Pre-surgical diagnostic tool using biomarkers to evaluate the risk factors of post surgical complications

Abstract

A method of electronically diagnosing a cause of an inflamed and/or painful joint of a patient using a joint specific biological material, the method including: receiving, data regarding tests performed on the joint specific biological material; determining if osteoarthritis (OA) is the cause of the inflamed and/or painful joint based upon one or more of the tests, wherein the diagnosing is based upon a level of cartilage oligomeric matrix protein (COMP) and a ratio of COMP to interleukin-8 (IL-8) in the joint specific biological material; if the one or more of the tests indicate OA is not the cause of the inflamed joint, determining if inflammatory arthritis, crystalline arthritis, rheumatoid arthritis, possible septic arthritis or septic arthritis is the cause of the inflamed joint based upon a further plurality of the tests; and generating a sample results report with result data including diagnosis for use by a clinician.

What is claimed is: 
     
         1 . A method of electronically diagnosing a cause of an inflamed and/or painful joint of a patient using a joint specific biological material, the method comprising:
 receiving, using an electronic device data regarding tests performed on the joint specific biological material;   determining with the electronic device if osteoarthritis (OA) is the cause of the inflamed and/or painful joint based upon one or more of the tests, wherein the diagnosing is based upon a level of cartilage oligomeric matrix protein (COMP) and a ratio of COMP to interleukin-8 (IL-8) in the joint specific biological material;   if the one or more of the tests indicate OA is not the cause of the inflamed joint, determining with the electronic device if inflammatory arthritis, crystalline arthritis, rheumatoid arthritis, possible septic arthritis or septic arthritis is the cause of the inflamed joint based upon a further plurality of the tests; and   generating with the electronic device a sample results report with result data including diagnosis for use by a clinician.   
     
     
         2 . The method of  claim 1 , wherein generating with the electronic device the sample results report includes a differential diagnosis of arthritis for the patient. 
     
     
         3 . The method of  claim 1 , wherein the determining the inflammatory arthritis, crystalline arthritis, rheumatoid arthritis, or septic arthritis is based upon presence of or absence of monosodium urate (MSU) crystals or calcium pyrophosphate dihydrate (CPPD) crystals in the joint specific biological material, the presence or absence of Immunoglobulin G (IgG) antibodies to citrullinated peptide (Anti-CCP), presence of absence of rheumatoid factor (RF), and by white blood cell (WBC) count and differential in the joint specific biological material. 
     
     
         4 . The method of  claim 3 , wherein the determining one of septic arthritis, inflammatory arthritis, and possible septic arthritis is by WBC count and percentage of polymorphonuclear cells (% PMN) in the joint specific biological material. 
     
     
         5 . The method of  claim 4 , wherein a results of WBC >3000 cells/μL and/or % PMN >70 is indicative of septic arthritis or possible septic arthritis. 
     
     
         6 . The method of  claim 4 , wherein the possible septic arthritis is determined by results of WBC >3000 cells/μL and/or % PMN >70, COMP/IL-8 ratio <4.3, negative for native septic arthritis (alpha defensin and lactate), negative for microbial ID, and negative for microbial culture in the joint specific biological material. 
     
     
         7 . The method of  claim 4 , wherein the septic arthritis is determined by results of WBC >3000 cells/μL and/or % PMN >70, COMP/IL-8 ratio <4.3, and at least one of: positive for native septic arthritis (alpha defensin and lactate), positive for microbial ID, or positive for microbial culture in the joint specific biological material. 
     
     
         8 . The method of  claim 4 , wherein the inflammatory arthritis is determined by absence of monosodium urate (MSU) crystals, absence of calcium pyrophosphate dihydrate (CPPD) crystals, absence of Anti-CCP and RF, COMP/IL-8 ratio <4.3 and WBC >3000 cells/μL or % PMN >70. 
     
     
         9 . The method of  claim 1 , further comprising categorizing the diagnosis according to one of a plurality of classes according to at least one of a level or type of inflammation, wherein the plurality of classes correspond to the diagnosis of OA, inflammatory arthritis, crystalline arthritis, rheumatoid arthritis, and septic arthritis. 
     
     
         10 . The method of  claim 9 , wherein the classes include subclassification related to presence of monosodium urate (MSU) crystals, presence of calcium pyrophosphate dihydrate (CPPD) crystals, presence of Anti-CCP, rheumatoid factor, and by one or more of a culture of the joint specific biological material, a microbial ID, or a presence or absence of alpha-defensin (AD) and L-lactate. 
     
     
         11 . The method of  claim 9 , further comprising electronically communicating the result data as an input to a pre-operative patient risk stratification tool and electronically determining with the patient risk stratification tool a predicted post-surgical patient outcome or risk based upon the result data. 
     
     
         12 . The method of  claim 10 , further comprising weighting the predicted patient outcome according to the one of several classes. 
     
     
         13 . The method of  claim 8 , wherein the categorizing the diagnosis according to the one of several classes is according to at least one of a type of inflammation or an inflammatory severity in addition to arthritic type. 
     
     
         14 . An electronically implemented system for diagnosing a cause of an inflamed and/or painful joint of a patient using a joint specific biological material, the system comprising:
 processing circuitry; and   a memory that includes instructions, the instructions, when executed by the processing circuitry, cause the processing circuitry to:
 receive data regarding tests performed on the joint specific biological material; 
 determine if osteoarthritis (OA) is the cause of the inflamed and/or painful joint based upon one or more of the tests, wherein the diagnosing is based upon a level of cartilage oligomeric matrix protein (COMP) and a ratio of COMP to interleukin-8 (IL-8) in the joint specific biological material; 
 determine, if the one more of the tests indicate OA is not the cause of the inflamed joint, if inflammatory arthritis, crystalline arthritis, rheumatoid arthritis, possible septic arthritis or septic arthritis is the cause of the inflamed joint based upon a further plurality of the tests; and 
 generate result data including joint specific diagnosis for use by a clinician. 
   
     
     
         15 . The system of  claim 14 , wherein the determination of the inflammatory arthritis, crystalline arthritis, rheumatoid arthritis, or septic arthritis is based upon presence of or absence of monosodium urate (MSU) crystals or calcium pyrophosphate dihydrate (CPPD) crystals in the joint specific biological material, the presence or absence of anti-cyclic citrullinated peptide, rheumatoid factor, and by a white blood cell (WBC) count and a percentage of polymorphonuclear cells (% PMN) in the joint specific biological material. 
     
     
         16 . The system of  claim 15 , wherein the instructions, when executed by the processing circuitry, cause the processing circuitry to determine one of the septic arthritis, the inflammatory arthritis and the possible septic arthritis is by WBC count or percentage of polymorphonuclear WBCs (% PMN) in the joint specific biological material. 
     
     
         17 . The system of  claim 16 , wherein a result of WBC >3000 cells/μL and/or % PMN >70 is indicative of septic arthritis or possible septic arthritis. 
     
     
         18 . The system of  claim 17 , wherein the possible septic arthritis is determined by the result WBC >3000 cells/μL and/or % PMN >70, and COMP/IL-8 ratio <4.3, negative for native septic arthritis, negative for microbial ID, and negative for microbial culture in the joint specific biological material and the septic arthritis is determined by determined by the ratio of WBC >3000 cells/μL and/or % PMN >70, COMP/IL-8 ratio <4.3, and at least one of: positive for native septic arthritis (alpha defensin and lactate), positive for microbial ID, or positive for microbial culture in the joint specific biological material. 
     
     
         19 . The system of  claim 17 , wherein a non-specific inflammatory arthritis is determined by absence of monosodium urate (MSU) crystals, absence of calcium pyrophosphate dihydrate (CPPD) crystals, absence of anti-cyclic citrullinated peptide, absence of RF, COMP/IL-8 ratio <4.3, WBC ≤3000, and % PMN <70. 
     
     
         20 . The system of  claim 14 , wherein the instructions, when executed by the processing circuitry, cause the processing circuitry to categorize the diagnosis according to one of a plurality of classes according to a level of inflammation, wherein the plurality of classes correspond to the diagnosis of OA, inflammatory arthritis, crystalline arthritis, rheumatoid arthritis, and septic arthritis. 
     
     
         21 . The system of  claim 20 , wherein the classes include subclassification related to presence or absence of monosodium urate (MSU) crystals, presence or absence of calcium pyrophosphate dihydrate (CPPD) crystals, presence or absence of anti-cyclic citrullinated peptide, presence of absence of rheumatoid factor, WBC count and differential, and by one or more of a culture of the joint specific biological material, positive identification of causative organism by microbial ID, or a presence or absence of alpha-defensin (AD) and L-lactate. 
     
     
         22 . The system of  claim 21 , further comprising:
 a second system including:
 processing circuitry; and 
 a memory that includes instructions, the instructions, when executed by the processing circuitry, cause the processing circuitry to:
 communicate with the system to retrieve the result data; and 
 determine, according to a risk stratification tool a predicted patient outcome based upon the result data. 
 
   
     
     
         23 . The system of  claim 22 , wherein the instructions, when executed by the processing circuitry, cause the processing circuitry to weight the predicted patient outcome according to the one of several classes. 
     
     
         24 . A method of electronically assessing a likelihood of an outcome for a patient experiencing an inflamed joint, the method comprising:
 determining, with a computing device, if an inflamed joint of the patient is caused by osteoarthritis (OA) inflammatory arthritis, crystalline arthritis, rheumatoid arthritis, possible septic arthritis or septic arthritis based upon tests performed on a joint specific biological material of the patient;   generating results data from the determining;   categorizing and weighting the results data; and   performing a risk analysis on the results data the risk analysis that accounts for one or more of the categorizing and weighting of the results data in accessing the patient outcome.