Diagnostic Value of Weight Bearing CT for Detecting Meniscal Tears

Meniscus Tear, Tibial Clinical Trial

Official title:

Comparison of Weight Bearing CT Arthrography With MRI for Detection of Knee Meniscal and Cartilage Lesions.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04430829
• Other study ID #: STUDY00145012
• Status: Completed
• Start date: June 8, 2020
• Est. completion date: November 14, 2023

Study information

• Verified date: May 2024
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 14, 2023
• Est. primary completion date: November 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Meniscus Tear, Tibial
• Tibial Meniscus Injuries

Intervention

Diagnostic Test:
• Weight-Bearing CT arthrography
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 MRI
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)

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Secondary	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.	Baseline
Secondary	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..	6 months