Objective assessment of joint damage
Inventors
McAlindon, Timothy • Driban, Jeffrey B. • Price, Lori Lyn • Lavalley, Michael • Zhang, Ming
Assignees
Boston University • Tufts Medical Center Inc
Publication Number
US-12307671-B2
Publication Date
2025-05-20
Expiration Date
2040-05-07
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Abstract
Determining a composite score includes deriving, based on an image set that includes at least one three-dimensional image of the synovial joint, first and second information. The first information indicates cumulative damage to the synovial joint. The second information indicates either one or both joint pain and loss of function of the synovial joint. The resulting composite score provides an objective measure of joint damage or an extent of joint disease.
Core Innovation
The invention provides a method and apparatus for objectively assessing damage and disease progression in synovial joints by deriving a composite score from three-dimensional images, such as those acquired by magnetic resonance imaging. This composite score is computed based on combining a cumulative damage assessment (e.g., cartilage damage) and a measure of disease activity (e.g., bone-marrow lesions or effusion-synovitis volume), thereby quantifying joint damage and disease extent in a standardized and objective way.
The problem addressed is the lack of objective, sensitive, and reliable metrics for assessing joint disease progression, particularly for conditions like osteoarthritis. Existing radiographic methods are limited by their inability to visualize soft tissues, as well as issues with sensitivity, reliability, and validity, making them insufficient for tracking disease progression or detecting treatment effects. While MRI enables 3D measurement of pathological features, current semi-quantitative MRI-based scales are insensitive to changes and fail to provide a unified composite score reflecting whole-joint health.
The disclosed solution involves using an MRI-based joint evaluator comprising a volumetric analyzer and a deterioration analyzer to extract, from image sets, measurements relevant to cartilage damage, bone-marrow lesions, and effusion-synovitis. These measurements are standardized and combined into cumulative damage and disease-activity scores, which are then aggregated into a composite score that serves as a biomarker, objectively measuring disease severity, predicting progression, and evaluating interventions for joint diseases such as osteoarthritis.
Claims Coverage
The patent includes two independent claims, each introducing unique inventive features for assessing joint damage using a composite score derived from MRI imaging.
Objective composite scoring method for joint damage using MRI-based evaluations
A method is implemented using a joint evaluator with a magnetic-resonance imaging machine to: 1. Acquire a first set of MRI images from a synovial joint, each corresponding to a cartilage location. 2. Determine a cartilage-damage index for each location and calculate a cumulative-damage score based on these indices. 3. Acquire a second set of images of volumes with bone-marrow lesions and effusion from synovitis. 4. Determine a disease-activity score from these images, indicative of joint disease activity. 5. Determine a composite score based on both the cumulative-damage score and the disease-activity score. 6. Use the composite score as a biomarker for indicating disease progression, enrichment of clinical trials, or quantifying severity of joint damage.
Joint evaluator apparatus with specialized analyzers for generating an objective joint condition composite score
An apparatus comprising: - A joint evaluator with a magnetic-resonance imaging machine for acquiring: - A first set of images of cartilage locations within a synovial joint - A second set of images of volumes with bone-marrow lesions and effusion from synovitis - A volumetric analyzer configured to determine a cartilage-damage index and cumulative-damage score from the first set - A deterioration analyzer to determine a disease-activity score from the second set - A composite-score generator to derive a composite score from the cartilage-damage and disease-activity scores - Utilization of the composite score as a biomarker to indicate disease progression, providing an objective basis for prediction and assessment of joint damage severity
The independent claims cover both a method and an apparatus for objective and quantitative assessment of joint disease progression using MRI-derived composite scores, including the detailed steps of acquiring specific image sets, extracting quantitative metrics, and generating a unified biomarker.
Stated Advantages
Provides an objective and reliable measure for assessing joint damage and disease progression.
Enables standardized quantification of cumulative structural damage and disease activity in joints.
Facilitates prediction of disease progression and identification of candidates for joint replacement.
Improves enrichment and assessment of efficacy in clinical trials and experimental therapies.
Permits composite scoring to serve as tissue-specific biomarkers and clinical endpoints for determining treatment effects.
Applicable to any synovial joint and agnostic to the cause of joint damage, supporting broad utility.
Documented Applications
Predicting progression of joint diseases, including osteoarthritis and rheumatoid arthritis.
Identifying individuals likely to progress toward joint replacement, such as knee replacement.
Objectively measuring tissue-specific effects of interventions for joint diseases.
Enriching clinical trial samples by selection of candidates based on progression risk.
Assessing the efficacy of candidate treatment methods for joint disease.
Using individual or composite biomarker scores to evaluate and compare interventions.
Providing clinical endpoints for structural joint damage and disease activity.
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