Diagnostic Value of Weight Bearing CT for Detecting Meniscal Tears

NCT04430829 | Completed FDA Device

• 1 other identifier: STUDY00145012
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Meniscus Tear, Tibial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• To determine the agreement between weight-bearing CT arthrography and MRI in evaluation of cartilage lesions.

  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

  6 months

Interventions

Weight-Bearing CT arthrography DIAGNOSTIC_TEST

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 DIAGNOSTIC_TEST

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)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Tibial Meniscus Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Neil A Segal, MD, MS

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 12, 2020
• Study Start: June 8, 2020
• Primary Completion: November 14, 2023
• Study Completion: November 14, 2023
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

US (1)