- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05764603
Comparison Between MR Arthrography ,ct Arthrography and Conventional MR in Osteoachondral Lesions of Knee Osteo Arthritis
March 9, 2023 updated by: Mahmoud Bakheet, Assiut University
Comparison of Conventional MRI,MR Arthrography and MSCT Arthrography in the Detection and Grading of Chondral Lesions of the Osteo Arthritic Knee
The aim of this study is to compare the diagnostic efficacy of conventional MRI, MR arthrography and MDCT arthrography in the detection and grading of chondral lesions of the osteoarthritic knee with arthroscopic correlation
Study Overview
Detailed Description
The knee is a diarthrodial joint formed by two joint surfaces: the tibiofemoral and patellofemoral surfaces.
The medial and lateral tibiofemoral compartments, together with the patellofemoral joint, form the three compartment of the knee, and these are covered by hyaline articular cartilage.
Hyaline articular cartilage is a kind of dense conjunctive tissue consisting of cells, water and matrix.
The normal hyaline cartilage is well-structured and elastic, with a smooth surface and its functions to protect the subchondral bone, allow the articular surfaces to slide across each other without friction and absorb impact.
Damage of the articular cartilage is considered to be the hallmark of osteoarthritis (OA), even if other factors are involved in the pathogenesis of the disease (1).
Knee osteoarthritis (OA) is a common progressive multifactorial joint disease and is characterized by chronic pain and functional disability.
Knee OA accounts for almost four fifths of the burden of OA worldwide and increases with obesity and age (2).
Knee osteoarthritis (OA) is often initially evaluated by plain x ray (AP, LAT) views which its useful technique for early diagnosis of OA whoever it is still limited imaging tool for detection of more findings as the disease progress including articular cartilage defect.
Ultrasound is extremely sensitive for identifying synovial cysts that sometimes form in people with osteoarthritis.
Ultrasound is excellent for evaluating the ligaments and tendons around the joint, which can be stretched or torn because of osteoarthritis and other advantages of ultrasound include its easy availability and multiplanar capability, as well as economic advantages but it has multiple disadvantages including that it is not suitable for evaluation the progression of OA (3).
Magnetic resonance imaging (MRI) can provide the most comprehensive assessment of OA with the advantages of being noninvasive and multiplanar with excellent soft tissue contrast.
However, MRI is expensive, time consuming, and not widely used for monitoring OA clinically.
(3) MSCT can also be used to evaluate OA as can get an isotropic sub-millimeter spatial resolution with improved longitudinal resolution, The examination time is substantially reduced with decreased motion artifact, The cost is relatively lower than MRA in most countries(4) ,also useful in providing guidance for therapeutic and diagnostic procedure, even patients with metallic devices or implants, who are poorly indicated for MRA, can undergo the procedure, and we can easily estimate the lesion in the vicinity of metal without artifacts , but CTA may have some limitations in the evaluation of soft tissues and these are also invasive and require radiation exposure.(5)
Magnetic resonance arthrography (MRA) and multi slice CT arthrography (MSCTA) of the knee are considered the best-performing imaging techniques in diagnosing knee osteo arthritis if prospectively compared with arthroscopic findings.
These two imaging procedures are definitely better than plain CT or MRI of the knee because of the contrast resolution due to the presence of intraarticular diluted paramagnetic contrast or iodinated agent, respectively, and to the distension of the joint capsule.
The evaluation of site, type, grade, and extent of the disease is more reliable.
The two techniques give different information due to a higher CT sensitivity for calcifications and bone injuries and an optimal MR contrast resolution for soft tissue abnormalities (3) The combined use of iodinated contrast material for fluoroscopic confirmation of the articular position of the needle before injection of gadolinium chelates for MR arthrography offers the unique opportunity to compare CTA and MRA findings in carefully selected cases(6) Gadopentetate dimeglumine and iodinated contrast material can be mixed before MR imaging without any release of free gadolinium and are therefore safe for confirming the intraarticular placement of contrast material before MR arthrography (6)
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mahmoud Bakheet, MASTER
- Phone Number: 01000531195
- Email: Mahmoudbakheet@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- In this study 50 patients confirmed by X-ray to have early or advanced osteoarthritic changes which referred from the orthopedic clinic will be included
Exclusion Criteria:
- The exclusion criteria include fractures, septic knee, previous knee arthroscopy or open surgery. All metallic (non titanium) body implants that may include cardiac pacemakers, brain aneurysm clips, cochlear implants, vascular stents are considered an absolute contraindication to the performance of the procedure. Pregnancy (especially early pregnancy) is an absolute contraindication to the performance of MDCT (radiation exposure). Young patients below 18 years old..
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Participants
|
MR ARTHROGRAPHY AND CT ARTHROGRAPHY IN PATIENT WITH KNEE OSTEOARTHRITIS
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of conventional MRI, MR arthrography in diagnosis and grading of chondral lesions of the osteoarthritic knee
Time Frame: two years
|
compare the MRI and MR arthrography in diagnosis and grading of severity of osteochondral lesions in knee osteoarthritis using I- V staging system
|
two years
|
|
Comparison of conventional MRI, MSCT arthrography in diagnosis and grading of chondral lesions of the osteoarthritic knee
Time Frame: Two years
|
compare the MRI and MSCT arthrography in diagnosis and grading of severity of osteochondral lesions in knee osteoarthritis using I- V staging system
|
Two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hunter DJ, Bierma-Zeinstra S. Osteoarthritis. Lancet. 2019 Apr 27;393(10182):1745-1759. doi: 10.1016/S0140-6736(19)30417-9.
- da Cunha Cavalcanti FM, Doca D, Cohen M, Ferretti M. UPDATING ON DIAGNOSIS AND TREATMENT OF CHONDRAL LESION OF THE KNEE. Rev Bras Ortop. 2015 Nov 16;47(1):12-20. doi: 10.1016/S2255-4971(15)30339-6. eCollection 2012 Jan-Feb.
- Li Q, Amano K, Link TM, Ma CB. Advanced Imaging in Osteoarthritis. Sports Health. 2016 Sep;8(5):418-28. doi: 10.1177/1941738116663922. Epub 2016 Aug 10.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 1, 2023
Primary Completion (Anticipated)
February 1, 2025
Study Completion (Anticipated)
March 1, 2025
Study Registration Dates
First Submitted
January 23, 2023
First Submitted That Met QC Criteria
March 9, 2023
First Posted (Estimate)
March 10, 2023
Study Record Updates
Last Update Posted (Estimate)
March 10, 2023
Last Update Submitted That Met QC Criteria
March 9, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04-2023-100016
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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