ID

40795

Descrizione

A Study Evaluating the Safety and Efficacy of Intra-articular Injections of TPX-100 in Subjects With Mild to Moderate Patello-Femoral Osteoarthritis Involving Both Knees; ODM derived from: https://clinicaltrials.gov/show/NCT01925261

collegamento

https://clinicaltrials.gov/show/NCT01925261

Keywords

versioni (1)
  1. 15/05/20 15/05/20 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

15 maggio 2020

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT01925261

Inglese

Eligibility Knee Osteoarthritis NCT01925261

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age ≥ 25 and ≤ 75
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
2. patello-femoral osteoarthritis of both knees of mild to moderate severity with intact meniscus and ligamentous stability (cruciate and collateral ligaments)
Descrizione

Osteoarthritis of both knees patellofemoral mild | Osteoarthritis of both knees patellofemoral moderate | Meniscus Intact | Cruciate ligament Stability | Collateral ligament Stability

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3508960
UMLS CUI [1,2]
C0447801
UMLS CUI [1,3]
C2945599
UMLS CUI [2,1]
C3508960
UMLS CUI [2,2]
C0447801
UMLS CUI [2,3]
C0205081
UMLS CUI [3,1]
C0224498
UMLS CUI [3,2]
C0205266
UMLS CUI [4,1]
C0835268
UMLS CUI [4,2]
C0205360
UMLS CUI [5,1]
C0206365
UMLS CUI [5,2]
C0205360
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.
Descrizione

Cartilage repair Society Classification Grade | Both knees MRI

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1112785
UMLS CUI [1,2]
C0037455
UMLS CUI [1,3]
C0008902
UMLS CUI [1,4]
C0441800
UMLS CUI [2,1]
C0230434
UMLS CUI [2,2]
C0024485
meniscus intact (mri degenerative signal up to and including grade ii acceptable)
Descrizione

Meniscus Intact | Degeneration Grade Acceptable MRI

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0224498
UMLS CUI [1,2]
C0205266
UMLS CUI [2,1]
C0011164
UMLS CUI [2,2]
C0441800
UMLS CUI [2,3]
C1879533
UMLS CUI [2,4]
C0024485
cruciate and collateral ligament stability as defined by clinical examination
Descrizione

Cruciate ligament Stability Clinical examination | Collateral ligament Stability Clinical examination

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0835268
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C1456356
UMLS CUI [2,1]
C0206365
UMLS CUI [2,2]
C0205360
UMLS CUI [2,3]
C1456356
3. able to read, understand, sign and date the subject informed consent
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
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).
Descrizione

Analgesic Primary | Acetaminophen Dose U/day

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C0000970
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0456683
5. willingness to use only hydrocodone/acetaminophen for breakthrough pain during the injection period (through study day 30).
Descrizione

Hydrocodone Breakthrough Pain | Acetaminophen Breakthrough Pain

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0020264
UMLS CUI [1,2]
C1135120
UMLS CUI [2,1]
C0000970
UMLS CUI [2,2]
C1135120
6. willingness not to use non-steroidal anti-inflammatory drugs (nsaids) such as aspirin, ibuprofen, naproxen for the first 30 days of the study.
Descrizione

NSAIDs Absent | Aspirin Absent | Ibuprofen Absent | Naproxen Absent

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0004057
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0020740
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0027396
UMLS CUI [4,2]
C0332197
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.
Descrizione

Childbearing Potential Sexually active Contraceptive methods Quantity | Contraceptives, Oral | Contraceptive implant | Injectable contraception | Intrauterine Devices | Female Condoms | Vaginal Spermicides | Sexual Abstinence

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0700589
UMLS CUI [1,4]
C1265611
UMLS CUI [2]
C0009905
UMLS CUI [3]
C1657106
UMLS CUI [4]
C1262153
UMLS CUI [5]
C0021900
UMLS CUI [6]
C0221829
UMLS CUI [7]
C0087145
UMLS CUI [8]
C0036899
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
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
Descrizione

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

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C0567346
UMLS CUI [3,1]
C0006104
UMLS CUI [3,2]
C0175722
UMLS CUI [4]
C0562528
UMLS CUI [5,1]
C0175722
UMLS CUI [5,2]
C0037922
UMLS CUI [6]
C3693688
UMLS CUI [7]
C0005910
UMLS CUI [8,1]
C0008909
UMLS CUI [8,2]
C0205081
UMLS CUI [9,1]
C0008909
UMLS CUI [9,2]
C0205082
UMLS CUI [10,1]
C0231199
UMLS CUI [10,2]
C0024485
2. icrs grade greater than grade 3, or grade 4 focal defects greater than 1 cm, as confirmed by centrally-read screening mri
Descrizione

Cartilage repair Society Classification Grade | MRI

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1112785
UMLS CUI [1,2]
C0037455
UMLS CUI [1,3]
C0008902
UMLS CUI [1,4]
C0441800
UMLS CUI [2]
C0024485
3. mri evidence of inflammatory or hypertrophic synovitis
Descrizione

Synovitis inflammatory MRI | Proliferative synovitis MRI

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0039103
UMLS CUI [1,2]
C0333348
UMLS CUI [1,3]
C0024485
UMLS CUI [2,1]
C0263949
UMLS CUI [2,2]
C0024485
4. prior surgery in the knees, excluding procedures for debridement only (no microfracture)
Descrizione

Operative procedure on knee | Exception Debridement procedure | Exception Microfractures

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0187769
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0011079
UMLS CUI [2,3]
C0184661
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1265651
5. joint replacement or any other knee surgery planned in the next 12 months
Descrizione

Joint replacement Planned | Operative procedure on knee Planned

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0185317
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0187769
UMLS CUI [2,2]
C1301732
6. history of rheumatoid arthritis, psoriatic arthritis, or any other autoimmune or infectious cause for arthritis
Descrizione

Rheumatoid Arthritis | Arthritis, Psoriatic | Arthritis Due to Autoimmune Disease | Arthritis Due to Communicable Disease

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C0003872
UMLS CUI [3,1]
C0003864
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0004364
UMLS CUI [4,1]
C0003864
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C0009450
7. knee effusion >2+ on the following clinical scale:
Descrizione

Knee effusion Grade

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0343166
UMLS CUI [1,2]
C0441800
zero = no wave produced on downstroke
Descrizione

Knee effusion Grade

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0343166
UMLS CUI [1,2]
C0441800
trace = small wave on medial side with downstroke
Descrizione

Knee effusion Grade

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0343166
UMLS CUI [1,2]
C0441800
1+ = larger bulge on medial side with downstroke
Descrizione

Knee effusion Grade

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0343166
UMLS CUI [1,2]
C0441800
2+ = effusion spontaneously returns to medial side after upstroke (no downstroke necessary)
Descrizione

Knee effusion Grade

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0343166
UMLS CUI [1,2]
C0441800
3+ = so much fluid that it is not possible to move the effusion out of the medial aspect of the knee
Descrizione

Knee effusion Grade

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0343166
UMLS CUI [1,2]
C0441800
8. last viscosupplementation (e.g. synvisc® or similar hyaluronic acid product) injected into either knee < 3 months before screening
Descrizione

Viscosupplementation Knee injection | Synvisc Knee injection | Hyaluronic Acid preparation Similar Knee injection

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2350507
UMLS CUI [1,2]
C0187946
UMLS CUI [2,1]
C3239840
UMLS CUI [2,2]
C0187946
UMLS CUI [3,1]
C0020196
UMLS CUI [3,2]
C2348205
UMLS CUI [3,3]
C0187946
9. last intra-articular knee injection of corticosteroids < 2 months before screening
Descrizione

Intraarticular steroid injection Knee

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2064783
UMLS CUI [1,2]
C0022742
10. use of any steroids (except inhaled corticosteroids for respiratory problems) during the previous month before screening
Descrizione

Steroid use | Exception Adrenal Cortex Hormones by inhalation Respiratory problem

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0281991
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0001617
UMLS CUI [2,3]
C0205535
UMLS CUI [2,4]
C1659989
11. known hypersensitivity to tpx-100
Descrizione

Other Coding

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3846158
12. known hypersensitivity to acetaminophen or hydrocodone
Descrizione

Allergy to acetaminophen | HYDROCODONE ALLERGY

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0570513
UMLS CUI [2]
C0745072
13. history of arthroscopy in either knee in the last 3 months before screening
Descrizione

Arthroscopy of knee

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1304878
14. history of septic arthritis, gout or pseudo-gout, of either knee in previous year before screening
Descrizione

Septic Arthritis Knee | Gout of knee | Pseudogout Knee

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0003869
UMLS CUI [1,2]
C0022742
UMLS CUI [2]
C2012373
UMLS CUI [3,1]
C0033802
UMLS CUI [3,2]
C0022742
15. clinical signs of acute meniscal tear (locking, new acute mechanical symptoms consistent with meniscal tear)
Descrizione

Sign or Symptom Meniscal tear

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0238218
16. patellar chondrocalcinosis on x-ray
Descrizione

Chondrocalcinosis Patellar X-Ray Computed Tomography

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0221621
UMLS CUI [1,2]
C0030647
UMLS CUI [1,3]
C0040405
17. skin problem, rash or hypersensitivity, affecting either knee at the injection site
Descrizione

Skin problem Injection site Knee | Exanthema Injection site Knee | Hypersensitivity Affecting Injection site Knee

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0281822
UMLS CUI [1,2]
C2700396
UMLS CUI [1,3]
C0022742
UMLS CUI [2,1]
C0015230
UMLS CUI [2,2]
C2700396
UMLS CUI [2,3]
C0022742
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C2700396
UMLS CUI [3,4]
C0022742
18. bleeding problem, platelet or coagulation deficiency contraindicating, in the doctor's opinion, any intra-articular injection
Descrizione

Bleeding problem | Blood Platelets Deficiency | Blood coagulation Deficiency | Intra-Articular Injection Contraindicated

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019080
UMLS CUI [2,1]
C0005821
UMLS CUI [2,2]
C0011155
UMLS CUI [3,1]
C0005778
UMLS CUI [3,2]
C0011155
UMLS CUI [4,1]
C0021488
UMLS CUI [4,2]
C1444657
19. active systemic infection
Descrizione

Sepsis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0243026
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
Descrizione

Cancer treatment | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
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
Descrizione

Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Unwilling

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0558080
22. participation in other clinical osteoarthritis drug studies within one year prior to screening
Descrizione

Study Subject Participation Status | Clinical Trial | Investigational New Drugs Osteoarthritis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
UMLS CUI [3,1]
C0013230
UMLS CUI [3,2]
C0029408
23. currently taking paclitaxel (mitotic inhibitor), and or natalizumab (anti-integrin monoclonal antibody).
Descrizione

Paclitaxel | natalizumab

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0144576
UMLS CUI [2]
C1172734
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).
Descrizione

Liver disease | Alcohol consumption Alcoholic Beverages U/day | Beer | Malt liquor | Wine | Distilled alcoholic beverage | Gin | Rum | Vodka | Whisky

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0001967
UMLS CUI [2,3]
C0456683
UMLS CUI [3]
C0004922
UMLS CUI [4]
C0678389
UMLS CUI [5]
C0043188
UMLS CUI [6]
C0301611
UMLS CUI [7]
C0452241
UMLS CUI [8]
C0452257
UMLS CUI [9]
C0452263
UMLS CUI [10]
C0475610
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Similar models

Eligibility Knee Osteoarthritis NCT01925261

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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