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

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Participants
Drug: MRI
MR ARTHROGRAPHY AND CT ARTHROGRAPHY IN PATIENT WITH KNEE OSTEOARTHRITIS
Other Names:
  • CT

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2023

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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