Diagnostic Value of Weight Bearing CT for Detecting Meniscal Tears

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.

Study Overview

• Status: Recruiting
• Conditions: Meniscus Tear, Tibial
• Intervention / Treatment: Diagnostic test: Weight-Bearing CT arthrography; Diagnostic test: Knee MRI

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 Type: Observational
• Enrollment (Anticipated): 125

Contacts and Locations

• Study Contact: Name: Jeannine Nilges, MD; Phone Number: 913-574-0961; Email: jnilges@kumc.edu
• Study Contact Backup: Name: Mairenn Mancina, BS; Phone Number: 913-574-0949; Email: m268m752@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
      • Contact: Jennifer Bedard, BA, CCRC; Phone Number: 913-574-0961; Email: jbedard@kumc.edu
      • Principal Investigator: Neil Segal, MD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Neil A Segal, MD, MS, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2020
• Primary Completion (Anticipated): November 14, 2023
• Study Completion (Anticipated): November 14, 2023

Study Registration Dates

• First Submitted: May 26, 2020
• First Submitted That Met QC Criteria: June 10, 2020
• First Posted (Actual): June 12, 2020

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Tibial Meniscus Injuries
• Other Study ID Numbers: STUDY00145012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes