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Diagnostic Value of Weight Bearing CT for Detecting Meniscal Tears

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University of Kansas

Status

Completed

Conditions

Meniscus Tear, Tibial

Treatments

Diagnostic Test: Knee MRI
Diagnostic Test: Weight-Bearing CT arthrography

Study type

Observational

Funder types

Other

Identifiers

NCT04430829
STUDY00145012

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Mairenn Mancina, BS; Jeannine Nilges, MD

Data sourced from clinicaltrials.gov

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