gender, age
Item
i) male or female subjects, aged between 18 and 75 years (inclusive).
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
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])
compliance
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
C1321605 (UMLS CUI [1])
total hip arthroplasty with cemented femoral component
Item
iv) subjects requiring primary total hip arthroplasty and are considered suitable for a cemented femoral component.
boolean
C0040508 (UMLS CUI [1,1])
C0492265 (UMLS CUI [1,2])
comorbidity
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
C0009488 (UMLS CUI [1])
pregnancy
Item
ii) women who are pregnant.
boolean
C0032961 (UMLS CUI [1])
substance abuse, psychological disorders
Item
iii) 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])
study participation, investigational product
Item
iv) subjects who have participated in a clinical study with an investigational product in the last 6 month(s).
boolean
C2348568 (UMLS CUI [1,1])
C3898691 (UMLS CUI [1,2])
injury litigation claims
Item
v) subjects who are currently involved in any injury litigation claims.
boolean
C3263723 (UMLS CUI [1,1])
C0079706 (UMLS CUI [1,2])
C0021677 (UMLS CUI [1,3])
bone cement contraindication
Item
vi) subjects with contraindications normally applicable to the use of conventional bone cement, in accordance with the manufacturer's instructions for use.
boolean
C0005934 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])