ID

19221

Beschreibung

A Multi-centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Primary Hip Resurfacing Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT00208377

Link

https://clinicaltrials.gov/show/NCT00208377

Stichworte

Versionen (2)
  1. 11.12.16 11.12.16 -
  2. 13.12.16 13.12.16 -
Hochgeladen am

13. Dezember 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00208377

Englisch

Eligibility Rheumatoid Arthritis NCT00208377

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
i) male or female subjects, aged between 18 and 65 years inclusive.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
ii) subjects with current indications for standard metal-on-metal (mom) hip resurfacing arthroplasty suitable for cementless fixation in the acetabulum. these include pain, deformity, and loss of function, which are not responsive to medical treatment.
Beschreibung

Indication Hip resurfacing arthroplasty | Acetabular component fixation Bone Cement Lack | Pain Unresponsive to Treatment | Deformity Unresponsive to Treatment | Function Loss Unresponsive to Treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1719287
UMLS CUI [2,1]
C0449349
UMLS CUI [2,2]
C0005934
UMLS CUI [2,3]
C0332268
UMLS CUI [3,1]
C0030193
UMLS CUI [3,2]
C0205269
UMLS CUI [4,1]
C0302142
UMLS CUI [4,2]
C0205269
UMLS CUI [5,1]
C0031843
UMLS CUI [5,2]
C1517945
UMLS CUI [5,3]
C0205269
iii) subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
iv) subjects, who, in the opinion of the investigator, are able to understand this investigation, co-operate with the investigational procedures, and are willing to return to the hospital for all the required post-operative follow-ups.
Beschreibung

Comprehension Study Protocol | Protocol Compliance | Postoperative follow-up visit Compliance behavior

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0525058
UMLS CUI [3,1]
C2585426
UMLS CUI [3,2]
C1321605
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
i) subjects who, in the opinion of the investigator, have an existing condition that would compromise their participation and follow-up in this study.
Beschreibung

Condition Affecting Study Subject Participation Status | Condition Affecting Clinical Study Follow-up

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C3274571
ii) subjects with proven significant osteoporosis and poor bone quality.
Beschreibung

Osteoporosis Significant | Bone Quality Poor

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0029456
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C0262950
UMLS CUI [2,2]
C0332306
UMLS CUI [2,3]
C0542537
iii) subjects with compromised renal function.
Beschreibung

Renal Insufficiency

Datentyp

boolean

Alias
UMLS CUI [1]
C1565489
iv) subjects with proven metal sensitivity.
Beschreibung

Metal allergy

Datentyp

boolean

Alias
UMLS CUI [1]
C0577627
v) subjects with infectious, highly communicable diseases, which may limit follow-up i.e. active tuberculosis, hepatitis, immuno-compromised conditions, etc.
Beschreibung

Highly Communicable Diseases | Clinical Study Follow-up Limited | Tuberculosis | Hepatitis | Immune system Impaired

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205250
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C0439801
UMLS CUI [3]
C0041296
UMLS CUI [4]
C0019158
UMLS CUI [5,1]
C0020962
UMLS CUI [5,2]
C0221099
vi) women who are pregnant.
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
vii) subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
Beschreibung

Substance Use Disorders | Mental disorders Affecting Follow-Up Care | Mental disorders Affecting Treatment outcome

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C3899107
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0085415
viii) subjects who have participated in a clinical study with an investigational product in the last 6 month(s).
Beschreibung

Study Subject Participation Status | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
ix) subjects who are currently, or have been in the last 12 months, participating in a clinical study which involves exposure to ionising radiation.
Beschreibung

Study Subject Participation Status | Involvement Exposure to Ionizing radiation

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C0332157
UMLS CUI [2,3]
C0034538
x) subjects who are currently involved in any injury litigation claims.
Beschreibung

Litigation Involvement with

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079706
UMLS CUI [1,2]
C1314939
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Ähnliche Modelle

Eligibility Rheumatoid Arthritis NCT00208377

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
i) male or female subjects, aged between 18 and 65 years inclusive.
boolean
C0001779 (UMLS CUI [1])
Indication Hip resurfacing arthroplasty | Acetabular component fixation Bone Cement Lack | Pain Unresponsive to Treatment | Deformity Unresponsive to Treatment | Function Loss Unresponsive to Treatment
Item
ii) subjects with current indications for standard metal-on-metal (mom) hip resurfacing arthroplasty suitable for cementless fixation in the acetabulum. these include pain, deformity, and loss of function, which are not responsive to medical treatment.
boolean
C3146298 (UMLS CUI [1,1])
C1719287 (UMLS CUI [1,2])
C0449349 (UMLS CUI [2,1])
C0005934 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
C0030193 (UMLS CUI [3,1])
C0205269 (UMLS CUI [3,2])
C0302142 (UMLS CUI [4,1])
C0205269 (UMLS CUI [4,2])
C0031843 (UMLS CUI [5,1])
C1517945 (UMLS CUI [5,2])
C0205269 (UMLS CUI [5,3])
Informed Consent
Item
iii) subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
boolean
C0021430 (UMLS CUI [1])
Comprehension Study Protocol | Protocol Compliance | Postoperative follow-up visit Compliance behavior
Item
iv) subjects, who, in the opinion of the investigator, are able to understand this investigation, co-operate with the investigational procedures, and are willing to return to the hospital for all the required post-operative follow-ups.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
C2585426 (UMLS CUI [3,1])
C1321605 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Condition Affecting Study Subject Participation Status | Condition Affecting Clinical Study Follow-up
Item
i) subjects who, in the opinion of the investigator, have an existing condition that would compromise their participation and follow-up in this study.
boolean
C0348080 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
Osteoporosis Significant | Bone Quality Poor
Item
ii) subjects with proven significant osteoporosis and poor bone quality.
boolean
C0029456 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0262950 (UMLS CUI [2,1])
C0332306 (UMLS CUI [2,2])
C0542537 (UMLS CUI [2,3])
Renal Insufficiency
Item
iii) subjects with compromised renal function.
boolean
C1565489 (UMLS CUI [1])
Metal allergy
Item
iv) subjects with proven metal sensitivity.
boolean
C0577627 (UMLS CUI [1])
Highly Communicable Diseases | Clinical Study Follow-up Limited | Tuberculosis | Hepatitis | Immune system Impaired
Item
v) subjects with infectious, highly communicable diseases, which may limit follow-up i.e. active tuberculosis, hepatitis, immuno-compromised conditions, etc.
boolean
C0009450 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
C3274571 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0041296 (UMLS CUI [3])
C0019158 (UMLS CUI [4])
C0020962 (UMLS CUI [5,1])
C0221099 (UMLS CUI [5,2])
Pregnancy
Item
vi) women who are pregnant.
boolean
C0032961 (UMLS CUI [1])
Substance Use Disorders | Mental disorders Affecting Follow-Up Care | Mental disorders Affecting Treatment outcome
Item
vii) subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
boolean
C0038586 (UMLS CUI [1])
C0004936 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C3899107 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0085415 (UMLS CUI [3,3])
Study Subject Participation Status | Investigational New Drugs
Item
viii) subjects who have participated in a clinical study with an investigational product in the last 6 month(s).
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Study Subject Participation Status | Involvement Exposure to Ionizing radiation
Item
ix) subjects who are currently, or have been in the last 12 months, participating in a clinical study which involves exposure to ionising radiation.
boolean
C2348568 (UMLS CUI [1])
C1314939 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0034538 (UMLS CUI [2,3])
Litigation Involvement with
Item
x) subjects who are currently involved in any injury litigation claims.
boolean
C0079706 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
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