Meniscus Tear, TibialNCT04430829
Diagnostic Value of Weight Bearing CT for Detecting Meniscal Tears
An observational study of Meniscus Tear, Tibial, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
This observational study will compare the clinical value of weight-bearing CT arthrography (WBCTa) with that for MRI in evaluating meniscal and cartilage lesions of the knee joint. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Meniscus Tear, Tibial
- What is being tested?
- Weight-Bearing CT arthrography and Knee MRI
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2020to 14 Nov 2023
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from orthopedic clinics as well as other musculoskeletal clinics that request knee MRI. Special efforts will be made to recruit the majority from orthopedic sports medicine clinical practices to include patients who are scheduled for arthroscopic meniscal repair of full-thickness radial tears of the posterior horn or body or root tears of the posterior horn after clinical MRI. There will be no exclusions based on sex or ethnic group.
Who may be able to join
- Male or female over 18 years of age with a knee MRI acquired in the previous 10 days to evaluate for suspected meniscal or cartilage pathology.
- Body mass index (BMI) ≤ 45 kg/m2
- Ability to stand with support without moving for at least 2 minutes.
Who cannot join
- End stage kidney disease
- Allergic to iodinated contrast material.
- Pregnancy
- Skin breakdown or rash at the knee joint which would prevent injection of the contrast.
- Any clinically significant degree of cognitive impairment or other condition, finding, or psychiatric illness at screening which, in the opinion of the investigator, affects their ability to ambulate to a sufficient degree and could compromise patient safety or interfere with the assessment of the safety of the study injection.
- Superficial or deep infection in or around the index knee joint or allergy to iodinated contrast media.
- History of inflammatory arthritis, meniscectomy, or end-stage OA
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Comparison of Weight Bearing CT Arthrography With MRI for Detection of Knee Meniscal and Cartilage Lesions.
This observational study will compare the clinical value of weight-bearing CT arthrography (WBCTa) with that for MRI in evaluating meniscal and cartilage lesions of the knee joint. The MRI Osteoarthritis Knee Score (MOAKS) and modified MOAKS for WBCTa will be used to compare findings between MRI and WBCTa of the knee while comparing with surgical measurements using the ICRS scoring system.
The study hypothesis is that meniscal and cartilage lesions may be missed by non-weight-bearing MRI, but detected by WBCTa.
Read the detailed description
Study Objectives:
Aim 1 Establish the accuracy of WBCTa and MRI for diagnosing knee cartilage and meniscal lesions in both surgical and non-surgical participants.
Hypothesis 1: Pre-operative cartilage and meniscal scoring on WBCTa is more accurate than MRI, in comparison with arthroscopic assessment.
Aim 2 Establish the accuracy of WBCTa for detecting persistent and recurrent meniscal root and radial tears not detected by MRI 6 months after meniscal repair (defined by diastasis of the repair or meniscal extrusion ≥3mm).
Hypothesis 2: Six months following meniscal repair, WBCTa detects persistent and recurrent meniscal root and radial re-tears not detected by MRI.
Study Type and Design: This cross-sectional, observational study will compare WBCTa with MRI to evaluate rate of detection of meniscal and cartilage lesions. The inter-rater reliability of WBCTa readings also will be assessed.
- Conditions
- Meniscus Tear, Tibial
- Being tested
- Weight-Bearing CT arthrography, Knee MRI
- Medical subject headings
- Tibial Meniscus Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight-Bearing CT arthrographyDiagnostic test
A 20ml mixture of 5ml 0.5% ropivacaine, 5ml preservative-free sterile saline, and 10ml of non-ionic iodinated contrast media (e.g. iohexol 240) will be instilled into the knee joint of each patient prior to WBCTa imaging of the knee (LineUp, CurveBeam, LLC).
Knee MRIDiagnostic test
MRI will be acquired (in-plane 0.25mm x 0.25mm, and 1.00mm slab thickness/separation and In-plane 0.25mm x 0.25mm, and 2.00mm slab thickness/separation)
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the agreement between weight-bearing CT arthrography (WBCTa) and MRI in evaluation of meniscal tears.
Pre-operative cartilage lesion scoring of meniscal lesions on WBCTa (modified MOAKS score) and MRI (modified MOAKS score) will be compared with arthroscopic visual MOAKS scoring of meniscal lesions.
Measured: Baseline
Secondary outcomes (2)
To determine the agreement between weight-bearing CT arthrography and MRI in evaluation of cartilage lesions.
Musculoskeletal radiologists, each with greater than 10 years of experience will assess the morphology of the medial and lateral tibiofemoral cartilage on MRI and WBCTa using the MOAKS scoring system. Area of cartilage damage per subregion will be graded according to the MOAKS classification from 0-3: 0= no cartilage damage, 1=cartilage damage involving <10% of the subregion area, 2= cartilage damage involving 10%-75% of the subregion area and 3=cartilage damage involving >75% of the subregion area. The scores will be compared by dichotomizing into lesion present/absent (primary) and also compared using the full ranges of ordinal scores.
Measured: Baseline
To determine the extent to which WBCTa identifies meniscal re-tears or failed repairs 6 months following meniscal root or radial tear surgical repairs
Participants who undergo a meniscal repair for radial meniscal tears and posterior root tears will undergo 6-month post-operative MRI and WBCTa and each of these 2 imaging modalities will be assessed for visualization of the presence or absence of a meniscal tear..
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start8 Jun 2020
- Primary completion14 Nov 2023
- Study completion14 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus Tear, TibialStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neil Segal, MD, MS, University of Kansas Medical Center
- Investigators
- Neil A Segal, MD, MS, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430829
- Sponsor's protocol ID
- STUDY00145012
- Status last verified
- May 2024
- First submitted
- 26 May 2020
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Weight Bearing CT Arthrography With MRI for Detection of Knee Meniscal and Cartilage Lesions.
- ClinicalTrials.gov ID
- NCT04430829
- Acronym / sponsor ID
- STUDY00145012
- Conditions
- Meniscus Tear, Tibial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 12 Jun 2020 (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.
This observational study will compare the clinical value of weight-bearing CT arthrography (WBCTa) with that for MRI in evaluating meniscal and cartilage lesions of the knee joint. The MRI Osteoarthritis Knee Score (MOAKS) and modified MOAKS for WBCTa will be used to compare findings between MRI and WBCTa of the knee while comparing with surgical measurements using the ICRS scoring system.
The study hypothesis is that meniscal and cartilage lesions may be missed by non-weight-bearing MRI, but detected by WBCTa.
Detailed description
Study Objectives:
Aim 1 Establish the accuracy of WBCTa and MRI for diagnosing knee cartilage and meniscal lesions in both surgical and non-surgical participants.
Hypothesis 1: Pre-operative cartilage and meniscal scoring on WBCTa is more accurate than MRI, in comparison with arthroscopic assessment.
Aim 2 Establish the accuracy of WBCTa for detecting persistent and recurrent meniscal root and radial tears not detected by MRI 6 months after meniscal repair (defined by diastasis of the repair or meniscal extrusion ≥3mm).
Hypothesis 2: Six months following meniscal repair, WBCTa detects persistent and recurrent meniscal root and radial re-tears not detected by MRI.
Study Type and Design: This cross-sectional, observational study will compare WBCTa with MRI to evaluate rate of detection of meniscal and cartilage lesions. The inter-rater reliability of WBCTa readings also will be assessed.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from orthopedic clinics as well as other musculoskeletal clinics that request knee MRI. Special efforts will be made to recruit the majority from orthopedic sports medicine clinical practices to include patients who are scheduled for arthroscopic meniscal repair of full-thickness radial tears of the posterior horn or body or root tears of the posterior horn after clinical MRI. There will be no exclusions based on sex or ethnic group.
Key inclusion criteria (3 listed)
- Male or female over 18 years of age with a knee MRI acquired in the previous 10 days to evaluate for suspected meniscal or cartilage pathology.
- Body mass index (BMI) ≤ 45 kg/m2
- Ability to stand with support without moving for at least 2 minutes.
Key exclusion criteria (7 listed)
- End stage kidney disease
- Allergic to iodinated contrast material.
- Pregnancy
- Skin breakdown or rash at the knee joint which would prevent injection of the contrast.
- Any clinically significant degree of cognitive impairment or other condition, finding, or psychiatric illness at screening which, in the opinion of the investigator, affects their ability to ambulate to a sufficient degree and could compromise patient safety or interfere with the assessment of the safety of the study injection.
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 |
|---|---|---|
| Weight-Bearing CT arthrographyA 20ml mixture of 5ml 0.5% ropivacaine, 5ml preservative-free sterile saline, and 10ml of non-ionic iodinated contrast media (e.g. iohexol 240) will be instilled into the knee joint of each patient prior to WBCTa imaging of the knee (LineUp, CurveBeam, LLC). | Diagnostic test | – |
| Knee MRIMRI will be acquired (in-plane 0.25mm x 0.25mm, and 1.00mm slab thickness/separation and In-plane 0.25mm x 0.25mm, and 2.00mm slab thickness/separation) | Diagnostic test | – |
Primary outcome
To determine the agreement between weight-bearing CT arthrography (WBCTa) and MRI in evaluation of meniscal tears.
Time frame: Baseline
Pre-operative cartilage lesion scoring of meniscal lesions on WBCTa (modified MOAKS score) and MRI (modified MOAKS score) will be compared with arthroscopic visual MOAKS scoring of meniscal lesions.
2 secondary outcomes
To determine the agreement between weight-bearing CT arthrography and MRI in evaluation of cartilage lesions.
Time frame: Baseline
To determine the extent to which WBCTa identifies meniscal re-tears or failed repairs 6 months following meniscal root or radial tear surgical repairs
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Meniscus Tear, Tibial
Recruiting
Operative vs Non-operative Management of Posterior-medial Meniscal Root Tears: A Randomized Multicenter Trial (RCT)
Meniscus Tear, Tibial
Recruiting
Hemi-tibial Plateau Osteotomy Combined With Arthroscopic Repair for Medial Meniscus Posterior Root Tears in Varus Knees
Knee Osteoarthristis, Meniscus Injury
RecruitingObservational study
Clinical Outcomes of Arthroscopic Surgeries for Shoulder and Knee Sports Injuries
Athletic Injuries (C26.857.500.124), Rotator Cuff Injuries
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.
Neil A Segal, MD, MS principal investigator
University of Kansas Medical Center
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 Meniscus Tear, Tibial, run by University of Kansas Medical Center at 1 site in United States.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 17 May 2024. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the agreement between weight-bearing CT arthrography (WBCTa) and MRI in evaluation of meniscal tears. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2024.