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])
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])