ID

19190

Description

A Multi-centre Study to Assess the Long-term Performance of the Summit™ Hip in Primary Total Hip Replacement; ODM derived from: https://clinicaltrials.gov/show/NCT00208390

Link

https://clinicaltrials.gov/show/NCT00208390

Keywords

Versions (2)
  1. 12/11/16 12/11/16 -
  2. 12/13/16 12/13/16 -
Uploaded on

December 11, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Rheumatoid Arthritis NCT00208390

English

Eligibility Rheumatoid Arthritis NCT00208390

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Age

Data type

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.
Description

Informed Consent

Data type

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.
Description

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

Data type

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 who require primary total hip replacement and are considered suitable for a cementless femoral stem.
Description

Total Hip Replacement Primary Patient need for | Indication Femoral Stem Component Bone Cement

Data type

boolean

Alias
UMLS CUI [1,1]
C0040508
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0686904
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C1961410
UMLS CUI [2,3]
C0005934
Exclusion Criteria
Description

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.
Description

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

Data type

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 who have previously undergone a hemi-arthroplasty or total hip arthroplasty.
Description

Hemiarthroplasty | Total Hip Replacement

Data type

boolean

Alias
UMLS CUI [1]
C0744743
UMLS CUI [2]
C0040508
iii) women who are pregnant.
Description

Pregnancy

Data type

boolean

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

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

Data type

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.
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
vi) subjects who are currently involved in any injury litigation claims.
Description

Litigation Involvement with

Data type

boolean

Alias
UMLS CUI [1,1]
C0079706
UMLS CUI [1,2]
C1314939
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Similar models

Eligibility Rheumatoid Arthritis NCT00208390

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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 Patient need for | Indication Femoral Stem Component Bone Cement
Item
iv) subjects who require primary total hip replacement and are considered suitable for a cementless femoral stem.
boolean
C0040508 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C3146298 (UMLS CUI [2,1])
C1961410 (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])
Hemiarthroplasty | Total Hip Replacement
Item
ii) subjects who have previously undergone a hemi-arthroplasty or total hip arthroplasty.
boolean
C0744743 (UMLS CUI [1])
C0040508 (UMLS CUI [2])
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 effect 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])
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