Meniscus LesionNCT03490799
Muskloskeletal Ultrasound Versus Magnetic Resonance Imaging in Meniscal Abnormalities
An observational study of Meniscus Lesion, run by Assiut University.
Trial summary
clinical examination alone is usually insufficient in assessment of knee meniscus and a more reliable diagnosis can be achieved by using the knee ultrasound , magnetic resonance imaging. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Meniscus Lesion
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- May 2018to Aug 2019
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study willbe on cases of meniscal lesion degenerative on different pathologieslike osteoarthritis, rumatoid arthritis and trumatic cases due to meniscal injury these cases willbe diagnsed by ultrasound and compared by magnetic resonance imaging results to prove role of muskloskeletal ultrasound in diagnosis of meniscal lesions
Who may be able to join
- High probability for requiring surgical intervention for diagnosis and/or treatment of the affected• Patients aged 14 years old and older. exclusion criteria. • Patients will be excluded when the criteria mentioned before not met. • When informed consent is not granted and documented .
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Musculoskeletal Ultrasound Versus Magnetic Resonance Imaging in Assessment of Meniscal Abnormalities.
clinical examination alone is usually insufficient in assessment of knee meniscus and a more reliable diagnosis can be achieved by using the knee ultrasound , magnetic resonance imaging.
magnetic resonance imaging is considered the most noninvasive diagnostic method of detecting lesions of the intra-articular reliable knee structures. However, there are recent reports concluding that ultrasound is a valid technique for diagnosing meniscal lesions, even though it is not part of the standard protocol for evaluating injuries to the intra-articular knee structures.
Read the detailed description
The aim of our study is to determine if any other available noninvasive method can reliably diagnose knee meniscal pathology as well as magnetic resonance imaging. In our case, we use ultrasound as a noninvasive method , and we want to see if this will be sufficient for diagnosing meniscal lesions , if it could be used for this task instead of magnetic resonance imaging investigations performed by a radiologist, as well as a guide for indication of knee arthroscopy .Knee ultrasound is widely accepted among orthopedic surgeons, and ultrasound is used as diagnostic tool for various pathological conditions in orthopedic surgery. ultrasound is currently popularly used in orthopedic surgery due to its simplicity and because it is less time-consuming and more practical than magnetic resonance imaging. It can diagnose location of the tear, joint effusion, synovial thickening, and osteophytosis. Rather, the goal is to determine whether or not meniscal pathology wanting surgical intervention .
We will also compare the diagnostic accuracies of these diagnostic procedures for both acute and chronic meniscal lesions of the knee.While magnetic resonance imaging (MRI) is often considered the gold standard diagnostic imaging modality for detection of meniscal abnormalities, it is associated with misdiagnosis in as high as 47% of cases, and is not readily available to a large number of patients. Ultrasonographic examination of the knee will be reported to be an effective diagnostic tool for this purpose with the potential to overcome many of the shortcomings of magnetic resonance imaging. The purpose of this study is to determine the clinical usefulness of ultrasonography for diagnosis of meniscal pathology in patients with acute knee pain and compare its diagnostic accuracy to magnetic resonance imaging in a clinical setting . Musculoskeletal ultrasound involves the use of high-frequency sound waves to image soft tissues and bony structures in the body for the purposes of diagnosing pathology . Recently, an increasing number of physicians have integrated musculoskeletal ultrasound into their practices to facilitate patient care. Technological advancements, improved portability, and reduced costs continue to drive the proliferation of ultrasound in clinical medicine the clinical applications of musculoskeletal ultrasound in clinical practice, including the ultrasonographic appearance of normal and abnormal tissues as well as specific diagnostic and interventional applications in major body regions.
- Conditions
- Meniscus Lesion
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of diagnosis of meniscal abnormalities
numbers of patient accurately diagnosed meniscal abnormality by ultrasound versus mri
Measured: 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study startMay 2018 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Meniscus LesionStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490799
- Sponsor's protocol ID
- MSK US Versus Mri
- Status last verified
- Mar 2018
- First submitted
- 31 Mar 2018
- Last updated
- 6 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Majewski M, Susanne H, Klaus S. Epidemiology of athletic knee injuries: A 10-year study. Knee. 2006 Jun;13(3):184-8. doi: 10.1016/j.knee.2006.01.005. Epub 2006 Apr 17.
PubMed 16603363Lee D, Bouffard JA. Ultrasound of the knee. Eur J Ultrasound. 2001 Oct;14(1):57-71. doi: 10.1016/s0929-8266(01)00146-x. No abstract available.
PubMed 11567855
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musculoskeletal Ultrasound Versus Magnetic Resonance Imaging in Assessment of Meniscal Abnormalities.
- ClinicalTrials.gov ID
- NCT03490799
- Acronym / sponsor ID
- MSK US Versus Mri
- Conditions
- Meniscus Lesion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2018 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 6 Apr 2018 (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.
clinical examination alone is usually insufficient in assessment of knee meniscus and a more reliable diagnosis can be achieved by using the knee ultrasound , magnetic resonance imaging.
magnetic resonance imaging is considered the most noninvasive diagnostic method of detecting lesions of the intra-articular reliable knee structures. However, there are recent reports concluding that ultrasound is a valid technique for diagnosing meniscal lesions, even though it is not part of the standard protocol for evaluating injuries to the intra-articular knee structures.
Detailed description
The aim of our study is to determine if any other available noninvasive method can reliably diagnose knee meniscal pathology as well as magnetic resonance imaging. In our case, we use ultrasound as a noninvasive method , and we want to see if this will be sufficient for diagnosing meniscal lesions , if it could be used for this task instead of magnetic resonance imaging investigations performed by a radiologist, as well as a guide for indication of knee arthroscopy .Knee ultrasound is widely accepted among orthopedic surgeons, and ultrasound is used as diagnostic tool for various pathological conditions in orthopedic surgery. ultrasound is currently popularly used in orthopedic surgery due to its simplicity and because it is less time-consuming and more practical than magnetic resonance imaging. It can diagnose location of the tear, joint effusion, synovial thickening, and osteophytosis. Rather, the goal is to determine whether or not meniscal pathology wanting surgical intervention .
We will also compare the diagnostic accuracies of these diagnostic procedures for both acute and chronic meniscal lesions of the knee.While magnetic resonance imaging (MRI) is often considered the gold standard diagnostic imaging modality for detection of meniscal abnormalities, it is associated with misdiagnosis in as high as 47% of cases, and is not readily available to a large number of patients. Ultrasonographic examination of the knee will be reported to be an effective diagnostic tool for this purpose with the potential to overcome many of the shortcomings of magnetic resonance imaging. The purpose of this study is to determine the clinical usefulness of ultrasonography for diagnosis of meniscal pathology in patients with acute knee pain and compare its diagnostic accuracy to magnetic resonance imaging in a clinical setting . Musculoskeletal ultrasound involves the use of high-frequency sound waves to image soft tissues and bony structures in the body for the purposes of diagnosing pathology . Recently, an increasing number of physicians have integrated musculoskeletal ultrasound into their practices to facilitate patient care. Technological advancements, improved portability, and reduced costs continue to drive the proliferation of ultrasound in clinical medicine the clinical applications of musculoskeletal ultrasound in clinical practice, including the ultrasonographic appearance of normal and abnormal tissues as well as specific diagnostic and interventional applications in major body regions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study willbe on cases of meniscal lesion degenerative on different pathologieslike osteoarthritis, rumatoid arthritis and trumatic cases due to meniscal injury these cases willbe diagnsed by ultrasound and compared by magnetic resonance imaging results to prove role of muskloskeletal ultrasound in diagnosis of meniscal lesions
Key inclusion criteria (1 listed)
- High probability for requiring surgical intervention for diagnosis and/or treatment of the affected• Patients aged 14 years old and older. exclusion criteria. • Patients will be excluded when the criteria mentioned before not met. • When informed consent is not granted and documented .
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
rate of diagnosis of meniscal abnormalities
Time frame: 48
numbers of patient accurately diagnosed meniscal abnormality by ultrasound versus mri
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
- Background: PubMed 16603363Majewski M, Susanne H, Klaus S. Epidemiology of athletic knee injuries: A 10-year study. Knee. 2006 Jun;13(3):184-8. doi: 10.1016/j.knee.2006.01.005. Epub 2006 Apr 17.
- Background: PubMed 11567855Lee D, Bouffard JA. Ultrasound of the knee. Eur J Ultrasound. 2001 Oct;14(1):57-71. doi: 10.1016/s0929-8266(01)00146-x. No abstract available.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Meniscus Lesion, run by Assiut 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 0 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 6 Apr 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact nagham mouhamed nabil, Assistant Professor (01028820041, nagham.omr@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of diagnosis of meniscal abnormalities (time frame: 48). 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 NCT03490799, which also lists 2 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 6 Apr 2018.