Age
Item
1. age ≥ 25 and ≤ 75
boolean
C0001779 (UMLS CUI [1])
Osteoarthritis of both knees patellofemoral mild | Osteoarthritis of both knees patellofemoral moderate | Meniscus Intact | Cruciate ligament Stability | Collateral ligament Stability
Item
2. patello-femoral osteoarthritis of both knees of mild to moderate severity with intact meniscus and ligamentous stability (cruciate and collateral ligaments)
boolean
C3508960 (UMLS CUI [1,1])
C0447801 (UMLS CUI [1,2])
C2945599 (UMLS CUI [1,3])
C3508960 (UMLS CUI [2,1])
C0447801 (UMLS CUI [2,2])
C0205081 (UMLS CUI [2,3])
C0224498 (UMLS CUI [3,1])
C0205266 (UMLS CUI [3,2])
C0835268 (UMLS CUI [4,1])
C0205360 (UMLS CUI [4,2])
C0206365 (UMLS CUI [5,1])
C0205360 (UMLS CUI [5,2])
Cartilage repair Society Classification Grade | Both knees MRI
Item
clinically, as determined by screening questionnaire and judgment of the principal investigator (may be supported by imaging studies of knees); confirmed by centrally read screening mri of both knees indicating icrs grade 1-3, or icrs grade 4 with only focal defects, no greater than 1 cm.
boolean
C1112785 (UMLS CUI [1,1])
C0037455 (UMLS CUI [1,2])
C0008902 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,4])
C0230434 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
Meniscus Intact | Degeneration Grade Acceptable MRI
Item
meniscus intact (mri degenerative signal up to and including grade ii acceptable)
boolean
C0224498 (UMLS CUI [1,1])
C0205266 (UMLS CUI [1,2])
C0011164 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
C1879533 (UMLS CUI [2,3])
C0024485 (UMLS CUI [2,4])
Cruciate ligament Stability Clinical examination | Collateral ligament Stability Clinical examination
Item
cruciate and collateral ligament stability as defined by clinical examination
boolean
C0835268 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C1456356 (UMLS CUI [1,3])
C0206365 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C1456356 (UMLS CUI [2,3])
Informed Consent
Item
3. able to read, understand, sign and date the subject informed consent
boolean
C0021430 (UMLS CUI [1])
Analgesic Primary | Acetaminophen Dose U/day
Item
4. willingness to use only acetaminophen as the primary analgesic (pain-relieving) study medication. the maximum dose of acetaminophen must not exceed 4 grams/day (4000 mg per day).
boolean
C0002771 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0000970 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
Hydrocodone Breakthrough Pain | Acetaminophen Breakthrough Pain
Item
5. willingness to use only hydrocodone/acetaminophen for breakthrough pain during the injection period (through study day 30).
boolean
C0020264 (UMLS CUI [1,1])
C1135120 (UMLS CUI [1,2])
C0000970 (UMLS CUI [2,1])
C1135120 (UMLS CUI [2,2])
NSAIDs Absent | Aspirin Absent | Ibuprofen Absent | Naproxen Absent
Item
6. willingness not to use non-steroidal anti-inflammatory drugs (nsaids) such as aspirin, ibuprofen, naproxen for the first 30 days of the study.
boolean
C0003211 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0004057 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0020740 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0027396 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Childbearing Potential Sexually active Contraceptive methods Quantity | Contraceptives, Oral | Contraceptive implant | Injectable contraception | Intrauterine Devices | Female Condoms | Vaginal Spermicides | Sexual Abstinence
Item
7. female subjects of child bearing potential who are sexually active (non-abstinent) must agree to and comply with using 2 highly effective methods of birth control (oral contraceptive, implant, injectable or indwelling intrauterine device, condom with spermicide, or sexual abstinence) while participating in the study.
boolean
C3831118 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0009905 (UMLS CUI [2])
C1657106 (UMLS CUI [3])
C1262153 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0221829 (UMLS CUI [6])
C0087145 (UMLS CUI [7])
C0036899 (UMLS CUI [8])
Medical contraindication MRI | Metallic material | Brain Clip | Metal foreign body in eye region | Clip Spinal Canal | Metallic device | Body Weight | Claustrophobia Moderate | Claustrophobia Severe | Intolerance MRI
Item
1. contraindication to mri, including: metallic fragments, clips or devices in the brain, eye, or spinal canal; implanted devices that are magnetically programmed; weight > 300 lbs.; moderate or severe claustrophobia; previous intolerance of mri procedure
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0567346 (UMLS CUI [2])
C0006104 (UMLS CUI [3,1])
C0175722 (UMLS CUI [3,2])
C0562528 (UMLS CUI [4])
C0175722 (UMLS CUI [5,1])
C0037922 (UMLS CUI [5,2])
C3693688 (UMLS CUI [6])
C0005910 (UMLS CUI [7])
C0008909 (UMLS CUI [8,1])
C0205081 (UMLS CUI [8,2])
C0008909 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
C0231199 (UMLS CUI [10,1])
C0024485 (UMLS CUI [10,2])
Cartilage repair Society Classification Grade | MRI
Item
2. icrs grade greater than grade 3, or grade 4 focal defects greater than 1 cm, as confirmed by centrally-read screening mri
boolean
C1112785 (UMLS CUI [1,1])
C0037455 (UMLS CUI [1,2])
C0008902 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,4])
C0024485 (UMLS CUI [2])
Synovitis inflammatory MRI | Proliferative synovitis MRI
Item
3. mri evidence of inflammatory or hypertrophic synovitis
boolean
C0039103 (UMLS CUI [1,1])
C0333348 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
C0263949 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
Operative procedure on knee | Exception Debridement procedure | Exception Microfractures
Item
4. prior surgery in the knees, excluding procedures for debridement only (no microfracture)
boolean
C0187769 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0011079 (UMLS CUI [2,2])
C0184661 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1265651 (UMLS CUI [3,2])
Joint replacement Planned | Operative procedure on knee Planned
Item
5. joint replacement or any other knee surgery planned in the next 12 months
boolean
C0185317 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0187769 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Rheumatoid Arthritis | Arthritis, Psoriatic | Arthritis Due to Autoimmune Disease | Arthritis Due to Communicable Disease
Item
6. history of rheumatoid arthritis, psoriatic arthritis, or any other autoimmune or infectious cause for arthritis
boolean
C0003873 (UMLS CUI [1])
C0003872 (UMLS CUI [2])
C0003864 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0004364 (UMLS CUI [3,3])
C0003864 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0009450 (UMLS CUI [4,3])
Knee effusion Grade
Item
7. knee effusion >2+ on the following clinical scale:
boolean
C0343166 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Knee effusion Grade
Item
zero = no wave produced on downstroke
boolean
C0343166 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Knee effusion Grade
Item
trace = small wave on medial side with downstroke
boolean
C0343166 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Knee effusion Grade
Item
1+ = larger bulge on medial side with downstroke
boolean
C0343166 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Knee effusion Grade
Item
2+ = effusion spontaneously returns to medial side after upstroke (no downstroke necessary)
boolean
C0343166 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Knee effusion Grade
Item
3+ = so much fluid that it is not possible to move the effusion out of the medial aspect of the knee
boolean
C0343166 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Viscosupplementation Knee injection | Synvisc Knee injection | Hyaluronic Acid preparation Similar Knee injection
Item
8. last viscosupplementation (e.g. synvisc® or similar hyaluronic acid product) injected into either knee < 3 months before screening
boolean
C2350507 (UMLS CUI [1,1])
C0187946 (UMLS CUI [1,2])
C3239840 (UMLS CUI [2,1])
C0187946 (UMLS CUI [2,2])
C0020196 (UMLS CUI [3,1])
C2348205 (UMLS CUI [3,2])
C0187946 (UMLS CUI [3,3])
Intraarticular steroid injection Knee
Item
9. last intra-articular knee injection of corticosteroids < 2 months before screening
boolean
C2064783 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
Steroid use | Exception Adrenal Cortex Hormones by inhalation Respiratory problem
Item
10. use of any steroids (except inhaled corticosteroids for respiratory problems) during the previous month before screening
boolean
C0281991 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0001617 (UMLS CUI [2,2])
C0205535 (UMLS CUI [2,3])
C1659989 (UMLS CUI [2,4])
Other Coding
Item
11. known hypersensitivity to tpx-100
boolean
C3846158 (UMLS CUI [1])
Allergy to acetaminophen | HYDROCODONE ALLERGY
Item
12. known hypersensitivity to acetaminophen or hydrocodone
boolean
C0570513 (UMLS CUI [1])
C0745072 (UMLS CUI [2])
Arthroscopy of knee
Item
13. history of arthroscopy in either knee in the last 3 months before screening
boolean
C1304878 (UMLS CUI [1])
Septic Arthritis Knee | Gout of knee | Pseudogout Knee
Item
14. history of septic arthritis, gout or pseudo-gout, of either knee in previous year before screening
boolean
C0003869 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C2012373 (UMLS CUI [2])
C0033802 (UMLS CUI [3,1])
C0022742 (UMLS CUI [3,2])
Sign or Symptom Meniscal tear
Item
15. clinical signs of acute meniscal tear (locking, new acute mechanical symptoms consistent with meniscal tear)
boolean
C3540840 (UMLS CUI [1,1])
C0238218 (UMLS CUI [1,2])
Chondrocalcinosis Patellar X-Ray Computed Tomography
Item
16. patellar chondrocalcinosis on x-ray
boolean
C0221621 (UMLS CUI [1,1])
C0030647 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
Skin problem Injection site Knee | Exanthema Injection site Knee | Hypersensitivity Affecting Injection site Knee
Item
17. skin problem, rash or hypersensitivity, affecting either knee at the injection site
boolean
C0281822 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
C0015230 (UMLS CUI [2,1])
C2700396 (UMLS CUI [2,2])
C0022742 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C2700396 (UMLS CUI [3,3])
C0022742 (UMLS CUI [3,4])
Bleeding problem | Blood Platelets Deficiency | Blood coagulation Deficiency | Intra-Articular Injection Contraindicated
Item
18. bleeding problem, platelet or coagulation deficiency contraindicating, in the doctor's opinion, any intra-articular injection
boolean
C0019080 (UMLS CUI [1])
C0005821 (UMLS CUI [2,1])
C0011155 (UMLS CUI [2,2])
C0005778 (UMLS CUI [3,1])
C0011155 (UMLS CUI [3,2])
C0021488 (UMLS CUI [4,1])
C1444657 (UMLS CUI [4,2])
Sepsis
Item
19. active systemic infection
boolean
C0243026 (UMLS CUI [1])
Cancer treatment | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
20. current treatment or treatment within the previous 2 years prior to the screening visit for any malignancy except basal cell or squamous cell carcinoma of the skin, unless with specific written permission is provided by the sponsor's medical monitor
boolean
C0920425 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Unwilling
Item
21. women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the entire study period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
Study Subject Participation Status | Clinical Trial | Investigational New Drugs Osteoarthritis
Item
22. participation in other clinical osteoarthritis drug studies within one year prior to screening
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C0013230 (UMLS CUI [3,1])
C0029408 (UMLS CUI [3,2])
Paclitaxel | natalizumab
Item
23. currently taking paclitaxel (mitotic inhibitor), and or natalizumab (anti-integrin monoclonal antibody).
boolean
C0144576 (UMLS CUI [1])
C1172734 (UMLS CUI [2])
Liver disease | Alcohol consumption Alcoholic Beverages U/day | Beer | Malt liquor | Wine | Distilled alcoholic beverage | Gin | Rum | Vodka | Whisky
Item
24. history of significant liver disease or consumption of more than 3 alcoholic drinks a day. (definition of one alcoholic drink: 12-ounces of beer, 8-ounces of malt liquor, 5-ounces of wine, 1.5-ounces or a "shot" of 80-proof distilled spirits or liquor such as gin, rum, vodka, or whiskey).
boolean
C0023895 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0001967 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
C0004922 (UMLS CUI [3])
C0678389 (UMLS CUI [4])
C0043188 (UMLS CUI [5])
C0301611 (UMLS CUI [6])
C0452241 (UMLS CUI [7])
C0452257 (UMLS CUI [8])
C0452263 (UMLS CUI [9])
C0475610 (UMLS CUI [10])