NCT04430829

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Meniscus Tear, Tibial

Interventions

Type	Name	Description
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).
DIAGNOSTIC_TEST	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)

Timeline

• Start date: 2020-06-08
• Primary completion: 2023-11-14
• Completion: 2023-11-14
• First posted: 2020-06-12
• Last updated: 2024-05-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study