MRI versus radiography as eligibility screening tool for knee osteoarthritis clinical trials: Data from the
Ali Guermazi1, Frank W Roemer2, Erin L Ashbeck3
1Department of Radiology, Boston University School of Medicine, Boston, MA, United States.
Objective:
To estimate the prevalence of knee structural pathologies that may warrant exclusion from disease-modifying osteoarthritis drug (DMOAD) trials, based on MRI versus radiography, among participants who would otherwise be considered eligible for enrollment based on commonly used radiographic inclusionary criteria.
Methods:
We selected participants from the baseline visit of the Osteoarthritis Initiative that met radiographic structural and clinical eligibility criteria for a DMOAD clinical trial: Radiographic OA (Kellgren-Lawrence grade 2 or 3 with medial minimum joint space width ≥ 1.5 mm); and WOMAC knee pain score between 8 and 18 (0-20 scale). A musculoskeletal radiologist read radiographs and a shortened 3-T MRI protocol for structural pathologies that have been suggested as exclusionary from DMOAD clinical trial participation, as proposed by the Rapid Osteoarthritis MRI Eligibility Score (ROAMES), including meniscal root tears, subchondral insufficiency fractures, osteonecrosis, tumors and bone marrow infiltration, and acute traumatic changes.
Results:
Among 380 eligible participants (219 KL2 knees, 161 KL3 knees), structural pathologies that warrant exclusion from clinical trials were found in 38 knees (10 %) based on MRI, versus three knees (0.8 %) on radiography. Based on MRI, the estimated probability of an exclusionary finding in a KL2 knee was 0.06 (95 %CI: 0.03, 0.09), and 0.16 (95 %CI: 0.10, 0.21) in a KL3 knee. The most common finding was complete meniscus posterior root tear (31 knees, 8.2 %).
Conclusion:
Structural pathologies that are unlikely to respond to investigational DMOADs were found in ∼10 % of eligible participants based on MRI screening, largely driven by complete meniscal root tears, while these findings were not visible on radiographs.
Insights
MRI screening reveals approximately 10% of knee osteoarthritis patients eligible for disease-modifying osteoarthritis drug (DMOAD) trials have exclusionary pathologies, primarily meniscal root tears, missed by standard radiography.
Area of Science:
- Orthopedics
- Radiology
- Clinical Trials
Background:
- Osteoarthritis (OA) clinical trials require precise patient selection.
- Disease-modifying osteoarthritis drug (DMOAD) trials often use radiographic criteria for eligibility.
- Certain structural pathologies may preclude participation in DMOAD trials.
Purpose of the Study:
- To determine the prevalence of knee structural pathologies excluding participants from DMOAD trials.
- To compare MRI and radiography for identifying these exclusionary findings.
- To assess eligibility based on common radiographic inclusion criteria for DMOAD studies.
Main Methods:
- Utilized data from the Osteoarthritis Initiative baseline visit.
- Included participants meeting Kellgren-Lawrence grade 2-3 OA and specific joint space width criteria.
- Assessed exclusionary pathologies using a 3-T MRI protocol and radiography, guided by the Rapid Osteoarthritis MRI Eligibility Score (ROAMES).
Main Results:
- 10% (38/380) of eligible participants had exclusionary pathologies on MRI, versus 0.8% (3/380) on radiography.
- Complete posterior meniscus root tears were the most common exclusionary finding (8.2%).
- MRI identified exclusionary findings in 6% of KL2 knees and 16% of KL3 knees.
Conclusions:
- MRI screening identifies significant knee structural pathologies (∼10%) that warrant exclusion from DMOAD trials.
- These exclusionary findings, mainly meniscal root tears, are often undetected by radiography.
- Current radiographic eligibility criteria may include patients unsuitable for DMOAD trials due to unaddressed structural issues.
Related Concept Videos
01:24Magnetic Resonance Imaging
01:14Imaging Studies I: CT and MRI
Description of the Procedures
Computed Tomography (CT) scan:
Computed Tomography (CT) scans use X-ray technology to generate detailed images of bones, organs, and tissues. During the scan, the patient lies on a moving table...
01:27Imaging Studies IV: Magnetic Resonance Imaging
01:21Imaging Studies for Cardiovascular System IV: CMRI
01:30Radiological Investigation II: MRI and Ventilation Perfusion Scan
Magnetic Resonance Imaging (MRI) and Ventilation Perfusion Scans are two radiological investigations that offer detailed diagnostic images of the body, particularly lung structures.
MRI
MRI uses magnetic fields and radiofrequency signals to distinguish between normal and abnormal tissues. This technology provides a more detailed diagnostic image than CT scans, enabling it to characterize pulmonary nodules, stage bronchogenic carcinoma, and evaluate inflammatory activity in...