s00590-017-2116-4. Epub 2018 Jan 3.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Mariana Raafat study chair
Assiut University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound Therapy; Complications, run by Assiut University at 2 sites in Egypt.
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 4 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: status not confirmed, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariana Raafat (01018838878, lokassamir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study the accuracy, sensitivity and specificity of Ultrasonography in assessment of lateral ankle disorders causing ankle instability and pain in comparison to MRI. (time frame: 1 year). 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 NCT04834479, which also lists 10 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 8 Apr 2021.