ID

15753

Beschreibung

Celution Prepared Adipose Derived Regenerative Cells in the Treatment of Osteoarthritis of the Knee; ODM derived from: https://clinicaltrials.gov/show/NCT02326961

Link

https://clinicaltrials.gov/show/NCT02326961

Stichworte

Versionen (1)
  1. 11.06.16 11.06.16 -
Hochgeladen am

11. Juni 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Osteoarthritis, Knee NCT02326961

Englisch

Eligibility Osteoarthritis, Knee NCT02326961

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. males or females ≥ 40 and < 70 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. able to provide written informed consent
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
3. diagnosis of osteoarthritis in one or both knees by american college of rheumatology (acr) criteria
Beschreibung

Osteoarthritis, Knee | American College of Rheumatology Improvement Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0409959
UMLS CUI [2]
C3273747
4. kellgren and lawrence grade 2 or 3 (standing ap x-ray) of the target knee within the preceding 6 months
Beschreibung

Kellgren-Lawrence score Knee | x-ray of knee, standing Diagnostic radiography, anteroposterior (AP)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3177117
UMLS CUI [1,2]
C0022742
UMLS CUI [2,1]
C3861234
UMLS CUI [2,2]
C0202572
5. pain due to osteoarthritis in the target knee ≥ 6 months
Beschreibung

Pain Due to Degenerative polyarthritis | Target Knee

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0029408
UMLS CUI [2,1]
C1521840
UMLS CUI [2,2]
C0022742
6. minimum score of "moderate" from koos question about pain on walking on a flat surface.
Beschreibung

KOOS: pain score Moderate Minimum | Pain Difficulty walking on the flat

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3836985
UMLS CUI [1,2]
C0205081
UMLS CUI [1,3]
C1524031
UMLS CUI [2,1]
C0030193
UMLS CUI [2,2]
C0560053
7. minimum score of "moderate" from koos question about degree of difficulty during walking on a flat surface.
Beschreibung

KOOS: pain score Moderate Minimum | Difficulty walking on the flat

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3836985
UMLS CUI [1,2]
C0205081
UMLS CUI [1,3]
C1524031
UMLS CUI [2]
C0560053
8. continued knee pain and limitations in knee function despite prescription of conservative therapy for at least 6 months.
Beschreibung

Knee pain Continuous | Knee Limited function | Conservative therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0231749
UMLS CUI [1,2]
C0549178
UMLS CUI [2,1]
C0022742
UMLS CUI [2,2]
C0497533
UMLS CUI [3]
C0459914
9. ability to safely undergo liposuction that will result in the harvest of a sufficient quantity of adipose tissue (approximately 300 ml)
Beschreibung

Suction Lipectomy Ability | Adipose tissue Quantity Sufficient

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038640
UMLS CUI [1,2]
C0085732
UMLS CUI [2,1]
C0001527
UMLS CUI [2,2]
C1699029
10. on stable regimen of one analgesic medication (rescue medication) for their knee pain due to osteoarthritis and ability and willingness to use the same analgesic medication during the study (screening period through to final study visit).
Beschreibung

Knee pain Due to Degenerative polyarthritis | Analgesics Stable status | Analgesics During Clinical Research

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0231749
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0029408
UMLS CUI [2,1]
C0002771
UMLS CUI [2,2]
C0205360
UMLS CUI [3,1]
C0002771
UMLS CUI [3,2]
C0347984
UMLS CUI [3,3]
C0008972
11. ability to perform procedures required of the pain index evaluations (unassisted walking 50 feet on a flat surface and going up and down stairs)
Beschreibung

Compliance behavior | Pain Index Evaluation | Able to walk on the flat | Able to walk up stairs | Able to walk down stairs

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2,1]
C0030193
UMLS CUI [2,2]
C0918012
UMLS CUI [2,3]
C0220825
UMLS CUI [3]
C0560049
UMLS CUI [4]
C0560077
UMLS CUI [5]
C0560081
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. any major injury to the target knee within the 12 months prior to the screening visit
Beschreibung

Major injury Target Knee

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332677
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0022742
2. need for cane or other assistance device for walking
Beschreibung

Dependence on walking stick | Walking assistive device Needed

Datentyp

boolean

Alias
UMLS CUI [1]
C0524378
UMLS CUI [2,1]
C3874140
UMLS CUI [2,2]
C0027552
3. any surgery to the target knee within the 6 months prior to the screening visit, or surgery to the contralateral knee or other weight-bearing joint if it will interfere with knee assessments
Beschreibung

Operative Surgical Procedures Target Knee | Operative Surgical Procedures Knee Contralateral | Operative Surgical Procedures Joint Weightbearing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0022742
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0022742
UMLS CUI [2,3]
C0441988
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0022417
UMLS CUI [3,3]
C1318107
4. prior articular transplant procedures
Beschreibung

Transplantation Articular Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040732
UMLS CUI [1,2]
C0521339
UMLS CUI [1,3]
C0205156
5. prior ligament reconstruction to the target knee within 12 months prior to the screening visit
Beschreibung

Target Knee | Ligament reconstruction Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0022742
UMLS CUI [2,1]
C0547071
UMLS CUI [2,2]
C0205156
6. inflammatory arthropathies such as rheumatoid arthritis, lupus arthropathy, or psoriatic arthritis
Beschreibung

Arthropathy | Rheumatoid Arthritis | Lupus erythematodes Arthropathy | Arthritis, Psoriatic

Datentyp

boolean

Alias
UMLS CUI [1]
C0022408
UMLS CUI [2]
C0003873
UMLS CUI [3,1]
C0866588
UMLS CUI [3,2]
C0022408
UMLS CUI [4]
C0003872
7. gout or calcium pyrophosphate (pseudogout) diseases that have flared within the previous 6 months prior to the screening visit
Beschreibung

Gout | Calcium pyrophosphate deposition disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0018099
UMLS CUI [2]
C0553730
8. x-ray findings of acute fractures, known severe loss of bone density (as determined by the investigator), avascular necrosis, and/or severe bone or joint deformity in the target knee (>5 degree valgus or varus deviation from mechanical axis)
Beschreibung

roentgenographic | Fracture | Bone Density Loss Severe | Avascular necrosis | Target Knee Deformity of bone Severe | Target Knee Joint deformity Severe

Datentyp

boolean

Alias
UMLS CUI [1]
C0034571
UMLS CUI [2]
C0016658
UMLS CUI [3,1]
C0005938
UMLS CUI [3,2]
C1517945
UMLS CUI [3,3]
C0205082
UMLS CUI [4]
C3887513
UMLS CUI [5,1]
C1521840
UMLS CUI [5,2]
C0022742
UMLS CUI [5,3]
C0410719
UMLS CUI [5,4]
C0205082
UMLS CUI [6,1]
C1521840
UMLS CUI [6,2]
C0022742
UMLS CUI [6,3]
C0427244
UMLS CUI [6,4]
C0205082
9. fibromyalgia, pes anserine bursitis, lumbar radiculopathy, and/or neurogenic or vascular claudication
Beschreibung

Fibromyalgia | Bursitis anserine bursa | Lumbar radiculopathy | Neurogenic claudication | Claudication Vascular

Datentyp

boolean

Alias
UMLS CUI [1]
C0016053
UMLS CUI [2,1]
C0006444
UMLS CUI [2,2]
C1305634
UMLS CUI [3]
C1263855
UMLS CUI [4]
C0580173
UMLS CUI [5,1]
C1456822
UMLS CUI [5,2]
C1801960
10. primary knee pain due to diagnosed isolated patella-femoral arthritis or chondromalacia in the target knee
Beschreibung

Knee pain Primary | Patellofemoral osteoarthritis Isolated | chondromalacia knee

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0231749
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C1542808
UMLS CUI [2,2]
C0205409
UMLS CUI [3]
C2902706
11. significant target knee joint infection or skin disorder/infection within the previous 6 months prior to the screening visit
Beschreibung

knee; infection, joint | Dermatologic disorders | Skin Diseases, Infectious

Datentyp

boolean

Alias
UMLS CUI [1]
C1400581
UMLS CUI [2]
C0037274
UMLS CUI [3]
C0037278
12. symptomatic oa of the hips, spine, or ankle, if it would interfere with the evaluation of the target knee
Beschreibung

Osteoarthritis of hip Symptomatic | Osteoarthritis, Spine Symptomatic | Osteoarthritis of ankle Symptomatic | Target Knee Evaluation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0029410
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C2350242
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C0409931
UMLS CUI [3,2]
C0231220
UMLS CUI [4,1]
C1521840
UMLS CUI [4,2]
C0022742
UMLS CUI [4,3]
C0220825
13. any condition requiring immunosuppressive medication or use of systemic steroids
Beschreibung

medical condition Requirement Immunosuppressive Agents | medical condition Requirement systemic steroids

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1699700
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0021081
UMLS CUI [2,1]
C1699700
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C2825233
14. intra-articular injection of steroids in previous 3 months or hyaluronic acid in previous 6 months in one or both knees prior to the screening visit
Beschreibung

intraarticular injection of corticosteroids | Intra-Articular Injection Hyaluronic Acid Knee

Datentyp

boolean

Alias
UMLS CUI [1]
C2064783
UMLS CUI [2,1]
C0021488
UMLS CUI [2,2]
C0020196
UMLS CUI [2,3]
C0022742
15. patients that have received prp, other platelet-based product, or investigational treatment in another cell/biologic study for the targeted treatment injury in the 12 months prior to the injection procedure
Beschreibung

Platelet rich plasma | Blood Platelets Product base | Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0370220
UMLS CUI [2,1]
C0005821
UMLS CUI [2,2]
C0360301
UMLS CUI [3]
C2348568
16. participation in any experimental drug or device study within the 6 months prior to the screening visit
Beschreibung

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
17. obesity defined as bmi > 35 kg/m2
Beschreibung

Obesity | Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C0028754
UMLS CUI [2]
C1305855
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Ähnliche Modelle

Eligibility Osteoarthritis, Knee NCT02326961

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. males or females ≥ 40 and < 70 years of age
boolean
C0001779 (UMLS CUI [1])
Informed consent
Item
2. able to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Osteoarthritis, Knee | American College of Rheumatology Improvement Criteria
Item
3. diagnosis of osteoarthritis in one or both knees by american college of rheumatology (acr) criteria
boolean
C0409959 (UMLS CUI [1])
C3273747 (UMLS CUI [2])
Kellgren-Lawrence score Knee | x-ray of knee, standing Diagnostic radiography, anteroposterior (AP)
Item
4. kellgren and lawrence grade 2 or 3 (standing ap x-ray) of the target knee within the preceding 6 months
boolean
C3177117 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C3861234 (UMLS CUI [2,1])
C0202572 (UMLS CUI [2,2])
Pain Due to Degenerative polyarthritis | Target Knee
Item
5. pain due to osteoarthritis in the target knee ≥ 6 months
boolean
C0030193 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0029408 (UMLS CUI [1,3])
C1521840 (UMLS CUI [2,1])
C0022742 (UMLS CUI [2,2])
KOOS: pain score Moderate Minimum | Pain Difficulty walking on the flat
Item
6. minimum score of "moderate" from koos question about pain on walking on a flat surface.
boolean
C3836985 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
C0030193 (UMLS CUI [2,1])
C0560053 (UMLS CUI [2,2])
KOOS: pain score Moderate Minimum | Difficulty walking on the flat
Item
7. minimum score of "moderate" from koos question about degree of difficulty during walking on a flat surface.
boolean
C3836985 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
C0560053 (UMLS CUI [2])
Knee pain Continuous | Knee Limited function | Conservative therapy
Item
8. continued knee pain and limitations in knee function despite prescription of conservative therapy for at least 6 months.
boolean
C0231749 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0022742 (UMLS CUI [2,1])
C0497533 (UMLS CUI [2,2])
C0459914 (UMLS CUI [3])
Suction Lipectomy Ability | Adipose tissue Quantity Sufficient
Item
9. ability to safely undergo liposuction that will result in the harvest of a sufficient quantity of adipose tissue (approximately 300 ml)
boolean
C0038640 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0001527 (UMLS CUI [2,1])
C1699029 (UMLS CUI [2,2])
Knee pain Due to Degenerative polyarthritis | Analgesics Stable status | Analgesics During Clinical Research
Item
10. on stable regimen of one analgesic medication (rescue medication) for their knee pain due to osteoarthritis and ability and willingness to use the same analgesic medication during the study (screening period through to final study visit).
boolean
C0231749 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0029408 (UMLS CUI [1,3])
C0002771 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0002771 (UMLS CUI [3,1])
C0347984 (UMLS CUI [3,2])
C0008972 (UMLS CUI [3,3])
Compliance behavior | Pain Index Evaluation | Able to walk on the flat | Able to walk up stairs | Able to walk down stairs
Item
11. ability to perform procedures required of the pain index evaluations (unassisted walking 50 feet on a flat surface and going up and down stairs)
boolean
C1321605 (UMLS CUI [1])
C0030193 (UMLS CUI [2,1])
C0918012 (UMLS CUI [2,2])
C0220825 (UMLS CUI [2,3])
C0560049 (UMLS CUI [3])
C0560077 (UMLS CUI [4])
C0560081 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Major injury Target Knee
Item
1. any major injury to the target knee within the 12 months prior to the screening visit
boolean
C0332677 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
Dependence on walking stick | Walking assistive device Needed
Item
2. need for cane or other assistance device for walking
boolean
C0524378 (UMLS CUI [1])
C3874140 (UMLS CUI [2,1])
C0027552 (UMLS CUI [2,2])
Operative Surgical Procedures Target Knee | Operative Surgical Procedures Knee Contralateral | Operative Surgical Procedures Joint Weightbearing
Item
3. any surgery to the target knee within the 6 months prior to the screening visit, or surgery to the contralateral knee or other weight-bearing joint if it will interfere with knee assessments
boolean
C0543467 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2,1])
C0022742 (UMLS CUI [2,2])
C0441988 (UMLS CUI [2,3])
C0543467 (UMLS CUI [3,1])
C0022417 (UMLS CUI [3,2])
C1318107 (UMLS CUI [3,3])
Transplantation Articular Previous
Item
4. prior articular transplant procedures
boolean
C0040732 (UMLS CUI [1,1])
C0521339 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Target Knee | Ligament reconstruction Previous
Item
5. prior ligament reconstruction to the target knee within 12 months prior to the screening visit
boolean
C1521840 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C0547071 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Arthropathy | Rheumatoid Arthritis | Lupus erythematodes Arthropathy | Arthritis, Psoriatic
Item
6. inflammatory arthropathies such as rheumatoid arthritis, lupus arthropathy, or psoriatic arthritis
boolean
C0022408 (UMLS CUI [1])
C0003873 (UMLS CUI [2])
C0866588 (UMLS CUI [3,1])
C0022408 (UMLS CUI [3,2])
C0003872 (UMLS CUI [4])
Gout | Calcium pyrophosphate deposition disease
Item
7. gout or calcium pyrophosphate (pseudogout) diseases that have flared within the previous 6 months prior to the screening visit
boolean
C0018099 (UMLS CUI [1])
C0553730 (UMLS CUI [2])
roentgenographic | Fracture | Bone Density Loss Severe | Avascular necrosis | Target Knee Deformity of bone Severe | Target Knee Joint deformity Severe
Item
8. x-ray findings of acute fractures, known severe loss of bone density (as determined by the investigator), avascular necrosis, and/or severe bone or joint deformity in the target knee (>5 degree valgus or varus deviation from mechanical axis)
boolean
C0034571 (UMLS CUI [1])
C0016658 (UMLS CUI [2])
C0005938 (UMLS CUI [3,1])
C1517945 (UMLS CUI [3,2])
C0205082 (UMLS CUI [3,3])
C3887513 (UMLS CUI [4])
C1521840 (UMLS CUI [5,1])
C0022742 (UMLS CUI [5,2])
C0410719 (UMLS CUI [5,3])
C0205082 (UMLS CUI [5,4])
C1521840 (UMLS CUI [6,1])
C0022742 (UMLS CUI [6,2])
C0427244 (UMLS CUI [6,3])
C0205082 (UMLS CUI [6,4])
Fibromyalgia | Bursitis anserine bursa | Lumbar radiculopathy | Neurogenic claudication | Claudication Vascular
Item
9. fibromyalgia, pes anserine bursitis, lumbar radiculopathy, and/or neurogenic or vascular claudication
boolean
C0016053 (UMLS CUI [1])
C0006444 (UMLS CUI [2,1])
C1305634 (UMLS CUI [2,2])
C1263855 (UMLS CUI [3])
C0580173 (UMLS CUI [4])
C1456822 (UMLS CUI [5,1])
C1801960 (UMLS CUI [5,2])
Knee pain Primary | Patellofemoral osteoarthritis Isolated | chondromalacia knee
Item
10. primary knee pain due to diagnosed isolated patella-femoral arthritis or chondromalacia in the target knee
boolean
C0231749 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1542808 (UMLS CUI [2,1])
C0205409 (UMLS CUI [2,2])
C2902706 (UMLS CUI [3])
knee; infection, joint | Dermatologic disorders | Skin Diseases, Infectious
Item
11. significant target knee joint infection or skin disorder/infection within the previous 6 months prior to the screening visit
boolean
C1400581 (UMLS CUI [1])
C0037274 (UMLS CUI [2])
C0037278 (UMLS CUI [3])
Osteoarthritis of hip Symptomatic | Osteoarthritis, Spine Symptomatic | Osteoarthritis of ankle Symptomatic | Target Knee Evaluation
Item
12. symptomatic oa of the hips, spine, or ankle, if it would interfere with the evaluation of the target knee
boolean
C0029410 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C2350242 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0409931 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C1521840 (UMLS CUI [4,1])
C0022742 (UMLS CUI [4,2])
C0220825 (UMLS CUI [4,3])
medical condition Requirement Immunosuppressive Agents | medical condition Requirement systemic steroids
Item
13. any condition requiring immunosuppressive medication or use of systemic steroids
boolean
C1699700 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0021081 (UMLS CUI [1,3])
C1699700 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C2825233 (UMLS CUI [2,3])
intraarticular injection of corticosteroids | Intra-Articular Injection Hyaluronic Acid Knee
Item
14. intra-articular injection of steroids in previous 3 months or hyaluronic acid in previous 6 months in one or both knees prior to the screening visit
boolean
C2064783 (UMLS CUI [1])
C0021488 (UMLS CUI [2,1])
C0020196 (UMLS CUI [2,2])
C0022742 (UMLS CUI [2,3])
Platelet rich plasma | Blood Platelets Product base | Study Subject Participation Status
Item
15. patients that have received prp, other platelet-based product, or investigational treatment in another cell/biologic study for the targeted treatment injury in the 12 months prior to the injection procedure
boolean
C0370220 (UMLS CUI [1])
C0005821 (UMLS CUI [2,1])
C0360301 (UMLS CUI [2,2])
C2348568 (UMLS CUI [3])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
16. participation in any experimental drug or device study within the 6 months prior to the screening visit
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Obesity | Body mass index
Item
17. obesity defined as bmi > 35 kg/m2
boolean
C0028754 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
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