ID

19186

Beschreibung

A Two Centre Study to Assess the Long-term Performance of the Pinnacle™ Cup With a Metal-on-Metal Bearing in Primary Total Hip Replacement; ODM derived from: https://clinicaltrials.gov/show/NCT00208364

Link

https://clinicaltrials.gov/show/NCT00208364

Stichworte

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

11. Dezember 2016

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Eligibility Rheumatoid Arthritis NCT00208364

Englisch

Eligibility Rheumatoid Arthritis NCT00208364

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
i) male or female subjects, aged between 18 and 70 years inclusive.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
ii) 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
iii) 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
iv) subjects undergoing primary total hip replacement who are suitable for cementless acetabular components.
Beschreibung

Total Hip Replacement Primary | Indication Acetabular component fixation Bone Cement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040508
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0449349
UMLS CUI [2,3]
C0005934
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 undergoing revision hip replacement.
Beschreibung

Revision of hip replacement

Datentyp

boolean

Alias
UMLS CUI [1]
C0186201
iii) women who are pregnant.
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
iv) 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
v) subjects who have participated in a clinical study with an investigational product in the last 12 months.
Beschreibung

Study Subject Participation Status | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
vi) 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
additional exclusion criteria for subjects having blood analysis:
Beschreibung

Exclusion Criteria Hematologic Tests

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0018941
1. subjects who currently have other metallic foreign bodies including trauma products and joint arthroplasties unless known to be pure titanium or titanium alloy.
Beschreibung

Metallic foreign body | Trauma product | Arthroplasty | Titanium | Titanium Alloy

Datentyp

boolean

Alias
UMLS CUI [1]
C1720389
UMLS CUI [2,1]
C3714660
UMLS CUI [2,2]
C1514468
UMLS CUI [3]
C0003893
UMLS CUI [4]
C0040302
UMLS CUI [5,1]
C0040302
UMLS CUI [5,2]
C0002154
2. subjects with an occupational exposure to cobalt or chromium.
Beschreibung

Occupational Exposure Cobalt | Occupational Exposure Chromium

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0028798
UMLS CUI [1,2]
C0009148
UMLS CUI [2,1]
C0028798
UMLS CUI [2,2]
C0008574
3. subjects who have ingested medication or vitamins containing cobalt or chromium within the last 12 months.
Beschreibung

Pharmaceutical Preparations Containing Cobalt | Pharmaceutical Preparations Containing Chromium | Vitamins Containing Cobalt | Vitamins Containing Chromium

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0009148
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0332256
UMLS CUI [2,3]
C0008574
UMLS CUI [3,1]
C0042890
UMLS CUI [3,2]
C0332256
UMLS CUI [3,3]
C0009148
UMLS CUI [4,1]
C0042890
UMLS CUI [4,2]
C0332256
UMLS CUI [4,3]
C0008574
4. subjects who, in the opinion of the investigator, will possibly require a separate joint replacement operation within the next two years, including revision operations.
Beschreibung

Joint replacement Separate Patient need for | Surgical revision Patient need for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0185317
UMLS CUI [1,2]
C0443299
UMLS CUI [1,3]
C0686904
UMLS CUI [2,1]
C0558347
UMLS CUI [2,2]
C0686904
5. subjects who are undergoing a simultaneous bilateral total hip replacement.
Beschreibung

Total Hip Replacement Bilateral

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040508
UMLS CUI [1,2]
C0238767
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Ähnliche Modelle

Eligibility Rheumatoid Arthritis NCT00208364

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 70 years inclusive.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
ii) 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
iii) 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])
Total Hip Replacement Primary | Indication Acetabular component fixation Bone Cement
Item
iv) subjects undergoing primary total hip replacement who are suitable for cementless acetabular components.
boolean
C0040508 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0449349 (UMLS CUI [2,2])
C0005934 (UMLS CUI [2,3])
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])
Revision of hip replacement
Item
ii) subjects undergoing revision hip replacement.
boolean
C0186201 (UMLS CUI [1])
Pregnancy
Item
iii) women who are pregnant.
boolean
C0032961 (UMLS CUI [1])
Substance Use Disorders | Mental disorders Affecting Follow-Up Care | Mental disorders Affecting Treatment outcome
Item
iv) 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
v) subjects who have participated in a clinical study with an investigational product in the last 12 months.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Litigation Involvement with
Item
vi) subjects who are currently involved in any injury litigation claims.
boolean
C0079706 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
Exclusion Criteria Hematologic Tests
Item
additional exclusion criteria for subjects having blood analysis:
boolean
C0680251 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Metallic foreign body | Trauma product | Arthroplasty | Titanium | Titanium Alloy
Item
1. subjects who currently have other metallic foreign bodies including trauma products and joint arthroplasties unless known to be pure titanium or titanium alloy.
boolean
C1720389 (UMLS CUI [1])
C3714660 (UMLS CUI [2,1])
C1514468 (UMLS CUI [2,2])
C0003893 (UMLS CUI [3])
C0040302 (UMLS CUI [4])
C0040302 (UMLS CUI [5,1])
C0002154 (UMLS CUI [5,2])
Occupational Exposure Cobalt | Occupational Exposure Chromium
Item
2. subjects with an occupational exposure to cobalt or chromium.
boolean
C0028798 (UMLS CUI [1,1])
C0009148 (UMLS CUI [1,2])
C0028798 (UMLS CUI [2,1])
C0008574 (UMLS CUI [2,2])
Pharmaceutical Preparations Containing Cobalt | Pharmaceutical Preparations Containing Chromium | Vitamins Containing Cobalt | Vitamins Containing Chromium
Item
3. subjects who have ingested medication or vitamins containing cobalt or chromium within the last 12 months.
boolean
C0013227 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0009148 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C0008574 (UMLS CUI [2,3])
C0042890 (UMLS CUI [3,1])
C0332256 (UMLS CUI [3,2])
C0009148 (UMLS CUI [3,3])
C0042890 (UMLS CUI [4,1])
C0332256 (UMLS CUI [4,2])
C0008574 (UMLS CUI [4,3])
Joint replacement Separate Patient need for | Surgical revision Patient need for
Item
4. subjects who, in the opinion of the investigator, will possibly require a separate joint replacement operation within the next two years, including revision operations.
boolean
C0185317 (UMLS CUI [1,1])
C0443299 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C0558347 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
Total Hip Replacement Bilateral
Item
5. subjects who are undergoing a simultaneous bilateral total hip replacement.
boolean
C0040508 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
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