Knee OsteoarthritisPhase 1/2NCT05764603
Comparison Between MR Arthrography ,ct Arthrography and Conventional MR in Osteoachondral Lesions of Knee Osteo Arthritis
A Phase 1/2 study testing MRI in people with Knee Osteoarthritis, run by Assiut University.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 1 Mar 2025
- Phase
- Phase 1/2
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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..
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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)
- Conditions
- Knee Osteoarthritis
- Being tested
- MRI
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDrug
Also called CT
MR ARTHROGRAPHY AND CT ARTHROGRAPHY IN PATIENT WITH KNEE OSTEOARTHRITIS
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | Not described Receives: Drug: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of conventional MRI, MR arthrography in diagnosis and grading of chondral lesions of the osteoarthritic knee
compare the MRI and MR arthrography in diagnosis and grading of severity of osteochondral lesions in knee osteoarthritis using I- V staging system
Measured: two years
Comparison of conventional MRI, MSCT arthrography in diagnosis and grading of chondral lesions of the osteoarthritic knee
compare the MRI and MSCT arthrography in diagnosis and grading of severity of osteochondral lesions in knee osteoarthritis using I- V staging system
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- mri and ct arthrography
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Bakheet, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764603
- Sponsor's protocol ID
- 04-2023-100016
- Status last verified
- Mar 2023
- First submitted
- 23 Jan 2023
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27027078Hunter DJ, Bierma-Zeinstra S. Osteoarthritis. Lancet. 2019 Apr 27;393(10182):1745-1759. doi: 10.1016/S0140-6736(19)30417-9.
PubMed 31034380Li 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.
PubMed 27510507
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conventional MRI,MR Arthrography and MSCT Arthrography in the Detection and Grading of Chondral Lesions of the Osteo Arthritic Knee
- ClinicalTrials.gov ID
- NCT05764603
- Acronym / sponsor ID
- 04-2023-100016
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 10 Mar 2023 (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.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- mri and ct arthrography
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Drug: MRI |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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..
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 |
|---|---|---|
| MRIAlso: CTMR ARTHROGRAPHY AND CT ARTHROGRAPHY IN PATIENT WITH KNEE OSTEOARTHRITIS | Drug | Participants |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Background: PubMed 27027078da 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.
- Background: PubMed 31034380Hunter DJ, Bierma-Zeinstra S. Osteoarthritis. Lancet. 2019 Apr 27;393(10182):1745-1759. doi: 10.1016/S0140-6736(19)30417-9.
- Background: PubMed 27510507Li 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.
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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?
A Phase 1/2 study testing MRI in people with Knee Osteoarthritis, 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 1 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 10 Mar 2023. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Mahmoud Bakheet, MASTER (01000531195, Mahmoudbakheet@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of conventional MRI, MR arthrography in diagnosis and grading of chondral lesions of the osteoarthritic knee (time frame: two years). 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 NCT05764603, which also lists 3 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 10 Mar 2023.