ID

31263

Beschreibung

Comparing X-3 To N2vac Polyethylene With the Triathlon Total Knee System; ODM derived from: https://clinicaltrials.gov/show/NCT00665964

Link

https://clinicaltrials.gov/show/NCT00665964

Stichworte

Versionen (1)
  1. 05.08.18 05.08.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

5. August 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT00665964

Englisch

Eligibility Osteoarthritis NCT00665964

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
the subject requires a primary cemented total knee replacement.
Beschreibung

Patient need for Primary cemented total knee replacement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0408401
the subject has a diagnosis of osteoarthritis (oa), traumatic arthritis (ta), or avascular necrosis (avn).
Beschreibung

Osteoarthritis | Traumatic arthritis | Avascular necrosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0029408
UMLS CUI [2]
C0152086
UMLS CUI [3]
C3887513
the subject has intact collateral ligaments.
Beschreibung

Collateral ligaments Intact

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0206365
UMLS CUI [1,2]
C0205266
the subject has signed the ethic committee approved, study specific informed patient consent form.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
the subject is willing and able to comply with post-operative scheduled clinical and radiographic evaluations and rehabilitation.
Beschreibung

Compliance behavior Evaluation Postoperative | Compliance behavior Postoperative rehabilitation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C1261322
UMLS CUI [1,3]
C0032790
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0877071
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
the subject has inflammatory arthritis.
Beschreibung

Arthritis

Datentyp

boolean

Alias
UMLS CUI [1]
C0003864
the subject is morbidly obese, bmi > 40.
Beschreibung

Obesity, Morbid | Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C0028756
UMLS CUI [2]
C1305855
the subject has a history of total or unicompartmental reconstruction of the affected joint.
Beschreibung

Arthroplasty Total Joint Affected | Arthroplasty Compartment Joint Affected

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003893
UMLS CUI [1,2]
C0439810
UMLS CUI [1,3]
C0022417
UMLS CUI [1,4]
C0392760
UMLS CUI [2,1]
C0003893
UMLS CUI [2,2]
C1185625
UMLS CUI [2,3]
C0022417
UMLS CUI [2,4]
C0392760
the subject has had a high tibial osteotomy or femoral osteotomy.
Beschreibung

Osteotomy of proximal tibia | Osteotomy Femoral

Datentyp

boolean

Alias
UMLS CUI [1]
C0407484
UMLS CUI [2,1]
C0029468
UMLS CUI [2,2]
C0015811
the subject has a neuromuscular or neurosensory deficiency, that would limit the ability to assess the performance of the device.
Beschreibung

Neuromuscular impairment | Neurosensory impairment | Assessment Performance Device Limited

Datentyp

boolean

Alias
UMLS CUI [1]
C4062805
UMLS CUI [2]
C4062958
UMLS CUI [3,1]
C1516048
UMLS CUI [3,2]
C1882330
UMLS CUI [3,3]
C0025080
UMLS CUI [3,4]
C0439801
the subject has a systemic or metabolic disorder leading to progressive bone deterioration.
Beschreibung

Systemic disease Resulting in Bone deterioration | Metabolic Disease Resulting in Bone deterioration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C0262950
UMLS CUI [1,4]
C0868945
UMLS CUI [2,1]
C0025517
UMLS CUI [2,2]
C0332294
UMLS CUI [2,3]
C0262950
UMLS CUI [2,4]
C0868945
the subject is immunologically suppressed, or receiving chronic steroids (>30 days duration).
Beschreibung

Therapeutic immunosuppression | Steroids chronic

Datentyp

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2,1]
C0038317
UMLS CUI [2,2]
C0205191
the subject's bone stock is compromised by disease or infection and cannot provide adequate support and/or fixation to the prosthesis.
Beschreibung

Bone Impaired Due to Disease | Bone Impaired Due to Communicable Disease | Prosthesis Support Inadequate | Prosthesis Fixation Inadequate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262950
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0012634
UMLS CUI [2,1]
C0262950
UMLS CUI [2,2]
C0221099
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0009450
UMLS CUI [3,1]
C0175649
UMLS CUI [3,2]
C1521721
UMLS CUI [3,3]
C0205412
UMLS CUI [4,1]
C3178966
UMLS CUI [4,2]
C0205412
the subject has had a knee fusion at the affected joint.
Beschreibung

Arthrodesis of knee Joint Affected

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0188172
UMLS CUI [1,2]
C0022417
UMLS CUI [1,3]
C0392760
the subject has an active or suspected latent infection in or about the knee joint.
Beschreibung

Latent infection Knee joint | Latent infection Suspected Knee joint

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0872054
UMLS CUI [1,2]
C0022745
UMLS CUI [2,1]
C0872054
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0022745
the subject is a prisoner.
Beschreibung

Prisoner

Datentyp

boolean

Alias
UMLS CUI [1]
C0033167
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Ähnliche Modelle

Eligibility Osteoarthritis NCT00665964

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Patient need for Primary cemented total knee replacement
Item
the subject requires a primary cemented total knee replacement.
boolean
C0686904 (UMLS CUI [1,1])
C0408401 (UMLS CUI [1,2])
Osteoarthritis | Traumatic arthritis | Avascular necrosis
Item
the subject has a diagnosis of osteoarthritis (oa), traumatic arthritis (ta), or avascular necrosis (avn).
boolean
C0029408 (UMLS CUI [1])
C0152086 (UMLS CUI [2])
C3887513 (UMLS CUI [3])
Collateral ligaments Intact
Item
the subject has intact collateral ligaments.
boolean
C0206365 (UMLS CUI [1,1])
C0205266 (UMLS CUI [1,2])
Informed Consent
Item
the subject has signed the ethic committee approved, study specific informed patient consent form.
boolean
C0021430 (UMLS CUI [1])
Compliance behavior Evaluation Postoperative | Compliance behavior Postoperative rehabilitation
Item
the subject is willing and able to comply with post-operative scheduled clinical and radiographic evaluations and rehabilitation.
boolean
C1321605 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
C0032790 (UMLS CUI [1,3])
C1321605 (UMLS CUI [2,1])
C0877071 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Arthritis
Item
the subject has inflammatory arthritis.
boolean
C0003864 (UMLS CUI [1])
Obesity, Morbid | Body mass index
Item
the subject is morbidly obese, bmi > 40.
boolean
C0028756 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Arthroplasty Total Joint Affected | Arthroplasty Compartment Joint Affected
Item
the subject has a history of total or unicompartmental reconstruction of the affected joint.
boolean
C0003893 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0022417 (UMLS CUI [1,3])
C0392760 (UMLS CUI [1,4])
C0003893 (UMLS CUI [2,1])
C1185625 (UMLS CUI [2,2])
C0022417 (UMLS CUI [2,3])
C0392760 (UMLS CUI [2,4])
Osteotomy of proximal tibia | Osteotomy Femoral
Item
the subject has had a high tibial osteotomy or femoral osteotomy.
boolean
C0407484 (UMLS CUI [1])
C0029468 (UMLS CUI [2,1])
C0015811 (UMLS CUI [2,2])
Neuromuscular impairment | Neurosensory impairment | Assessment Performance Device Limited
Item
the subject has a neuromuscular or neurosensory deficiency, that would limit the ability to assess the performance of the device.
boolean
C4062805 (UMLS CUI [1])
C4062958 (UMLS CUI [2])
C1516048 (UMLS CUI [3,1])
C1882330 (UMLS CUI [3,2])
C0025080 (UMLS CUI [3,3])
C0439801 (UMLS CUI [3,4])
Systemic disease Resulting in Bone deterioration | Metabolic Disease Resulting in Bone deterioration
Item
the subject has a systemic or metabolic disorder leading to progressive bone deterioration.
boolean
C0442893 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C0262950 (UMLS CUI [1,3])
C0868945 (UMLS CUI [1,4])
C0025517 (UMLS CUI [2,1])
C0332294 (UMLS CUI [2,2])
C0262950 (UMLS CUI [2,3])
C0868945 (UMLS CUI [2,4])
Therapeutic immunosuppression | Steroids chronic
Item
the subject is immunologically suppressed, or receiving chronic steroids (>30 days duration).
boolean
C0021079 (UMLS CUI [1])
C0038317 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Bone Impaired Due to Disease | Bone Impaired Due to Communicable Disease | Prosthesis Support Inadequate | Prosthesis Fixation Inadequate
Item
the subject's bone stock is compromised by disease or infection and cannot provide adequate support and/or fixation to the prosthesis.
boolean
C0262950 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,4])
C0262950 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0009450 (UMLS CUI [2,4])
C0175649 (UMLS CUI [3,1])
C1521721 (UMLS CUI [3,2])
C0205412 (UMLS CUI [3,3])
C3178966 (UMLS CUI [4,1])
C0205412 (UMLS CUI [4,2])
Arthrodesis of knee Joint Affected
Item
the subject has had a knee fusion at the affected joint.
boolean
C0188172 (UMLS CUI [1,1])
C0022417 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
Latent infection Knee joint | Latent infection Suspected Knee joint
Item
the subject has an active or suspected latent infection in or about the knee joint.
boolean
C0872054 (UMLS CUI [1,1])
C0022745 (UMLS CUI [1,2])
C0872054 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0022745 (UMLS CUI [2,3])
Prisoner
Item
the subject is a prisoner.
boolean
C0033167 (UMLS CUI [1])
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