ID

19222

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

Lien

https://clinicaltrials.gov/show/NCT00208390

Mots-clés

Versions (2)
  1. 11/12/2016 11/12/2016 -
  2. 13/12/2016 13/12/2016 -
Téléchargé le

13 décembre 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Rheumatoid Arthritis NCT00208390

Anglais

Eligibility Rheumatoid Arthritis NCT00208390

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

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

Age

Type de données

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

Type de données

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

Type de données

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 | Femoral Stem Component Bone Cement Lack

Type de données

boolean

Alias
UMLS CUI [1,1]
C0040508
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0686904
UMLS CUI [2,1]
C1961410
UMLS CUI [2,2]
C0005934
UMLS CUI [2,3]
C0332268
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

Type de données

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

Type de données

boolean

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

Pregnancy

Type de données

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

Type de données

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

Type de données

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

Type de données

boolean

Alias
UMLS CUI [1,1]
C0079706
UMLS CUI [1,2]
C1314939
Retour au début de la page

Similar models

Eligibility Rheumatoid Arthritis NCT00208390

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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 | Femoral Stem Component Bone Cement Lack
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])
C1961410 (UMLS CUI [2,1])
C0005934 (UMLS CUI [2,2])
C0332268 (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])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial