Diagnostic Value of Weight Bearing CT for Detecting Meniscal Tears

Completed

• Conditions: Meniscus Tear, Tibial

• Registration Number: NCT04430829
• Lead Sponsor: University of Kansas Medical Center

Brief 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.

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 Timeline

• Study First Submitted: 2020-05-26
• Study Start: 2020-06-08
• Study First Submitted QC: 2020-06-10
• Study First Posted: 2020-06-12
• Primary Completion: 2023-11-14
• Study Completion: 2023-11-14
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the agreement between weight-bearing CT arthrography (WBCTa) and MRI in evaluation of meniscal tears.	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.

Secondary Outcome Measures

Name	Time	Method
To determine the extent to which WBCTa identifies meniscal re-tears or failed repairs 6 months following meniscal root or radial tear surgical repairs	6 months	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..
To determine the agreement between weight-bearing CT arthrography and MRI in evaluation of cartilage lesions.	Baseline	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.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States