Ankle Impingement SyndromeNCT03860922
Conventional MRI Versus MR Arthrography in Evaluation of Ankle Impingement Syndromes and Intra Articular Pathologies.
An observational study of Ankle Impingement Syndrome, run by Assiut University at 1 site in Egypt.
Trial summary
Chronic ankle pain is a common clinical problem with a wide differential diagnosis. Soft-tissue and osseous impingement syndromes are now increasingly recognized as a significant cause of chronic ankle pain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ankle Impingement Syndrome
- What is being tested?
- Magnetic Resonance Imaging
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2020to 30 Dec 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients in different age groups and both sex clinically presented with chronic ankle pain.
Who may be able to join
- patients in different age groups and both sex referred from orthopedic outpatient clinic with chronic ankle pain and suspected clinically to have impingement syndrome.
Who cannot join
- Inflammatory arthritis of ankle joint, infection in ankle joint, neoplasm around ankle joint.
- Patients with contraindications for MRI, e.g. an implanted magnetic device, pacemakers or claustrophobia.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine
Asyut, 71111
Samy Sayed, 01006788053, samy5abdelaziz@yahoo.com
01003331902, koriemomar@yahoo.com
About this study
Official title: Conventional Magnetic Resonance Imaging Versus Magnetic Resonance Arthrography in Evaluation of Ankle Impingement Syndromes and Intra Articular Pathologies.
Chronic ankle pain is a common clinical problem with a wide differential diagnosis. Soft-tissue and osseous impingement syndromes are now increasingly recognized as a significant cause of chronic ankle pain. Ankle impingement syndromes are defined as pathologic conditions resulting in chronic, painful restriction to movement at the tibiotalar articulation secondary to soft-tissue or osseous abnormalities. Ankle impingement is classified according to its anatomic relationship to the tibiotalar joint as anterolateral, anterior, anteromedial, posteromedial, or posterior impingement.
Read the detailed description
The anterolateral impingement syndrome is caused by obstruction of the so-called anterolateral gutter (ALG) or recess secondary to an inversion injury resulting in disruption of the syndesmotic and/or lateral collateral ligaments and capsule.
In anterior impingement,Arthroscopic evaluations suggest direct microtrauma to the talus and tibia as the aetiology. The natural course of this microtraumas to form osseous spurs.
In anteromedial impingement,The mechanism is not well understood but is likely a rare complication of a supination (inversion) injury rather than a pronation (eversion) injury as initially hypothesized.During the acute injury, there is damage to the anterior tibiotalar ligament, which subsequently thickens. In addition toligament thickening, osteophytes, synovitis and fractures have been described as other possible causative factors.
In posteromedial impingement, the common precipitating injury for posteromedial ankle impingement is a plantar flexion, inversion and internal rotation trauma. This can lead to damage to the PTTL and associated synovitis.
The majority of the posterior impingement syndromes are related to the posterior talus.The secondary ossification centre of the posterolateral talus forms around 8-13 years of age and then subsequently fuses within 1 year of that. Occasionally (approximately 7%), there may be non-fusion with a resultant ostrigonum.
Conventional MR imaging can accurately detect and localize osteophytes and associated lesions. In addition, MR imaging provides an easy evaluation of any articular cartilage changes, ligamentous injury, and occult bony contusions.
Direct magnetic resonance (MR) arthrography extends the capabilities of conventional MR imaging and utilizes the natural advantages gained from joint effusion. Contrast solution distends the joint capsule, outlines intra articular structures,and leaks into abnormalities.It can detect cartilage damage, intra articular loose bodies and osteochondral talar lesions.
- Conditions
- Ankle Impingement Syndrome
- Being tested
- Magnetic Resonance Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDevice
all patient will undergo Magnetic resonance imaging and magnetic imaging arthrography of the ankle joint.
What is being measured
The primary outcome is the main question the study is designed to answer.
Ligamentous disruption and thickening.
to detect the ligamentous disruption and thickening by conventional MRI and direct MR arthrography of the ankle joint.
Measured: base line
Capsular thickening and synovitis.
to detect the capsular thickening and synovitis by conventional MRI and direct MR arthrography of the ankle joint.
Measured: baseline
Secondary outcomes (1)
correlate the findings of conventional MRI and MR Arthrography of the ankle with clinical and operative findings.
to correlate the ligamentous disruption and thickening, capsular thickening and synovitis with clinical and operative findings (arthroscopy or open surgery).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start10 Sep 2020
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Dec 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 Ankle Impingement SyndromeStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kawsar Abdel Halim Mohamed, Assiut University
- Investigators
- Kawsar Mohamed, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860922
- Sponsor's protocol ID
- MRAAIS
- Status last verified
- Jul 2021
- First submitted
- 23 Feb 2019
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Steinbach LS, Palmer WE, Schweitzer ME. Special focus session. MR arthrography. Radiographics. 2002 Sep-Oct;22(5):1223-46. doi: 10.1148/radiographics.22.5.g02se301223.
PubMed 12235350Mosier-La Clair SM, Monroe MT, Manoli A. Medial impingement syndrome of the anterior tibiotalar fascicle of the deltoid ligament on the talus. Foot Ankle Int. 2000 May;21(5):385-91. doi: 10.1177/107110070002100505.
PubMed 10830656Robinson P, White LM, Salonen D, Ogilvie-Harris D. Anteromedial impingement of the ankle: using MR arthrography to assess the anteromedial recess. AJR Am J Roentgenol. 2002 Mar;178(3):601-4. doi: 10.2214/ajr.178.3.1780601.
PubMed 11856682Donovan A, Rosenberg ZS. Extraarticular lateral hindfoot impingement with posterior tibial tendon tear: MRI correlation. AJR Am J Roentgenol. 2009 Sep;193(3):672-8. doi: 10.2214/AJR.08.2215.
PubMed 19696280Murawski CD, Kennedy JG. Anteromedial impingement in the ankle joint: outcomes following arthroscopy. Am J Sports Med. 2010 Oct;38(10):2017-24. doi: 10.1177/0363546510369335. Epub 2010 May 17.
PubMed 20479141Giannini S, Buda R, Mosca M, Parma A, Di Caprio F. Posterior ankle impingement. Foot Ankle Int. 2013 Mar;34(3):459-65. doi: 10.1177/1071100713477609.
PubMed 23520307Hayashi D, Roemer FW, D'Hooghe P, Guermazi A. Posterior ankle impingement in athletes: Pathogenesis, imaging features and differential diagnoses. Eur J Radiol. 2015 Nov;84(11):2231-41. doi: 10.1016/j.ejrad.2015.07.017. Epub 2015 Jul 17.
PubMed 26239710Paterson RS, Brown JN. The posteromedial impingement lesion of the ankle. A series of six cases. Am J Sports Med. 2001 Sep-Oct;29(5):550-7. doi: 10.1177/03635465010290050501.
PubMed 11573911Haller J, Bernt R, Seeger T, Weissenback A, Tuchler H, Resnick D. MR-imaging of anterior tibiotalar impingement syndrome: agreement, sensitivity and specificity of MR-imaging and indirect MR-arthrography. Eur J Radiol. 2006 Jun;58(3):450-60. doi: 10.1016/j.ejrad.2006.03.008. Epub 2006 Apr 18.
PubMed 16621392Robinson P, White LM, Salonen DC, Daniels TR, Ogilvie-Harris D. Anterolateral ankle impingement: mr arthrographic assessment of the anterolateral recess. Radiology. 2001 Oct;221(1):186-90. doi: 10.1148/radiol.2211001666.
PubMed 11568338
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Magnetic Resonance Imaging Versus Magnetic Resonance Arthrography in Evaluation of Ankle Impingement Syndromes and Intra Articular Pathologies.
- ClinicalTrials.gov ID
- NCT03860922
- Acronym / sponsor ID
- MRAAIS
- Conditions
- Ankle Impingement Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 4 Mar 2019 (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 pain is a common clinical problem with a wide differential diagnosis. Soft-tissue and osseous impingement syndromes are now increasingly recognized as a significant cause of chronic ankle pain. Ankle impingement syndromes are defined as pathologic conditions resulting in chronic, painful restriction to movement at the tibiotalar articulation secondary to soft-tissue or osseous abnormalities. Ankle impingement is classified according to its anatomic relationship to the tibiotalar joint as anterolateral, anterior, anteromedial, posteromedial, or posterior impingement.
Detailed description
The anterolateral impingement syndrome is caused by obstruction of the so-called anterolateral gutter (ALG) or recess secondary to an inversion injury resulting in disruption of the syndesmotic and/or lateral collateral ligaments and capsule.
In anterior impingement,Arthroscopic evaluations suggest direct microtrauma to the talus and tibia as the aetiology. The natural course of this microtraumas to form osseous spurs.
In anteromedial impingement,The mechanism is not well understood but is likely a rare complication of a supination (inversion) injury rather than a pronation (eversion) injury as initially hypothesized.During the acute injury, there is damage to the anterior tibiotalar ligament, which subsequently thickens. In addition toligament thickening, osteophytes, synovitis and fractures have been described as other possible causative factors.
In posteromedial impingement, the common precipitating injury for posteromedial ankle impingement is a plantar flexion, inversion and internal rotation trauma. This can lead to damage to the PTTL and associated synovitis.
The majority of the posterior impingement syndromes are related to the posterior talus.The secondary ossification centre of the posterolateral talus forms around 8-13 years of age and then subsequently fuses within 1 year of that. Occasionally (approximately 7%), there may be non-fusion with a resultant ostrigonum.
Conventional MR imaging can accurately detect and localize osteophytes and associated lesions. In addition, MR imaging provides an easy evaluation of any articular cartilage changes, ligamentous injury, and occult bony contusions.
Direct magnetic resonance (MR) arthrography extends the capabilities of conventional MR imaging and utilizes the natural advantages gained from joint effusion. Contrast solution distends the joint capsule, outlines intra articular structures,and leaks into abnormalities.It can detect cartilage damage, intra articular loose bodies and osteochondral talar lesions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients in different age groups and both sex clinically presented with chronic ankle pain.
Key inclusion criteria (1 listed)
- patients in different age groups and both sex referred from orthopedic outpatient clinic with chronic ankle pain and suspected clinically to have impingement syndrome.
Key exclusion criteria (2 listed)
- Inflammatory arthritis of ankle joint, infection in ankle joint, neoplasm around ankle joint.
- Patients with contraindications for MRI, e.g. an implanted magnetic device, pacemakers or claustrophobia.
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 |
|---|---|---|
| Magnetic Resonance Imagingall patient will undergo Magnetic resonance imaging and magnetic imaging arthrography of the ankle joint. | Device | – |
Primary outcome
Ligamentous disruption and thickening.
Time frame: base line
to detect the ligamentous disruption and thickening by conventional MRI and direct MR arthrography of the ankle joint.
Capsular thickening and synovitis.
Time frame: baseline
to detect the capsular thickening and synovitis by conventional MRI and direct MR arthrography of the ankle joint.
1 secondary outcome
correlate the findings of conventional MRI and MR Arthrography of the ankle with clinical and operative findings.
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Background: PubMed 12235350Steinbach LS, Palmer WE, Schweitzer ME. Special focus session. MR arthrography. Radiographics. 2002 Sep-Oct;22(5):1223-46. doi: 10.1148/radiographics.22.5.g02se301223.
- Results publication: PubMed 10830656Mosier-La Clair SM, Monroe MT, Manoli A. Medial impingement syndrome of the anterior tibiotalar fascicle of the deltoid ligament on the talus. Foot Ankle Int. 2000 May;21(5):385-91. doi: 10.1177/107110070002100505.
- Results publication: PubMed 11856682Robinson P, White LM, Salonen D, Ogilvie-Harris D. Anteromedial impingement of the ankle: using MR arthrography to assess the anteromedial recess. AJR Am J Roentgenol. 2002 Mar;178(3):601-4. doi: 10.2214/ajr.178.3.1780601.
- Results publication: PubMed 19696280Donovan A, Rosenberg ZS. Extraarticular lateral hindfoot impingement with posterior tibial tendon tear: MRI correlation. AJR Am J Roentgenol. 2009 Sep;193(3):672-8. doi: 10.2214/AJR.08.2215.
- Results publication: PubMed 20479141Murawski CD, Kennedy JG. Anteromedial impingement in the ankle joint: outcomes following arthroscopy. Am J Sports Med. 2010 Oct;38(10):2017-24. doi: 10.1177/0363546510369335. Epub 2010 May 17.
- Results publication: PubMed 23520307Giannini S, Buda R, Mosca M, Parma A, Di Caprio F. Posterior ankle impingement. Foot Ankle Int. 2013 Mar;34(3):459-65. doi: 10.1177/1071100713477609.
- Results publication: PubMed 26239710Hayashi D, Roemer FW, D'Hooghe P, Guermazi A. Posterior ankle impingement in athletes: Pathogenesis, imaging features and differential diagnoses. Eur J Radiol. 2015 Nov;84(11):2231-41. doi: 10.1016/j.ejrad.2015.07.017. Epub 2015 Jul 17.
- Results publication: PubMed 11573911Paterson RS, Brown JN. The posteromedial impingement lesion of the ankle. A series of six cases. Am J Sports Med. 2001 Sep-Oct;29(5):550-7. doi: 10.1177/03635465010290050501.
- Results publication: PubMed 16621392Haller J, Bernt R, Seeger T, Weissenback A, Tuchler H, Resnick D. MR-imaging of anterior tibiotalar impingement syndrome: agreement, sensitivity and specificity of MR-imaging and indirect MR-arthrography. Eur J Radiol. 2006 Jun;58(3):450-60. doi: 10.1016/j.ejrad.2006.03.008. Epub 2006 Apr 18.
- Results publication: PubMed 11568338Robinson P, White LM, Salonen DC, Daniels TR, Ogilvie-Harris D. Anterolateral ankle impingement: mr arthrographic assessment of the anterolateral recess. Radiology. 2001 Oct;221(1):186-90. doi: 10.1148/radiol.2211001666.
- 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. This study is not recruiting at the moment.
Kawsar Mohamed principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Impingement Syndrome, run by Assiut University at 1 site 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 2 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 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Samy Sayed (01006788053, samy5abdelaziz@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ligamentous disruption and thickening. (time frame: base line). The study lists 2 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 NCT03860922, 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 1 Aug 2022.