ID

30127

Beschreibung

Minimally Invasive Knee Replacement Outcomes (MIKRO) Study; ODM derived from: https://clinicaltrials.gov/show/NCT00633113

Link

https://clinicaltrials.gov/show/NCT00633113

Stichworte

Versionen (1)
  1. 14.05.18 14.05.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

14. Mai 2018

DOI

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Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT00633113

Englisch

Eligibility Knee Osteoarthritis NCT00633113

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
presence of severely symptomatic knee osteoarthritis that has failed non- operative treatment
Beschreibung

Knee Osteoarthritis Symptomatic | Nonoperative procedures failed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0161969
UMLS CUI [2,2]
C0231175
males and non-pregnant females, 35-85 years of age at the time of surgery
Beschreibung

Gender | Pregnancy Absent | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0001779
asa class 1 or 2
Beschreibung

ASA class

Datentyp

boolean

Alias
UMLS CUI [1]
C0578808
procedure will not require computer navigation
Beschreibung

Procedure | Computer Navigation Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0184661
UMLS CUI [2,1]
C0009622
UMLS CUI [2,2]
C2827562
UMLS CUI [2,3]
C0332197
patient/surgeon has not requested another implant
Beschreibung

Implant Other Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021102
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0332197
patient has signed an irb approved study consent form
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
patient is able and willing to actively participate in post-operative rehabilitation program
Beschreibung

Participation Rehabilitation therapy Postoperative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0034991
UMLS CUI [1,3]
C0032790
patient understands study requirements
Beschreibung

Comprehension Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
patient is willing to comply with follow-up visits and diary documentations
Beschreibung

Compliance behavior Follow-up | Compliance behavior Subject Diary

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C3274571
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C3890583
patient is capable of independent ambulation
Beschreibung

Independent walking Capability

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0429979
UMLS CUI [1,2]
C2698977
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
skeletal immaturity
Beschreibung

Immaturity Skeletal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205252
UMLS CUI [1,2]
C0521324
more than 10 degrees of valgus or varus deformity as measured from a weight bearing ap alignment view
Beschreibung

Valgus deformity Degree Quantity | Varus angulation Degree Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042282
UMLS CUI [1,2]
C2348088
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0432593
UMLS CUI [2,2]
C2348088
UMLS CUI [2,3]
C1265611
patients with bilateral knee osteoarthritis who are considering a simultaneous bilateral procedure
Beschreibung

Bilateral primary osteoarthritis of knee | Bilateral Procedure considering

Datentyp

boolean

Alias
UMLS CUI [1]
C2893930
UMLS CUI [2,1]
C0520250
UMLS CUI [2,2]
C0750591
bone or ligament insufficiency that requires the use of augments or stems, or constrained component
Beschreibung

Bone Insufficiency | Ligaments Insufficiency | Requirement Augment bone graft | Requirement Stem cells | Requirement Component Constrained

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262950
UMLS CUI [1,2]
C0231179
UMLS CUI [2,1]
C0023685
UMLS CUI [2,2]
C0231179
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C2930703
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0038250
UMLS CUI [5,1]
C1514873
UMLS CUI [5,2]
C1705248
UMLS CUI [5,3]
C1707494
daily pre-operative use of narcotic pain medication
Beschreibung

Narcotic Analgesics Preoperative Daily

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027409
UMLS CUI [1,2]
C0445204
UMLS CUI [1,3]
C0332173
prior knee arthroplasty
Beschreibung

Knee Arthroplasty

Datentyp

boolean

Alias
UMLS CUI [1]
C0086511
patient is a prisoner
Beschreibung

Prisoners

Datentyp

boolean

Alias
UMLS CUI [1]
C0033167
patient has had prior tibial tubercle osteotomy
Beschreibung

Osteotomy Tibial tubercle

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0029468
UMLS CUI [1,2]
C0448216
patient's surgical knee would require removal of hardware prior to tka
Beschreibung

Removal Hardware Before Total Knee Arthroplasty

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1883720
UMLS CUI [1,2]
C1523994
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0086511
patient has < 95 degrees flexion pre-operatively
Beschreibung

Flexion Degree Quantity Preoperative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0231452
UMLS CUI [1,2]
C2348088
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0445204
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Ähnliche Modelle

Eligibility Knee Osteoarthritis NCT00633113

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Knee Osteoarthritis Symptomatic | Nonoperative procedures failed
Item
presence of severely symptomatic knee osteoarthritis that has failed non- operative treatment
boolean
C0409959 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0161969 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Gender | Pregnancy Absent | Age
Item
males and non-pregnant females, 35-85 years of age at the time of surgery
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3])
ASA class
Item
asa class 1 or 2
boolean
C0578808 (UMLS CUI [1])
Procedure | Computer Navigation Absent
Item
procedure will not require computer navigation
boolean
C0184661 (UMLS CUI [1])
C0009622 (UMLS CUI [2,1])
C2827562 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Implant Other Absent
Item
patient/surgeon has not requested another implant
boolean
C0021102 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Informed Consent
Item
patient has signed an irb approved study consent form
boolean
C0021430 (UMLS CUI [1])
Participation Rehabilitation therapy Postoperative
Item
patient is able and willing to actively participate in post-operative rehabilitation program
boolean
C0679823 (UMLS CUI [1,1])
C0034991 (UMLS CUI [1,2])
C0032790 (UMLS CUI [1,3])
Comprehension Study Protocol
Item
patient understands study requirements
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Compliance behavior Follow-up | Compliance behavior Subject Diary
Item
patient is willing to comply with follow-up visits and diary documentations
boolean
C1321605 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C3890583 (UMLS CUI [2,2])
Independent walking Capability
Item
patient is capable of independent ambulation
boolean
C0429979 (UMLS CUI [1,1])
C2698977 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Immaturity Skeletal
Item
skeletal immaturity
boolean
C0205252 (UMLS CUI [1,1])
C0521324 (UMLS CUI [1,2])
Valgus deformity Degree Quantity | Varus angulation Degree Quantity
Item
more than 10 degrees of valgus or varus deformity as measured from a weight bearing ap alignment view
boolean
C0042282 (UMLS CUI [1,1])
C2348088 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0432593 (UMLS CUI [2,1])
C2348088 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Bilateral primary osteoarthritis of knee | Bilateral Procedure considering
Item
patients with bilateral knee osteoarthritis who are considering a simultaneous bilateral procedure
boolean
C2893930 (UMLS CUI [1])
C0520250 (UMLS CUI [2,1])
C0750591 (UMLS CUI [2,2])
Bone Insufficiency | Ligaments Insufficiency | Requirement Augment bone graft | Requirement Stem cells | Requirement Component Constrained
Item
bone or ligament insufficiency that requires the use of augments or stems, or constrained component
boolean
C0262950 (UMLS CUI [1,1])
C0231179 (UMLS CUI [1,2])
C0023685 (UMLS CUI [2,1])
C0231179 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C2930703 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C0038250 (UMLS CUI [4,2])
C1514873 (UMLS CUI [5,1])
C1705248 (UMLS CUI [5,2])
C1707494 (UMLS CUI [5,3])
Narcotic Analgesics Preoperative Daily
Item
daily pre-operative use of narcotic pain medication
boolean
C0027409 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
Knee Arthroplasty
Item
prior knee arthroplasty
boolean
C0086511 (UMLS CUI [1])
Prisoners
Item
patient is a prisoner
boolean
C0033167 (UMLS CUI [1])
Osteotomy Tibial tubercle
Item
patient has had prior tibial tubercle osteotomy
boolean
C0029468 (UMLS CUI [1,1])
C0448216 (UMLS CUI [1,2])
Removal Hardware Before Total Knee Arthroplasty
Item
patient's surgical knee would require removal of hardware prior to tka
boolean
C1883720 (UMLS CUI [1,1])
C1523994 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0086511 (UMLS CUI [1,4])
Flexion Degree Quantity Preoperative
Item
patient has < 95 degrees flexion pre-operatively
boolean
C0231452 (UMLS CUI [1,1])
C2348088 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0445204 (UMLS CUI [1,4])
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